ERELZI 25 mg Инъекционный Раствор

Содержание инструкции

1. Erelzi 25 mg injectable solution in pre-filled syringe, 50 mg injectable solution in pre-filled syringe
   1. What is Erelzi and what it is used for
   2. What you need to know before using Erelzi
   3. How to use Erelzi
   4. Possible side effects
   5. How to store Erelzi
   6. Contents of the pack and other information
   7. Instructions for use of Erelzi pre-filled syringe
2. Erelzi 50 mg solution for injection in pre-filled pen
   1. What is Erelzi and what it is used for
   2. What you need to know before using Erelzi
   3. How to use Erelzi
   4. Possible side effects
   5. How to store Erelzi
   6. Contents of the pack and other information
   7. Instructions for use of Erelzi pre-filled pen
   8. Important safety checks before injection:
   9. Injection site cleaning:
   10. Removing the cap:
   11. Pen position:
   12. Start the injection:
   13. Complete the injection:
   14. Check that the green indicator fills the window:
   15. Disposing of the pre-filled pen of Erelzi:

Erelzi 25 mg injectable solution in pre-filled syringe, 50 mg injectable solution in pre-filled syringe

etanercept (etanerceptum)

Read this leaflet carefully before using this medicine as 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 Erelzi.
• 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 may 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 Erelzi is and what it is used for
• 2. What you need to know before you use Erelzi
• 3. How to use Erelzi
• 4. Possible side effects
• 5. How to store Erelzi
• 6. Contents of the pack and other information
• 7. Instructions for use of Erelzi pre-filled syringe

1. What is Erelzi and what it is used for

Erelzi is a medicine made from two human proteins. It blocks the activity of another protein that
causes inflammation in the human body. Erelzi works by reducing the inflammation associated
with some diseases.
In adults (aged 18 years and over), Erelzi 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 arthritisrheumatoid, Erelzi is usually used in association with methotrexate, although
it can also be used alone if treatment with methotrexate is not suitable for you. Whether
used alone or in combination with methotrexate, Erelzi can slow down the damage to the joints
caused by rheumatoid arthritis and improve the ability to perform normal daily activities.
For patients with psoriatic arthritiswith involvement of multiple joints, Erelzi can
improve the ability to perform daily activities.
For patients with multiple symmetrical painful or swollen joints(e.g. hands, wrists and
feet), Erelzi can slow down the structural damage to these joints caused by the disease.
Erelzi 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 or older with a weight equal to or greater than 62.5 kg.
• Psoriatic arthritis in patients aged 12 years or older with a weight equal to or greater than 62.5 kg.
• For arthritis related to enthesitis in patients aged 12 years or older with a weight equal to or greater than 62.5 kg, 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 with a weight equal to or greater than 62.5 kg who have had an inadequate response with (or cannot take) phototherapies or other systemic therapies.

2. What you need to know before using Erelzi

Do not use Erelzi

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

Warnings and precautions
Talk to your doctor before using Erelzi.

• Allergic reactions:If you, or the child, experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Erelzi and contact your doctor immediately.
• Infections/surgery:If you, or the child, develop a new infection or are about to undergo any major surgical procedure, your doctor may want to check your treatment with Erelzi.
• Infections/diabetes:Tell your doctor if you or the 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 the child, develop symptoms of an infection such as fever, chills or cough, inform your doctor immediately. The doctor may decide to continue monitoring you or the child for infections after you or the child have stopped taking Erelzi.
• Tuberculosis: Because cases of tuberculosis have been reported in patients treated with Erelzi, your doctor will check you for signs and symptoms of tuberculosis before starting treatment with Erelzi. 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 the 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 the child have or have had hepatitis B. Your doctor should test for hepatitis B before you or the child start treatment with Erelzi. Treatment with Erelzi may cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. If this happens, you must stop using Erelzi.
• Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may consider monitoring treatment with Erelzi if the infection worsens.
• Blood disorders: Seek immediate medical attention if you or the 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 Erelzi.
• Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). The doctor will assess whether Erelzi is an appropriate treatment.
• Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, as Erelzi 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 Erelzi. Patients with severe, long-standing rheumatoid arthritis may be at a higher than average risk of developing lymphoma. Children and adults who take Erelzi may have an increased risk of developing lymphoma or another cancer. Some children and adolescent patients who have been treated with Erelzi or other medicines that work like Erelzi have developed cancers, sometimes rare, sometimes fatal. Some patients receiving Erelzi have developed skin cancers. Tell your doctor if you or the child develop any changes in the appearance of the skin or growths on the skin.
• Chickenpox:Tell your doctor if you or the child are exposed to chickenpox while using Erelzi. The doctor will assess whether preventive treatment for chickenpox is appropriate.
• Alcohol abuse:Erelzi should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or the child have a history of alcohol abuse.
• Wegener's granulomatosis:Erelzi is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or the child have Wegener's granulomatosis, consult your doctor.
• Anti-diabetic medicinesTell your doctor if you or the child suffer from diabetes or are taking medicines to treat diabetes. Your doctor may decide whether you or the child need to receive less anti-diabetic medicine while using Erelzi.

Children and adolescents
The use of Erelzi is not indicated in children and adolescents weighing less than 62.5 kg.

• Vaccinations:If possible, before using Erelzi, children should be up to date with all vaccinations. Some vaccines, such as the oral polio vaccine, should not be given while taking Erelzi. Consult your doctor before you or the child receive any vaccine.

Generally, Erelzi should not be used in children with polyarticular or extended oligoarticular arthritis under the age of
2 years or weighing less than 62.5 kg, or in children with arthritis associated with enthesitis or
psoriatic arthritis under the age of 12 years or weighing less than 62.5 kg, or in children with psoriasis of
age less than 6 years or weighing less than 62.5 kg.

Other medicines and Erelzi
Tell your doctor or pharmacist if you or the 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 the child must not useErelzi together with the active substance anakinra or abatacept.

Pregnancy and breastfeeding
Erelzi should be used in pregnancy only if clearly necessary. If you are pregnant, or
suspect you are pregnant, or are planning a pregnancy, ask your doctor for advice.
If you have received Erelzi during pregnancy, the newborn may be at increased risk of
infection. Also, one study has indicated that there was a higher number of birth defects in mothers who received etanercept during pregnancy
compared to mothers who did not receive
etanercept 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 Erelzi during pregnancy. Your doctor will
help you decide whether the benefits of treatment outweigh the potential risk to your baby.
Contact your doctor if you wish to breastfeed while using Erelzi. It is important
to inform the child's pediatricians and other healthcare professionals about the use of Erelzi during pregnancy
and breastfeeding before the child receives any vaccine.

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

Erelzi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 25 mg or 50 mg, i.e. essentially
‘sodium-free’.

3. How to use Erelzi

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 Erelzi is too strong or too weak, consult your doctor or
pharmacist.
Erelzi is available in dosages of 25 mg and 50 mg.

Use in 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 Erelzi.
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 use Erelzi and whether, based on your response, further
treatment is necessary. If, after 12 weeks, Erelzi 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
body weight and the disease. The doctor will establish the correct dose for your child and prescribe an
appropriate dosage of etanercept. Pediatric patients weighing 62.5 kg or more can
receive 25 mg twice a week or 50 mg once a week and can use both the prefilled syringe and the prefilled pen with fixed doses.
Other products containing etanercept with a dosage suitable for children are available.
For polyarticular or extended oligoarticular arthritis in patients starting from 2 years of age with a weight equal to or greater than
62.5 kg, or arthritis related to enthesitis or psoriatic arthritis in patients starting from 12 years of age
with a weight equal to or greater than 62.5 kg, the usual dose is 25 mg administered twice a week or
50 mg administered once a week.
For psoriasis in patients starting from 6 years of age with a weight equal to or greater than 62.5 kg, the dose
usual is 50 mg and must be administered once a week. If Erelzi 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
Erelzi is administered by injection under the skin (subcutaneous injection).

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

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

If you forget to take Erelzi
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 missed 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 missed dose.

If you stop treatment with Erelzi
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 Erelzi 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 flushing 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 Erelzi; 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 changes, such as bleeding, bruising or paleness.
• Symptoms of nerve changes, 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 discoloration of the nails or lips.
• Symptoms of tumors: tumors can affect any part of the body, including 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, pain in joints or muscles, 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 Erelzi include those listed below, grouped by decreasing frequency:

• Very common(may affect more than 1 in 10 people) Infections (including cold, 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 tumor (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); skin rash that can lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish/purple rash and/or whitish-greyish filamentous lines 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 (the frequency cannot be estimated from the 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, pharmacist or nurse. 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 Erelzi

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 carton and on the label of the
pre-filled syringe after “Expiry/EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 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
solution of Erelzi in the syringe to reach room temperature.Do not heat it in any other
way. Immediate use is then recommended.
Erelzi can be stored at a maximum temperature of 25 °C for up to 4 weeks, for one
time only; after this period it cannot be returned to the refrigerator. If not used within 4
weeks outside the refrigerator, Erelzi must be discarded. It is recommended to note the date on which Erelzi is
removed from the refrigerator and the date by which Erelzi 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 slightly yellowish and may contain small white or
almost translucent protein particles. This is the normal appearance of Erelzi. Do not use this solution if it presents alterations
of 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 wastewater and household waste. Ask your pharmacist how
to dispose of medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Erelzi contains
The active ingredient is etanercept.
Each pre-filled syringe contains 25 mg of etanercept or 50 mg of etanercept.
The other ingredients are anhydrous citric acid, disodium citrate dihydrate, sodium chloride, sucrose, L-lysine
hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Erelzi and contents of the pack
Erelzi is supplied as a pre-filled syringe containing a solution for injection
(injectable preparation) that is clear to slightly opalescent, from colourless to slightly yellowish.
The pre-filled syringes are type I glass syringes, with a rubber stopper (bromobutyl rubber), plunger, 29 G stainless steel needle attached and needle cap
(thermoplastic elastomer). The syringes are provided with an automatic needle protection device. Each box contains 1, 2 or 4 pre-filled syringes with needle protection device,
multiple packs contain 12 (3 packs of 4) pre-filled syringes of 25 mg or 50 mg with
needle protection device or 8 (2 packs of 4) or 24 (6 packs of 4) pre-filled syringes
of 25 mg with needle protection device. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestrasse 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf/Sími/Tel: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 48 20 0600

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu .

7. Instructions for use of Erelzi pre-filled syringe

Read ALL of these instructions completely before administering the injection.
It is important not to attempt to self-inject the medication until you have been adequately instructed by your
doctor, nurse or pharmacist. The package contains a pre-filled syringe/syringes of
Erelzi sealed individually in a plastic blister.

DO NOT USEIn this configuration the needle safety device
is ACTIVE – DO NOT USE the pre-filled syringe

READY TO USEIn this configuration the needle safety device
is NOT ACTIVE and the pre-filled syringe is ready
for use

Appearance of Erelzi pre-filled syringe with needle safety device and add-on grip

After administering the medication, the needle safety device is activated. This is designed to
help protect healthcare professionals, patients who self-administer the injection, doctors and prescribers of the medication, and those assisting patients
with the procedure from accidental needle stick injuries.

What you need for the injection:

• Alcohol-soaked wipe.
• Cotton ball or gauze.
• Sharps container for disposal of sharp materials.

Important safety information
Caution: Keep the syringe out of the sight and reach of children.

• 1. Do not open the outer packaging until you are ready to use this medication.
• 2. Do not use this medication if the blister seal is damaged as use may not be safe.
• 3. Do not shake the syringe.
• 4. Never leave the syringe unattended where others could damage it.
• 5. The pre-filled syringe is equipped with a needle safety device that activates at the end of the injection, covering the needle. The needle safety device helps prevent needle stick injuries to anyone handling the pre-filled syringe. Be careful not to touch the flaps of the needle safety device before use. Touching them may cause the needle safety device to activate prematurely.
• 6. Do not remove the needle cap until you are ready to inject.
• 7. The syringe cannot be reused. Dispose of the syringe immediately after use in a sharps container.
• 8. Do not use if the syringe has fallen onto a hard surface or has fallen after removing the needle cap.

Storage of the Erelzi pre-filled syringe

• 1. Store this medication well closed in its box to protect the medication from light. Store in a refrigerator between 2 °C – 8 °C. DO NOT FREEZE.
• 2. Before preparing the syringe for injection, remember to remove the blister from the refrigerator and allow it to reach room temperature (15-30 minutes).
• 3. Do not use the syringe after the expiration date which is stated on the box after “Exp.” or on the syringe label after “EXP”. If it is expired, return the entire package to the pharmacy.

The injection site

The injection site corresponds to the point on the body where the
pre-filled syringe will be used.

• The recommended site is the front of the thighs. You can also use the lower abdomen, but notthe area within 5 centimeters around the navel.
• Choose a different site each time you administer the injection.
• Do not inject into areas where the skin is sensitive, bruised, red, flaky or hardened. Avoid areas where there are scars or stretch marks. If you have psoriasis, the injection should NOT be performed directly on areas or lesions where the skin appears raised, thick, red or flaky (“psoriatic skin lesions”). If the injection is being administered by someone assisting you, the outer upper arms can also be used.

Preparation of the Erelzi pre-filled syringe

• 1. Remove the blister from the refrigerator and leave it closedfor about 15-30 minutes to allow it to reach room temperature.
• 2. When you are ready to use the syringe, open the blister and wash your hands thoroughly with soap and water.
• 3. Clean the injection site with an alcohol-soaked swab.
• 4. Remove the syringe from the blister.
• 5. Inspect the syringe. The liquid should be clear or slightly opalescent, from colorless to slightly yellowish and may contain small translucent or white protein particles. This is the normal appearance of Erelzi. Do not use if the liquid is cloudy, has a color change, or if there are clumps, flakes or colored particles. Do not use if the syringe is damaged or the needle safety device is activated. In all these cases, return the entire package to the pharmacy.

How to use the Erelzi pre-filled syringe

Carefully remove the needle cap from the syringe and
discard it. A drop of liquid may come out
of the tip of the needle. This is normal.

Gently pinch the skin at the injection site and
insert the needle as shown. Push the needle in deeply
to ensure that all of the medication is administered.

Hold the grip of the syringe as shown. Press

slowlythe plunger all the way downso that the head
of the plunger is between the flaps of the needle safety
device.
Continue to hold the plunger pressed while keeping
the syringe in position for 5 seconds.

Continue to hold the plunger pressedwhile carefully
withdrawing the needle from the injection site.

Slowly release the plunger to allow the
needle safety device to automatically cover
the exposed needle.
There may be slight bleeding at the injection
site. If so, press a cotton ball or gauze on the injection site and hold it for 10
seconds. Do not rub the injection site. If necessary, you can cover the injection site with a small bandage.

Disposal instructions

Dispose of the used syringe by placing it in a special
sharps container (a resealable, puncture-resistant container). For your health and safety and
the safety of others, used needles and syringes must neverbe
reused.

If you have any questions, please contact a doctor, nurse or pharmacist who is familiar with
Erelzi.

Erelzi 50 mg solution for injection in pre-filled pen

etanercept (etanerceptum)

Read this leaflet carefully before using this medicine as 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 Erelzi.
• 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 dangerous.
• 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 Erelzi is and what it is used for
• 2. What you need to know before you use Erelzi
• 3. How to use Erelzi
• 4. Possible side effects
• 5. How to store Erelzi
• 6. Contents of the pack and other information
• 7. Instructions for use of Erelzi pre-filled pen

1. What is Erelzi and what it is used for

Erelzi is a medicine made from two human proteins. It blocks the activity of another protein that
causes inflammation in the human body. Erelzi works by reducing inflammation associated
with certain diseases.
In adults (aged 18 years and over), Erelzi can be used for the treatment
of rheumatoid arthritisfrom moderate to severe, psoriatic arthritis,axial spondyloarthritis
severe, including ankylosing spondylitisand psoriasisfrom moderate to severe - in each case, it is
usually used when other widely used treatments have not worked well enough or
are not suitable for you.
For rheumatoid arthritis, Erelzi is usually used in combination with methotrexate, although
it can also be used alone if treatment with methotrexate is not suitable for you. Whether
used alone or in combination with methotrexate, Erelzi can slow down the damage to the joints
caused by rheumatoid arthritis and improve the ability to perform normal daily activities.
For patients with psoriatic arthritiswith involvement of multiple joints, Erelzi can
improve the ability to perform daily activities.
For patients with multiple symmetrical painful or swollen joints(e.g. hands, wrists and
feet), Erelzi can slow down the structural damage to these joints caused by the disease.
Erelzi 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 with a weight equal to or greater than 62.5 kg.
• Psoriatic arthritis in patients aged 12 years and over with a weight equal to or greater than 62.5 kg.
• For arthritis related to enthesitis in patients aged 12 years and over with a weight equal to or greater than 62.5 kg, 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 with a weight equal to or greater than 62.5 kg who have had an inadequate response with (or cannot take) phototherapies or other systemic therapies.

2. What you need to know before using Erelzi

Do not use Erelzi

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

Warnings and precautions
Talk to your doctor before using Erelzi.

• Allergic reactions:If you, or the child, experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Erelzi and contact your doctor immediately.
• Infections/surgery:If you, or the child, develop a new infection or are about to undergo any major surgery. Your doctor may want to check your treatment with Erelzi.
• Infections/diabetes: Tell your doctor if you or the 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 the 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 the child for infections after you or the child have stopped taking Erelzi.
• Tuberculosis: Because cases of tuberculosis have been reported in patients treated with Erelzi, your doctor will check you for signs and symptoms of tuberculosis before starting treatment with Erelzi. 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 the 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, inform your doctor immediately.
• Hepatitis B: Tell your doctor if you or the child have or have had hepatitis B. Your doctor should test for hepatitis B before you or the child start treatment with Erelzi. Treatment with Erelzi may cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. In this case, you must stop using Erelzi.
• Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may consider monitoring treatment with Erelzi if the infection worsens.
• Blood disorders: Seek immediate medical attention if you or the 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 Erelzi.
• Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). Your doctor will assess whether Erelzi is an appropriate treatment.
• Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, as Erelzi 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 Erelzi. Patients with severe, long-standing rheumatoid arthritis may be at a higher than average risk of developing lymphoma. Children and adults taking Erelzi may have an increased risk of developing lymphoma or another cancer. Some children and adolescent patients who have been treated with Erelzi or other medicines that work like Erelzi have developed tumors, sometimes unusual and sometimes fatal. Some patients receiving Erelzi have developed skin tumors. Tell your doctor if you or the child develop any changes in the appearance of the skin or growths on the skin.
• Chickenpox:Tell your doctor if you or the child are exposed to chickenpox while using Erelzi. Your doctor will assess whether preventive treatment for chickenpox is appropriate.
• Alcohol abuse:Erelzi should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or the child have a history of alcohol abuse.
• Wegener's granulomatosis:Erelzi is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or the child have Wegener's granulomatosis, consult your doctor.
• Antidiabetic medicines: Tell your doctor if you or the child suffer from diabetes or are taking medicines to treat diabetes. Your doctor may decide whether you or the child need to receive less antidiabetic medicine while using Erelzi.

Children and adolescents
The use of Erelzi is not indicated in children and adolescents weighing less than 62.5 kg.

• Vaccinations: If possible, before using Erelzi, children should be up to date with all vaccinations. Some vaccines, such as oral polio vaccine, should not be given while taking Erelzi. Consult your doctor before you or the child receive any vaccine.

As a rule, Erelzi should not be used in children with polyarticular or extended oligoarticular arthritis under the age of
2 years or weighing less than 62.5 kg, or in children with enthesitis-related arthritis or
psoriatic arthritis under the age of 12 years or weighing less than 62.5 kg, or in children with psoriasis of
age less than 6 years or weighing less than 62.5 kg.

Other medicines and Erelzi
Tell your doctor or pharmacist if you or the 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 the child must not useErelzi together with the active ingredients anakinra or abatacept.

Pregnancy and breastfeeding
Erelzi should be used during pregnancy only if clearly necessary. If you are pregnant, or
suspect you are pregnant, or are planning to become pregnant, ask your doctor for advice.
If you have received Erelzi 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 etanercept during pregnancy
compared to mothers who did not receive
etanercept 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 Erelzi during pregnancy. Your doctor will
help you decide whether the benefits of treatment outweigh the potential risks to your baby.
Contact your doctor if you wish to breastfeed while taking Erelzi. It is important
to inform the child's pediatricians and other healthcare professionals about the use of Erelzi during pregnancy
and breastfeeding before the child receives any vaccine.

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

Erelzi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 50 mg, i.e. essentially ‘sodium-free’.

3. How to use Erelzi

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 Erelzi is too strong or too weak, consult your doctor or
pharmacist.
You have been prescribed a dosage of Erelzi 50 mg. A dosage of Erelzi 25 mg is available for
25 mg doses.

Use inadult 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 Erelzi.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week or 50 mg administered once a
week.
Alternatively, a 50 mg dose can 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 use Erelzi and whether, based on your response, further
treatment is necessary. If, after 12 weeks, Erelzi 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 an
appropriate dosage of etanercept. Pediatric patients weighing 62.5 kg or more may
receive 25 mg twice a week or 50 mg once a week and can use both the prefilled syringe and the fixed-dose prefilled pen.
Other etanercept products with dosages suitable for children are available.
For polyarticular or extended oligoarticular arthritis in patients starting from 2 years of age weighing 62.5 kg or more, or enthesitis-related arthritis or psoriatic arthritis in patients starting from 12 years of age
weighing 62.5 kg or more, the usual dose is 25 mg administered twice a week or
50 mg administered once a week.
For psoriasis in patients starting from 6 years of age weighing 62.5 kg or more, the dose
is usually 50 mg and must be administered once a week. If Erelzi 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.

Route of administration and how to administer
Erelzi is administered by injection under the skin (subcutaneous injection).

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

If you use more Erelzi than you should
If you have used more Erelzi 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 forget to take Erelzi
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 taking Erelzi
Following discontinuation of treatment, the symptoms of the disease may return.
If you have any questions 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.

Allergic reactions
If any of the following side effects occur, do not inject Erelzi 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 above symptoms may indicate an allergic reaction to Erelzi; 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 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 Erelzi 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) 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); 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-greyish filamentous lines 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 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 get any side effects, talk to your doctor, pharmacist or nurse. 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 Erelzi

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 of the
pre-filled pen after “Expiry Date/EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 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 out of the refrigerator, wait approximately 15-30 minutes to allow
the Erelzi solution in the pen to reach room temperature.Do not heat it in any other
way. Immediate use is then recommended.
Erelzi can be stored at a maximum temperature of 25 °C for up to 4 weeks, for a single
time; after this period it cannot be returned to the refrigerator. If not used within 4
weeks outside the refrigerator, Erelzi must be discarded. It is recommended to note the date on which Erelzi is
removed from the refrigerator and the date by which Erelzi must be disposed of (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 slightly
yellowish and may contain small, white or almost translucent protein particles. This is the normal appearance of Erelzi. 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 the 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 Erelzi contains
The active ingredient is etanercept.
Each pre-filled pen contains 50 mg of etanercept.
The other components are anhydrous citric acid, disodium citrate dihydrate, sodium chloride, sucrose, L-lysine
hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Erelzi and contents of the pack
Erelzi is supplied as an injectable solution in a pre-filled pen. The pre-filled pen
contains a solution for injection (injectable preparation) from clear to slightly opalescent,
from colourless to slightly yellowish. The pre-filled syringes are type I glass syringes, with a stopper
made of rubber (bromobutyl rubber), plunger, a 29 G stainless steel needle
attached and a needle cap (thermoplastic elastomer).
Each box contains 1, 2 or 4 pens, multiple packs contain 12 (3 packs of 4) pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestrasse 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf/Sími/Tel: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 48 20 0600

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu .

7. Instructions for use of Erelzi pre-filled pen

Read these instructions COMPLETELY before performing the injection.
These instructions are to help you perform the injection correctly by
using the Erelzi pre-filled pen.
It is important not to attempt the injection yourself until you have been
adequately instructed by your doctor, nurse, or pharmacist.

Appearance of the Erelzi pre-filled pen:

Store the pen packaged in a refrigeratorbetween
2 °C – 8 °C and keep it out of the reach of
children.

• Do not freezethe pen.
• Do not shake the pen.
• Do not use the pen if it has been droppedwithout a cap. For a more comfortable injection, remove the pen from the refrigerator 15-30 minutes before the injectionto allow it to reach room temperature. Needle

Cap
Internal needle cover
Erelzi pre-filled pen shown with the cap
removed. Do notremove the cap until you are
ready for the injection.

What you need for the injection:
Included in the package: Not included in the package:

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. A new and unused Erelzi pre-filled pen.

Before the injection:

1. Important safety checks before injection:

The solution should be from clear to slightly opalescent, from
colorless to slightly yellowish and may contain small
protein particles that are white or nearly translucent. This is the normal appearance of
Erelzi.

Do not useif the liquid is cloudy, shows color changes
or if it contains clumps, flakes or colored particles.

Do not usethe pen after the expiry date.

Do not useif the safety sealhas been opened.
Contact your pharmacist if the pen does not meet any of
these checks.

2a. Choice of injection site:

• The recommended site is the front of the thighs. You can also use the lower abdomen, but notthe area within 5 centimeters around the navel.
• Choose a different site for each new injection.
• Do not inject into areas where the skin is sensitive, there are bruises, it is reddened, flaky or hardened. Avoid areas where there are scars or stretch marks. If you have psoriasis, the injection should NOT be made directly into areas or lesions where the skin appears raised, thickened, reddened or flaky (“psoriatic skin lesions”). 2b. Only for people caring for the patient and healthcare professionals:
• If the injection is administered by a caregiveror healthcare professionals, it can also be performed in the upper outer part of the arms.

3. Injection site cleaning:

• Wash your hands with soap and warm water.
• Using a circular motion, clean the injection site with a swab soaked in alcohol. Allow to dry before performing the injection.
• Do not touch the cleaned area again before performing the injection.

Injection:

4. Removing the cap:

• Remove the cap only when you are ready to use the pen.
• Unscrew the cap in the direction of the arrows.
• Discard the cap. Do not attempt to replace the cap.
• Use the pen within 5 minutes of removing the cap.

5. Pen position:

• Hold the pen at a 90-degree angle to the cleaned injection site.

CorrectIncorrect

READ BEFORE PERFORMING THE INJECTION.
During the injection you will hear 2 audible clicks.
The first clickindicates that the injection has started. Several seconds later a

second clickwill indicate that the injection is almostcomplete.
You must continue to hold the pen firmly against the skin until
the green indicatorfills the window and stops moving.

6. Start the injection:

• Press the pen firmly against the skin to start the injection.
• The first clickindicates that the injection has started.
• Continue to keepthe pen firmly against the skin.
• The green indicatorshows the progress of the injection.

7. Complete the injection:

• Wait for the sound of the second click. This indicates that the injection is almostcomplete.
• Check that the green indicatorfills the window and has stopped.
• The pen can now be removed.

After the injection:

8. Check that the green indicator fills the window:

• This means that the medicine has been administered. Contact your doctor if the green indicator is not visible.
• Slight bleeding may occur at the injection site. If this happens, you can press a cotton ball or gauze on the injection site and hold it for 10 seconds. Do not rub the injection site. If necessary, you can cover the injection site with a small bandage.

9. Disposing of the pre-filled pen of Erelzi:

• Dispose of the used pen by placing it in a suitable sharps container (e.g., a closable, puncture-resistant container or similar).
• Never attempt to reuse the pen.

If you have any questions, please contact a doctor, nurse, or pharmacist who is familiar with
Erelzi.