ENBREL 25 мг Порошок и раствор для инъекционного раствора

Наталья Бессолицына

Наталья Бессолицына — врач-ревматолог высшей категории. Проводит онлайн-консультации по диагностике, лечению и сопровождению пациентов с заболеваниями суставов и системными болезнями соединительной ткани. В работе опирается на международные клинические рекомендации и методы доказательной медицины.

С какими симптомами и диагнозами можно обратиться:

Боли в суставах — острая, хроническая, рецидивирующая боль.
Артриты: ревматоидный артрит, псориатический артрит, полиартрит, подагрический артрит.
Артрозы: остеоартроз, коксартроз, гонартроз, узелковый полиостеоартроз.
Плечелопаточный периартрит и спондилоартриты.
Хронические воспалительные заболевания позвоночника — болезнь Бехтерева.
Системные аутоиммунные заболевания: системная красная волчанка, склеродермия, системные васкулиты.
Остеопороз и нарушение плотности костей.

Наталья Бессолицына помогает разобраться в причинах болей, назначает необходимые обследования и подбирает индивидуальное лечение с учётом состояния пациента, образа жизни и риска прогрессирования болезни. Основной акцент — на раннюю диагностику, профилактику осложнений и улучшение качества жизни.

Онлайн-формат позволяет получить квалифицированную ревматологическую помощь независимо от региона проживания.

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Инструкция по применению ENBREL

Содержание инструкции

Enbrel 25 mg powder for injectable solution
Enbrel 25 mg powder and solvent for injectable solution
Enbrel 25 mg injectable solution in pre-filled syringes, 50 mg injectable solution in pre-filled syringe
Enbrel 25 mg solution for injection in pre-filled pen
Enbrel 50 mg solution for injection in pre-filled pen
Enbrel 10 mg powder and solvent for injectable solution for paediatric use
Enbrel 25 mg solution for injection in cartridge for delivery device
Enbrel
Enbrel 50 mg injectable solution in cartridge for delivery device
Enbrel

Enbrel 25 mg powder for injectable solution

etanercept

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will provide you with the Patient Information Card which contains important safety information that you should be aware of before and during treatment with Enbrel
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or for your child. Do not give it to other people, even if they have the same symptoms as you or your child, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Enbrel is and what it is used for
2. What you need to know before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Contents of the pack and other information
7. Instructions for use

1. What is Enbrel and what it is used for

Enbrel is a biological medicine obtained from two human proteins. It blocks the activity of another
protein that causes inflammation in the human body. Enbrel works by reducing
inflammation associated with certain diseases.
In adults (aged 18 years and over), Enbrel can be used for the treatment
of rheumatoid arthritisfrom moderate to severe, psoriatic arthritis, axial spondyloarthritis
severe, including ankylosing spondylitis,and psoriasisfrom moderate to severe - in each case
usually when other widely used treatments have not worked well enough or are not
suitable for you.
For rheumatoid arthritis, Enbrel is usually used in association with methotrexate, although it may
also be used alone if treatment with methotrexate is not suitable for you. Whether used
alone or in combination with methotrexate, Enbrel can slow down joint damage
caused by rheumatoid arthritis and improves the ability to perform normal daily activities.
For patients with psoriatic arthritis with multiple joint involvement, Enbrel can
improve the ability to perform daily activities. For patients with multiple
painful or swollen symmetrical joints (e.g. hands, wrists and feet), Enbrel can slow down structural damage
to these joints caused by the disease.
Enbrel is also prescribed for the treatment of the following conditions in children and adolescents:

For the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficiently good response or is not appropriate:
Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients aged 2 years and over
Psoriatic arthritis in patients aged 12 years and over.
For arthritis related to enthesitis in patients aged 12 years and over, when other widely used treatments have not given a sufficiently good response or are not appropriate.
Severe psoriasis in patients aged 6 years and over who have had an inadequate response to (or cannot take) phototherapies or other systemic therapies.

2. Cosa deve sapere prima di usare Enbrel

Do not use Enbrel

if you, or your child, are allergic to etanercept or to any of the other ingredients of Enbrel (listed in section 6). If you or your child experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
if you, or your child, have or are at risk of developing a severe blood infection called sepsis. If you are unsure, contact your doctor.
if you, or your child, have any type of infection. If you are unsure, consult your doctor.

Warnings and precautions
Talk to your doctor before taking Enbrel.

Allergic reactions:If you, or your child, experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
Infections/surgery: If you, or your child, develop a new infection or are about to have major surgery, your doctor may want to check your treatment with Enbrel.
Infections/diabetes: Tell your doctor if you, or your child, have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
Infections/monitoring: Tell your doctor about any recent travel outside of Europe. If you, or your child, develop symptoms of an infection such as fever, chills or cough, inform your doctor immediately. Your doctor may decide to continue monitoring you or your child for infections after you or your child have stopped taking Enbrel.
Tuberculosis: Because cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will check you for signs and symptoms of tuberculosis before starting treatment with Enbrel. This may include a thorough review of your medical history, chest X-rays and a tuberculin test. The results of these tests should be recorded in your Patient Card. It is very important that you tell your doctor if you or your child have ever had tuberculosis or if you have been in close contact with someone with tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness, mild fever) or any other infection appear during or after therapy, tell your doctor immediately.
Hepatitis B: Tell your doctor if you or your child have or have had hepatitis B. Your doctor should test for hepatitis B before you or your child start treatment with Enbrel. Treatment with Enbrel may cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. If this happens, you must stop using Enbrel.
Hepatitis C: Tell your doctor if you or your child have hepatitis C. Your doctor may consider monitoring treatment with Enbrel if the infection worsens.
Blood disorders: Seek immediate medical attention if you or your child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.

These symptoms may indicate the presence of blood disorders that are potentially life-threatening and may require discontinuation of treatment with Enbrel.

Nervous system and eye disorders: Tell your doctor if you or your child have multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). Your doctor will assess whether Enbrel is an appropriate treatment.
Congestive heart failure: Tell your doctor if you or your child have a history of congestive heart failure, as Enbrel should be used with caution in these circumstances.
Cancer:Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer, before taking Enbrel. Patients with severe, long-standing rheumatoid arthritis may be at higher than average risk of developing lymphoma. Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer. Some children and adolescent patients who have been treated with Enbrel or other medicines that work like Enbrel have developed tumors, sometimes unusual, and sometimes fatal. Some patients receiving Enbrel have developed skin cancers. Tell your doctor if you or your child develop any changes in the appearance of the skin or growths on the skin.
Chickenpox:Tell your doctor if you or your child are exposed to chickenpox while using Enbrel. Your doctor will assess whether preventive treatment for chickenpox is appropriate.
Alcohol abuse:Enbrel should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or your child have a history of alcohol abuse.
Wegener's granulomatosis: Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or your child have Wegener's granulomatosis, consult your doctor.
Anti-diabetic medicines: Tell your doctor if you or your child suffer from diabetes or are taking medicines to treat diabetes. Your doctor may decide whether you or your child need to receive less anti-diabetic medicine while taking Enbrel.

Children and adolescents
Vaccinations: If possible, before using Enbrel, children should be up to date with all vaccinations. Some vaccines, such as oral polio vaccine, should not be given while taking Enbrel. Consult your doctor before you or your child receive any vaccine.
Generally, Enbrel should not be used in children with extended polyarthritis or oligoarthritis under the age of 2 years, or in children with arthritis related to enthesitis or psoriatic arthritis under the age of 12 years, or in children with psoriasis under the age of 6 years.

Other medicines and Enbrel
Tell your doctor or pharmacist if you, or your child, are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those available without a prescription. You or your child should not use Enbrel together with the active ingredient anakinra or abatacept.

Pregnancy and breastfeeding
Enbrel should only be used during pregnancy if clearly necessary. If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice.
If you have received Enbrel during pregnancy, the newborn may be at increased risk of infection. In addition, one study indicated that there was a higher number of birth defects in mothers who received Enbrel during pregnancy compared to mothers who did not receive Enbrel or other similar medicines (TNF antagonists), but no particular type of birth defect emerged among those reported. Another study did not show an increased risk of birth defects when mothers received Enbrel during pregnancy. Your doctor will help you decide whether the benefits of treatment outweigh the potential risks to your baby.
Talk to your doctor if you wish to breastfeed while taking Enbrel. It is important to inform the child's pediatricians and other healthcare professionals about the use of Enbrel during pregnancy and breastfeeding before the child receives any vaccine.

Driving and using machines
It is not expected that the use of Enbrel will affect your ability to drive or use machines.

3. How to use Enbrel

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
If you feel that the effect of Enbrel is too strong or too weak, consult your doctor or
pharmacist.

Dosage for adult patients (aged 18 years or older)
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg, administered twice a week or 50 mg once a week
by subcutaneous injection. In any case, the doctor may establish a different frequency with which to
inject Enbrel.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week or 50 mg administered once
a week.
Alternatively, a dose of 50 mg can be administered twice a week for up to 12
weeks, followed by a dose of 25 mg administered twice a week or a dose of 50 mg
administered once a week.
The doctor will decide how long you should take Enbrel and whether, based on your response, a new
treatment is necessary. If, after 12 weeks, Enbrel has no effect on your condition
your doctor may tell you to stop the treatment.

Use in children and adolescents
The appropriate dose and frequency of dosage for the child or adolescent will depend on the
body weight and the disease. The doctor will provide you with detailed information on how to prepare and measure the
appropriate dosage.
For polyarticular or extended oligoarticular arthritis in patients starting from 2 years of age, or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of Enbrel
per kilogram of body weight (up to a maximum of 25 mg) administered 2 times a week, or 0.8 mg
of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of Enbrel per kilogram of
body weight (up to a maximum of 50 mg) and must be administered once a week. If
Enbrel has no effect on the child's condition after 12 weeks, the doctor may tell you to
discontinue treatment with this medicine.

Method and route of administration:
Enbrel is administered by injection under the skin (subcutaneous injection)
Enbrel can be taken with or without food or drinks.
The powder must be dissolved before use. Detailed instructions on how to prepare and
inject Enbrel are provided in section 7, “Instructions for Use”. Do not mix the solution of
Enbrel with other medicines.
To help you remember, it may be useful to write in a diary on which day(s) of the week
Enbrel should be used

If you use more Enbrel than you should
If you have used more Enbrel than you should (either by injecting too much on a single occasion or by using it
too frequently), immediately consult a doctor or pharmacist (either by injecting too much on
a single occasion or by using it too frequently). Always keep the package of
the medicine with you, even if it is empty.

If you forget to take Enbrel
If you forget a dose, administer it as soon as you remember, unless the next dose is scheduled for the next day, in which case you should skip the forgotten dose.
Then continue to administer the medicine on the scheduled day(s). If you have forgotten the dose
until the day the next dose is due, do not take a double dose (two doses in the same
day) to make up for the forgotten dose.

If you stop taking Enbrel
Following discontinuation of treatment, the symptoms of the disease may return.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions
If any of the following side effects occur, do not inject Enbrel anymore. Immediately inform your
doctor, or go to the nearest hospital emergency room.

Difficulty swallowing or breathing
Swelling of the face, throat, hands or feet
Feeling of nervousness or anxiety, palpitations, sudden redness of the skin and/or feeling of warmth
Severe skin rash, itching, hives (raised, red or pale patches of skin that often itch)

Severe allergic reactions are rare. However, any of the symptoms listed above may indicate
an allergic reaction to Enbrel; therefore, you should seek immediate medical attention.

Serious side effects
If you notice any of the following effects, you or the child may need urgent medical
care.

Symptoms of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area in the skin or joints.
Symptoms of blood disorders, such as bleeding, bruising or paleness.
Symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg.
Symptoms of heart failure or worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of swelling in the neck or abdomen, shortness of breath at night or cough, bluish color of the fingernails or lips.
Symptoms of tumors: tumors can affect any part of the body, including the skin and blood, and the possible symptoms depend on the type and location of the tumor. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin.
Symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensations or vision.
Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
Symptoms of inflammation of blood vessels, such as pain, fever, redness or overheating of the skin or itching.

These side effects are rare or uncommon, but are serious conditions (some of which
can rarely cause death). If these symptoms occur, immediately inform your doctor,
or go to the nearest hospital emergency room.
The known side effects of Enbrel include those listed below, grouped by
decreasing frequency:

Very common(may affect more than 1 in 10 people): Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain and swelling) (these do not occur as often after the first month of treatment; some patients have developed a reaction at a recently used injection site); headache.
Common(may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).
Uncommon(may affect up to 1 in 100 people): Serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin tumor (excluding melanoma); localized swelling of the skin (angioedema); hives (raised, red or pale patches of skin that often itch); inflammation of the eyes; psoriasis (first occurrence or worsening), inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also treated with methotrexate, the frequency of increased liver enzymes in the blood is common); abdominal pain and cramps, diarrhea, weight loss or blood in the stool (symptoms of bowel problems).
Rare(may affect up to 1 in 1,000): Severe allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer affecting the blood and bone marrow); melanoma (a type of
skin cancer); joint reduction in the number of platelets, red blood cells and white
blood cells; changes in the nervous system (with severe muscle weakness and signs and symptoms similar
to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord);
tuberculosis; new onset of congestive heart failure; seizures; lupus or
lupus-like syndrome (symptoms may include a persistent rash, fever,
joint pain and fatigue); rash that can lead to blisters and
severe skin peeling; lichenoid reactions (itchy reddish/purple rash and/or whitish-greyish filamentous lines on mucous membranes); inflammation
of the liver caused by its immune system (autoimmune hepatitis; in patients also treated
with methotrexate, the frequency is uncommon), immune disorder that can affect the
lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in
patients also treated with methotrexate, the frequency of inflammation or
scarring of the lungs is uncommon); damage to the tiny filters inside the kidneys that
determines reduced kidney function (glomerulonephritis).

Very rare(may affect up to 1 in 10,000): inability of the bone marrow to produce essential blood cells.

Not known(frequency cannot be estimated based on available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Additional side effects in children and adolescents
The side effects and their frequency observed in children and adolescents are similar to those described
above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Enbrel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and label after
“Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Before preparing the Enbrel solution, the medicine may be stored outside the fridge at a
maximum temperature of 25°C for up to 4 weeks, for single use only; after this period it cannot be
returned to the fridge. If not used within 4 weeks outside the fridge, Enbrel must be
discarded. It is recommended to note the date on which Enbrel is placed outside the fridge and the date by which
Enbrel must be disposed of (no more than 4 weeks outside the fridge).
After preparing the Enbrel solution, immediate use is recommended. However, the solution may
be used within 6 hours if stored at a maximum temperature of 25°C.
Do not use this medicine if you notice that the solution is not clear or if it contains particles. The
solution should appear clear, from colourless to light yellow or light brown, without any lumps,
flocculi or particles.
Carefully discard any Enbrel solution that has not been injected within 6 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Enbrel contains
The active ingredient of Enbrel is etanercept. Each vial of Enbrel 25 mg contains 25 mg of
etanercept.
The other ingredients are:
Powder: Mannitol (E421), sucrose and trometamol

Description of the appearance of Enbrel and contents of the pack
Enbrel 25 mg is supplied as a white powder for solution for injection (powder for
injection). Each pack contains 4 single-dose vials and 8 alcohol swabs. Not all pack sizes may be
marketed.

Marketing Authorisation Holder

and
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12,
2870 Puurs-Sint-Amands
Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Κύπρος
PFIZER ΕΛΛΑΣ A.E. (CYPRUS BRANCH)
T  : +357 22 817690

Česká Republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Magyarország
Pfizer Kft.
Tel: +36 1 488 3700

Danmark
Pfizer ApS
Tlf: +45 44 201 100

Malta
Vivian Corporation Ltd.
Tel: +35621 344610

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

България
Пфайзер Люксембург САРЛ,
Клон България
Teл: +359 2 970 4333

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
PFIZER ΕΛΛΑΣ A.E.
Τηλ.: +30 210 67 85 800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Télf: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00

France
Pfizer
Tél +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL ,Pfizer, podružnica
for consulting in the field of pharmaceutical
activities, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská Republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Tel: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel. +371 67035775

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +3705 2514000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

7. Instructions for Use

This paragraph is divided into the following sub-paragraphs:

a.Introduction
b.Preparing the injection
c.Preparing the Enbrel dose for injection
d.Adding water for injectable preparations
e.Withdrawing the Enbrel solution from the vial
f.Choosing an injection site
g.Preparing the injection site and injecting the Enbrel solution
h.Disposing of materials
a.Introduction

The following instructions explain how to prepare and inject Enbrel. Read the instructions carefully and
follow them step by step. You will be instructed by your doctor or nurse on the self-injection technique or how to administer an injection to a child. Do not attempt to administer an
injection until you are certain you have understood how to prepare and how to give the injection.
This injection should not be mixed with any other medicine.

b.Preparing the injection

Wash your hands thoroughly.
Choose a clean, well-lit, and flat work surface.
Remove the vial of ENBREL from the refrigerator and place it on a flat surface.
You will also need the following materials: a sterile syringe and sterile needles of size 25x16 mm or similar, a vial or ampule of water for injectable preparations, 2 alcohol swabs
Check the expiration date on both the ENBREL vial and the water for injectable preparations. They should not be used after the month and year indicated.

c.Preparing the Enbrel dose for injection

Remove the plastic cap from the Enbrel vial. DO NOTremove the gray cap or the aluminum ring around the neck of the vial.
Use a new alcohol swab to clean the gray cap on the Enbrel vial. After cleaning, do not touch the gray cap with your hands.
Make sure the needle is inserted into the syringe. If you are not sure how to insert the needle, ask your doctor or nurse.
Remove the needle cap from the syringe by pulling it off firmly, being careful not to touch the needle or allow the needle to touch any surface (see Figure 1). Be careful not to bend or twist the cap to avoid damaging the needle.

Figure 1

Hand holding a syringe connected to a needle, preparation for

Make sure the syringe contains 1 mL of water for injectable preparations.
If you are not sure how to fill the syringe, ask your doctor or nurse.
Make sure the syringe does not contain any air bubbles.
With the ENBREL vial placed upright on a flat surface, for example a table, insert the syringe needle perpendicularly through the central ring of the gray cap of the vial (see Figure 2). If the needle is aligned correctly, you will feel slight resistance and then a “pop” indicating that the needle has passed through the center of the cap. Look at the tip of the needle through the slit of the cap (see Figure 3). If the needle is not aligned correctly, you will feel constant resistance as it passes through the cap, without any “pop”. Insert the needle without tilting it; this could cause the needle to bend and/or hinder the correct introduction of the solvent into the vial (see Figure 4).

Figure 2 Figure 3 Figure 4

Medicine vial with rubber cap and metal ring, needle piercing the cap to

Hand holding a glass vial and a syringe with a needle, arrow indicating the direction of insertion

Glass vial with rubber cap and needle penetrating the center of the cap itself symbol of prohibition

Transparent glass vial with blue rubber stopper and metal needle connected

Uniform white space without visible elements

d.Adding water for injectable preparations

Push the plunger VERY SLOWLY until all the water for injectable preparations has passed into the vial. This will help reduce foam formation (numerous bubbles) (see Figure 5).

Figure 5

Hand holding a syringe connected to a vial through an adapter, black arrow indicates the direction

Leave the syringe in place. To dissolve the powder, gently move the vial in circular motions several times (see Figure 6). DO NOTshake the vial. Wait until all the powder has dissolved (usually less than 10 minutes). The solution should appear clear and colorless to pale yellow or light brown, without any fragments, flakes, or

particles. Some white foam may remain in the vial - this is
normal. DO NOTuse Enbrel if all the powder in the vial does not dissolve within 10
minutes. Start again with a new vial of ENBREL, new water for injectable
preparations, a new syringe, needle and swabs.
Figure 6

Prefilled syringe with needle inserted into the skin and curved arrow indicating the rotation for

eWithdrawing the Enbrel solution from the vial

With the needle still in the vial, hold the vial upside down at eye level. Slowly pull back the plunger to draw the liquid into the syringe (see Figure 7). As the liquid level in the vial lowers, you may need to partially withdraw the needle to keep the tip in the liquid. For adult patients, withdraw the entire volume. For children, withdraw only the portion of liquid as prescribed by the child's doctor.

Figure 7

Hand grasping a prefilled syringe with needle inserted into the skin, black arrow indicates direction of subcutaneous injection

With the needle still inserted in the vial, check for air bubbles in the syringe. Gently tap the syringe to make the air bubbles rise to the beginning of the syringe, near the needle (see Figure 8). Slowly press the plunger to push the air bubbles from the syringe into the vial. If liquid is accidentally pushed back into the vial during this operation, slowly pull back the plunger to draw the liquid back into the syringe. Figure 8

Hand holding a pre-filled syringe with needle connected and an adapter for

Completely remove the needle from the vial. Again, do not touch the needle and avoid letting it touch any surface.

(Note: After completing these steps, a small amount of liquid may remain in

the vial. This is normal).

f.Choosing an injection site

The three recommended injection sites for Enbrel include: (1) the mid-anterior thigh;

(2) the abdomen, except for the area within 5 cm of the navel; and (3) the outer area of the upper arms (see Figure 9). If you are self-injecting, you should not use the outer area of the upper arms.

Figure 9

Female body diagram with shaded areas indicating possible subcutaneous injection sites on abdomen and thighs

A different site must be used for each new injection. Each new injection must be made at least 3 cm from a previous site. Do notinject into areas where the skin is sensitive, bruised, red, or hardened. Avoid areas with scars or stretch marks (it may be helpful to note the location of previous injection sites).
If you or the child suffers from psoriasis, you should try to avoid injecting directly into the swollen, thickened, red, or scaly areas of the skin (“psoriatic skin lesions”).

g.Preparing the injection site and injecting the Enbrel solution

Rub the injection site where Enbrel is to be injected with the alcohol swab using a circular motion. DO NOTtouch this area again before giving the injection.
When the cleaned skin area has dried, pinch it and hold it firmly with one hand. With the other hand, hold the syringe like a pencil
With a quick, short motion, fully insert the needle into the skin at an angle of 45° to 90° (see Figure 10). With experience, you will find the angle that is most comfortable for you or the child. Be careful not to push the needle into the skin too slowly or with great force. Figure 10

Hand holding a syringe tilted at 45 degrees while

When the needle is fully inserted into the skin, release the skin you are holding. With your free hand, hold the syringe near its base to stabilize it. Then push the plunger to inject all the solution at a slowand steady rate (see Figure 11).

Figure 11

When the syringe is empty, remove the needle from the skin, being careful to keep it at the same angle at which it was inserted.
Press a cotton swab on the injection site for 10 seconds. Slight bleeding may occur. DO NOTrub the injection site. A bandage is optional.

h.Disposing of materials

The syringe and needle should NEVERbe reused. Do not recap the needle. Dispose of the needle and syringe as suggested by your doctor, nurse, or pharmacist.

If you have any questions, talk to a doctor, nurse, or pharmacist who is familiar
with Enbrel.

Enbrel 25 mg powder and solvent for injectable solution

etanercept

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will provide you with the Patient Card which contains important safety information that you should be aware of before and during treatment with Enbrel
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or for your child. Do not pass it on to others, even if their symptoms are the same as yours or your child's, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Enbrel is and what it is used for
2. What you need to know before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Contents of the pack and other information
7. Instructions for use

1. What is Enbrel and what it is used for

Enbrel is a medicine made from two human proteins. It blocks the activity of another protein that
causes inflammation in the human body. Enbrel works by reducing the inflammation associated
with certain diseases.
In adults (aged 18 years and over), Enbrel can be used for the treatment of rheumatoid arthritisfrom moderate to severe, psoriatic arthritis, severe axial spondyloarthritis
including ankylosing spondylitis,and moderate to severe psoriasis- in each case
usually when other widely used treatments have not worked well enough or are not
suitable for you.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may
also be used alone if treatment with methotrexate is not suitable for you. Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to the joints
caused by rheumatoid arthritis and improves the ability to perform normal daily activities.
For patients with psoriatic arthritis with multiple joint involvement, Enbrel can
improve the ability to perform daily activities. For patients with multiple symmetrical painful or swollen joints (e.g. hands, wrists and feet), Enbrel can slow down the structural damage
to these joints caused by the disease.
Enbrel is also prescribed for the treatment of the following conditions in children and adolescents:

For the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficiently good response or is not appropriate:
Polyarthritis (positive or negative for rheumatoid factor) and extended oligoarthritis in patients aged 2 years and over
Psoriatic arthritis in patients aged 12 years and over.
For arthritis related to enthesitis in patients aged 12 years and over, when other widely used treatments have not given a sufficiently good response or are not appropriate.
Severe psoriasis in patients starting from 6 years of age who have had an inadequate response with (or cannot take) phototherapies or other systemic therapies.

2. What you need to know before using Enbrel

Do not use Enbrel

If you, or your child, are allergic to etanercept or to any of the other ingredients of Enbrel (listed in section 6). If you or your child experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
If you, or your child, have or are at risk of developing a severe blood infection called sepsis. If you are unsure, contact your doctor.
If you, or your child, have any type of infection. If you are unsure, consult your doctor.

Warnings and precautions
Talk to your doctor before taking Enbrel.

Allergic reactions:If you, or your child, experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
Latex:The rubber cap of the syringe is made of latex (dried natural rubber). Contact your doctor before using Enbrel if the syringe will be handled by, or if Enbrel will be administered to, people with a known or suspected hypersensitivity (allergy) to latex.
Infections/surgery:If you, or your child, develop a new infection or are about to undergo any major surgical procedure. Your doctor may want to check your treatment with Enbrel.
Infections/diabetes:Tell your doctor if you, or your child, have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
Infections/monitoring: Tell your doctor about any recent travel outside of Europe. If you, or your child, develop symptoms of an infection such as fever, chills or cough, inform your doctor immediately. Your doctor may decide to continue monitoring you or your child for infections after you or your child have stopped taking Enbrel.
Tuberculosis: Because cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will check you for signs and symptoms of tuberculosis before starting treatment with Enbrel. This may include a thorough review of your medical history, chest X-rays and a tuberculin test. The results of these tests must be reported on your Patient Card. It is very important that you tell your doctor if you or your child have ever had tuberculosis or if you have been in close contact with someone with tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness, low-grade fever) or any other infection appear during or after therapy, tell your doctor immediately.
Hepatitis B: Tell your doctor if you or your child have or have had hepatitis B. Your doctor must test for hepatitis B before you or your child start treatment with Enbrel. Treatment with Enbrel may cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. If this happens, you must stop using Enbrel.
Hepatitis C: Tell your doctor if you or your child have hepatitis C. Your doctor may want to monitor your treatment with Enbrel if the infection worsens.
Blood disorders: Seek immediate medical attention if you or your child have any sign or symptom such as persistent fever, sore throat, bruising, bleeding or paleness. These symptoms may indicate the presence of blood disorders that are potentially life-threatening and may require discontinuation of treatment with Enbrel.
Nervous system and eye disorders: Tell your doctor if you or your child have multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). Your doctor will assess whether Enbrel is an appropriate treatment.
Congestive heart failure: Tell your doctor if you or your child have a history of congestive heart failure, as Enbrel should be used with caution in these circumstances.
Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer, before taking Enbrel. Patients with severe, long-standing rheumatoid arthritis may be at a higher than average risk of developing lymphoma. Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer. Some children and adolescent patients who have been treated with Enbrel or other medicines that work like Enbrel have developed cancers, sometimes unusual, and sometimes fatal. Some patients receiving Enbrel have developed skin cancers. Tell your doctor if you or your child develop any changes in the appearance of the skin or growths on the skin.
Chickenpox:Tell your doctor if you or your child are exposed to chickenpox when using Enbrel. Your doctor will assess whether preventive treatment for chickenpox is appropriate.
Alcohol abuse:Enbrel should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or your child have a history of alcohol abuse.
Wegener's granulomatosis:Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or your child have Wegener's granulomatosis, consult your doctor.
Anti-diabetic medicines: Tell your doctor if you or your child have diabetes or are taking medicines to treat diabetes. Your doctor may decide that you or your child need to receive less anti-diabetic medicine while taking Enbrel.

Children and adolescents
Vaccinations: If possible, before using Enbrel, children should be up to date with
all vaccinations. Some vaccines, such as the oral polio vaccine, should not be given
while taking Enbrel. Consult your doctor before you or your child receive any
vaccine.
Generally Enbrel should not be used in children with extended polyarthritis or oligoarthritis under the age of
2 years, or in children with arthritis related to enthesitis or psoriatic arthritis under the age of
12 years, or in children with psoriasis under the age of 6 years.

Other medicines and Enbrel
Tell your doctor or pharmacist if you, or your child, are taking, have recently taken or
may take any other medicines (including anakinra, abatacept or sulfasalazine), even those
available without a prescription. You or your child should not use Enbrel together with the active ingredient
anakinra or abatacept.

Pregnancy and breastfeeding
Enbrel should only be used in pregnancy if clearly necessary. If you are pregnant,
suspect you are pregnant or are planning a pregnancy, ask your doctor for advice
If you have received Enbrel during pregnancy, the newborn may be at increased risk of
infection. In addition, one study has shown that there was a higher number of birth defects in mothers who received Enbrel during pregnancy compared to mothers who did not receive Enbrel or other
similar medicines (TNF antagonists), but no particular type of birth defect emerged among those reported. Another study did not show an increased risk of birth defects when mothers received Enbrel during pregnancy. Your doctor will help you
decide if the benefits of treatment outweigh the potential risk to your baby.
Talk to your doctor if you wish to breastfeed while taking Enbrel. It is important
to inform your child's pediatricians and other healthcare professionals about the use of Enbrel during
pregnancy and breastfeeding before your child receives any vaccine.

Driving and using machines
It is not expected that the use of Enbrel will affect your ability to drive or operate
machinery.

3. How to use Enbrel

Dosage for adult patients (aged 18 years or older)
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg, administered twice a week or 50 mg once a week
by subcutaneous injection. In any case, the doctor may establish a different frequency with which to inject Enbrel.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week or 50 mg administered once a
week.
Alternatively, a dose of 50 mg can be administered twice a week for up to 12
weeks, followed by a dose of 25 mg administered twice a week or a dose of 50 mg
administered once a week.
The doctor will decide how long you should take Enbrel and whether, based on your response, a new treatment is
necessary. If, after 12 weeks, Enbrel has no effect on your condition, your doctor may tell you to stop treatment.

Use in children and adolescents
The appropriate dose and frequency of dosage for the child or adolescent will depend on the
body weight and the disease. The doctor will provide you with detailed information on how to prepare and measure the
appropriate dosage.
For polyarticular or extended oligoarticular arthritis in patients starting from 2 years of age, or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of Enbrel
per kilogram of body weight (up to a maximum of 25 mg), administered 2 times a week, or 0.8 mg
of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of Enbrel per kilogram of
body weight (up to a maximum of 50 mg) and must be administered once a week. If
Enbrel has no effect on the child's condition after 12 weeks, the doctor may tell you to
discontinue treatment with this medicine.

How and route of administration
Enbrel is administered by injection under the skin (subcutaneous injection).
Enbrel can be taken with or without food and beverages.
The powder must be dissolved before use. Detailed instructions on how to prepare and
inject Enbrel are provided in section 7, “Instructions for Use”. Do not mix the solution of
Enbrel with other medicines.
To help you remember, it may be useful to write in an agenda on which day(s) of the week
Enbrel must be used.
Enbrel must be dissolved before use. The injection must not be mixed in the same syringe or
vial with any other medicine.

If you use more Enbrel than you should
If you have used more Enbrel than you should (either by injecting too much on a single occasion or by using it
too frequently), speak to a doctor or pharmacist immediately. Always keep the
medicine packaging with you, even if it is empty.

If you stop taking Enbrel
Following discontinuation of treatment, the symptoms of the disease may return.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions
If any of the following side effects occur, do not inject Enbrel anymore. Immediately inform your doctor, or go to the nearest hospital emergency room.

Difficulty swallowing or breathing
Swelling of the face, throat, hands or feet
Feeling of nervousness or anxiety, palpitations, sudden redness of the skin and/or feeling of warmth
Severe skin rash, itching, hives (raised, red or pale patches of skin that often itch)

Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel; therefore, you should seek immediate medical attention.

Serious side effects
If you notice any of the following effects, you or the child may need urgent medical care.

Symptoms of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area of skin or joints.
Symptoms of blood disorders, such as bleeding, bruising or paleness.
Symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg.
Symptoms of heart failure or worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of swelling in the neck or abdomen, shortness of breath at night or cough, bluish color of the nails or lips.
Symptoms of tumors: tumors can affect any part of the body, including the skin and blood, and the possible symptoms depend on the type and location of the tumor. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin.
Symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensations or vision.
Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
Symptoms of blood vessel inflammation, such as pain, fever, redness or overheating of the skin or itching.

These side effects are rare or uncommon, but are serious conditions (some of which can rarely cause death). If these symptoms occur, immediately inform your doctor, or go to the nearest hospital emergency room.
The known side effects of Enbrel include those listed below, grouped by decreasing frequency:

Very common(may affect more than 1 in 10 people): Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain and swelling) (these are less common after the first month of treatment; some patients have developed a reaction at a recently used injection site); headache.
Common(may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).
Uncommon(may affect up to 1 in 100 people): Serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin tumor (excluding melanoma); localized swelling of the skin (angioedema); hives (raised, red or pale patches of skin that often itch); eye inflammation; psoriasis (first appearance or worsening), inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood

elevated (in patients also treated with methotrexate, the frequency of increased liver enzymes in the blood is common); abdominal pain and cramps, diarrhea, weight loss or blood in the stool (symptoms of bowel problems).

Rare(may affect up to 1 in 1,000): Serious allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer that affects the blood and bone marrow); melanoma (a type of skin cancer); joint reduction in the number of platelets, red blood cells and white blood cells; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include a persistent rash, fever, joint pain and fatigue); skin rash that can lead to blisters and severe skin peeling; lichenoid reactions (itchy reddish/purple rash and/or whitish-grayish linear streaks on mucous membranes); inflammation of the liver caused by your immune system (autoimmune hepatitis; in patients also treated with methotrexate, the frequency is uncommon), immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also treated with methotrexate, the frequency of inflammation or scarring of the lungs is uncommon); damage to the tiny filters inside the kidneys that determines reduced kidney function (glomerulonephritis).
Very rare(may affect up to 1 in 10,000): inability of the bone marrow to produce essential blood cells.
Not known(frequency cannot be estimated based on available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Additional side effects in children and adolescents
The side effects and their frequency observed in children and adolescents are similar to those described above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store Enbrel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and the label after
“Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Before preparing the Enbrel solution, the medicine may be stored outside the refrigerator at a
maximum temperature of 25°C for up to 4 weeks, for single use only; after this period it cannot be
returned to the refrigerator. If not used within 4 weeks outside the refrigerator, Enbrel must be
discarded. It is recommended to note the date on which Enbrel is placed outside the refrigerator and the date by which
Enbrel must be disposed of (no more than 4 weeks outside the refrigerator).
After preparing the Enbrel solution, immediate use is recommended. However, the solution may
be used within 6 hours if stored at a maximum temperature of 25°C.
Do not use this medicine if you notice that the solution is not clear or if it contains particles. The
solution should appear clear and from colourless to light yellow or light brown, without any clumps,
flocculi or particles.
Carefully dispose of any Enbrel solution that has not been injected within 6 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

Description of the appearance of Enbrel and contents of the pack
Enbrel 25 mg is supplied as a white powder and solvent for injection. Each
pack contains 4, 8 or 24 single-dose vials, 4, 8 or 24 pre-filled syringes of water for
injections, 4, 8 or 24 needles, 4, 8 or 24 vial adapters and 8, 16 or 48 alcohol swabs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

in
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Κύπρος
PFIZER ΕΛΛΑΣ A.E. (CYPRUS BRANCH)
T  : +357 22 817690

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Pfizer, spol. s r.o.
Tel: +420-283-004-111

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Pfizer Kft.
Tel: +36 1 488 3700

Danmark
Pfizer ApS
Tlf: +45 44 201 100

Malta
Vivian Corporation Ltd.
Tel: +35621 344610

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

България/
Пфайзер Люксембург САРЛ,
Клон България
Teл: +359 2 970 4333

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Pfizer AS
Tlf: +47 67 52 61 00

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Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

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Tel: +43 (0)1 521 15-0

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PFIZER ΕΛΛΑΣ A.E.
Τηλ.: +30 210 67 85 800

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Télf: +34 91 490 99 00

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Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00

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Tél +33 (0)1 58 07 34 40

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za svetovanje s področja farmacevtske
dejavnosti, Ljubljana
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Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

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Tel: +421 2 3355 5500

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Tel: +354 540 8000

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Pfizer Oy
Puh/Tel: +358 (0)9 430 040

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Pfizer Luxembourg SARL filiāle Latvijā
Tel. +371 67035775

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

7. Instructions for Use

This paragraph is divided into the following sub-paragraphs:

a.Introduction
b.Preparing the injection
c.Preparing the Enbrel dose for injection
d.Adding the solvent
e.Withdrawing the Enbrel solution from the vial
f.Attaching the needle to the syringe
g.Choosing an injection site
h.Preparing the injection site and injecting the Enbrel solution
i.Disposing of the materials
a.Introduction

b.Preparing the injection

Wash your hands thoroughly.
Choose a clean, well-lit, and flat work surface
The tray with the dose must contain the materials listed below (if this is not the case, do not use the tray and consult your pharmacist). Use only the listed materials. DO NOTuse any other syringe. 1 Vial of Enbrel1 Prefilled syringe containing clear, colorless solvent (water for injections)1 Needle1 Vial adapter2 Alcohol swabs
Check the expiration dates on both the vial label and the syringe label. They must not be used after the month and year indicated.

c.Preparing the Enbrel dose for injection

Remove the contents of the tray
Remove the plastic cap from the Enbrel vial (see Figure 1). DO NOTremove the gray cap or the aluminum ring around the neck of the vial.

Figure 1

Hand grasping a glass vial with a gray cap and a needle partially inserted

Use a new alcohol swab to clean the gray cap on the Enbrel vial. After cleaning, do not touch the gray cap with your hands or allow it to touch any other surface.
Place the vial upright on a clean, flat surface.
Remove the paper backing from the vial adapter packaging.
Place the vial adapter on top of the Enbrel vial while it is still in the plastic packaging so that the tip of the vial adapter is centered with the raised circle above the vial cap (see Figure 2).
With one hand, hold the Enbrel vial firmly on a flat surface. With the other hand, push DOWN FIRMLYon the adapter packaging until you feel the tip of the adapter penetrate the vial cap AND YOU DO NOT FEEL THE EDGE OF THE ADAPTER SNAPPING INTO PLACE(see Figure 3). DO NOTpush the adapter down at an angle (see Figure 4). It is important that the tip of the vial adapter completely penetrates the vial cap.

Figure 2 Figure 3 Figure 4

Medicine vial with gray cap and needle connected via a transparent protective adapter

Medicine vial with cap and needle penetrating vertically, arrows indicate insertion and withdrawal direction


i

CORRECTWRONG

Holding the vial in one hand, remove the plastic packaging from the adapter (see Figure 5)

Figure 5

Medicine vial with rubber cap and upper protection, connected to a vertical infusion device

Remove the protective cap from the end of the syringe by breaking the white cap along the perforation. This is done by holding the ring of the white cap while gripping the end of the white cap with the other hand and bending it down and then up until it breaks (see Figure 6). DO NOT remove the white ring that remains on the syringe.

Figure 6

Hand removing the cap from a transparent liquid vial, an arrow indicating the direction to the left

Do not use the syringe if this perforation has already been broken. Start over with another dose-tray
Holding the glass cylinder of the syringe in one hand (not the white ring), and the vial adapter (not the vial) in the other, connect the syringe to the vial adapter by inserting the cap into the opening and turning it clockwise until it is fully engaged (see Figure 7).

Figure 7

Syringe with needle connected and safety device activated with arrows indicating the direction of rotation

d.Adding the solvent

Holding the vial upright on a flat surface, push the plunger VERY SLOWLY until all the solvent is in the vial. This will help reduce foam formation (numerous bubbles) (see Figure 8)
Once the solvent has been added to Enbrel, the plunger may move on its own. This is caused by air pressure and is not a concern.

Figure 8

Syringe with needle inserted vertically into the skin, highlighted

With the syringe still attached, gently move the vial back and forth several times with circular motions to dissolve the powder (see Figure 9). DO NOTshake the vial. Wait until all the powder has dissolved (usually less than 10 minutes). The solution should appear clear and from colorless to pale yellow or light brown, without any debris, flakes, or particles. Some white foam may remain in the vial - this is normal. DO NOTuse Enbrel if all the powder in the vial does not dissolve within 10 minutes. Start over with another dose-tray. Figure 9

Hand holding a prefilled syringe with needle inserted and curved arrows indicating the rotation of the device

e.Withdrawing the Enbrel solution from the vial

With the syringe still attached to the vial and vial adapter, hold the vial upside down at eye level. Push the plunger all the way into the syringe (see Figure 10).

Figure 10

Hand holding a syringe with needle inserted into the skin, an arrow indicating the direction of injection and a dashed line showing the subcutaneous layer

Then, slowly pull back the plunger to draw the liquid into the syringe (see Figure 11). For adult patients, withdraw the entire volume. For children, withdraw only the portion of liquid as prescribed by the child's doctor. After withdrawing Enbrel from the vial, there may be air in the syringe. Do not worry as the air can be removed later.

Figure 11

Syringe with needle pointing downwards and hand holding it in a vertical position for

Holding the vial upside down, unscrew the syringe from the vial adapter by turning it counterclockwise (see Figure 12).

Figure 12

Injection device with needle connected and rotation mechanism indicated by curved and straight arrows

Place the filled syringe on a clean, flat surface. Make sure the tip does not touch anything. Be careful not to push the plunger down.

(Note: After completing these steps, a small amount of liquid may remain in the
vial. This is normal).

f.Attaching the needle to the syringe

The needle, to maintain sterility, is placed in a plastic container.
To open the plastic container, hold the short, wide end in one hand. Place the other hand on the longer part of the container.
To break the seal, bend the short, wide end down and then up until it breaks (see Figure 13).

Figure 13

Hand holding a syringe inclined at 45 degrees while

Once the seal has been broken, remove the short, wide end of the plastic container.
The needle will remain in the long part of the packaging.
Holding the needle and container in one hand, take the syringe and insert the tip of the syringe into the opening of the needle.
Attach the syringe to the needle by turning it clockwise until it is fully engaged (see Figure 14).

Figure 14

Syringe with needle tilted shown with arrows indicating direction of insertion and rotation for fixing

Remove the needle cap from the syringe by pulling it firmly, being careful not to touch the needle or allow the needle to touch any surface (see Figure 15). Be careful not to bend or twist the cap to avoid damaging the needle.

Figure 15

Syringe with needle pointing to the left

Holding the syringe straight, remove the air by slowly pushing the plunger until all the air is removed (see Figure 16).

Figure 16

Hand holding a syringe with needle inserted into the skin, stylized fingers gripping the cylindrical body

g.Choosing an injection site

The three recommended injection sites for Enbrel include: (1) the mid-anterior thighs;

(2) the abdomen, except for the area 5 cm away from the navel; and (3) the outer area of the upper arms (see Figure 17). If you are self-administering an injection, you should not use the outer area of the upper arms.

Figure 17

A different site must be used for each new injection. Each new injection must be made at least 3 cm from a previous site. Do notinject into areas where the skin is sensitive, bruised, red, or hardened. Avoid areas where there are scars or stretch marks (it may be helpful to note the location of previous injection sites).
If you or the child have psoriasis, you should try to avoid injecting directly into the swollen, thickened, red, or scaly areas of the skin (“psoriatic skin lesions”).

h.Preparing the injection site and injecting the Enbrel solution

Rub the injection site where Enbrel is to be injected with an alcohol swab using a circular motion. DO NOTtouch this area again before giving the injection.
When the cleaned skin area is dry, pinch it firmly with one hand. With the other hand, hold the syringe like a pencil.
With a quick, short motion, fully insert the needle into the skin at an angle of 45° to 90° (see Figure 18). With experience, you will find the angle that is most comfortable

for you or the child. Be careful not to insert the needle into the skin too slowly or with
great force.
Figure 18

When the needle is fully inserted into the skin, release the skin you are holding. With your free hand, hold the syringe near its base to stabilize it. Then push the plunger to inject all the solution at a slowand steady rate (see Figure 19).

Figure 19

When the syringe is empty, remove the needle from the skin, being careful to keep it at the same angle as it was inserted.
Press an alcohol swab on the injection site for 10 seconds. Slight bleeding may occur. DO NOTrub the injection site. A bandage is optional.

i.Disposing of the materials

The syringe and needles should NEVERbe reused. Dispose of the needles and syringe as suggested by your doctor, nurse, or pharmacist.

If you have any questions, talk to a doctor, nurse, or pharmacist who is familiar
with Enbrel.

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Enbrel 25 mg injectable solution in pre-filled syringes, 50 mg injectable solution in pre-filled syringe

etanercept

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will provide you with the Patient Information Sheet which contains important safety information that you should be aware of before and during treatment with Enbrel.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or for your child. Do not give it to other people, even if their symptoms are the same as yours or your child's, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Enbrel is and what it is used for
2. What you need to know before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Contents of the pack and other information
7. Instructions for use

1. What is Enbrel and what it is used for

Enbrel is a medicine made from two human proteins. It blocks the activity of another protein that
causes inflammation in the human body. Enbrel works by reducing the inflammation associated
with certain diseases.
In adults (aged 18 years or older), Enbrel can be used for the treatment of rheumatoid arthritisfrom moderate to severe, psoriatic arthritis, axial spondyloarthritis
severe, including ankylosing spondylitis,and psoriasisfrom moderate to severe - in each case
usually when other widely used treatments have not worked well enough or are not
suitable for you.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may
also be used alone if treatment with methotrexate is not suitable for you. Whether used
alone or in combination with methotrexate, Enbrel can slow down the damage to the joints
caused by rheumatoid arthritis and improves the ability to perform normal daily activities.
For patients with psoriatic arthritis with multiple joint involvement, Enbrel can
improve the ability to perform daily activities. For patients with multiple
symmetrical painful or swollen joints (e.g. hands, wrists and feet), Enbrel can slow down the structural damage
to these joints caused by the disease.
Enbrel is also prescribed for the treatment of the following conditions in children and adolescents:

For the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficiently good response or is not appropriate:
Polyarthritis (positive or negative for rheumatoid factor) and extended oligoarthritis in patients aged 2 years and over
Psoriatic arthritis in patients aged 12 years and over.
For arthritis related to enthesitis in patients aged 12 years and over, when other widely used treatments have not given a sufficiently good response or are not appropriate.
Severe psoriasis in patients aged 6 years and over who have had an inadequate response with (or cannot take) phototherapies or other systemic therapies.

2. What you need to know before using Enbrel

Do not use Enbrel

if you, or your child, are allergic to etanercept or any of the other ingredients of Enbrel (listed in section 6). If you or your child experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
if you, or your child, have or are at risk of developing a serious blood infection called sepsis. If you are unsure, contact your doctor.
if you, or your child, have any type of infection. If you are unsure, consult your doctor.

Warnings and precautions
Talk to your doctor before taking Enbrel.

Allergic reactions:If you, or your child, experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
Infections/surgery:If you, or your child, develop a new infection or are about to have any major surgery. Your doctor may want to check your treatment with Enbrel.
Infections/diabetes:Tell your doctor if you, or your child, have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
Infections/monitoring: Tell your doctor about any recent travel outside of Europe. If you, or your child, develop symptoms of an infection such as fever, chills or cough, inform your doctor immediately. Your doctor may decide to continue monitoring you or your child for infections after you or your child have stopped taking Enbrel.
Tuberculosis: Because cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will check you for signs and symptoms of tuberculosis before starting treatment with Enbrel. This may include a thorough review of your medical history, a chest X-ray and a tuberculin test. The results of these tests must be reported on the Patient Card. It is very important that you tell your doctor if you or your child have ever had tuberculosis or if you have been in close contact with someone with tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness, mild fever) or any other infection appear during or after therapy, tell your doctor immediately.
Hepatitis B: Tell your doctor if you or your child have or have had hepatitis B. Your doctor must test for hepatitis B before you or your child start treatment with Enbrel. Treatment with Enbrel can cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. In this case, you must stop using Enbrel.
Hepatitis C: Tell your doctor if you or your child have hepatitis C. Your doctor may consider monitoring your treatment with Enbrel if the infection worsens.
Blood disorders: Seek immediate medical attention if you or your child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. These symptoms may indicate the presence of blood disorders that are potentially life-threatening and may require discontinuation of treatment with Enbrel.
Nervous system and eye disorders: Tell your doctor if you or your child have multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). Your doctor will assess whether Enbrel is an appropriate treatment.
Congestive heart failure: Tell your doctor if you or your child have a history of congestive heart failure, as Enbrel should be used with caution in these circumstances.
Cancer:Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer, before taking Enbrel. Patients with severe, long-standing rheumatoid arthritis may be at a higher than average risk of developing lymphoma. Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer. Some children and adolescent patients who have been treated with Enbrel or other medicines that act like Enbrel have developed cancers, sometimes rare, sometimes fatal. Some patients receiving Enbrel have developed skin cancers. Tell your doctor if you or your child develop any changes in the appearance of the skin or growths on the skin.
Chickenpox:Tell your doctor if you or your child are exposed to chickenpox while using Enbrel. Your doctor will assess whether preventive treatment for chickenpox is appropriate.
Latex:The needle cap is made of latex (dried natural rubber). Contact your doctor before using Enbrel if the needle cap is handled by, or Enbrel is administered to, a person with known or possible hypersensitivity (allergy) to latex.
Alcohol abuse:Enbrel should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or your child have a history of alcohol abuse.
Wegener's granulomatosis:Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or your child have Wegener's granulomatosis, consult your doctor.
Anti-diabetic medicines: Tell your doctor if you or your child have diabetes or are taking medicines to treat diabetes. Your doctor may decide if you or your child need to receive less anti-diabetic medicine while taking Enbrel.

Children and adolescents
Vaccinations: If possible, before using Enbrel, children should be up to date with
all vaccinations. Some vaccines, such as the oral polio vaccine, should not be given
while taking Enbrel. Consult your doctor before you or your child receive any
vaccine.
Generally, Enbrel should not be used in children with extended polyarthritis or oligoarthritis aged
under 2 years, or in children with arthritis related to enthesitis or psoriatic arthritis under the
age of 12 years, or in children with psoriasis under the age of 6 years.

Pregnancy and breastfeeding
Enbrel should be used in pregnancy only if clearly necessary. If you are pregnant,
suspect you are pregnant or are planning a pregnancy, ask your doctor for advice.
If you have received Enbrel during pregnancy, the newborn may be at increased risk of
infection. In addition, one study indicated that there was a higher number of birth defects in mothers who received Enbrel during pregnancy compared to mothers who did not receive Enbrel or other
similar medicines (TNF antagonists), but no particular type of birth defect emerged among those reported. Another study did not show an increased risk of birth defects when mothers received Enbrel during pregnancy. Your doctor will help you
decide if the benefits of treatment outweigh the potential risk to your baby.
Talk to your doctor if you want to breastfeed while taking Enbrel. It is important
to inform your child's pediatricians and other healthcare professionals about the use of Enbrel during
pregnancy and breastfeeding before your child receives any vaccine.

Driving and using machines
It is not expected that the use of Enbrel will affect your ability to drive or operate
machinery.

Enbrel contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially “sodium-free”.

3. How to use Enbrel

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
If you feel that the effect of Enbrel is too strong or too weak, consult your doctor or
pharmacist.
The pre-filled syringe is available in dosages of 25 mg and 50 mg.

Dosage for adult patients (age 18 years or older)
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg, administered twice a week or 50 mg once a week
by subcutaneous injection. In any case, the doctor may establish a different frequency with which to inject Enbrel.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week or 50 mg administered once a week.
Alternatively, a dose of 50 mg can be administered twice a week for up to 12
weeks, followed by a dose of 25 mg administered twice a week or a dose of 50 mg
administered once a week.
The doctor will decide how long you should take Enbrel and whether, based on your response, a new treatment is necessary. If, after 12 weeks, Enbrel has no effect on your condition, your doctor may tell you to stop treatment.

Use in children and adolescents
The appropriate dose and frequency for the child or adolescent will depend on body weight
and the disease. The doctor will establish the correct dose for your child and prescribe an
appropriate dosage of Enbrel (10 mg, 25 mg or 50 mg).
For polyarticular or extended oligoarticular arthritis in patients starting from 2 years of age, or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of Enbrel
per kilogram of body weight (up to a maximum of 25 mg) administered 2 times a week or 0.8 mg
of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of Enbrel per kilogram of
body weight (up to a maximum of 50 mg) and must be administered once a week. If
Enbrel has no effect on the child's condition after 12 weeks, the doctor may tell you to
interrupt the treatment with this medicine.
The doctor will provide you with detailed information on how to prepare and measure the appropriate dosage.

Route of administration
Enbrel is administered by injection under the skin (subcutaneous injection).
Enbrel can be taken with or without food and beverages

Detailed instructions on how to inject Enbrel are provided in section 7, “Instructions for
use”.Do not mix the Enbrel solution with other medicines.
To help you remember, it may be useful to write in an agenda on which day(s) of the week
Enbrel must be used.

If you use more Enbrel than you should
If you have used more Enbrel than you should (either by injecting too much on a single occasion or by using it
too frequently), immediately consult a doctor or pharmacist. Always keep the
medicine packaging with you, even if it is empty.

If you forget to take Enbrel
If you forget a dose, administer it as soon as you remember, unless the next dose is scheduled for the next day, in which case you should skip the forgotten dose.
Then continue to administer the medicine on the scheduled day(s). If you have forgotten the dose
until the day the next dose is due, do not take a double dose (two doses at the same
time) to make up for the forgotten dose.

If you stop treatment with Enbrel
Following discontinuation of treatment, the symptoms of the disease may return.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions
If any of the following side effects occur, do not inject Enbrel anymore. Immediately inform your doctor, or go to the nearest hospital emergency room.

Difficulty swallowing or breathing
Swelling of the face, throat, hands or feet
Feeling of nervousness or anxiety, palpitations, sudden redness of the skin and/or feeling of warmth
Severe skin rash, itching, hives (raised, red or pale patches of skin that often itch)

Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel; therefore, you should seek immediate medical attention.

Serious side effects
If you notice any of the following effects, you or the child may need urgent medical attention.

Symptoms of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area of skin or joints.
Symptoms of blood disorders, such as bleeding, bruising or paleness.
Symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg.
Symptoms of heart failure or worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of swelling in the neck or abdomen, shortness of breath at night or cough, bluish color of the fingernails or lips.
Symptoms of tumors: tumors can affect any part of the body, including the skin and blood, and the possible symptoms depend on the type and location of the tumor. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin.
Symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensations or vision.
Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
Symptoms of blood vessel inflammation, such as pain, fever, redness or overheating of the skin or itching.

These side effects are rare or uncommon, but are serious conditions (some of which can rarely cause death). If these symptoms occur, immediately inform your doctor, or go to the nearest hospital emergency room.
The known side effects of Enbrel include those listed below, grouped by decreasing frequency:

Very common(may affect more than 1 in 10 people): Infections (including colds, sinusitis, bronchitis, urinary tract infections, and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain and swelling) (these do not occur as often after the first month of treatment; some patients have developed a reaction at a recently used injection site); headache.
Common(may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).
Uncommon(may affect up to 1 in 100 people): Serious infections (including pneumonia, deep skin infections, joint infections, blood infections, and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin cancer (excluding melanoma); localized swelling of the skin (angioedema); hives (raised, red or pale patches of skin that often itch); eye inflammation; psoriasis (first occurrence or worsening), inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also treated with methotrexate, the frequency of increased liver enzymes in the blood is common); abdominal pain and cramps, diarrhea, weight loss or blood in the stool (symptoms of bowel problems).
Rare(may affect up to 1 in 1,000): Serious allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); joint reduction in the number of platelets, red blood cells and white blood cells; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include a persistent rash, fever, joint pain, and fatigue); rash that can lead to blisters and severe skin peeling; lichenoid reactions (itchy reddish/purple rash and/or whitish-grayish linear streaks on mucous membranes); inflammation of the liver caused by your immune system (autoimmune hepatitis; in patients also treated with methotrexate, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also treated with methotrexate, the frequency of inflammation or scarring of the lungs is uncommon); damage to the tiny filters inside the kidneys that determines reduced kidney function (glomerulonephritis).
Very rare(may affect up to 1 in 10,000): inability of the bone marrow to produce essential blood cells.
Not known(frequency cannot be estimated based on available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer related to human herpesvirus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Additional side effects in children and adolescents
The side effects and their frequency observed in children and adolescents are similar to those described above.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Enbrel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the pre-filled syringe after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Keep the pre-filled syringes in the outer packaging to protect the medicine from light.
After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the
Enbrel solution in the syringe to reach room temperature.Do not heat it in any
other way. Immediate use is then recommended.
Enbrel can be stored at a maximum temperature of 25°C for up to 4 weeks, for a single
occasion; after this period it cannot be returned to the refrigerator. If not used within 4
weeks outside the refrigerator, Enbrel must be discarded. It is recommended to note the date on which Enbrel is
removed from the refrigerator and the date by which Enbrel must be disposed of (no more than 4 weeks outside
the refrigerator).
Inspect the solution inside the syringe. The solution should be from clear to slightly
opalescent, from colourless to light yellow or light brown and may contain small, white or almost transparent protein
particles. This is the normal appearance of Enbrel. Do not use this solution if it presents
colour changes or appears cloudy or if particles other than those described are visible. If
you have any doubts about the appearance of the solution, contact your pharmacist for assistance.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enbrel contains
Enbrel 25 mg solution for injection in pre-filled syringe
The active ingredient of Enbrel is etanercept. Each pre-filled syringe of Enbrel contains 0.5 mL of
solution, containing 25 mg of etanercept.
Enbrel 50 mg solution for injection in pre-filled syringe
The active ingredient of Enbrel is etanercept. Each pre-filled syringe of Enbrel contains 1.0 mL of
solution, containing 50 mg of etanercept.
The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, monobasic sodium phosphate
dihydrate and dibasic sodium phosphate dihydrate and water for injections.

Description of Enbrel and package contents
Enbrel 25 mg solution for injection in pre-filled syringe
Enbrel is supplied as a pre-filled syringe containing a clear, injectable solution, from
colorless to light yellow or light brown. Each pack contains 4, 8, 12 or 24 pre-filled syringes and 4,
8, 12 or 24 alcohol swabs. Not all pack sizes may be marketed.
Enbrel 50 mg solution for injection in pre-filled syringe
Enbrel is supplied as a pre-filled syringe containing a clear, injectable solution, from
colorless to light yellow or light brown. Each pack contains 2, 4 or 12 pre-filled syringes and 2, 4 or
12 alcohol swabs. Not all pack sizes may be marketed.

Marketing Authorisation Holder

and
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12,
2870 Puurs-Sint-Amands
Belgium
For further information on this medicine, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Κύπρος
PFIZER ΕΛΛΑΣ A.E. (CYPRUS BRANCH)
T  : +357 22 817690

Česká Republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Magyarország
Pfizer Kft.
Tel: +36 1 488 3700

Danmark
Pfizer ApS
Tlf: +45 44 201 100

Malta
Vivian Corporation Ltd.
Tel: +35621 344610

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

България
Пфайзер Люксембург САРЛ,
Клон България
Teл: +359 2 970 4333

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
FIZER EΛΛAΣ A.E.
Τηλ.: +30 210 67 85 800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Télf: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00

France
Pfizer
Tél +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL ,Pfizer, podružnica
for advisory services in the field of pharmaceutical
activities, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská Republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Tel: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel. +371 67035775

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +3705 2514000
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu.

7. Instructions for Use

This section is divided into the following subsections:

Introduction
Point 1: Preparing the injection
Point 2: Choosing an injection site
Point 3: Injecting the Enbrel solution
Point 4: Disposing of materials
Introduction
The following instructions explain how to prepare and inject Enbrel. Read the instructions carefully and
follow them step by step. You will be instructed by your doctor or nurse on the appropriate
techniques for self-injection or injection into a child. Do not attempt self-injection or
injection into a child until you are certain you understand how to prepare and how to
inject.
The Enbrel solution should not be mixed with any other medicine before use.

Point 1: Preparing the injection

1. Choose a clean, well-lit, and flat work surface.
2. Take the box of Enbrel containing the prefilled syringes from the refrigerator and place it on the flat work surface. Starting from one of the upper corners, pull the protective paper from the top and sides of the tray. Remove one prefilled syringe and one alcohol swab and place them on the work surface. Do not shake the prefilled Enbrel syringe. Fold the protective paper back onto the tray and place the box containing the remaining prefilled syringes back in the refrigerator. See section 5 for instructions on how to store Enbrel. If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
3. You must wait 15-30 minutes to allow the Enbrel solution in the syringeto reach room temperature. DOnot remove the needle cover while waiting for the solution to reach room temperature. Waiting until the solution reaches room temperature may make the injection more comfortable. Do not heat Enbrel in any other way (for example, do not heat it in a microwave or in hot water).
4. Prepare the other materials you will need for your injection. These include the alcohol swab from the Enbrel package and a cotton ball or gauze.
5. Wash your hands with soap and warm water.

6 .Inspect the solution inside the syringe. The solution should be from clear to
slightly opalescent, from colorless to light yellow or light brown, and may contain small
white or nearly transparent protein particles. This is the normal appearance of Enbrel. Do not use
this solution if it has color changes or appears cloudy, or if particles other than those described are visible.
If you have any doubts about the appearance of the solution, contact your
pharmacist for assistance.

Point 2: Choosing an injection site

1. The three recommended injection sites for Enbrel when using a prefilled syringe include:
(1) the mid-anterior thigh; (2) the abdomen, except for the area within 5 cm around the navel; and (3) the outer area of the upper arms (see Figure 1). If you are self-administering an injection, you should not use the outer area of the upper arms. Figure 1

2. A different site should be used for each new injection. Each new injection should be made at least 3 cm from a previous site. Do not inject into areas where the skin is sensitive, bruised, red, or hardened. Avoid areas where there are scars or stretch marks (it may be helpful to note the location of previous injection sites).
3. If you or the child have psoriasis, you should try to avoid injecting directly into the swollen, thickened, red, or scaly areas of the skin (“psoriatic skin lesions”).

Point 3: Injecting the Enbrel solution

1. Rub the injection site where Enbrel is to be injected with the alcohol swab using a circular motion. DOnot touch this area again before making the injection.
2. Take the prefilled syringe from the flat work surface. Remove the needle cover by firmly pulling it off the syringe (see Figure 2). Be careful not to bend ortwist the cover during removal to avoid damage to the needle.

When you remove the needle cover, a drop of liquid may remain at the end
of the needle; this is normal. Do not touch the needle or let it touch any surface. Do not
touch or push the plunger. This could cause the liquid to leak.
Figure 2

Hands holding a syringe with the needle facing to the right and bidirectional arrows indicating the movement of the plunger

3. Once the cleaned skin area is dry, pinch and hold it firmly with one hand. With the other hand, hold the syringe like a pencil.
4. With a quick, short motion, push the needle completely into the skin at an angle of 45° to 90° (see Figure 3). With experience, you will find the angle that is most comfortable for you or the child. Be careful not to push the needle into the skin too slowly, or with great force.

Figure 3

5. Once the needle is fully inserted into the skin, release the skin you are holding. With your free hand, hold the syringe near its base to stabilize it. Then push the plunger to inject all the solution at a slowand steady rate (see Figure 4).

Figure 4

Hand holding a prefilled syringe with needle inserted into the skin of the arm at approximately 45 degrees

6. When the syringe is empty, remove the needle from the skin, being careful to keep it at the same angle it was inserted. Slight bleeding may occur at the injection site. You can press a cotton ball or gauze onto the injection site for 10 seconds. Do not rub the injection site. If necessary, you can cover the injection site with a bandage.

Point 4: Disposing of materials

The prefilled syringe is for single-use only. The syringe and needle should NEVERbe reused. Never recap a needle with the cap. Dispose of needles and syringes as suggested by your doctor, nurse, or pharmacist.

If you have any questions, talk to a doctor, nurse, or pharmacist who is familiar
with Enbrel.

Enbrel 25 mg solution for injection in pre-filled pen

etanercept

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you

Keep this leaflet. You may need to read it again.
Your doctor will provide you with the Patient Information Sheet which contains important safety information that you should be aware of before and during treatment with Enbrel.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or for a child. Do not pass it on to others, even if their symptoms are the same as yours or those of the child, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Enbrel is and what it is used for
2. What you need to know before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Contents of the pack and other information
7. Instructions for use

1. What is Enbrel and what it is used for

Enbrel is a medicine made from two human proteins. It blocks the activity of another protein that
causes inflammation in the human body. Enbrel works by reducing the inflammation associated
with certain diseases.
In adults (aged 18 years or older), Enbrel can be used for the treatment of rheumatoid arthritisfrom moderate to severe, psoriatic arthritis, severe axial spondyloarthritis
including ankylosing spondylitis, and moderate to severe psoriasis- in each case
usually when other widely used treatments have not worked well enough or are not
suitable for you.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may
also be used alone if treatment with methotrexate is not suitable for you. Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to the joints
caused by rheumatoid arthritis and improves the ability to perform normal daily activities.
For patients with psoriatic arthritis with involvement of multiple joints, Enbrel can
improve the ability to perform daily activities. For patients with multiple symmetrical painful or swollen joints (e.g. hands, wrists and feet), Enbrel can slow down the structural damage
to these joints caused by the disease.
Enbrel is also prescribed for the treatment of the following conditions in children and adolescents:

For the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficiently good response or is not appropriate:
Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients aged 2 years and over
Psoriatic arthritis in patients aged 12 years and over.
For arthritis related to enthesitis in patients aged 12 years and over, when other widely used treatments have not given a sufficiently good response or are not appropriate.
Severe psoriasis in patients from 6 years of age who have had an inadequate response with (or cannot take) phototherapies or other systemic therapies.

2. What you need to know before using Enbrel

Do not use Enbrel

if you, or your child, are allergic to etanercept or any of the other ingredients of Enbrel (listed in section 6). If you or your child experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
if you, or your child, have or are at risk of developing a serious blood infection called sepsis. If you are unsure, contact your doctor.
if you, or your child, have any type of infection. If you are unsure, consult your doctor.

Warnings and precautions
Talk to your doctor before taking Enbrel.

Allergic reactions:If you, or your child, experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
Infections/surgery:If you, or your child, develop a new infection or are about to have any major surgery. Your doctor may want to check your treatment with Enbrel.
Infections/diabetes: Tell your doctor if you or your child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
Infections/monitoring: Tell your doctor about any recent travel outside of Europe. If you, or your child, develop symptoms of an infection such as fever, chills or cough, inform your doctor immediately. Your doctor may decide to continue monitoring you or your child for infections after you or your child have stopped taking Enbrel.
Tuberculosis: Because cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will check you for signs and symptoms of tuberculosis before starting treatment with Enbrel. This may include a thorough review of your medical history, a chest X-ray and a tuberculin test. The results of these tests should be reported on your Patient Card. It is very important that you tell your doctor if you or your child have ever had tuberculosis or if you have been in close contact with someone with tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness, low-grade fever) or any other infection appear during or after therapy, tell your doctor immediately.
Hepatitis B: Tell your doctor if you or your child have or have had hepatitis B. Your doctor should test you for hepatitis B before you or your child start treatment. Treatment with Enbrel may cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. If this happens, you must stop using Enbrel.

with Enbrel. The treatment with Enbrel can cause reactivation of hepatitis B in patients with
previous infection from hepatitis B virus. In such case, you must stop using Enbrel.

Hepatitis C: Tell your doctor if you or your child have hepatitis C. Your doctor may consider monitoring your treatment with Enbrel if the infection worsens.
Blood disorders: Seek immediate medical attention if you or your child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. These symptoms may indicate the presence of blood disorders that could be life-threatening and may require discontinuation of treatment with Enbrel.
Nervous system and eye disorders: Tell your doctor if you or your child have multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). Your doctor will assess whether Enbrel is an appropriate treatment.
Congestive heart failure: Tell your doctor if you or your child have a history of congestive heart failure, as Enbrel should be used with caution in these circumstances.
Cancer:Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer, before taking Enbrel. Patients with long-standing, severe rheumatoid arthritis may be at a higher than average risk of developing lymphoma. Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer. Some children and adolescent patients who have been treated with Enbrel or other medicines that work like Enbrel have developed cancers, sometimes rare, sometimes fatal. Some patients receiving Enbrel have developed skin cancers. Tell your doctor if you or your child develop any changes in the appearance of the skin or growths on the skin.
Chickenpox:Tell your doctor if you or your child are exposed to chickenpox while using Enbrel. Your doctor will assess whether preventive treatment for chickenpox is appropriate.
Latex: The needle cap of the MYCLIC pen is made of latex (dried natural rubber). Contact your doctor before using Enbrel if the needle cap is handled by, or Enbrel is administered to, a person with known or possible hypersensitivity (allergy) to latex.
Alcohol abuse:Enbrel should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or your child have a history of alcohol abuse.
Wegener's granulomatosis:Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or your child have Wegener's granulomatosis, consult your doctor.
Anti-diabetic medicines:Tell your doctor if you or your child have diabetes or are taking medicines to treat diabetes. Your doctor may decide if you or your child need to receive less anti-diabetic medicine while taking Enbrel.

Other medicines and Enbrel
Tell your doctor or pharmacist if you or your child are taking, have recently taken or
may take any other medicines (including anakinra, abatacept or sulfasalazine), even those
available without a prescription. You or your child should not use Enbrel together with the active ingredient
anakinra or abatacept.

Pregnancy and breastfeeding
Enbrel should only be used during pregnancy if clearly necessary. If you are pregnant,
suspect you are pregnant or are planning a pregnancy, ask your doctor for advice.
If you have received Enbrel during pregnancy, the newborn may be at increased risk of
infection. Also, one study indicated that there was a higher number of birth defects in mothers who received Enbrel during pregnancy compared to mothers who did not receive Enbrel or other
similar medicines (TNF antagonists), but no particular type of birth defect emerged among the reported defects. Another study did not show an increased risk of birth defects when mothers received Enbrel during pregnancy. Your doctor will help you
decide if the benefits of treatment outweigh the potential risk to your baby.
Talk to your doctor if you wish to breastfeed while taking Enbrel. It is important
to inform the baby's pediatricians and other healthcare professionals about the use of Enbrel during
pregnancy and breastfeeding before the baby receives any vaccine.

Driving and using machines
It is not expected that the use of Enbrel will affect your ability to drive or operate
machinery.

Enbrel contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially “sodium-free”.

3. How to use Enbrel

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
If you feel that the effect of Enbrel is too strong or too weak, consult your doctor or
pharmacist.
You have been prescribed a dosage of Enbrel 25 mg. A dosage of Enbrel 50 mg is available for
50 mg doses.

Dosage for adult patients
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg, administered twice a week or 50 mg once a week
by subcutaneous injection. In any case, the doctor may establish a different frequency with which to inject Enbrel.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week or 50 mg administered once a
week.
Alternatively, a dose of 50 mg may be administered twice a week for up to 12
weeks, followed by a dose of 25 mg administered twice a week or a dose of 50 mg
administered once a week.
The doctor will decide how long you should take Enbrel and whether, based on your response, a new treatment is
necessary. If, after 12 weeks, Enbrel has no effect on your condition, your doctor may tell you to stop treatment.

Use in children and adolescents
The appropriate dose and frequency of dosage for the child or adolescent will depend on the
body weight and the disease. The doctor will establish the correct dose for your child and prescribe a
suitable dosage of Enbrel (10 mg, 25 mg or 50 mg).
For polyarticular or extended oligoarticular arthritis in patients starting from 2 years of age, or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of Enbrel
per kg of body weight (up to a maximum of 25 mg), administered twice a week, or 0.8 mg
of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of Enbrel per kilogram of
body weight (up to a maximum of 50 mg) and must be administered once a week. If
Enbrel has no effect on the child's condition after 12 weeks, the doctor may tell you to
interrupt the treatment with this medicine.
The doctor will provide you with detailed information on how to prepare and measure the appropriate dosage.

Method and route of administration
Enbrel is administered by injection under the skin (subcutaneous injection).
Enbrel can be taken with or without food and beverages.

If you stop treatment with Enbrel
Following the interruption of treatment, the symptoms of the disease may return.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions
If any of the following side effects occur, do not inject Enbrel anymore. Immediately inform your doctor, or go to the nearest hospital emergency room.

Difficulty swallowing or breathing
Swelling of the face, throat, hands or feet
Feeling of nervousness or anxiety, palpitations, sudden redness of the skin and/or feeling of warmth
Severe skin rash, itching, hives (raised, red or pale patches of skin that often itch)

Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel; therefore, you should seek immediate medical attention.

Serious side effects
If you notice any of the following effects, you or the child may need urgent medical care.

Symptoms of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area of skin or joints.
Symptoms of blood disorders, such as bleeding, bruising or paleness.
Symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg.
Symptoms of heart failure or worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of fullness in the neck or abdomen, shortness of breath at night or cough, bluish color of the nails or lips.
Symptoms of tumors: tumors can affect any part of the body, including the skin and blood, and the possible symptoms depend on the type and location of the tumor. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin.
Symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensations or vision.
Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
Symptoms of inflammation of blood vessels, such as pain, fever, redness or overheating of the skin or itching.

These side effects are rare or uncommon, but are serious conditions (some of which can rarely cause death). If these symptoms occur, immediately inform your doctor, or go to the nearest hospital emergency room.
The known side effects of Enbrel include those listed below, grouped by decreasing frequency:

Very common(may affect more than 1 in 10 people): Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain and swelling) (these are less common after the first month of treatment; some patients have developed a reaction at a recently used injection site); headache.
Common(may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).
Uncommon(may affect up to 1 in 100 people): Serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin cancer (excluding melanoma); localized swelling of the skin (angioedema); hives (raised, red or pale patches of skin that often itch); eye inflammation; psoriasis (first occurrence or worsening); inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also undergoing treatment with methotrexate, the frequency of increased liver enzymes in the blood is common); abdominal pain and cramps, diarrhea, weight loss or blood in the stool (symptoms of bowel problems).
Rare(may affect up to 1 in 1,000 people): Serious allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); joint reduction in the number of platelets, red blood cells and white blood cells; diseases of the nervous system (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include a persistent rash, fever, joint pain and fatigue); skin rash that can lead to blisters and severe skin scaling; lichenoid reactions (itchy reddish/purple rash and/or whitish-greyish linear streaks on mucous membranes); inflammation of the liver caused by your immune system (autoimmune hepatitis; in patients also undergoing treatment with methotrexate, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also undergoing treatment with methotrexate, the frequency of inflammation or scarring of the lungs is uncommon); damage to the tiny filters inside the kidneys that determines reduced kidney function (glomerulonephritis).
Very rare(may affect up to 1 in 10,000 people): inability of the bone marrow to produce essential blood cells.
Not known(frequency cannot be estimated from available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Additional side effects in children and adolescents
The side effects and their frequency observed in children and adolescents are similar to those described above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enbrel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the MYCLIC pre-filled pen after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Keep the pre-filled pens in the outer packaging to protect the medicine from light.
After taking a pre-filled pen from the refrigerator wait approximately 15-30 minutes to allow
the Enbrel solution in the pen to reach room temperature.Do not heat it in
any other way. Immediate use is then recommended.
Enbrel can be stored at a maximum temperature of 25°C for up to 4 weeks, for a single
time only; after this period it cannot be returned to the refrigerator. If not used within 4
weeks outside the refrigerator, Enbrel must be discarded. It is recommended to note the date on which Enbrel is
removed from the refrigerator and the date by which Enbrel must be discarded (no more than 4 weeks outside
the refrigerator).
Inspect the solution inside the pen by looking through the transparent inspection window.
The solution should be from clear to slightly opalescent, from colourless to light yellow or
light brown and may contain small, white or almost transparent protein particles. This is
the normal appearance of Enbrel. Do not use this solution if it has changes in colour or appears cloudy
or if particles other than those described are visible. If you have any doubts about the appearance of
the solution, contact your pharmacist for assistance.
Do not dispose of any medicine in the water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enbrel contains
The active ingredient of Enbrel is etanercept. Each MYCLIC pre-filled pen contains 25 mg of
etanercept.
The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, monobasic sodium
phosphate dihydrate and dibasic sodium phosphate dihydrate and water for injections.

Description of the appearance of Enbrel and contents of the pack
Enbrel is supplied as an injectable solution in a pre-filled pen (MYCLIC)
(injectable solution). The MYCLIC pen contains a clear injectable solution, from colourless to
light yellow or light brown. Each pack contains 4, 8 or 24 pre-filled pens and 4, 8 or 24
alcohol swabs. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12,
2870 Puurs-Sint-Amands
Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Κύπρος
PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH)
T  : +357 22 817690

Česká Republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Magyarország
Pfizer Kft.
Tel: +36 1 488 3700

Danmark
Pfizer ApS
Tlf: +45 44 201 100

Malta
Vivian Corporation Ltd.
Tel: +35621 344610

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

България
Пфайзер Люксембург САРЛ,
Клон България
Teл: +359 2 970 4333

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
PFIZER EΛΛAΣ A.E.
Τηλ.: +30 210 67 85 800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Télf: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00

France
Pfizer
Tél +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL ,Pfizer, podružnica
for pharmaceutical consulting activities, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská Republika
Pfizer Luxembourg SARL, organizational component
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Tel: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel. +371 67035775

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

7. Instructions for Use

Enbrel 25 mg solution for injection in pre-filled pen
(etanercept)
For subcutaneous injection only

Introduction

The following instructions explain how to use the MYCLIC pen to administer Enbrel.
Read the instructions carefully and follow them step by step.
Your doctor will tell you how to inject Enbrel. Do not attempt an injection until you are sure you understand how to use the MYCLIC pen appropriately.
If you have any questions about how to perform the injection, ask your doctor for help.

The pre-filled MYCLIC pen
Before the injection

White and light blue MYCLIC pre-compiled pen with arrow indications on piston and protective cap

White cap
of the needle
Grey activation button
Expiration date Transparent control window

After the injection

White and light blue MYCLIC injectable pen with dose indicator and lateral blue button

Control window full Open end:
safety protection

Point 1: Prepare the Enbrel injection

White container with screw cap next to an insulin pen and two absorbent swabs in sealed packages

Arrangethe following material needed for each injection on a flat, clean and well-lit surface: o One MYCLIC pre-filled pen. o An alcohol-soaked swab. o A suitable container for sharp objects (not included). o Cotton balls or clean gauze pads (not included).
Do notshake the pen.
Do notremove the white cap until you are asked to do so.
For a more comfortable injection, leave the pen at room temperature for 15-30 minutes with the white cap in place.
Do notuse other methods to warm the pen.

Point 2: Check expiration date and dose on the label

MyClic injection pen held by a hand, with indication of the release button and detail of the

Checkthe expiration date (month/year) printed on the pen label.
Make surethat the correct dose is indicated on the pen label.
Do notuse the pen if the expiration date has passed or if the dose indicated is not the one prescribed and contact your doctor for assistance.

Point 3: Inspect the medicine

Hand holding a diagnostic test device with a viewing window and a positive result indicated by a colored line

Inspectthe medicine inside the pen by looking through the transparent control window. The solution should be clear or slightly opalescent, from colorless to light yellow or light brown, and may contain small, white or nearly transparent protein particles. This appearance is normal for Enbrel.
Do notuse the medicine if it has a color change, appears cloudy, or if particles other than those described are visible. If you have doubts about the appearance of the medicine, contact your doctor for assistance.
Note:you may observe an air bubble in the window. This is normal.

Point 4: Choose and clean the injection site

Diagram of the human body with areas highlighted for subcutaneous injection abdominal and gluteal with enlargement of the back

Diagram of the human body with injection areas indicated on the

Choosethe middle front of the upper thighs or the stomach area 5 cm away from the navel as the injection site. If the injection is performed by an assistant, the outer area of the upper arms can also be used.
Eachinjection must be made at least 3 cm away from the site where the previous injection was made. Do notinject into areas where the skin is sensitive, reddened or hardened. Avoid areas with scars or stretch marks. If you have psoriasis, do notinject directly into swollen, thickened, red or scaly areas of the skin.
Cleanthe injection site with soap and water or, if appropriate, with an alcohol-soaked swab.
Letit dry. Do nottouch, wave or blow on the cleaned injection site.

Point 5: Remove the needle cap

Hands assembling a pen device for injection with two white and grey cylindrical components

Removethe white needle cap by pulling it firmly, being careful notto bend it.
Do notreattach it once it has been removed.
After removing the needle cap, a violet-colored needle safety protection will be slightly visible protruding from the end of the pen. Do notpush the safety protection at the end with your fingers or thumbs.
Do notuse the pen if it falls without the needle cap. Note:a drop of liquid may remain at the end of the needle. This is normal.

Point 6: Press the pen firmly against the skin

Hand holding an injection pen device with an arrow indicating the

Pressthe open end of the pen firmly against the skin at a 90-degree angle so as to push the violet-colored needle safety protection completely inside the pen. Note:you will only be able to press the grey button when the needle protection is completely pushed inside the pen. Pinching or stretching the skin before the injection may allow you to further stretch the injection site, facilitating the pressing of the injection button.

Point 7: Start the injection

Auto-injector device with two phases illustrated by arrows and writings: first click to start and second click or 10 seconds to finish

Uniform purple background without any visible elements or text

Uniform light lavender background without any visible elements or details

Uniform purple background without any elements or details

Uniform purple background with shades from bluish to pale pink

Prefilled syringe with needle protected by transparent safety cap on a pale purple background

Pressthe grey button completely until you hear a “click”, which indicates the start of the injection.
Continue to holdthe pen firmly pressed against the skin until you hear a second “click”or for a total of 10 seconds after the first click (depending on which event occurs first). Note:if you are unable to start the injection as described, press the pen more firmly against the skin, then press the grey button again.

Point 8: Lift from the skin

Hand holding a white auto-injector device with needle pointing downwards and blue arrow indicating the direction of insertion

Removethe pen from the skin by lifting it perpendicularly from the injection site.
The violet-colored needle safety protection will automatically extend to cover the needle.

Point 9: Check the control window

Injectable pen with blue button and needle protected by black cap on a light grey background

Checkthe pen control window: it should be completely purple.
If the window is not purple, the pen may not have injected the dose completely. Contact your doctor for assistance. Do notattempt to use the pen again. Do notattempt to use another pen.
If you notice a blood stain at the injection site, press a cotton ball or gauze pad on the injection site for 10 seconds. Do notrub the injection site. Note:the injection button may remain pressed. This is normal.

Point 10: Dispose of

Hand pressing a blue pen device onto a grey pharmaceutical container with a sealing membrane

Dispose ofthe used pen as instructed by your doctor. Do notattempt to re-cap the pen.
Do notpress on the end of the needle safety protection. If you have any questions, please contact your referring doctor.
-End of instructions for use-

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Enbrel 50 mg solution for injection in pre-filled pen

etanercept

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you

Keep this leaflet. You may need to read it again.
Your doctor will provide you with the Patient Information Card which contains important safety information that you should be aware of before and during treatment with Enbrel.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or for a child. Do not pass it on to others, even if their symptoms are the same as yours or the child’s, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Enbrel is and what it is used for
2. What you need to know before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Contents of the pack and other information
7. Instructions for use

1. What is Enbrel and what it is used for

Enbrel is a medicine made from two human proteins. It blocks the activity of another protein that
causes inflammation in the human body. Enbrel works by reducing the inflammation associated
with certain diseases.
In adults (aged 18 years and over), Enbrel can be used for the treatment of rheumatoid arthritisfrom moderate to severe, psoriatic arthritis, severe axial spondyloarthritis
including ankylosing spondylitis, and moderate to severe psoriasis- in each case
usually when other widely used treatments have not worked well enough or are not
suitable for you.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may
also be used alone if treatment with methotrexate is not suitable for you. Whether used alone or in
combination with methotrexate, Enbrel can slow down the damage to the joints
caused by rheumatoid arthritis and improves the ability to perform normal daily activities.
For patients with psoriatic arthritis with involvement of multiple joints, Enbrel can
improve the ability to perform daily activities. For patients with multiple symmetrical painful or
swollen joints (e.g. hands, wrists and feet), Enbrel can slow down the structural damage
to these joints caused by the disease.
Enbrel is also prescribed for the treatment of the following conditions in children and adolescents:

For the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficiently good response or is not appropriate:
Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients aged 2 years and over
Psoriatic arthritis in patients aged 12 years and over.
For arthritis related to enthesitis in patients aged 12 years and over, when other widely used treatments have not given a sufficiently good response or are not appropriate.
Severe psoriasis in patients aged 6 years and over who have had an inadequate response with (or cannot take) phototherapies or other systemic therapies.

2. What you need to know before using Enbrel

Do not use Enbrel

if you, or your child, are allergic to etanercept or to any of the other ingredients of Enbrel (listed in section 6). If you or your child experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
if you, or your child, have or are at risk of developing a serious blood infection called sepsis. If you are unsure, contact your doctor.
if you, or your child, have any type of infection. If you are unsure, consult your doctor.

Warnings and precautions
Talk to your doctor before taking Enbrel.

Allergic reactions:If you, or your child, experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact your doctor immediately.
Infections/surgery:If you, or your child, develop a new infection or are about to have any major surgery. Your doctor may want to check your treatment with Enbrel.
Infections/diabetes: Tell your doctor if you or your child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
Infections/monitoring: Tell your doctor about any recent travel outside of Europe. If you, or your child, develop symptoms of an infection such as fever, chills or cough, inform your doctor immediately. Your doctor may decide to continue monitoring you or your child for infections after you or your child have stopped taking Enbrel.
Tuberculosis: Because cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will check you for signs and symptoms of tuberculosis before starting treatment with Enbrel. This may include a thorough review of your medical history, chest X-rays and a tuberculin test. The results of these tests should be reported on the Patient Card. It is very important that you tell your doctor if you or your child have ever had tuberculosis or if you have been in close contact with someone with tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness, low-grade fever) or any other infection appear during or after therapy, tell your doctor immediately.
Hepatitis B: Tell your doctor if you or your child have or have had hepatitis B. Your doctor must test for hepatitis B before you or your child start treatment with Enbrel. Treatment with Enbrel can cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. In this case, you must stop using Enbrel.
Hepatitis C: Tell your doctor if you or your child have hepatitis C. Your doctor may consider monitoring your treatment with Enbrel if the infection worsens.
Blood disorders: Seek immediate medical attention if you or your child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. These symptoms may indicate the presence of blood disorders that are potentially life-threatening and may require discontinuation of treatment with Enbrel.
Nervous system and eye disorders: Tell your doctor if you or your child have multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). Your doctor will assess whether Enbrel is an appropriate treatment.
Congestive heart failure: Tell your doctor if you or your child have a history of congestive heart failure, as Enbrel should be used with caution in these circumstances.
Cancer:Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer, before taking Enbrel. Patients with severe, long-standing rheumatoid arthritis may be at a higher than average risk of developing lymphoma. Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer. Some children and adolescent patients who have been treated with Enbrel or other medicines that work like Enbrel have developed cancers, sometimes rare, sometimes fatal. Some patients receiving Enbrel have developed skin cancers. Tell your doctor if you or your child develop any changes in the appearance of the skin or growths on the skin.
Chickenpox:Tell your doctor if you or your child are exposed to chickenpox while using Enbrel. Your doctor will assess whether preventive treatment for chickenpox is appropriate.
Latex: The needle cap of the MYCLIC pen is made of latex (dried natural rubber). Contact your doctor before using Enbrel if the needle cap is handled by, or Enbrel is administered to, a person with known or possible hypersensitivity (allergy) to latex.
Alcohol abuse:Enbrel should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or your child have a history of alcohol abuse.
Wegener's granulomatosis:Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or your child have Wegener's granulomatosis, consult your doctor.
Anti-diabetic medicines:Tell your doctor if you or your child suffer from diabetes or are taking medicines to treat diabetes. Your doctor may decide whether you or your child need to receive less anti-diabetic medicine while taking Enbrel.

Children and adolescents
Vaccinations: If possible, before using Enbrel, children should be up to date with
all vaccinations. Some vaccines, such as the oral polio vaccine, should not be given
while taking Enbrel. Consult your doctor before you or your child receive any
vaccine.
Generally Enbrel should not be used in children with extended polyarthritis or oligoarthritis under the age of
2 years, or in children with enthesitis-related arthritis or psoriatic arthritis under the age of
12 years, or in children with psoriasis under the age of 6 years.

Pregnancy and breastfeeding
Enbrel should be used in pregnancy only if clearly necessary. If you are pregnant,
suspect you are pregnant, or are planning a pregnancy, ask your doctor for advice.
If you have received Enbrel during pregnancy, the newborn may be at increased risk of
infection. In addition, one study indicated that there was a higher number of birth defects in mothers who received Enbrel during pregnancy compared to mothers who did not receive Enbrel or other
similar medicines (TNF antagonists), but no particular type of birth defect emerged among those reported. Another study did not show an increased risk of birth defects when mothers received Enbrel during pregnancy. Your doctor will help you
decide if the benefits of treatment outweigh the potential risks to your baby.
Talk to your doctor if you wish to breastfeed while taking Enbrel. It is important
to inform your child’s pediatricians and other healthcare professionals about the use of Enbrel during
pregnancy and breastfeeding before your baby receives any vaccine.

Driving and using machines
It is not expected that the use of Enbrel will affect your ability to drive or operate
machinery.

Enbrel contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially “sodium-free”.

3. How to use Enbrel

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
If you feel that the effect of Enbrel is too strong or too weak, consult your doctor or
pharmacist.
You have been prescribed a dosage of Enbrel 50 mg. A dosage of Enbrel 25 mg is available for
25 mg doses.

Dosage for adult patients
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg, administered twice a week or 50 mg once a week
by subcutaneous injection. In any case, the doctor may establish a different frequency with which to inject Enbrel.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week or 50 mg administered once
a week.
Alternatively, a 50 mg dose may be administered twice a week for up to 12
weeks, followed by a 25 mg dose administered twice a week or a 50 mg dose
administered once a week.
The doctor will decide how long you should take Enbrel and whether, based on your response, a new treatment is
necessary. If, after 12 weeks, Enbrel has no effect on your condition, your doctor may tell you to stop treatment.

Use in children and adolescents
The appropriate dose and frequency of dosage for the child or adolescent will depend on the
body weight and the disease. The doctor will establish the correct dose for your child and prescribe a
suitable dosage of Enbrel (10 mg, 25 mg or 50 mg).
For polyarticular or extended oligoarticular arthritis in patients starting from 2 years of age, or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of Enbrel
per kg of body weight (up to a maximum of 25 mg), administered twice a week, or 0.8 mg
of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of Enbrel per kilogram of
body weight (up to a maximum of 50 mg) and must be administered once a week. If
Enbrel has no effect on the child's condition after 12 weeks, the doctor may tell you to
stop treatment with this medicine.
The doctor will provide you with detailed information on how to prepare and measure the appropriate dosage.

How and route of administration
Enbrel is administered by injection under the skin (subcutaneous injection).
Enbrel can be taken with or without food and beverages.

Detailed instructions on how to inject Enbrel are provided in section 7 “Instructions for
use”.Do not mix the Enbrel solution with other medicines.
To help you remember, it may be useful to write in an agenda on which day(s) of the week
Enbrel should be used.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions
If any of the following side effects occur, do not inject Enbrel any more. Immediately inform your doctor, or go to the nearest hospital emergency room.

Difficulty swallowing or breathing
Swelling of the face, throat, hands or feet
Feeling of nervousness or anxiety, palpitations, sudden redness of the skin and/or feeling of warmth
Severe skin rash, itching, hives (raised, red or pale patches of skin that often itch)

Severe allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel; therefore, you should seek immediate medical attention.

Serious side effects
If you notice any of the following effects, you or the child may need urgent medical attention.

Symptoms of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area of skin or joints.
Symptoms of blood disorders, such as bleeding, bruising or paleness.
Symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg.
Symptoms of heart failure or worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of swelling in the neck or abdomen, shortness of breath at night or cough, bluish color of the fingernails or lips.
Symptoms of tumors: tumors can affect any part of the body, including the skin and blood, and the possible symptoms depend on the type and location of the tumor. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin.
Symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensations or vision.
Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
Symptoms of blood vessel inflammation, such as pain, fever, redness or overheating of the skin or itching.

These side effects are rare or uncommon, but are serious conditions (some of which can rarely cause death). If these symptoms occur, immediately inform your doctor, or go to the nearest hospital emergency room.
The known side effects of Enbrel include those listed below, grouped by decreasing frequency:

Very common(may affect more than 1 in 10 people): Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain and swelling) (these are less common after the first month of treatment; some patients have developed a reaction at a recently used injection site); headache.
Common(may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).
Uncommon(may affect up to 1 in 100 people): Serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin cancer (excluding melanoma); localized swelling of the skin (angioedema); hives (raised, red or pale patches of skin that often itch); eye inflammation; psoriasis (first appearance or worsening); inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also undergoing treatment with methotrexate, the frequency of increased liver enzymes in the blood is common); abdominal pain and cramps, diarrhea, weight loss or blood in the stool (symptoms of bowel problems).
Rare(may affect up to 1 in 1,000 people): Severe allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); joint reduction in the number of platelets, red blood cells and white blood cells; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include a persistent rash, fever, joint pain and fatigue); rash that can lead to blisters and severe skin peeling; lichenoid reactions (itchy reddish/purple rash and/or whitish-greyish linear streaks on mucous membranes); inflammation of the liver caused by your immune system (autoimmune hepatitis; in patients also undergoing treatment with methotrexate, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also undergoing treatment with methotrexate, the frequency of inflammation or scarring of the lungs is uncommon); damage to the tiny filters within the kidneys that determines reduced kidney function (glomerulonephritis).
Very rare(may affect up to 1 in 10,000 people): inability of the bone marrow to produce essential blood cells.
Not known(frequency cannot be estimated from available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Additional side effects in children and adolescents
The side effects and their frequency observed in children and adolescents are similar to those described above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Enbrel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the MYCLIC pre-filled pen after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Keep the pre-filled pens in the outer packaging to protect the medicine from light.
After taking a pre-filled pen from the refrigerator wait approximately 15-30 minutes to allow
the Enbrel solution in the pen to reach room temperature.Do not heat it in
any other way. Immediate use is then recommended.
Enbrel can be stored at a maximum temperature of 25°C for up to 4 weeks, for a single
time only; after this period it cannot be returned to the refrigerator. If not used within 4
weeks outside the refrigerator, Enbrel must be discarded. It is recommended to note the date on which Enbrel is
removed from the refrigerator and the date by which Enbrel must be discarded (no more than 4 weeks outside
the refrigerator).
Inspect the solution inside the pen by looking through the transparent inspection window.
The solution should be from clear to slightly opalescent, from colourless to light yellow or
light brown and may contain small, white or almost transparent protein particles. This is
the normal appearance of Enbrel. Do not use this solution if it shows colour changes or appears cloudy
or if particles other than those described are visible. If you have any doubts about the appearance of
the solution, contact your pharmacist for assistance.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enbrel contains
The active ingredient of Enbrel is etanercept. Each MYCLIC pre-filled pen contains 50 mg of
etanercept.
The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, monobasic sodium
phosphate dihydrate and dibasic sodium phosphate dihydrate and water for injections.

Description of Enbrel’s appearance and package contents
Enbrel is supplied as an injectable solution in a pre-filled pen (MYCLIC)
(injectable solution). The MYCLIC pen contains a clear, colorless to light yellow or light brown injectable solution. Each pack contains 2, 4 or 12 pre-filled pens and 2, 4 or 12
alcohol swabs. Not all pack sizes may be marketed.

Marketing Authorisation Holder

and
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Κύπρος
PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH)
T  : +357 22 817690

Česká Republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Magyarország
Pfizer Kft.
Tel: +36 1 488 3700

Danmark
Pfizer ApS
Tlf: +45 44 201 100

Malta
Vivian Corporation Ltd.
Tel: +35621 344610

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

България
Пфайзер Люксембург САРЛ,
Клон България
Teл: +359 2 970 4333

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Pfizer AS
Tlf: +47 67 52 61 00

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Tel: +372 666 7500

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Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

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PFIZER EΛΛAΣ A.E.
Τηλ.: +30 210 67 85 800

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Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

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Télf: +34 91 490 99 00

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Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00

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Pfizer
Tél +33 (0)1 58 07 34 40

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Tel: +40 (0) 21 207 28 00

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Tel: +385 1 3908 777

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for pharmaceutical consulting activities, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

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Tel: +421 2 3355 5500

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Tel: +354 540 8000

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Pfizer Oy
Puh/Tel: +358 (0)9 430 040

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Pfizer S.r.l.
Tel: +39 06 33 18 21

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Tel: +46 (0)8 550 520 00

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel. +371 67035775

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

7. Instructions for Use

Enbrel 50 mg solution for injection in pre-filled pen
(etanercept)
For subcutaneous injection only

Introduction

The following instructions explain how to use the MYCLIC pen to administer Enbrel.
Read the instructions carefully and follow them step by step.
Your doctor will tell you how to inject Enbrel. Do not attempt an injection until you are sure you understand how to use the MYCLIC pen correctly.
If you have any questions about how to perform the injection, ask your doctor for help.

The pre-filled MYCLIC pen
Before the injection

White and light blue MYCLIC device with scale indicator and arrows showing the drug release mechanism

White cap
of the needle
Green activation button
Expiry date Transparent control
window

After the injection

White and blue prefilled MYCLIC pen with batch and expiry indications and lateral blue release button

Control window full Open end: safety
protection

Point 1: Prepare the Enbrel injection

White container with screw cap, two gauze swabs, two plasters and a blue and white injectable pen

Arrangethe following materials needed for each injection on a flat, clean and well-lit surface: o One pre-filled MYCLIC pen. o An alcohol swab. o A suitable sharps container (not included). o Cotton balls or clean gauze pads (not included).
Do notshake the pen.
Do notremove the white cap until you are asked to do so.
For a more comfortable injection, leave the pen at room temperature for 15-30 minutes with the white cap in place.
Do notuse other methods to warm the pen.

Point 2: Check expiry date and dose on the label

MYCLIC injection pen with finger pressing the button and enlarged detail of the words Lot and Exp on the label

Checkthe expiry date (month/year) printed on the pen label.
Make surethe pen label shows the correct dose.
Do notuse the pen if the expiry date has passed or if the dose shown is not the one prescribed and contact your doctor for assistance.

Point 3: Inspect the medicine

Hand holding an injection pen with yellow cartridge visible through the

Inspectthe medicine inside the pen by looking through the transparent control window. The solution should be clear or slightly opalescent, from colorless to light yellow or light brown, and may contain small white or almost transparent protein particles. This appearance is normal for Enbrel.
Do notuse the medicine if it has a change in color, appears cloudy, or if particles other than those described are visible. If you have any doubts about the appearance of the medicine, contact your doctor for assistance.
Note:you may observe an air bubble in the window. This is normal.

Point 4: Choose and clean the injection site

Diagram of the human body with areas highlighted for intramuscular injection: buttocks, thighs and upper lateral abdominal area

Diagram of the human body with indications for

Choosethe middle anterior part of the upper thighs or the stomach area 5 cm away from the navel as the injection site. If the injection is performed by an assistant, the outer area of the upper arms can also be used.
Eachinjection must be made at least 3 cm away from the site where the previous injection was made. Do notinject into areas where the skin is sensitive, red or hardened. Avoid areas where there are scars or stretch marks. If you have psoriasis, do notinject directly into swollen, thickened, red or scaly areas of the skin.
Cleanthe injection site with soap and water or, if appropriate, with an alcohol swab.
Letit dry. Do nottouch, wave or blow on the cleaned injection site.

Point 5: Remove the needle cap

Hands assembling a pen injection device with a white protective needle and a gray and white pen body

Removethe white needle cap by pulling it firmly, being careful notto bend it.
Do notre-attach it once it has been removed.
After removing the needle cap, a purple needle safety protection will be slightly visible, protruding from the end of the pen. Do notpush the safety protection at the end with your fingers or thumbs.
Do notuse the pen if it falls without the needle cap. Note:a drop of liquid may remain at the end of the needle. This is normal.

Point 6: Press the pen firmly against the skin

Hand holding an auto-injector device with an arrow indicating downward pressure and enlargement of the injection mechanism

Pressthe open end of the pen firmly against the skin at a 90-degree angle to push the purple needle safety protection completely inside the pen. Note:you will only be able to press the green button when the needle protection is fully pushed inside the pen. Pinching or stretching the skin before the injection may further stretch the injection site, facilitating the pressure of the injection button.

Point 7: Start the injection

Hand pressing a button with an arrow and text

Syringe with needle injecting the drug into the subcutaneous tissue with an injection angle indicated

Pressthe green button completely until you hear a “click”, which indicates the start of the injection.
Continue to holdthe pen firmly against the skin until you hear a second “click”or for a total of 10 seconds after the first click (depending on which event occurs first). Note:if you cannot start the injection as described, press the pen more firmly against the skin, then press the green button again.

Point 8: Lift from the skin

Hand holding an auto-injector device with needle pointing downwards on a skin surface and blue arrow towards

Removethe pen from the skin by lifting it perpendicularly from the injection site.
The purple needle safety protection will automatically extend to cover the needle.

Point 9: Check the control window

Injectable pen with blue button pressed by a finger on a white circular background with rays

Checkthe pen control window: it should be completely purple.
If the window is not purple, the pen may not have injected the full dose. Contact your doctor for assistance. Do notattempt to use the pen again. Do notattempt to use another pen.
If you notice a blood stain at the injection site, press a cotton ball or gauze onto the injection site for 10 seconds. Do notrub the injection site. Note:the injection button may remain pressed. This is normal.

Point 10: Dispose of

Hand holding a blue and black pen device over a gray cylindrical container with a snap-on lid

Dispose ofthe used pen as instructed by your doctor. Do notattempt to re-cap the pen.
Do notpress on the end of the needle safety protection. If you have any questions, please contact your doctor.
-End of instructions for use--

Enbrel 10 mg powder and solvent for injectable solution for paediatric use

etanercept

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will provide you with the Patient Information Sheet which contains important safety information that you should be aware of before and during treatment with Enbrel.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a child. Do not give it to other people, even if their symptoms are the same as those of the child, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Enbrel is and what it is used for
2. What you need to know before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Contents of the pack and other information
7. Instructions for use

1. What is Enbrel and what is it used for

Enbrel is a medicine obtained from two human proteins. It blocks the activity of another protein that
causes inflammation in the human body. Enbrel works by reducing the inflammation associated
with certain diseases.
Enbrel is prescribed for the treatment of the following conditions in children and adolescents:

For the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficiently good response or is not appropriate:
Polyarthritis (positive or negative for rheumatoid factor) and extended oligoarthritis in patients aged 2 years and older
Psoriatic arthritis in patients aged 12 years and older.
For arthritis related to enthesitis in patients aged 12 years and older, when other widely used treatments have not given a sufficiently good response or are not appropriate.
Severe psoriasis in patients starting from 6 years of age who have had an inadequate response with (or cannot take) phototherapies or other systemic therapies.

2. What you need to know before using Enbrel

Do not use Enbrel

if the child is allergic to etanercept or to any of the other ingredients of Enbrel (listed in section 6). If the child were to experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact the doctor immediately.
if the child has or is at risk of developing a serious blood infection called sepsis. If you have any doubts, contact the doctor.
if the child has any type of infection. If you have doubts, consult your doctor.

Warnings and precautions
Consult your doctor before taking Enbrel.

Allergic reactions:If the child experiences allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Enbrel and contact the doctor immediately.
Latex:The rubber cap of the syringe is made of latex (dried natural rubber). Contact your doctor before using Enbrel if the syringe will be handled by, or if Enbrel will be administered to, people with a known or suspected hypersensitivity (allergy) to latex.
Infections/surgery:If the child develops a new infection or is about to undergo any major surgical procedure, the doctor may want to check the child’s treatment with Enbrel.
Infections/diabetes: Tell the doctor if the child has a history of recurrent infections or suffers from diabetes or other conditions that increase the risk of infection.
Infections/monitoring: Tell the doctor about any recent travel outside of Europe. If the child develops symptoms of an infection such as fever, chills or cough, inform the doctor immediately. The doctor may decide to continue monitoring the child for infections after the child has stopped taking Enbrel.
Tuberculosis: Because cases of tuberculosis have been reported in patients treated with Enbrel, the doctor will check to see if there are any signs and symptoms of tuberculosis before starting treatment with Enbrel. This may include a thorough review of their medical history, chest X-rays and a tuberculin test. The results of these tests should be reported on the Patient Card. It is very important that you tell the doctor if the child has ever had tuberculosis or if they have been in close contact with someone with tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness, mild fever) or any other infection appear during or after therapy, inform the doctor immediately.
Hepatitis B: Tell the doctor if the child has hepatitis B. The doctor must test for hepatitis B before the child starts treatment with Enbrel. Treatment with Enbrel can cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. In this case, you must stop using Enbrel.
Hepatitis C: Tell the doctor if the child has hepatitis C. The doctor may consider it appropriate to monitor treatment with Enbrel if the infection worsens.
Blood disorders: Seek immediate medical attention if the child has any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. These symptoms may indicate the presence of blood disorders that are potentially life-threatening and may require discontinuation of treatment with Enbrel.
Nervous system and eye disorders: Tell the doctor if the child has multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). The doctor will assess whether Enbrel is an appropriate treatment.
Cancer:Tell the doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer, before taking Enbrel.

Patients with severe, long-standing rheumatoid arthritis may be at a higher risk
than average of developing lymphoma.
Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer.
Some children and adolescent patients who have been treated with Enbrel or other medicines that
act like Enbrel have developed tumors, sometimes unusual, and sometimes fatal.
Some patients receiving Enbrel have developed skin tumors. Tell the doctor if
the child develops any changes in the appearance of the skin or growths on the skin.

Congestive heart failure: Tell the doctor if the child has a history of congestive heart failure, as Enbrel should be used with caution in these circumstances.
Chickenpox:Tell the doctor if the child is exposed to chickenpox while using Enbrel. The doctor will assess whether prophylactic treatment for chickenpox is appropriate.
Alcohol abuse: Enbrel should not be used to treat hepatitis related to alcohol abuse. Tell the doctor if the child has a history of alcohol abuse.
Wegener's granulomatosis:Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If the child has Wegener's granulomatosis, consult your doctor.
Anti-diabetic medicines: Tell the doctor if the child suffers from diabetes or is taking medicines to treat diabetes. Your doctor may decide whether the child needs to receive less anti-diabetic medicine while taking Enbrel.

Children and adolescents
Vaccinations: If possible, before using Enbrel, children should be up to date with
all vaccinations. Some vaccines, such as oral polio vaccine, should not be given
while taking Enbrel. Consult your doctor before the child receives any
vaccine.
Generally, Enbrel should not be used in children with extended polyarthritis or oligoarthritis under the age of
2 years, or in children with enthesitis-related arthritis or psoriatic arthritis under the age of
12 years, or in children with psoriasis under the age of 6 years.

Other medicines and Enbrel
Tell your doctor or pharmacist if the child is taking, has recently taken or might take
other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the child’s doctor.
The child should not use Enbrel together with the active ingredient anakinra or
abatacept.

Pregnancy and breastfeeding
Enbrel should be used in pregnancy only if clearly necessary. If you are pregnant,
suspect you are pregnant or are planning a pregnancy, ask your doctor for advice.
If you have received Enbrel during pregnancy, the newborn may be at increased risk of
infection. In addition, one study indicated that there was a higher number of birth defects in mothers who received Enbrel during pregnancy compared to mothers who did not receive Enbrel or other
medicines similar (TNF antagonists), but no particular type of birth defect emerged among those reported. Another study did not show an increased risk of birth defects when mothers received Enbrel during pregnancy. Your doctor will help you
decide if the benefits of treatment outweigh the potential risk to your baby.
Contact your doctor if you wish to breastfeed while taking Enbrel. It is important
to inform the child’s pediatricians and other healthcare professionals about the use of Enbrel during
pregnancy and breastfeeding before the child receives any vaccine.

Driving and using machines
It is not expected that the use of Enbrel will affect the ability to drive vehicles or use
machinery.

3. How to use Enbrel

Use in children and adolescents
Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
If you feel that the effect of Enbrel is too strong or too weak, contact your doctor or
pharmacist.
The appropriate dose and frequency of dosage for the child or adolescent will depend on body
weight and the disease. The doctor will provide you with detailed information on how to prepare and measure the
appropriate dosage.
The 10 mg vial is for children who have been prescribed a dose of 10 mg or less. Each
vial must be used only as a single dose for one patient and any unused solution
in the vial must be discarded.
For polyarthritis or extended oligoarthritis in patients starting from 2 years of age or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of Enbrel
per kilogram of body weight (up to a maximum of 25 mg) administered 2 times a week or 0.8 mg
of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of Enbrel per kilogram of
body weight (up to a maximum of 50 mg) and must be administered once a week. If
Enbrel has no effect on the child's condition after 12 weeks, your doctor may tell you to
stop treatment with this medicine.

Route of administration and how to administer
Enbrel is administered by injection under the skin (subcutaneous injection).
Enbrel can be taken with or without food and beverages.

Detailed instructions on how to inject Enbrel are in “Instructions for Use”.Do not mix the
Enbrel solution with other medicines.
To help you remember, it may be useful to write in an agenda on which day(s) of the week
Enbrel should be used.

If you use more Enbrel than you should
If you have used more Enbrel than you should (either by injecting too much at one time or by using
it too frequently), talk to a doctor or pharmacist immediately. Always keep the
medicine packaging with you, even if it is empty.

If you stop taking Enbrel
Following discontinuation of treatment, the symptoms of the disease may return.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions
If any of the following side effects occur in the child, do not inject Enbrel anymore.
Immediately inform the doctor, or go to the nearest hospital emergency room.

Difficulty swallowing or breathing
Swelling of the face, throat, hands or feet
Feeling of nervousness or anxiety, palpitations, sudden redness of the skin and/or feeling of warmth
Severe skin rash, itching, hives (raised red or pale patches of skin that often itch)

Severe allergic reactions are rare. If the child presents any of the symptoms above
it may indicate that he/she has an allergic reaction to Enbrel; therefore, immediate
medical attention should be sought.

Serious side effects
If you notice any of the following effects, the child may need urgent medical attention.

Symptoms of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area on the child’s skin or joints.
Symptoms of blood disorders, such as bleeding, bruising or paleness.
Symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg.
Symptoms of heart failure or worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of swelling in the neck or abdomen, shortness of breath at night or coughing, bluish color of the child’s fingernails or lips.
Symptoms of tumors: tumors can affect any part of the body, including the skin and blood, and the possible symptoms depend on the type and location of the tumor. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin.
Symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensations or vision.
Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
Symptoms of blood vessel inflammation, such as pain, fever, redness or overheating of the skin or itching.

These side effects are rare or uncommon, but are serious conditions (some of which
can rarely cause death). If these symptoms occur, immediately inform the doctor,
or take the child to the nearest hospital emergency room.
The known side effects of Enbrel include those listed below, grouped by
decreasing frequency:

Very common(may affect more than 1 in 10 people): Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain and swelling) (these do not occur as often after the first month of treatment; some patients have developed a reaction at a recently used injection site); headache.
Common(may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).
Uncommon(may affect up to 1 in 100 people): Serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin tumor (excluding melanoma); localized swelling of the skin (angioedema); hives (raised red or pale patches of skin that often itch); eye inflammation; psoriasis (first appearance or worsening); blood vessel inflammation affecting more than one organ; elevated liver enzymes in the blood (in patients also treated with methotrexate, the frequency of increased liver enzymes in the blood is common); abdominal pain and cramps, diarrhea, weight loss or blood in the stool (symptoms of bowel problems).
Rare(may affect up to 1 in 1,000 people): Severe allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer that affects the blood and bone marrow); melanoma (a type of skin cancer); combined reduction in the number of platelets, red blood cells and white blood cells; diseases of the nervous system (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include a persistent rash, fever, joint pain and fatigue); skin rash that can lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish/purple rash and/or whitish-greyish linear streaks on mucous membranes); inflammation of the liver caused by its immune system (autoimmune hepatitis; in patients also treated with methotrexate, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also treated with methotrexate, the frequency of inflammation or scarring of the lungs is uncommon); damage to the tiny filters inside the kidneys that determines reduced kidney function (glomerulonephritis).
Very rare(may affect up to 1 in 10,000 people): inability of the bone marrow to produce essential blood cells.
Not known(frequency cannot be estimated from available data): Merkel cell carcinoma (a type of skin cancer); Kaposi’s sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi’s sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Additional side effects in children and adolescents
The side effects and their frequency observed in children and adolescents are similar to those
described above.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Enbrel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Before preparing the Enbrel solution, Enbrel may be stored outside the refrigerator at
temperatures up to a maximum of 25°C, for a single period of time of four weeks; after
this period, it must not be placed back in the refrigerator. Enbrel must be discarded if it is not
used within the four weeks it has been kept out of the refrigerator. It is recommended to make a
note of the date on which Enbrel was removed from the refrigerator and the date after which Enbrel must
be discarded (no later than four weeks after removing it from the refrigerator). This new
expiry date must not exceed the one stated on the pack.
It is recommended to use the Enbrel solution immediately after preparation. However, the solution
can be used within a maximum period of 6 hours when stored at a temperature up to 25°C.
Do not use this medicine if you notice that the solution is not clear or if it contains particles. The
solution must appear clear and from colourless to light yellow or light brown, without any lumps,
flocculi or particles.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enbrel contains
The active ingredient of Enbrel is etanercept. Each vial of Enbrel 10 mg powder and solvent for
solution for injection for pediatric use contains 10 mg of etanercept. When reconstituted, the solution
contains 10 mg/mL of etanercept.
The other ingredients are:
Powder: Mannitol (E421), sucrose and trometamol
Solvent: water for injections

Description of the appearance of Enbrel and contents of the pack
Enbrel 10 mg powder and solvent for solution for injection for pediatric use is supplied as a powder
white with solvent for solution for injection (powder for injection). Each pack contains 4
vials, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adapters and 8 alcohol-soaked
pads.

Marketing authorization holder

in commerce
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Κύπρος
PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH)
T  : +357 22 817690

Česká Republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Magyarország
Pfizer Kft.
Tel: +36 1 488 3700

Danmark
Pfizer ApS
Tlf: +45 44 201 100

Malta
Vivian Corporation Ltd.
Tel: +35621 344610

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

България
Пфайзер Люксембург САРЛ,
Клон България
Teл: +359 2 970 4333

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
PFIZER EΛΛAΣ A.E.
Τηλ.: +30 210 67 85 800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Télf: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00

France
Pfizer
Tél +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL ,Pfizer, podružnica
for advisory services in the field of pharmaceutical
activity, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská Republika
Pfizer Luxembourg SARL, organizational component
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Tel: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel. +371 67035775

United Kingdom
Pfizer Limited
Tel: +44 (0)8 550 520 00

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +3705 2514000

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

7. Instructions for Use

This paragraph is divided into the following sub-paragraphs:

a.Introduction
b.Preparation of the injection
c.Prepare the dose of Enbrel for the injection
d.Adding the solvent
e.Withdrawing the Enbrel solution from the vial
f.Positioning the needle on the syringe
g.Choosing an injection site
h.Preparing the injection site and injecting the Enbrel solution
i.Disposal of materials
a.Introduction

The following instructions explain how to prepare and inject Enbrel. Read the instructions carefully and
follow them step by step. You will be instructed by your child’s doctor or nurse on the
injection technique and the amount to administer to the child. Do not attempt to administer
an injection until you are certain you have understood how to prepare and how to give the injection.
This injection must not be mixed in the same syringe or vial with any other
medication. See paragraph 5 for instructions on how to store Enbrel.

b.Preparation of the injection

Wash your hands thoroughly.
Choose a clean, well-lit, and flat work surface.
The dose tray should contain the materials listed below (if this is not the case, do not use the tray and consult your pharmacist). Use only the listed materials. DO NOTuse any other syringe. 1 Vial of Enbrel1 Prefilled syringe containing clear, colorless solvent (water for injections)1 Needle1 Vial adapter2 Alcohol swabs
Check the expiration dates on both the vial label and the syringe label. They must not be used after the month and year indicated.

c.Prepare the dose of Enbrel for the injection

Remove the contents of the tray.
Remove the plastic cap from the Enbrel vial (see Figure 1). DO NOTremove the gray cap or the aluminum ring around the neck of the vial.

Figure 1

Hand grabbing a glass vial with a gray cap and a needle partially inserted

Use a new alcohol swab to clean the gray cap on the Enbrel vial. After cleaning, do not touch the gray cap with your hands or allow it to touch any other surface.
Place the vial upright on a clean, flat surface.
Remove the paper backing from the vial adapter packaging.
Place the vial adapter on top of the Enbrel vial while it is still in the plastic packaging so that the tip of the vial adapter is centered with the raised circle above the vial cap (see Figure 2).
With one hand, hold the Enbrel vial firmly on a flat surface. With the other hand, push DOWN FIRMLYon the adapter packaging until you feel the tip of the adapter penetrate the vial cap AND YOU DO NOT FEEL THE ADAPTER EDGE SNAP INTO PLACE(see Figure 3). DO NOTpush the adapter down at an angle (see Figure 4). It is important that the tip of the vial adapter completely penetrates the vial cap.

Figure 2 Figure 3 Figure 4

Drug vial with gray cap and needle connected via a transparent protective adapter

Medicine vial with cap and needle penetrating vertically, arrows indicate the direction of insertion

CORRECTWRONG

Holding the vial in one hand, remove the plastic packaging from the adapter (see Figure 5).

Figure 5

Remove the protective cap from the end of the syringe by breaking the white cap along the perforation. This is done by holding the ring of the white cap while gripping the end of the white cap with the other hand and bending it down and then up until it breaks (see Figure 6). DO NOT remove the white ring thatremains on the syringe.

Figure 6

Hand removing the cap from a glass vial with a syringe connected, black arrow indicates direction of extraction

Do not use the syringe if the perforation between the end and the ring is already broken. Start over with another dose tray.
Holding the glass cylinder of the syringe in one hand (not the white ring), and the vial adapter (not the vial) in the other, connect the syringe to the vial adapter by inserting the cap into the opening and turning it clockwise until it is fully engaged (see Figure 7).

Figure 7

d.Adding the solvent

Holding the vial upright on a flat surface, push the plunger VERY SLOWLY until all the solvent is in the vial. This will help reduce foam formation (numerous bubbles) (see Figure 8).
Once the solvent has been added to Enbrel, the plunger may move on its own. This is caused by air pressure and is not a concern.

Figure 8

Syringe with needle inserted vertically into the skin, highlighted l

With the syringe still attached, gently move the vial back and forth several times with circular motions to dissolve the powder (see Figure 9). DO NOTshake the vial. Wait until all the powder has dissolved (usually less than 10 minutes). The solution should appear clear and from colorless to pale yellow or light brown, without any fragments, flakes, or particles. Some white foam may remain in the vial - this is normal. DO NOTuse Enbrel if all the powder in the vial does not dissolve within 10 minutes. Start over with another dose tray. Figure 9

Hand holding a prefilled syringe with needle inserted into a rubber stopper and curved arrows indicating the direction of rotation

e.Withdrawing the Enbrel solution from the vial

Your doctor or nurse will have instructed you on the correct amount of solution to withdraw from the vial. If your doctor has not given you instructions, contact them.
With the syringe still attached to the vial and vial adapter, hold the vial upside down at eye level. Push the plunger all the way into the syringe (see Figure 10).

Figure 10

Hand holding a syringe with needle inserted into the skin, arrow indicates direction of injection and dashed line shows subcutaneous layer

Then, slowly pull back the plunger to draw the liquid into the syringe (see Figure 11). Withdraw only the portion of liquid as prescribed by the child’s doctor. After withdrawing Enbrel from the vial, there may be air in the syringe. Do not worry as the air can be removed later.

Figure 11

Syringe with needle pointing downwards and hand holding it, black arrow indicates the direction of insertion

Holding the vial upside down, unscrew the syringe from the vial adapter by turning it counterclockwise (see Figure 12).

Figure 12

Place the filled syringe on a clean, flat surface. Make sure the tip does not touch anything. Be careful not to push the plunger down.

f.Positioning the needle on the syringe

The needle, to maintain its sterility, is placed in a plastic container.
To open the plastic container, hold the short, wide end in one hand. Place the other hand on the longer part of the container.
To break the seal, bend the wider short end down and then up until it breaks (see Figure 13).

Figure 13

Once the seal has been broken, remove the short, wide end of the plastic container.
The needle will remain in the long part of the packaging.
Holding the needle and container in one hand, take the syringe and insert the tip of the syringe into the opening of the needle.
Attach the syringe to the needle by turning it clockwise until it is fully engaged (see Figure 14).

Figure 14

Syringe with needle tilted shown with curved arrows indicating the direction of insertion and rotation

Remove the needle cap from the syringe by pulling it firmly, being careful not to touch the needle or allow the needle to touch any surface (see Figure 15). Be careful not to bend or twist the cap to avoid damaging the needle.

Figure 15

Holding the syringe straight, remove the air by slowly pushing the plunger until all the air is removed (see Figure 16).

Figure 16

g.Choosing an injection site

The three recommended injection sites for Enbrel include: (1) the mid-anterior thighs;

(2) the abdomen, except for the area 5 cm from around the navel; and (3) the outer area of the upper arms (see Figure 17). If you are self-administering an injection, you should not use the outer area of the upper arms.

Figure 17

A different site must be used for each new injection. Each new injection must be made at least 3 cm from a previous site. Do notinject into areas where the skin is sensitive, bruised, red, or hardened. Avoid areas where there are scars or stretch marks (it may be helpful to note the location of previous injection sites).
If the child suffers from psoriasis, you should try not to inject directly into the swollen, thickened, red, or scaly areas of the skin (“psoriatic skin lesions”).

h.Preparing the injection site and injecting the Enbrel solution

Rub the injection site where Enbrel is to be injected with a new alcohol swab using a circular motion. DO NOTtouch this area again before giving the injection.
When the cleaned skin area has dried, pinch it firmly with one hand. With the other hand, hold the syringe like a pencil.
With a quick, short motion, insert the needle completely into the skin at an angle of 45° to 90° (see Figure 18). With experience, you will find the angle that is most comfortable for the child. Be careful not to insert the needle into the skin too slowly or with great force.

Figure 18

When the needle is fully inserted into the skin, release the skin you are holding. With your free hand, hold the syringe near its base to stabilize it. Then push the plunger to inject all the solution at a slowand steady rate (see Figure 19).

Figure 19

When the syringe is empty, remove the needle from the skin, being careful to keep it at the same angle it was inserted. Press a cotton swab on the injection site for 10 seconds. Some slight bleeding may occur. DO NOTrub the injection site. A bandage is optional.

i.Disposal of materials

The syringe and needles must NEVERbe reused. Dispose of the needles and syringe as suggested by your doctor, nurse, or pharmacist.

If you have any questions, talk to a doctor, nurse, or pharmacist who is familiar
with Enbrel.

Enbrel 25 mg solution for injection in cartridge for delivery device

etanercept

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will provide you with the Patient Information Sheet which contains important safety information that you should be aware of before and during treatment with Enbrel.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or for a child. Do not give it to other people, even if they have the same symptoms as you or the child, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Enbrel is and what it is used for
2. What you need to know before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Contents of the pack and other information (see Instructions for Use)

1. What is Enbrel and what it is used for

Enbrel is a medicine made from two human proteins. It blocks the activity of another protein that
causes inflammation in the human body. Enbrel works by reducing the inflammation associated
with certain diseases.
In adults (aged 18 years or older), Enbrel can be used for the treatment of rheumatoid arthritisfrom moderate to severe, psoriatic arthritis, severe axial spondyloarthritis
including ankylosing spondylitis,and moderate to severe psoriasis- in each case
usually when other widely used treatments have not worked well enough or are not
suitable for you.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may
also be used alone if treatment with methotrexate is not suitable for you. Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to the joints
caused by rheumatoid arthritis and improves the ability to perform normal daily activities.
For patients with psoriatic arthritis with multiple joint involvement, Enbrel can
improve the ability to perform daily activities. For patients with multiple symmetrical painful or swollen joints (e.g. hands, wrists and feet), Enbrel can slow down the structural damage
to these joints caused by the disease.
Enbrel is also prescribed for the treatment of the following conditions in children and adolescents:

For the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficient response or is not appropriate:
Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients aged 2 years and over
Psoriatic arthritis in patients aged 12 years and over.
For arthritis related to enthesitis in patients aged 12 years and over, when other widely used treatments have not given a sufficient response or are not appropriate.
Severe psoriasis in patients aged 6 years and over who have had an inadequate response to (or cannot take) phototherapies or other systemic therapies.

2. Cosa deve sapere prima di usare Enbrel

Non usi Enbrel

Se lei, o il bambino, siete allergici ad etanercept o ad uno qualsiasi degli altri componenti di Enbrel (elencati al paragrafo 6). Se lei, o il bambino, manifestate reazioni allergiche quali costrizione toracica, respiro affannoso, capogiro od eruzione cutanea, non inietti altro Enbrel e contatti il medico immediatamente.
Se lei, o il bambino, presentate o siete a rischio di sviluppo di un’infezione grave del sangue chiamata sepsi. Se ha dei dubbi, contatti il medico.
Se lei, o il bambino, avete un’infezione di qualunque tipo. Se ha dubbi, si rivolga al medico.

Avvertenze e precauzioni
Si rivolga al medico prima di prendere Enbrel.

Reazioni allergiche:se lei, o il bambino, manifestate reazioni allergiche quali costrizione toracica, respiro affannoso, capogiro od eruzione cutanea, non inietti altro Enbrel e contatti il medico immediatamente.
Infezioni/operazioni chirurgiche:se lei, o il bambino, sviluppate una nuova infezione o state per essere sottoposti ad un qualsiasi intervento chirurgico importante. Il medico potrebbe voler controllare il trattamento con Enbrel.
Infezioni/diabete:informi il medico se lei o il bambino avete una storia di infezioni ricorrenti o soffrite di diabete o di altre condizioni che aumentano il rischio di infezione.
Infezioni/monitoraggio:informi il medico di qualsiasi recente viaggio fuori dall’Europa. Se lei, o il bambino, sviluppate i sintomi di un’infezione come febbre, brividi o tosse, avverta immediatamente il medico. Il medico può decidere di continuare a monitorare lei o il bambino per la presenza di infezioni dopo che lei o il bambino avete sospeso l’assunzione di Enbrel.
Tubercolosi:poiché sono stati riportati casi di tubercolosi in pazienti trattati con Enbrel, il medico la controllerà per verificare se ci sono segni e sintomi di tubercolosi prima di iniziare il trattamento con Enbrel. Questo potrebbe includere una accurata raccolta della sua storia clinica, raggi X del torace e il test alla tubercolina. L’esito di queste analisi deve essere riportato nella Scheda per il paziente. È molto importante che riferisca al medico se lei o il bambino avete mai contratto tubercolosi o se siete stati a stretto contatto con qualcuno affetto da tubercolosi. Se i sintomi della tubercolosi (come tosse persistente, perdita di peso, debolezza, febbre leggera) o qualsiasi altra infezione appaiono durante o dopo la terapia, lo comunichi immediatamente al medico.
Epatite B:informi il medico se lei o il bambino siete affetti o siete stati affetti da epatite B. Il medico deve effettuare il test per l’epatite B prima che lei o il bambino iniziate il trattamento con Enbrel. Il trattamento con Enbrel può causare la riattivazione di epatite B in pazienti con precedente infezione da virus dell’epatite B. In tal caso, deve smettere di usare Enbrel.
Epatite C:informi il medico se lei o il bambino siete affetti da epatite C. Il medico potrebbe ritenere opportuno monitorare il trattamento con Enbrel qualora l’infezione peggiori.
Disturbi del sangue:richieda immediatamente assistenza medica se lei o il bambino avete qualsiasi segno o sintomo quale febbre persistente, mal di gola, lividi, sanguinamento o pallore. Tali sintomi possono indicare la presenza di disordini del sangue potenzialmente pericolosi per la vita che possono richiedere l’interruzione del trattamento con Enbrel.
Disturbi del sistema nervoso e degli occhi:informi il medico se lei o il bambino avete la sclerosi multipla, la neurite ottica (infiammazione dei nervi ottici) o la mielite trasversa (infiammazione del midollo spinale). Il medico valuterà se Enbrel è un trattamento appropriato.
Insufficienza cardiaca congestizia:informi il medico se lei o il bambino avete una storia di insufficienza cardiaca congestizia, poiché Enbrel deve essere usato con cautela in queste circostanze.
Tumore:informi il medico se ha o ha mai avuto un linfoma (un tipo di tumore del sangue) o qualsiasi altro tumore, prima di assumere Enbrel. Pazienti affetti da artrite reumatoide grave da lungo tempo possono essere a rischio più alto della media di sviluppare un linfoma. Bambini ed adulti che prendono Enbrel possono avere un rischio maggiore di sviluppare un linfoma o un altro tumore. Alcuni bambini e pazienti adolescenti che sono stati trattati con Enbrel o con altri medicinali che agiscono come Enbrel hanno sviluppato tumori, anche di tipo insolito, talora con esito fatale. Alcuni pazienti che ricevevano Enbrel hanno sviluppato tumori della pelle. Informi il medico se lei o il bambino sviluppate qualsiasi cambiamento nell’aspetto della cute o proliferazioni sulla cute.
Varicella:informi il medico se lei o il bambino siete esposti alla varicella durante l’utilizzo di Enbrel. Il medico valuterà se è appropriato un trattamento preventivo per la varicella.
Lattice:la copertura dell’ago è fatta di lattice (gomma naturale essiccata). Contatti il medico prima di usare Enbrel nel caso che la copertura dell’ago venga maneggiata da, o nel caso che Enbrel venga somministrato ad, una persona con nota o possibile ipersensibilità (allergia) al lattice.
Abuso di alcol:Enbrel non deve essere utilizzato per il trattamento dell’epatite correlata all’abuso di alcol. Informi il medico se lei o il bambino avete una storia di abuso di alcol.
Granulomatosi di Wegener:Enbrel non è raccomandato per il trattamento della granulomatosi di Wegener, una malattia infiammatoria rara. Se lei o il bambino siete affetti da granulomatosi di Wegener, si rivolga al medico.
Medicinali anti-diabete:informi il medico se lei o il bambino soffrite di diabete o se state assumendo medicinali per trattare il diabete. Il suo medico può decidere se per lei o per il bambino è necessario ricevere meno medicinale anti-diabete, mentre state assumendo Enbrel.

Bambini e adolescenti
Vaccinazioni: Se possibile, prima di utilizzare Enbrel, i bambini devono essere in regola con tutte le
vaccinazioni. Alcuni vaccini, come il vaccino antipolio orale, non devono essere assunti mentre si sta
prendendo Enbrel. Consulti il pediatra prima che il bambino riceva qualsiasi vaccino.
Di norma Enbrel non deve essere utilizzato nei bambini con poliartrite o oligoartrite estesa di età
inferiore ai 2 anni, o nei bambini con artrite correlata ad entesite o artrite psoriasica di età inferiore ai
12 anni, o nei bambini con psoriasi di età inferiore ai 6 anni.

Altri medicinali ed Enbrel
Informi il medico o il farmacista se lei o il bambino state assumendo, avete recentemente assunto o
potreste assumere qualsiasi altro medicinale (inclusi anakinra, abatacept o sulfasalazina), anche quelli
senza prescrizione medica. Lei o il bambino non dovete utilizzare Enbrel insieme al principio attivo
anakinra o abatacept.

Gravidanza e allattamento
Enbrel deve essere usato in gravidanza solo se chiaramente necessario. Se è in corso una gravidanza,
se sospetta o sta pianificando una gravidanza, chieda consiglio al medico.
Se lei ha ricevuto Enbrel durante la gravidanza, il neonato potrebbe essere a maggior rischio di
infezione. Inoltre, uno studio ha indicato che nelle madri che hanno ricevuto Enbrel in gravidanza vi è
stato un maggior numero di difetti alla nascita rispetto alle madri che non hanno ricevuto Enbrel o altri
medicinali simili (antagonisti del TNF), ma tra i difetti alla nascita segnalati non è emersa una
particolare tipologia. Un altro studio non ha evidenziato alcun aumento del rischio di difetti alla
nascita quando le madri hanno ricevuto Enbrel durante la gravidanza. Il suo medico la aiuterà a
decidere se i benefici del trattamento siano superiori al rischio potenziale per il suo bambino.
Si rivolga al suo medico se desidera allattare al seno durante il trattamento con Enbrel. È importante
avvisare i pediatri del bambino e gli altri professionisti sanitari dell’uso di Enbrel durante la
gravidanza e l’allattamento prima che il bambino riceva qualsiasi vaccino.

Guida di veicoli e utilizzo di macchinari
Non si prevede che l’utilizzo di Enbrel possa influire sulla capacità di guidare veicoli o usare
macchinari.

Enbrel contiene sodio
Questo medicinale contiene meno di 1 mmol (23 mg) di sodio per dose, cioè è essenzialmente “senza
sodio”.

3. How to use Enbrel

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
If you feel that the effect of Enbrel is too strong or too weak, consult your doctor or
pharmacist.
The cartridge for the delivery device is available in dosages of 25 and 50 mg.

Dosage for adult patients (aged 18 years or over)
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg, administered twice a week or 50 mg once a week
by subcutaneous injection. In any case, the doctor may establish a different frequency with which to inject Enbrel.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week or 50 mg administered once a
week.
Alternatively, a dose of 50 mg may be administered twice a week for up to 12
weeks, followed by a dose of 25 mg administered twice a week or a dose of 50 mg
administered once a week.
The doctor will decide how long you should take Enbrel and whether, based on your response, a new treatment is
necessary. If, after 12 weeks, Enbrel has no effect on your condition, your doctor may tell you to stop treatment.

Use in children and adolescents
The appropriate dose and frequency of dosage for the child or adolescent will depend on the
body weight and the disease. The doctor will establish the correct dose for your child and prescribe a
suitable dosage of Enbrel (10 mg, 25 mg or 50 mg).
For polyarthritis or extended oligoarthritis in patients starting from 2 years of age, or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of Enbrel
per kg of body weight (up to a maximum of 25 mg), administered twice a week, or 0.8 mg
of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of Enbrel per kg of body
weight (up to a maximum of 50 mg) and must be administered once a week. If Enbrel
has no effect on the child's condition after 12 weeks, the doctor may tell you to
discontinue treatment with this medicine.
The doctor will provide you with detailed information on how to prepare and measure the appropriate dosage.

Method and route of administration
Enbrel is administered by injection under the skin (subcutaneous injection).
Enbrel can be taken with or without food and beverages.

Detailed instructions on how to inject Enbrel are provided in “Instructions for Use”.Do not mix
the Enbrel solution with other medicines.
To help you remember, it may be useful to write in an agenda on which day(s) of the week
Enbrel should be used.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions
If any of the following side effects occur, do not inject Enbrel any more. Immediately inform your doctor, or go to the nearest hospital emergency room.

Difficulty swallowing or breathing
Swelling of the face, throat, hands or feet
Feeling of nervousness or anxiety, palpitations, sudden redness of the skin and/or feeling of warmth
Severe skin rash, itching, hives (raised, red or pale patches of skin that often itch)

Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel; therefore, you should seek immediate medical attention.

Serious side effects
If you notice any of the following effects, you or the child may need urgent medical attention.

Symptoms of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area of skin or joints.
Symptoms of blood disorders, such as bleeding, bruising or paleness.
Symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg.
Symptoms of heart failure or worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of swelling in the neck or abdomen, shortness of breath at night or cough, bluish color of the nails or lips.
Symptoms of cancer:cancers can affect any part of the body, including the skin and blood, and the possible symptoms depend on the type and location of the cancer. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin.
Symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensations or vision.
Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
Symptoms of blood vessel inflammation, such as pain, fever, redness or overheating of the skin or itching.

These side effects are rare or uncommon, but are serious conditions (some of which can rarely cause death). If these symptoms occur, immediately inform your doctor, or go to the nearest hospital emergency room. The known side effects of Enbrel include those listed below, grouped by decreasing frequency:

Very common(may affect more than 1 in 10 people):
Infections (including colds, sinusitis, bronchitis, urinary tract infections, and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching,

pain and swelling) (these are less likely to occur after the first month of treatment; some patients have developed a reaction at a recently used injection site); headache.

Common(may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).
Uncommon(may affect up to 1 in 100 people):
Serious infections (including pneumonia, deep skin infections, joint infections, blood infections, and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin cancer (excluding melanoma); localized swelling of the skin (angioedema); hives (raised, red or pale patches of skin that often itch); eye inflammation; psoriasis (first appearance or worsening); inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also treated with methotrexate, the frequency of increased liver enzymes in the blood is common); abdominal pain and cramps, diarrhea, weight loss or blood in the stool (symptoms of bowel problems).
Rare(may affect up to 1 in 1,000 people): Serious allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined reduction in the number of platelets, red blood cells and white blood cells; diseases of the nervous system (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include a persistent rash, fever, joint pain and fatigue); skin rash that can lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish/purple rash and/or whitish-greyish linear streaks on mucous membranes); inflammation of the liver caused by your immune system (autoimmune hepatitis; in patients also treated with methotrexate, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also treated with methotrexate, the frequency of inflammation or scarring of the lungs is uncommon); damage to the tiny filters inside the kidneys resulting in reduced kidney function (glomerulonephritis).
Very rare(may affect up to 1 in 10,000 people): inability of the bone marrow to produce essential blood cells.
Not known(frequency cannot be estimated from available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Side effects in children and adolescents
Side effects and their frequency observed in children and adolescents are similar to those described above.

5. How to store Enbrel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and the label after
“Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Keep the cartridge for the delivery device in the outer packaging to protect the
medicine from light.
After taking a cartridge for the delivery device from the refrigerator, wait approximately 15-
30 minutes to allow the Enbrel solution in the cartridge for the delivery device to
reach room temperature. Do not heat it in any other way. Immediate use is then recommended.
The cartridges for the delivery device can be stored at room temperature
(up to 25°C) for up to 4 weeks, for single use only, ensuring they are protected from light; after
this period they cannot be returned to the refrigerator. If not used within 4 weeks outside
the refrigerator, Enbrel must be discarded. It is recommended to note the date on which the Enbrel
delivery device is removed from the refrigerator and the date by which Enbrel must be disposed of
(no more than 4 weeks outside the refrigerator).
Inspect the solution inside the cartridge for the delivery device by looking
through the inspection window. The solution should be from clear to slightly opalescent, from
colourless to light yellow or light brown and may contain small, white or almost
transparent protein particles. This is the normal appearance of Enbrel. Do not use this solution if it shows changes in
colour or appears cloudy, or if particles other than those described are visible. If you have any doubts
regarding the appearance of the solution, contact your pharmacist for assistance.
Do not dispose of any medicine in the drain or in household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Enbrel contains
Enbrel 25 mg solution for injection in a cartridge for a delivery device
The active ingredient of Enbrel is etanercept. Each cartridge for delivery device contains
0.5 mL of solution, containing 25 mg of etanercept.
The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, monobasic sodium
phosphate dihydrate and dibasic sodium phosphate dihydrate and water for injections.

Description of Enbrel and contents of the pack
Enbrel is supplied as a solution for injection in a cartridge for a delivery device ready
for use. The cartridge for delivery device must be used with the SMARTCLIC device. The device is supplied separately. The solution is from clear to opalescent, from
colourless to pale yellow or light brown.
Enbrel 25 mg solution for injection in a cartridge for a delivery device
Packs contain 4, 8 or 24 cartridges for delivery device with 8, 16 or
48 alcohol wipes. Not all pack sizes may be marketed.

Marketing authorisation holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Κύπρος
PFIZER ΕΛΛΑΣ A.E. (CYPRUS BRANCH)
T  : +357 22 817690

Česká Republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Magyarország
Pfizer Kft.
Tel: +36 1 488 3700

Danmark
Pfizer ApS
Tlf: +45 44 201 100

Malta
Vivian Corporation Ltd.
Tel: +35621 344610

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

България
Пфайзер Люксембург САРЛ,
Клон България
Teл: +359 2 970 4333

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
PFIZER ΕΛΛΑΣ A.E.
Τηλ.: +30 210 67 85 800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Télf: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00

France
Pfizer
Tél +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL , Pfizer, podružnica

zasvetovanje s področja farmacevtske
dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská Republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Tel: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel. +371 67035775

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

Instructions for use

Enbrel

(etanercept)
25 mg/0.5 mL
For subcutaneous injection only

Important information

Keep these Instructions for Use as they provide detailed instructions on how to prepare and administer an injection.
Use Enbrel only after reading and understanding these Instructions for Use.
Use Enbrel only after receiving training from your healthcare provider.
The cartridge for the delivery device contains a single dose of Enbrel and must be used only with the SMARTCLIC device.
In these Instructions for Use, the cartridge for the delivery device and the SMARTCLIC device will be referred to as “cartridge” and “device”.
If this is the first time you are using the device, be sure to follow the setup instructions in the dedicated User Manual. You will not be able to use the device until you have completed the setup.
Do notattempt to use the cartridges with other devices.
Do notshare the cartridges or the device with other people.
Do notshake the cartridges or the device containing a cartridge.
Do notreuse the cartridges after removing the needle cap.
Be careful not to spill liquids on the cartridges or the device. Do not rinse or put the cartridges or the device under water.
Refer to the additional device User Manual for access to menus, use of the training cartridge, advanced usage and troubleshooting related to error messages.

Storage

Store the cartridges in a refrigerator at a temperature between 2°C and 8°C. Do notfreeze the cartridges. Do notstore the cartridges in the device.
Store the cartridges in the original packaging until the time of use, to protect the product from direct sunlight.
You can store the cartridges at room temperature up to 25°C for a maximum of 4 weeks. Do notreturn them to the refrigerator after they have reached room temperature.
Store the cartridges and the device out of the sight and reach of children and adolescents.
Refer to the device User Manual for instructions on how to store and clean the device.

Material needed

Preparethe following material on a clean, flat surface: o Enbrel packaging containing the cartridges o SMARTCLIC device o Alcohol-soaked pads o Cotton balls or clean gauze pads (not included) o A suitable sharps container (not included)
Do notuse the product if the packaging has been dropped or damaged. Note:if you do not have all the necessary material, contact your healthcare provider.

The device:
Refer to the User Manual for more information.

Medical device with LCD screen, injection button and up/down buttons to navigate the menu, arrow indicates the top

Medical device with cartridge ejection indicator, blue arrow for injection, cartridge port and skin sensor

The cartridge:

Syringe with blue plunger and orange needle protected by gray cap with text indications

Preparation procedure

Remove1 cartridge from the tray inside the packaging.
Returnthe box and tray to the refrigerator along with any unused cartridges.
Washand dry your hands.
For a more comfortable injection, leave the cartridge at room temperature for about 15-30 minutes, away from direct sunlight. Do notuse other methods to warm the cartridge.

Medicine cartridge with blue and transparent cap, label with lot number, expiration date and dose indicated, arrows indicating its parts

Checkthe expiration date and the medicine dose printed on the label. Do notuse the product if the expiration date has passed or if you have been prescribed a different dose.
Checkthe cartridge, do notuse it if: o it has been dropped, even if it does not appear damaged o it is damaged o the needle cap is loose o it has been frozen or exposed to heat o it has been at room temperature for more than 4 weeks o it has been stored in the refrigerator after reaching room temperature
Do notremove the needle cap until you are asked to do so.

Hand holding a blue and silver injection pen with transparent window for dose visualization

Inspectthe medicine through the inspection window, the solution should be from clear to slightly opalescent, from colorless to light yellow or light brown and may contain small, whitish or nearly transparent protein particles. This is normal.
Do notuse this medicine if it has color changes or appears cloudy or if particles other than those described are visible.
Do notshake the cartridge. Note:for any questions about the medicine, contact your healthcare provider.

Diagram of the human body with recommended injection areas abdomen and thigh highlighted and spaced apart

Always choosea point on the abdomen, the upper thigh or the outer area of the upper arm (healthcare professionals only).
Choosean injection site at least 3 cm away from the last injection site and at least 5 cm away from the navel.
Do notinject into areas where there are bones or areas where the skin is damaged, bruised, red, painful (sensitive) or stiff. Avoid injecting into areas with scars or stretch marks.
Do notinject through clothing. Note:if you suffer from psoriasis, do notinject directly into areas where the skin is raised, thickened, red or scaly or on lesions.
Cleanthe injection site with the alcohol-soaked pad provided and wait for it to dry.

Cleanthe injection end of the device with the alcohol-soaked pad provided separately.
Waitfor the injection end to dry before proceeding with the injection.

Injection procedure

Blue and white medical device held in hand with green arrow indicating the

Pressthe cartridge firmly straightthrough the cartridge port, without rotating the device, until you feel you have pressed it all the way in. The device will turn on once the cartridge is correctly inserted.
Checkthat the display shows 25 mg and that the expiration date has not passed. Note:the device will turn off after 90 seconds of inactivity. Press and hold the injection button to turn the device back on.

Syringe with blue plunger and white cap, green arrow indicating removal of protective cap held by a hand

Removethe needle cap by pulling it firmly downwards.
Dispose ofthe needle cap in a suitable sharps container.
Performthe injection immediately after removing the needle cap.
Do notreplace the needle cap. Caution: do notinsert your fingers into the device after removing the needle cap to avoid needle stick injuries. Note:to cancel the injection and eject the cartridge, press the Cancel/Eject button for 1 second.

Dark blue cross symbol on a white square background indicating prohibition or cancellation

White medical device with buttons and directional arrows positioned on gray skin with green arrow indicating downwards

Positionthe device with the blue arrowpointing at a 90-degree angle to the injection site.
Make sureyou can see the device display.
Do notpinch the skin around the injection site. Caution:if the device falls with the cartridge inserted, eject and dispose of the cartridge. Refer to the Troubleshooting page in the device User Manual.

Gray medical device with screen and buttons, finger pressing down, green arrow with checkmark and number 9 in the upper left corner

Press and holdthe injection button to start the injection when indicated on the display. Note:you can release the injection button after the injection has started.

Subcutaneous injection in progress with needle inserted into the skin and green and blue arrows indicating the direction

Holdthe device against the skin and wait for the medicine to be delivered.
Watchthe device display.
Do notmove, tilt or remove the device from the skin until you are prompted to do so on the display. Note:if you remove the device before indicated, do notreposition it on the injection site or administer another dose. Contact your healthcare provider for instructions.

Medical device with green arrow towards the

Lift and holdthe device away from the skin. The device will indicate on the display that the injection is complete.
Wait.The cartridge will be partially ejected from the bottom of the device. This may take up to 10 seconds. Do notcover the bottom of the device during this time. Do notinsert your fingers into the device as the needle will be exposed during this time.
If you notice blood, press a cotton ball or gauze pad over the injection site until the bleeding stops. Do notrub.

Syringe with gray and blue cartridge, green arrow indicating cartridge removal and hand holding the

Extractthe cartridge once it has been partially ejected from the device.
Checkthat the medicine in the cartridge is used up by verifying that a gray bar is visible in the inspection window. If not, you may not have injected the full dose. Contact your healthcare provider for instructions.
Do notreuse or reinsert the cartridge into the device.
Dispose ofthe used cartridge immediately in a suitable sharps container, as directed by your healthcare provider or pharmacist and in accordance with local health and safety regulations.
-End of Instructions for Use--

Enbrel 50 mg injectable solution in cartridge for delivery device

etanercept

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will provide you with the Patient Information Sheet which contains important safety information that you should be aware of before and during treatment with Enbrel.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or for a child. Do not give it to other people, even if they have the same symptoms as you or the child, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Enbrel is and what it is used for
2. What you need to know before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Contents of the pack and other information (see Instructions for Use)

1. What is Enbrel and what it is used for

Enbrel is a medicine made from two human proteins. It blocks the activity of another protein that
causes inflammation in the human body. Enbrel works by reducing the inflammation associated
with certain diseases.
In adults (aged 18 years and over), Enbrel can be used for the treatment of rheumatoid arthritisfrom moderate to severe, psoriatic arthritis, severe axial spondyloarthritis
including ankylosing spondylitis, and moderate to severe psoriasis- in each case
usually when other widely used treatments have not worked well enough or are not
suitable for you.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may
also be used alone if treatment with methotrexate is not suitable for you. Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to the joints
caused by rheumatoid arthritis and improves the ability to perform normal daily activities.
For patients with psoriatic arthritis with multiple joint involvement, Enbrel can
improve the ability to perform daily activities. For patients with multiple symmetrical painful or swollen joints (e.g. hands, wrists and feet), Enbrel can slow down the structural damage
to these joints caused by the disease.
Enbrel is also prescribed for the treatment of the following conditions in children and adolescents:

For the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficiently good response or is not appropriate:
Polyarthritis (positive or negative for rheumatoid factor) and extended oligoarthritis in patients aged 2 years and over
Psoriatic arthritis in patients aged 12 years and over.
For arthritis related to enthesitis in patients aged 12 years and over, when other widely used treatments have not given a sufficiently good response or are not appropriate.
Severe psoriasis in patients aged 6 years and over who have had an inadequate response with (or cannot take) phototherapies or other systemic therapies.

2. Cosa deve sapere prima di usare Enbrel

Non usi Enbrel

Se lei, o il bambino, siete allergici ad etanercept o ad uno qualsiasi degli altri componenti di Enbrel (elencati al paragrafo 6). Se lei, o il bambino, manifestate reazioni allergiche quali costrizione toracica, respiro affannoso, capogiro od eruzione cutanea, non inietti altro Enbrel e contatti il medico immediatamente.
Se lei, o il bambino, presentate o siete a rischio di sviluppo di un’infezione grave del sangue chiamata sepsi. Se ha dei dubbi, contatti il medico.
Se lei, o il bambino, avete un’infezione di qualunque tipo. Se ha dubbi, si rivolga al medico.

Avvertenze e precauzioni
Si rivolga al medico prima di prendere Enbrel.

Reazioni allergiche:se lei, o il bambino, manifestate reazioni allergiche quali costrizione toracica, respiro affannoso, capogiro od eruzione cutanea, non inietti altro Enbrel e contatti il medico immediatamente.
Infezioni/operazioni chirurgiche:se lei, o il bambino, sviluppate una nuova infezione o state per essere sottoposti ad un qualsiasi intervento chirurgico importante. Il medico potrebbe voler controllare il trattamento con Enbrel.
Infezioni/diabete:informi il medico se lei o il bambino avete una storia di infezioni ricorrenti o soffrite di diabete o di altre condizioni che aumentano il rischio di infezione.
Infezioni/monitoraggio:informi il medico di qualsiasi recente viaggio fuori dall’Europa. Se lei, o il bambino, sviluppate i sintomi di un’infezione come febbre, brividi o tosse, avverta immediatamente il medico. Il medico può decidere di continuare a monitorare lei o il bambino per la presenza di infezioni dopo che lei o il bambino avete sospeso l’assunzione di Enbrel.
Tubercolosi:poiché sono stati riportati casi di tubercolosi in pazienti trattati con Enbrel, il medico la controllerà per verificare se ci sono segni e sintomi di tubercolosi prima di iniziare il trattamento con Enbrel. Questo potrebbe includere una accurata raccolta della sua storia clinica, raggi X del torace e il test alla tubercolina. L’esito di queste analisi deve essere riportato nella Scheda per il paziente. È molto importante che riferisca al medico se lei o il bambino avete mai contratto tubercolosi o se siete stati a stretto contatto con qualcuno affetto da tubercolosi. Se i sintomi della tubercolosi (come tosse persistente, perdita di peso, debolezza, febbre leggera) o qualsiasi altra infezione appaiono durante o dopo la terapia, lo comunichi immediatamente al medico.
Epatite B:informi il medico se lei o il bambino siete affetti o siete stati affetti da epatite B. Il medico deve effettuare il test per l’epatite B prima che lei o il bambino iniziate il trattamento con Enbrel. Il trattamento con Enbrel può causare la riattivazione di epatite B in pazienti con precedente infezione da virus dell’epatite B. In tal caso, deve smettere di usare Enbrel.
Epatite C:informi il medico se lei o il bambino siete affetti da epatite C. Il medico potrebbe ritenere opportuno monitorare il trattamento con Enbrel qualora l’infezione peggiori.
Disturbi del sangue:richieda immediatamente assistenza medica se lei o il bambino avete qualsiasi segno o sintomo quale febbre persistente, mal di gola, lividi, sanguinamento o pallore. Tali sintomi possono indicare la presenza di disordini del sangue potenzialmente pericolosi per la vita che possono richiedere l’interruzione del trattamento con Enbrel.
Disturbi del sistema nervoso e degli occhi:informi il medico se lei o il bambino avete la sclerosi multipla, la neurite ottica (infiammazione dei nervi ottici) o la mielite trasversa (infiammazione del midollo spinale). Il medico valuterà se Enbrel è un trattamento appropriato.
Insufficienza cardiaca congestizia:informi il medico se lei o il bambino avete una storia di insufficienza cardiaca congestizia, poiché Enbrel deve essere usato con cautela in queste circostanze.
Tumore:informi il medico se ha o ha mai avuto un linfoma (un tipo di tumore del sangue) o qualsiasi altro tumore, prima di assumere Enbrel. Pazienti affetti da artrite reumatoide grave da lungo tempo possono essere a rischio più alto della media di sviluppare un linfoma. Bambini ed adulti che prendono Enbrel possono avere un rischio maggiore di sviluppare un linfoma o un altro tumore. Alcuni bambini e pazienti adolescenti che sono stati trattati con Enbrel o con altri medicinali che agiscono come Enbrel hanno sviluppato tumori, anche di tipo insolito, talora con esito fatale. Alcuni pazienti che ricevevano Enbrel hanno sviluppato tumori della pelle. Informi il medico se lei o il bambino sviluppate qualsiasi cambiamento nell’aspetto della cute o proliferazioni sulla cute.
Varicella:informi il medico se lei o il bambino siete esposti alla varicella durante l’utilizzo di Enbrel. Il medico valuterà se è appropriato un trattamento preventivo per la varicella.
Lattice:la copertura dell’ago è fatta di lattice (gomma naturale essiccata). Contatti il medico prima di usare Enbrel nel caso che la copertura dell’ago venga maneggiata da, o nel caso che Enbrel venga somministrato ad, una persona con nota o possibile ipersensibilità (allergia) al lattice.
Abuso di alcol:Enbrel non deve essere utilizzato per il trattamento dell’epatite correlata all’abuso di alcol. Informi il medico se lei o il bambino avete una storia di abuso di alcol.
Granulomatosi di Wegener:Enbrel non è raccomandato per il trattamento della granulomatosi di Wegener, una malattia infiammatoria rara. Se lei o il bambino siete affetti da granulomatosi di Wegener, si rivolga al medico.
Medicinali anti-diabete:informi il medico se lei o il bambino soffrite di diabete o se state assumendo medicinali per trattare il diabete. Il suo medico può decidere se per lei o per il bambino è necessario ricevere meno medicinale anti-diabete, mentre state assumendo Enbrel.

Bambini e adolescenti
Vaccinazioni: se possibile, prima di utilizzare Enbrel, i bambini devono essere in regola con tutte le
vaccinazioni. Alcuni vaccini, come il vaccino antipolio orale, non devono essere assunti mentre si sta
prendendo Enbrel. Consulti il pediatra prima che il bambino riceva qualsiasi vaccino.
Di norma Enbrel non deve essere utilizzato nei bambini con poliartrite o oligoartrite estesa di età
inferiore ai 2 anni, o nei bambini con artrite correlata ad entesite o artrite psoriasica di età inferiore ai
12 anni, o nei bambini con psoriasi di età inferiore ai 6 anni.

Guida di veicoli e utilizzo di macchinari
Non si prevede che l’utilizzo di Enbrel possa influire sulla capacità di guidare veicoli o usare
macchinari.

Enbrel contiene sodio
Questo medicinale contiene meno di 1 mmol (23 mg) di sodio per dose, cioè è essenzialmente “senza
sodio”.

3. How to use Enbrel

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
If you feel that the effect of Enbrel is too strong or too weak, consult your doctor or
pharmacist.
The cartridge for the delivery device is available in dosages of 25 and 50 mg.

Dosage for adult patients (age 18 years or older)
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg, administered twice a week or 50 mg once a week
by subcutaneous injection. In any case, the doctor may establish a different frequency with which to inject Enbrel.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week or 50 mg administered once a
week.
Alternatively, a dose of 50 mg may be administered twice a week for up to
12 weeks, followed by a dose of 25 mg administered twice a week or a dose of
50 mg administered once a week.
The doctor will decide how long you should take Enbrel and whether, based on your response, a new treatment is
necessary. If, after 12 weeks, Enbrel has no effect on your condition
the doctor may tell you to stop treatment.

Use in children and adolescents
The appropriate dose and frequency of dosage for the child or adolescent will depend on the
body weight and the disease. The doctor will establish the correct dose for your child and prescribe a
suitable dosage of Enbrel (10 mg, 25 mg or 50 mg).
For polyarticular or extended oligoarticular arthritis in patients starting from 2 years of age, or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of Enbrel
per kg of body weight (up to a maximum of 25 mg), administered twice a week, or 0.8 mg
of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of Enbrel per kg of body
weight (up to a maximum of 50 mg) and must be administered once a week. If Enbrel
has no effect on the child's condition after 12 weeks, the doctor may tell you to
interrupt the treatment with this medicine.
The doctor will provide you with detailed information on how to prepare and measure the appropriate dosage.

Method and route of administration
Enbrel is administered by injection under the skin (subcutaneous injection).
Enbrel can be taken with or without food and beverages.

If you stop taking Enbrel
Following discontinuation of treatment, the symptoms of the disease may return.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
li manifestino.

Allergic reactions
If any of the following side effects occur, do not inject Enbrel anymore. Inform your doctor
immediately, or go to the nearest hospital emergency room.

Difficulty swallowing or breathing
Swelling of the face, throat, hands or feet
Feeling of nervousness or anxiety, palpitations, sudden redness of the skin and/or feeling of warmth
Severe skin rash, itching, hives (raised red or pale patches of skin that often itch)

Severe allergic reactions are rare. However, any of the above symptoms may indicate
an allergic reaction to Enbrel; therefore, you should seek immediate medical attention.

Serious side effects
If you notice any of the following effects, you or the child may need urgent medical
care.

Symptoms of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area of skin or joints.
Symptoms of blood disorders, such as bleeding, bruising or paleness.
Symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg.
Symptoms of heart failure or worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of swelling in the neck or abdomen, shortness of breath at night or cough, bluish color of the fingernails or lips.
Symptoms of cancer:cancers can affect any part of the body, including the skin and blood, and the possible symptoms depend on the type and location of the cancer. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin.
Symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensations or vision.
Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
Symptoms of inflammation of blood vessels, such as pain, fever, redness or warmth of the skin or itching.

These side effects are rare or uncommon, but are serious conditions (some of which
can rarely cause death). If these symptoms occur, tell your doctor immediately,
or go to the nearest hospital emergency room.
The known side effects of Enbrel include those listed below, grouped by
decreasing frequency:

Very common(may affect more than 1 in 10 people):
Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching,

pain and swelling) (these are less likely to occur after the first month of treatment;
some patients have developed a reaction at a recently used injection site);
headache.

Common(may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).
Uncommon(may affect up to 1 in 100 people):
Serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin cancer (excluding melanoma); localized swelling of the skin (angioedema); hives (raised red or pale patches of skin that often itch); eye inflammation; psoriasis (first occurrence or worsening); inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also treated with methotrexate, the frequency of increased liver enzymes in the blood is common); abdominal pain and cramps, diarrhea, weight loss or blood in the stool (symptoms of bowel problems).
Rare(may affect up to 1 in 1,000 people): Serious allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); joint reduction in the number of platelets, red blood cells and white blood cells; diseases of the nervous system (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include a persistent rash, fever, joint pain and fatigue); rash that can lead to severe blistering and scaling of the skin; lichenoid reactions (itchy reddish/purple rash and/or whitish-grayish linear streaks on mucous membranes); inflammation of the liver caused by your immune system (autoimmune hepatitis; in patients also treated with methotrexate, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also treated with methotrexate, the frequency of inflammation or scarring of the lungs is uncommon); damage to the tiny filters inside the kidneys that determines reduced kidney function (glomerulonephritis).
Very rare(may affect up to 1 in 10,000 people): inability of the bone marrow to produce essential blood cells.
Not known(frequency cannot be estimated from available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Side effects in children and adolescents
Side effects and their frequency observed in children and adolescents are similar to those
described above.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Enbrel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the label after
“Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Keep the cartridge for the delivery device in the outer packaging to protect the
medicine from light.
After taking a cartridge for the delivery device from the refrigerator, wait approximately 15-
30 minutes to allow the Enbrel solution in the cartridge for the delivery device to
reach room temperature. Do not heat it in any other way. Immediate use is then recommended.
The cartridges for the delivery device can be stored at room temperature
(up to 25°C) for up to 4 weeks, for single use only, ensuring they are protected from light; after
this period they must not be returned to the refrigerator. If not used within 4 weeks outside
the refrigerator, Enbrel must be discarded. It is recommended to note the date on which the Enbrel
delivery device is removed from the refrigerator and the date by which Enbrel must be disposed of
(no more than 4 weeks outside the refrigerator).
Inspect the solution inside the cartridge for the delivery device by looking
through the inspection window. The solution should be from clear to slightly opalescent, from
colourless to light yellow or light brown and may contain small, white or almost
transparent protein particles. This is the normal appearance of Enbrel. Do not use this solution if it shows changes in
colour or appears cloudy, or if particles other than those described are visible. If you have any doubts
regarding the appearance of the solution, contact your pharmacist for assistance.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enbrel contains
Enbrel 50 mg solution for injection in a cartridge for a delivery device
The active ingredient of Enbrel is etanercept. Each cartridge for delivery device contains
1.0 mL of solution, containing 50 mg of etanercept.
The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, monobasic sodium
phosphate dihydrate and dibasic sodium phosphate dihydrate and water for injections.

Description of the appearance of Enbrel and contents of the pack
Enbrel is supplied as a solution for injection in a cartridge for a delivery device ready for
use. The cartridge for delivery device must be used with the SMARTCLIC device. The device is supplied separately. The solution is from clear to opalescent, from
colorless to light yellow or light brown.
Enbrel 50 mg solution for injection in a cartridge for a delivery device
The packs contain 2, 4 or 12 cartridges for delivery device with 4, 8 or
24 alcohol swabs. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Κύπρος
PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH)
T  : +357 22 817690

Česká Republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Magyarország
Pfizer Kft.
Tel: +36 1 488 3700

Danmark
Pfizer ApS
Tlf: +45 44 201 100

Malta
Vivian Corporation Ltd.
Tel: +35621 344610

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

България
Пфайзер Люксембург САРЛ,
Клон България
Teл: +359 2 970 4333

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
PFIZER EΛΛAΣ A.E.
Τηλ.: +30 210 67 85 800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Télf: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00

France
Pfizer
Tél +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL , Pfizer, podružnica

zasvetovanje s področja farmacevtske
dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská Republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Tel: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel. +371 67035775

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

Instructions for use

Enbrel

(etanercept)
50 mg/1 mL
For subcutaneous injection only

Important information

Keep these Instructions for Use as they provide detailed instructions on how to prepare and administer an injection.
Use Enbrel only after reading and understanding these Instructions for Use.
Use Enbrel only after receiving training from your healthcare provider.
The cartridge for the delivery device contains a single dose of Enbrel and must only be used with the SMARTCLIC device.
In these Instructions for Use, the cartridge for the delivery device and the SMARTCLIC device will be referred to as “cartridge” and “device”.
If this is the first time you are using the device, be sure to follow the setup instructions in the dedicated User Manual. You will not be able to use the device until you have completed the setup.
Do notattempt to use the cartridges with other devices.
Do notshare the cartridges or the device with other people.
Do notshake the cartridges or the device containing a cartridge.
Do notreuse the cartridges after removing the needle cap.
Be careful not to spill liquids on the cartridges or the device. Do not rinse or put the cartridges or the device under water.
Refer to the additional device User Manual for access to menus, use of the training cartridge, advanced use and troubleshooting related to error messages.

Storage

Store the cartridges in a refrigerator at a temperature between 2°C and 8°C. Do notfreeze the cartridges. Do notstore the cartridges in the device.
Store the cartridges in the original packaging until the time of use, to protect the product from direct sunlight.
You can store the cartridges at room temperature up to 25°C for a maximum of 4 weeks. Do notreturn them to the refrigerator after they have reached room temperature.
Store the cartridges and the device out of the sight and reach of children and adolescents.
Refer to the device User Manual for instructions on how to store and clean the device.

Materials needed

Arrangethe following materials on a clean, flat surface: o Enbrel packaging containing the cartridges o SMARTCLIC device o Alcohol-soaked pads o Cotton balls or clean gauze pads (not included) o A suitable sharps container (not included)
Do notuse the product if the packaging has been dropped or damaged. Note:if you do not have all the necessary materials, contact your healthcare provider.

The device:
Refer to the User Manual for more information.

Medical device with LCD screen, injection button and up/down buttons to navigate the menu, arrow indicates the application point

Medical device with screen and blue arrow, textual indications on cartridge ejection, menu selection and lower parts of the device

The cartridge:

Injection cartridge with indications of upper part, inspection window, needle cap

Preparation procedure

Hand removing a pre-filled syringe from a transparent blister containing other blue and gray syringes green arrow towards the

Remove1 cartridge from the tray inside the packaging.
Returnthe box and tray to the refrigerator along with any unused cartridges.
Washand dry your hands.
For a more comfortable injection, leave the cartridge at room temperature for about 15-30 minutes, away from direct sunlight. Do notuse other methods to warm the cartridge.

Blue and white injectable pen with transparent cartridge, indications on lot, expiry date and dose on the

Checkthe expiry date and the medicine dose printed on the label. Do notuse the product if the expiry date has passed or if you have been prescribed a different dose.
Checkthe cartridge, do notuse it if: o it has been dropped, even if it does not appear damaged o it is damaged o the needle cap is loose o it has been frozen or exposed to heat o it has been at room temperature for more than 4 weeks o it has been stored in the refrigerator after reaching room temperature
Do notremove the needle cap until you are asked to do so.

Hand holding a blue and white injection pen with visible dosage indications and medicine check

Inspectthe medicine through the inspection window, the solution should be from clear to slightly opalescent, from colorless to light yellow or light brown and may contain small, whitish or nearly transparent protein particles. This is normal.
Do notuse this medicine if it has a color change or appears cloudy or if particles other than those described are visible.
Do notshake the cartridge. Note:if you have any questions about the medicine, contact your healthcare provider.

Sketch of a human torso with shaded areas for suggested injections on buttocks and outer upper arm with distance indications

Always choosea point on the abdomen, upper thigh or outer area of the upper arm (healthcare professionals only).
Choosean injection site at least 3 cm away from the last injection site and at least 5 cm away from the navel.
Do notinject into areas where there are bones or areas where the skin is damaged, bruised, red, painful (sensitive) or stiff. Avoid injecting into areas with scars or stretch marks.
Do notinject through clothing. Note:if you suffer from psoriasis, do notinject directly into areas where the skin is raised, thickened, red or scaly or on lesions.
Cleanthe injection site with the alcohol-soaked pad provided and wait for it to dry.

Cleanthe injection end of the device with the alcohol-soaked pad provided separately.
Waitfor the injection end to dry before proceeding with the injection.

Injection procedure

Hand firmly pressing the cartridge straight through the cartridge port, without rotating the device, until you feel it has been pressed all the way in. The device will turn on once the cartridge is inserted correctly.

Pressthe cartridge firmly straightthrough the cartridge port, without rotating the device, until you feel it has been pressed all the way in. The device will turn on once the cartridge is inserted correctly.
Checkthat the display shows 50 mg and that the expiry date has not passed. Note:the device will turn off after 90 seconds of inactivity. Press and hold the injection button to turn the device back on.

Removing the protective cap from the pre-filled syringe with a green arrow indicating the direction and a cross on the cap

Removethe needle cap by pulling it firmly downwards.
Dispose ofthe needle cap in a suitable sharps container.
Administerthe injection immediately after removing the needle cap.
Do notreplace the needle cap. Caution: do notinsert your fingers into the device after removing the needle cap to avoid needle stick injuries. Note:to cancel the injection and eject the cartridge, press the Cancel/Eject button for 1 second.

Dark blue cross symbol on a white background to

Auto-injector device with up and down buttons and an X arrow pointing to the skin

Positionthe device with the blue arrowpointing 90 degrees towards the injection site.
Make sureyou can see the device display.
Do notpinch the skin around the injection site. Caution:if the device with the cartridge inserted falls, eject and dispose of the cartridge. Refer to the Troubleshooting page in the device User Manual.

Hand pressing the button on a gray auto-injector with a green arrow and numbered instructions Step 9

Press and holdthe injection button to start the injection when indicated by the display. Note:you can release the injection button after the injection has started.

Subcutaneous injection in progress with needle inserted into the skin indicated by a blue arrow and a green arrow indicating the direction

Keep holdingthe device against the skin and wait for the medicine to be delivered.
Watchthe device display.
Do notmove, tilt or remove the device from the skin until you are prompted to do so on the display. Note:if you remove the device before prompted, do notreposition it on the injection site or administer another dose. Contact your healthcare provider for guidance.

Lift away from the skin indicated by a green arrow on a gray and blue area with a cross symbol and numbered instructions Step 11

Lift and holdthe device away from the skin. The device will indicate on the display that the injection is complete.
Wait.The cartridge will be partially ejected from the bottom of the device. This may take up to 10 seconds. Do notcover the bottom of the device during this time. Do notinsert your fingers into the device as the needle will be exposed during this time.
If you notice bleeding, press a cotton ball or gauze pad over the injection site until the bleeding stops. Do notrub.

Hand removing the cartridge from a blue and white device with a green arrow pointing downwards

Extractthe cartridge once it has been partially ejected from the device.
Checkthat the medicine in the cartridge has been used up by checking that a gray bar is visible in the inspection window. If it is not, you may not have injected the full dose. Contact your healthcare provider for guidance.
Do notreuse or reinsert the cartridge into the device.
Dispose ofthe used cartridge immediately in a suitable sharps container, as directed by your healthcare provider or pharmacist and in accordance with local health and safety regulations.
-End of Instructions for Use-

Страна регистрации
Италия
Форма выпуска
Powder and solvent for injectable solution, 25 MG
Код АТХ
L04AB01
Действующее вещество
Этанерцепт
Отпускается по рецепту
Да
Производитель
PFIZER EUROPE MA EEIG
Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
Аналоги ENBREL
BENEPALI
Форма выпуска: Injectable solution, 50 MG
Действующее вещество: Этанерцепт
Производитель: SAMSUNG BIOEPIS NL B.V.
Отпускается по рецепту
ERELTSI
Форма выпуска: Injectable solution, 25 MG
Действующее вещество: Этанерцепт
Производитель: SANDOZ GMBH
Отпускается по рецепту
NEPEXTO
Форма выпуска: Injectable solution, 25 MG
Действующее вещество: Этанерцепт
Производитель: BIOSIMILAR COLLABORATIONS IRELAND LIMITED
Отпускается по рецепту

Аналоги ENBREL в других странах

Лекарства с тем же действующим веществом, доступные в других странах.

Аналог ENBREL в Украина

ЕНБРЕЛ

Форма выпуска: раствор, 50 мг/мл

Действующее вещество: Этанерцепт

Производитель: Pfajzer Menufekcuring Bel'gia NV

Отпускается по рецепту

Аналог ENBREL в Испания

НЕПЕКСТО 50 мг раствор для инъекций в предварительно заполненной шприц-ручке

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 50 мг

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Производитель: Biosimilar Collaborations Ireland Limited

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Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 25 мг

Действующее вещество: Этанерцепт

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Отпускается по рецепту

ЭРЕЛЬЗИ 50 мг РАСТВОР ДЛЯ ИНЪЕКЦИЙ В ПРЕДНАПОЛНЕННОМ ШПРИЦЕ-РУЧКЕ

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 50 мг

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Производитель: Sandoz Gmbh

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ЭРЕЛЬЗИ 50 мг РАСТВОР ДЛЯ ИНЪЕКЦИЙ В ПРЕДНАПОЛНЕННОМ ШПРИЦЕ

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 50 мг

Действующее вещество: Этанерцепт

Производитель: Sandoz Gmbh

Отпускается по рецепту

ЭРЕЛЬЗИ 25 мг РАСТВОР ДЛЯ ИНЪЕКЦИЙ В ПРЕДНАПОЛНЕННОМ ШПРИЦЕ

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 25 мг

Действующее вещество: Этанерцепт

Производитель: Sandoz Gmbh

Отпускается по рецепту

ЭНБРЕЛЬ 50 мг РАСТВОР ДЛЯ ИНЪЕКЦИЙ В ПРЕДНАПОЛНЕННЫХ ШПРИЦАХ-РУЧКАХ

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 50 мг этанерцепта

Действующее вещество: Этанерцепт

Производитель: Pfizer Europe Ma Eeig

Отпускается по рецепту

Врачи онлайн по ENBREL

Обсудите применение ENBREL и возможные следующие шаги — по оценке врача.

5.0(2)

Наталья Бессолицына

Ревматология26 лет опыта

С какими симптомами и диагнозами можно обратиться:

Боли в суставах — острая, хроническая, рецидивирующая боль.
Артриты: ревматоидный артрит, псориатический артрит, полиартрит, подагрический артрит.
Артрозы: остеоартроз, коксартроз, гонартроз, узелковый полиостеоартроз.
Плечелопаточный периартрит и спондилоартриты.
Хронические воспалительные заболевания позвоночника — болезнь Бехтерева.
Системные аутоиммунные заболевания: системная красная волчанка, склеродермия, системные васкулиты.
Остеопороз и нарушение плотности костей.

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Требуется ли рецепт для ENBREL?

ENBREL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.

Какое действующее вещество у ENBREL?

Действующее вещество ENBREL — Этанерцепт. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.

Кто производит ENBREL?

ENBREL производится компанией PFIZER EUROPE MA EEIG. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.

Какие врачи могут оценить применение ENBREL онлайн?

Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения ENBREL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.

Как купить ENBREL в Польше?

Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.

Вы можете купить ENBREL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.

Чтобы получить рецепт, вы можете воспользоваться Oladoctor:

Какие есть альтернативы ENBREL?

Другие лекарства с тем же действующим веществом (Этанерцепт) включают BENEPALI, ERELTSI, NEPEXTO. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.

ENBREL 25 мг Порошок и раствор для инъекционного раствора

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