STIMUFEND 6 мг Инъекционный раствор

Содержание инструкции

1. Stimufend 6 mg injectable solution in pre-filled syringe
   1. What is Stimufend and what is it used for
   2. What you need to know before you use Stimufend
   3. How to use Stimufend
   4. Possible side effects
   5. How to store Stimufend
   6. Content of the pack and other information
   7. 1 Wash your hands
   8. 1 Remove the pre-filled syringe from the sealed plastic tray
   9. 2 Check the syringe
   10. 3 Check the liquid
   11. 4 Check the label
   12. 1 Choose an injection site (Figure M)
   13. 2 Clean the injection site
   14. 1 Remove the needle cap
   15. 2 Pinch the skin

Stimufend 6 mg injectable solution in pre-filled syringe

pegfilgrastim

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others,
even if their symptoms are the same as yours, as it may be harmful.
If any side effects occur, including those not listed in this
leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Stimufend and what is it used for

Stimufend contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced using
a biotechnological technique in a bacterial cell called Escherichia coli. It belongs
to a group of proteins called cytokines and is very similar to a natural protein (granulocyte colony-stimulating factor) produced by our body.
Stimufend is used to reduce the duration of neutropenia (low number of white blood cells)
and the occurrence of febrile neutropenia (low number of white blood cells with fever) that
may be caused by cytotoxic chemotherapy (medicines that destroy
rapidly growing cells). White blood cells are important because they help the body to
fight infections. These cells are very sensitive to the effects of chemotherapy;
this can cause a decrease in the number of these cells in the body. If the
number of white blood cells drops to a low level, there may not be enough left
to fight bacteria and you may be at greater risk of contracting an infection.
Your doctor has prescribed Stimufend to stimulate the bone marrow (the part of the bone that
produces blood cells) to produce more white blood cells to help the body to
fight infections.

2. What you need to know before you use Stimufend

Do not use Stimufend

• If you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you use Stimufend:

• if you have an allergic reaction including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and itchy skin areas.
• if you have an allergy to latex. The needle cap of the prefilled syringe contains a latex derivative that can cause serious allergic reactions.
• if you have cough, fever and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if you have one or more of the following side effects:
• swelling or bloating, which may be associated with decreased fluid passage, difficulty breathing, abdominal swelling and a feeling of fullness and a general feeling of fatigue. These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from small blood vessels in the body. See section 4.
• if you have pain in the upper left side of your abdomen or pain at the tip of your shoulder. These could be signs of a problem with the spleen (splenomegaly).
• if you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), inflammation of the lungs (interstitial lung disease) or an abnormality found on an X-ray (pulmonary infiltration).
• if you know you have abnormal blood cell counts (e.g. increased white blood cells or anemia) or a decrease in platelet levels, which reduces the body's ability to clot (thrombocytopenia). Your doctor may want to monitor you closely.
• if you have sickle cell anemia. Your doctor may want to monitor you closely.
• if you have breast or lung cancer, Stimufend in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-cancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever and easy bruising or bleeding.
• if you suddenly have signs of allergy such as skin rash, hives or itching, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing, these could be signs of a severe allergic reaction.
• if you have symptoms of inflammation of the aorta (the large blood vessel that carries blood from the heart to the rest of the body), which have been reported rarely in cancer patients and healthy people. Symptoms may include fever, abdominal pain, malaise, back pain and increased markers of inflammation. Tell your doctor if you experience such symptoms.

Your doctor will regularly check your blood and urine because Stimufend can
damage the tiny filters inside your kidneys (glomerulonephritis).
Serious skin reactions (Stevens-Johnson syndrome) have been observed with the use of pegfilgrastim. If
you notice any of the symptoms described in section 4, stop using
pegfilgrastim and seek immediate medical attention.
You should talk to your doctor about the risks of developing a blood cancer. If you have or may
have a blood cancer, you should not use Stimufend unless directed to do so by
your doctor.

Loss of response to pegfilgrastim
If you have a decrease in response or failure to maintain response to
treatment with pegfilgrastim, your doctor will investigate the reasons, including the possibility that you
have developed antibodies that neutralize the activity of pegfilgrastim.

Other medicines and Stimufend
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Stimufend has not been studied in pregnant women. It is important that
you inform your doctor if:

• you are pregnant;
• suspect you may be pregnant; or
• are planning to become pregnant.

If you become pregnant during treatment with Stimufend, tell your doctor.
Unless your doctor tells you otherwise, you should stop breastfeeding if you use Stimufend.

Driving and using machines
Stimufend does not or negligibly alters the ability to drive or operate
machines.

Stimufend contains sorbitol (E420) and sodium acetate
This medicine contains 30 mg of sorbitol in each 6 mg dose, which is equivalent to 50 mg/ml.
This medicine contains less than 1 mmol of sodium (23 mg) per 6 mg dose, i.e. essentially
‘sodium-free’.

3. How to use Stimufend

Stimufend is indicated in adults aged 18 years or older.
Take Stimufend following the doctor's instructions exactly at all times. If you have any doubts, consult
your doctor or pharmacist.
The usual dose is a subcutaneous injection (injection under the skin) of 6 mg which must be
administered at least 24 hours after the last dose of chemotherapy at the end of each cycle of
chemotherapy.

How to self-inject Stimufend
Your doctor may consider that it is better for you to self-inject Stimufend. The
doctor or nurse will show you how to self-inject Stimufend. Do not attempt to self-inject
if you have not been shown how to do it.
self-inject Stimufend .
Do not shake Stimufend vigorously as this may compromise its activity.

If you use more Stimufend than you should
If you use more Stimufend than you should, you should contact your doctor, pharmacist or nurse.

If you forget to inject Stimufend
If you self-inject and have forgotten your dose of Stimufend, you should contact your doctor
to determine when to administer the next injection.
If you have any doubts about the use of this medicine, please consult your doctor or pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediately inform your doctor if you experience any one or a combination of the following
side effects:

• swelling or edema, which may be associated with less frequent passage of water, difficulty breathing, abdominal bloating and a feeling of fullness, and a general feeling of fatigue. These symptoms usually develop rapidly.

These could be symptoms of an uncommon condition (may affect up to 1
in 100 people) called "Capillary Leak Syndrome", which causes blood to leak
from small blood vessels inside the body and requires urgent medical attention.

Very common side effects(may affect more than 1 in 10 people):

• bone pain. Your doctor will tell you what to take to relieve bone pain.
• nausea and headache.

Common side effects(may affect up to 1 in 10 people):

• pain at the injection site.
• general pain and joint and muscle pain.
• some changes may occur in the blood, but these will be detected during routine blood tests. White blood cell counts may increase for a short period of time. Platelet counts may decrease causing bruising.

Uncommon side effects(may affect up to 1 in 100 people):

• allergic-type reactions, including redness and flushing, skin rash (skin redness) and itchy skin swelling.
• severe allergic reactions including anaphylaxis (weakness, low blood pressure, difficulty breathing, facial swelling).
• increased spleen volume.
• spleen rupture. Some cases of spleen rupture have been fatal. It is important that you contact your doctor immediately if you feel pain in the upper left side of your abdomen or left shoulder as this may indicate problems with the spleen.
• breathing problems. If you have cough, fever and difficulty breathing, contact your doctor.
• cases of Sweet syndrome (purple, raised and painful lesions on the limbs and sometimes on the face and neck, associated with fever) have occurred, but other factors may have contributed to these.
• cutaneous vasculitis (inflammation of the skin blood vessels).
• damage to the tiny filters inside the kidneys (glomerulonephritis).
• redness at the injection site.
• coughing up blood (hemoptysis).
• blood diseases (myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML]).

Rare side effects(may affect up to 1 in 1,000 people):

• inflammation of the aorta (the large blood vessel that carries blood from the heart to the rest of the body), see section 2.
• bleeding from the lungs (pulmonary hemorrhage).
• Stevens-Johnson syndrome, which can manifest as reddish patches or round spots, often with central blisters, located on the trunk, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes, and may be preceded by fever and flu-like symptoms. If
  you develop these symptoms, stop using Stimufend and contact your doctor or seek medical attention immediately. See also section 2.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Stimufend

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 package and on the label
of the syringe after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Stimufend may be exposed to room temperature (not exceeding 30°C) for a single period
of up to 72 hours. Stimufend left at room temperature for more than 72 hours must be
discarded. For any questions about storage, ask your doctor, nurse or pharmacist.
Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice that it is cloudy or if you see particles.
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. Content of the pack and other information

What Stimufend contains

• The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in
• 0.6 mL of solution.
• The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20, glacial acetic acid and water for injections. See section 2 ‘Stimufend contains sorbitol (E420) and sodium acetate’.

Description of the appearance of Stimufend and content of the pack
Stimufend is a clear, colorless injectable solution in a pre-filled syringe (6 mg/0.6 mL). Each
pack contains 1 pre-filled glass syringe with a stainless steel needle attached and a needle
cap.
The pre-filled syringe is provided with automatic needle protection.

Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kroener Strasse 1
61352 Bad Homburg v.d.Hoehe
Germany

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu/

Instructions for use of Stimufend (pegfilgrastim)
Single dose pre-filled syringe for subcutaneous injection

Important:
use these instructions for use of Stimufend.
Before using a pre-filled syringe of Stimufend, read these important information.

Storage of pre-filled syringes of Stimufend:

• Store Stimufend in a refrigerator between 2°C and 8°C.
• Do notfreeze.
• Keep the pre-filled syringe in the original packaging to protect it from light.
• Discard (dispose of) any remaining Stimufend at room temperature, not exceeding 30°C, for more than 72 hours.
• Keep the pre-filled syringe of Stimufend out of the reach of children.

Using the pre-filled syringe:

• It is important that you do not try to inject Stimufend unless you or your caregiver have received training from your healthcare provider.
• Do not inject Stimufend into children.
• It is not possible to accurately measure a dose less than 6 mg/0.6 ml using the Stimufend pre-filled syringe.
• Do notuse a pre-filled syringe after the expiry date on the label as it may harm you.
• Do notshake the pre-filled syringe .
• Do notremove the needle cap from the pre-filled syringe until you are ready to inject.
• Do notuse the pre-filled syringe if the packaging is open or damaged.
• Do notuse the pre-filled syringe if it has fallen onto a hard surface. The pre-filled syringe may be broken even if you cannot see the break. Use a new pre-filled syringe.
• Do notuse Stimufend that has been frozen or left in direct sunlight.
• The needle cap on the pre-filled syringe contains dry natural rubber (latex). Inform your doctor if you are allergic to latex. You should not administer Stimufend using the pre-filled syringe if you suffer from latex allergies.
• The Stimufend pre-filled syringe has a transparent needle shield that covers the needle after the injection has been completed.
• Do nottry to activate the transparent needle shield before injection.
• Do notinsert your fingers into the opening of the transparent needle shield as the needle may injure you.
• Do nottry to reuse the Stimufend pre-filled syringe as it may cause an infection.

Call your healthcare provider if you have any questions.

Step 1: Preparing the injection
Before the injection

Figure A

After complete injection(Transparent needle shield locked in position)

Figure B

a 1.1 Prepare the materials
n Prepare a flat, clean surface, such as a table or worktop, in a well lit area.
a You will also need (not included) (Figure C): i 1 alcohol swab l 1 cotton ball or gauze and a a container for disposing of sharps. t I	Figure C
a Remove the pack from the refrigerator.
i Remove the sealed plastic tray from the packaging
z Place the syringe in the sealed plastic tray on a clean flat surface.
n Leave the syringe in its sealed plastic tray and leave it at room temperature for 30 minutes before injection (Figure D). Injecting the medicine cold may be painful A	30 minutes Figure D

• Do notheat the syringe in any other way, such as in a microwave, hot water or direct sunlight.
• Do notremove the needle cap while the syringe is reaching room temperature. Step 2: Wash your hands

2.1 Wash your hands

• Wash your hands thoroughly with water and soap and

dry them with a clean towel (Figure E).

• Wearing gloves does not replace the need to wash your hands.

Figure E

Step 3: Check the syringe

3.1 Remove the pre-filled syringe from the sealed plastic tray

• Peel off the seal from the sealed plastic tray.
• Place two fingers on both sides, in the center of the

transparent cap. Pull the pre-filled syringe
upwards and remove it from the tray (Figure F).

Do notgrasp the pre-filled syringe by the plunger or
the needle cap. This could damage the
syringe or activate the needle transparent protection.

Figure F

3.2 Check the syringe

• Check that the pre-filled syringe, the transparent needle cover and the needle cap are not cracked or damaged (Figure G).

Figure G

• Verify that the needle cap is securely attached

firmly (Figure H).

Figure H

• Verify that the needle protection spring is not

extended (Figure I).

Figure I

Do notuse the pre-filled syringe if it shows signs of damage. In this case, discard the syringe in the
sharps disposal container (see step 6) and contact your
doctor or pharmacist immediately.

3.3 Check the liquid

• Check the liquid through the transparent window on the label to ensure that the medicine is clear, colorless and free of particles and flocculi (Figure J).

Figure J

Do notuse the prefilled syringe if the medicine is cloudy or colored or if it contains particles or
flocculi. In this case, discard the syringe in the sharps disposal container
(see step 6) and call your doctor or pharmacist immediately .

3.4 Check the label

• Check the label on the syringeto make sure that
• The name on the label is Stimufend (Figure K).
• The expiration date has not passed (Figure

L).

• The dosage is 6 mg/0.6 ml

Figure K

Do notuse the prefilled syringe if:

• The name on the label is not Stimufend.
• The expiration date has passed.
• The dosage is not 6 mg/0.6 mL.

EXP: MM/YYYY

Figure L
In this case, discard the syringe in a sharps container (see
step 6) and call your doctor or pharmacist immediately.

Step 4: Prepare for the injection

4.1 Choose an injection site (Figure M)

You can use:

• Upper thighs, or
• Abdominal area (lower abdomen), except for the area

5 centimeters away from the navel (belly button).

Figure M

• If you are injecting someone else, it is possible

to use the back of the arm or the upper outer areas of the buttocks (Figure N).

• Inject only in the sites shown

Figure N

Do notinject into an area that is painful (tender), bruised, red, hard, scarred, or where you have
stretch marks or tattoos

Do notinject through clothing

4.2 Clean the injection site

• Clean the skin of the injection site with a

swab soaked in alcohol (Figure O). Allow
the skin to dry.

Do nottouch the injection site again before
injecting.

Figure O

Step 5: inject the medicine

5.1 Remove the needle cap

• Hold the syringe by the transparent protector

of the needle.

• Use the other hand to remove the needle cap by pulling it off (Figure P).
• Dispose of the needle cap in a sharps container. Figure PDo nottouch the needle or allow it to come into contact with any surface after removing the needle cap.

5.2 Pinch the skin

Gently pinch the skin around the area where you plan to give the injection (without compressing or touching the cleaned area) to avoid injecting into the muscle (Figure Q).	o c a Figura Q
m 5.3 Insert the needle
Hold the syringe in your other hand like a pencil. Quickly insert the needle directly into the skin at an angle between 45 and 90 degrees (Figure R).	r a F Figura R
l e 5.4 Inject
Use your thumb to gently push the plunger all the way down to inject the entire dose (Figure S). a n	d Figura S
a i The plunger must be pushed completely down to ensure that the entire dose has been injected (Figure T). a Hold the syringe firmly without moving it. t I	Figura T
a Do not remove the needle from the skin when the plunger reaches the end.
i 5.5 Complete the injection
z Slowly release your thumb upwards. This will allow the needle to move upwards into the transparent guard and cover the entire needle (Figure U). g A	Figura U
Important: Call your doctor or pharmacist immediately if: you have not injected the entire dose or the needle guard does not activate after a complete injection.

Injecting an incorrect amount of medicine could affect or delay treatment

Do notreuse a syringe if an incomplete injection occurred.

Do notattempt to recap the needle as this could cause needle stick injuries.

• If there is blood or fluid at the injection site

injection, gently press a cotton ball or gauze onto the skin (Figure V). If necessary, you can use an adhesive bandage.

Figure V

Do notrub the injection site.

Step 6: Dispose of the prefilled syringe

• 6.1Immediately after use, place used prefilled syringes in a sharps disposal container (Figure W).

Do notdiscard (dispose of) prefilled syringes in household waste.

Figure W

• If you do not have a sharps disposal container, you can use a household container that:
• is made of strong plastic;
• can be closed with a tight, puncture-resistant lid, preventing sharp objects from escaping;
• is upright and stable during use;
• is leak-proof and
• is adequately labeled to indicate the presence of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow local guidelines to properly dispose of the sharps disposal container. There may be local regulations on how to dispose of used needles and syringes. Do notdiscard the used sharps disposal container in household waste unless local guidelines allow it .

Do notrecycle the used sharps disposal container.