Vivlipeg

Package leaflet: Information for the user

Vivlipeg 6 mg solution for injection in pre-filled syringe

Pegfilgrastim
▼ This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:
What Vivlipeg is and what it is used for
What you need to know before you use Vivlipeg
How to use Vivlipeg
Possible side effects
How to store Vivlipeg
Contents of the pack and other information

1. What Vivlipeg is and what it is used for

Vivlipeg contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced using biotechnological methods in a bacterial cell called E. coli. It belongs to a group of proteins known as cytokines and is very similar to a naturally occurring protein (granulocyte colony-stimulating factor) produced by the human body.
Vivlipeg 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), which can be caused by cytotoxic chemotherapy (medicines that destroy rapidly dividing cells). White blood cells are important because they help the body fight infections. These cells are highly sensitive to the effects of chemotherapy; this can lead to 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, increasing the risk of developing an infection.
Your doctor has prescribed Vivlipeg to stimulate the bone marrow (the part of the bones that produces blood cells) to produce more white blood cells, helping the body to fight infections.
Vivlipeg is intended for adults aged 18 years and older.

2. What you need to know before using Vivlipeg Do not use Vivlipeg

• if you are allergic to pegfilgrastim, filgrastim, or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist, or nurse before using Vivlipeg:
• if you have an allergic reaction, including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), flushing and redness, skin rash, or itchy skin areas.
• if you have cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if you experience one or more of the following side effects:
• swelling or bloating, which may be associated with reduced fluid passage, difficulty breathing, abdominal swelling, a feeling of fullness, and a general feeling of fatigue.
• These could be symptoms of a condition called "Capillary Leak Syndrome" that causes leakage of blood from small vessels in the body. See section 4.
• if you have pain in the upper left side of the abdomen or shoulder tip pain.
• These could be signs of a spleen problem (splenomegaly).
• if you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), lung inflammation (pulmonary interstitial disease), or an abnormal finding on X-ray (pulmonary infiltration).
• if you know you have abnormal blood cell counts (e.g., increased white blood cells or anemia) or decreased 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 cancer or lung cancer, Vivlipeg in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-leukemic blood condition called myelodysplastic syndrome (MDS) or a blood tumor called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, and easy bruising or bleeding.
• if you suddenly develop 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 carrying blood from the heart to the rest of the body), which has been rarely reported in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and elevated inflammatory markers. Inform your doctor if such symptoms occur.

Your doctor will regularly check your blood and urine, as Vivlipeg may damage the tiny filters in your kidneys (glomerulonephritis).
Severe 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 Vivlipeg and seek immediate medical help.
Discuss with your doctor the risks of developing blood cancer. If you have or may have blood cancer, you must not use Vivlipeg unless otherwise instructed by your doctor.
Loss of response to Vivlipeg
If you experience a decreased response or failure to maintain response to pegfilgrastim treatment, your doctor will investigate the reasons, including the possibility that you have developed antibodies that neutralize the activity of pegfilgrastim.
Children and adolescents
The use of Vivlipeg is not recommended in children and adolescents due to insufficient data on safety and efficacy.
Other medicines and Vivlipeg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Vivlipeg has not been studied in pregnant women. Therefore, your doctor may advise against using this medicine.
If you become pregnant while being treated with Vivlipeg, inform your doctor.
Unless otherwise instructed by your doctor, you must stop breastfeeding while using Vivlipeg.
Driving and using machines
Vivlipeg does not affect or has negligible effect on the ability to drive or operate machinery.
Vivlipeg contains sorbitol, polysorbate, and sodium
This medicine contains 30 mg of sorbitol in each pre-filled syringe, equivalent to 50 mg/mL.
This medicine contains 0.024 mg of polysorbate 20 in each 6 mg/0.6 mL pre-filled syringe, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
This medicine contains less than 1 mmol (23 mg) of sodium per 6 mg dose, i.e., essentially "sodium-free".

3. How to use Vivlipeg

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose is one subcutaneous injection (an injection under the skin) of 6 mg, which should be administered at least 24 hours after the last dose of chemotherapy at the end of each chemotherapy cycle.

How to self-administer the Vivlipeg injection
Your doctor may consider it appropriate for you to self-inject Vivlipeg. Your doctor or nurse will show you how to administer the injection. Do not attempt to inject yourself unless you have been properly instructed how to do so.
For further instructions on how to administer the Vivlipeg injection, please read the instructions for use provided in the package.
Do not shake Vivlipeg vigorously, as this may impair its activity.

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

If you forget to use Vivlipeg
If you have missed your dose of Vivlipeg, you must contact your doctor to determine when to administer the next injection.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• swelling or puffiness, which may be associated with less frequent urination, difficulty breathing, abdominal swelling 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 into the body and requires urgent medical treatment.

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

• bone pain. Your doctor will advise you on 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 aches.
• some changes may occur in the blood, but these will be detected during routine blood tests. White blood cell levels may rise temporarily. Platelet levels may decrease, leading to bruising.
• chest pain.

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

• allergic-type reactions, including flushing and hot flushes, skin rash (skin redness), and swollen, itchy skin.
• severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
• sickle cell crisis in patients with sickle cell anaemia.
• enlargement of the spleen.
• 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 part of the abdomen or left shoulder, as this may indicate spleen problems.
• breathing problems. If you develop cough, fever, and difficulty breathing, contact your doctor.
• cases of Sweet’s syndrome (purple, raised, painful skin lesions on limbs, and sometimes on face and neck, associated with fever) have been reported, although other factors may have contributed.
• cutaneous vasculitis (inflammation of the skin blood vessels).
• damage to the tiny filters in the kidneys (glomerulonephritis).
• redness at the injection site.
• coughing up blood (haemoptysis).
• blood disorders (MDS or AML).

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

• inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), see section 2.
• bleeding from the lungs (pulmonary haemorrhage).
• Stevens-Johnson syndrome, which may present as reddish or roundish spots, often with central blisters, located on the trunk, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes, and which may be preceded by fever and flu-like symptoms.
• if you develop these symptoms, stop using Vivlipeg and contact your doctor or seek immediate medical assistance. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Vivlipeg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and on the syringe label after "Exp". The expiry date refers to the last day of that month.
Store in the refrigerator (2°C-8°C).
Do not freeze. Vivlipeg may be used if it has been accidentally frozen once for less than 24 hours.
Keep the container in the outer packaging to protect the medicine from light.
Vivlipeg may be removed from the refrigerator and stored at room temperature (not above 30°C) for up to 3 days. Once the syringe has been removed from the refrigerator and has reached room temperature (not above 30°C), it must be used within 3 days or discarded.
Do not use this medicine if you notice it is cloudy or if particles are visible.
Do not dispose of any medicine via 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 Vivlipeg contains

• The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL of solution.
• The other components are sodium acetate, sorbitol (E420), polysorbate 20, and water for injections. See section 2 “Vivlipeg contains sorbitol and sodium”.

Description of the appearance of Vivlipeg and contents of the pack
Vivlipeg is a clear, colourless injectable solution in a glass pre-filled syringe with a stainless steel needle and needle cap. The syringe is supplied in a pack with a blister.
Each pack contains 1 pre-filled syringe.
Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited Unit 35/36
Grange Parade,
Baldoyle Industrial Estate, Dublin 13
DUBLIN
Ireland D13 R20R
Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne Dublin
D09 C6X8
Ireland
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Biocon Biologics Belgium BV Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910 Tel: 0080008250910
България Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited Biocon Biologics France S.A.S
Тел: 0080008250910 Tél/Tel: 0080008250910
(Belgique/Belgien)
Česká republika Magyarország
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel.: 0080008250910
Danmark Malta
Biocon Biologics Finland OY Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910 Tel.: 0080008250910
Deutschland Nederland
Biocon Biologics Germany GmbH Biocon Biologics France S.A.S
Tel: 0080008250910 Tel: 0080008250910
Eesti Norge
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tlf: +47 800 62 671
Ελλάδα Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Biocon Biologics Germany GmbH
Ι.Κ.Ε Tel: 0080008250910
Τηλ.: 0080008250910
España Polska
Biocon Biologics Spain S.L. Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
France Portugal
Laboratories Biogaran Biocon Biologics Spain S.L.
Tél: +33 (0) 800 970 109 Tel: 0080008250910
Hrvatska România
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
Ireland Slovenija
Biosimilar Collaborations Ireland Limited Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794 Tel: 0080008250910
Ísland Slovenská republika
Biocon Biologics Finland OY Biocon Biologics Germany GmbH
Sími: +345 800 4316 Tel: 0080008250910
Italia Suomi/Finland
Biocon Biologics Spain S.L. Biocon Biologics Finland OY
Tel: 0080008250910 Puh/Tel: 99980008250910
Κύπρος Sverige
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Τηλ: 0080008250910 Tel: 0080008250910
Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .
Instructions for injecting Vivlipeg from a pre-filled syringe
This section contains information on how to self-administer an injection of Vivlipeg. It is important that you do not try to give yourself an injection unless your doctor, nurse, or pharmacist has shown you how to do so. If you have any questions about how to inject, please consult your doctor, nurse, or pharmacist.
How you, or the person administering the injection, should use Vivlipeg in a pre-filled syringe
You must inject the medicine just under the skin. This type of injection is called subcutaneous.
What you need
To give a subcutaneous injection, you will need:

• one pre-filled syringe of Vivlipeg; and
• alcohol swabs or similar disinfectants.

What should I do before giving myself a subcutaneous injection of Vivlipeg?
Remove the medicine from the refrigerator.
Do not shake the pre-filled syringe.
Do not remove the needle cap from the syringe until you are ready to give the injection.
Check the expiry date on the label of the pre-filled syringe (Exp.). Do not use it after the last day of the month stated.
Check the appearance of Vivlipeg. It should be a clear, colourless liquid. If you see particles, do not use it.
For a more comfortable injection, leave the pre-filled syringe outside the refrigerator for half an hour to allow it to reach room temperature, or hold it gently in your hand for a few minutes. Do not heat the syringe in any other way (for example, do not heat it in a microwave or in hot water).
Wash your hands thoroughly.
Find a comfortable, well-lit, and clean surface and keep everything you need within reach.
How do I prepare the Vivlipeg injection?
Before giving yourself the Vivlipeg injection, you must perform the following steps:
Take the syringe in hand and gently remove the needle cap without bending it. Pull

horizontally as shown in figures 1 and 2. Do not touch the needle or push the plunger.
You may notice a small air bubble in the pre-filled syringe. You do not need to remove the air bubble before the injection. Injecting the solution with the air bubble is harmless.
You may now use the pre-filled syringe.
Where should I give myself the injection?

The most suitable sites for injection are:
the upper part of the thighs; and
the abdomen, except the area around the navel.
If someone else is giving you the injection, the back of the upper arms may also be used.
How do I give myself the injection?
1 Clean the skin using an alcohol wipe.
Pinch the skin between your thumb and index finger (without squeezing it). Insert the needle into the skin.
Push the plunger down slowly and steadily. Push the plunger all the way down until all the liquid has been injected.
After injecting the liquid, withdraw the needle and release the skin.
If you notice a small drop of blood at the injection site, gently wipe it away with a cotton ball or gauze. Do not rub the injection site.
If necessary, you may cover the injection site with a plaster.
Do not reuse any remaining Vivlipeg left in the syringe.
To remember
Use each syringe for one injection only. If you have any problems, do not hesitate to consult your doctor or nurse for help and advice.
Disposal of used syringes

• Do not recap used needles.
• Keep used syringes out of sight and reach of children.
• Used syringes must be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Package leaflet: Information for the user

Vivlipeg 6 mg solution for injection in pre-filled syringe

pegfilgrastim
▼ This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.

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

Contents of this leaflet:
What Vivlipeg is and what it is used for
What you need to know before using Vivlipeg
How to use Vivlipeg
Possible side effects
How to store Vivlipeg
Contents of the pack and other information

1. What Vivlipeg is and what it is used for

Vivlipeg contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced using biotechnology in a bacterial cell called E. coli. It belongs to a group of proteins known as cytokines and is very similar to a naturally occurring protein (granulocyte colony-stimulating factor) produced by our body.
Vivlipeg 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), which may be caused by cytotoxic chemotherapy (medicines that destroy rapidly dividing cells). White blood cells are important because they help the body fight infections. These cells are highly sensitive to the effects of chemotherapy; this can cause a decrease in the number of these cells present in the body. If the number of white blood cells drops to a low level, there may not be enough left to fight bacteria, increasing the risk of developing an infection.
Your doctor has prescribed Vivlipeg to stimulate the bone marrow (the part of the bones that produces blood cells) to produce more white blood cells, helping your body to fight infections.
Vivlipeg is intended for adults aged 18 years and older.

2. What you need to know before using Vivlipeg Do not use Vivlipeg

• 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 using Vivlipeg:

• if you have an allergic reaction, including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), flushing, skin rash, and itchy skin areas.
• if you have cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if you experience one or more of the following side effects:
• swelling or bloating, which may be associated with reduced 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 leakage of blood from small vessels in the body. See section 4.
• if you have pain in the upper left side of your abdomen or shoulder tip pain.
• These could be signs of a problem with your spleen (splenomegaly).
• if you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), lung inflammation (pulmonary interstitial disease), or an abnormal finding on 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 your body's ability to clot (thrombocytopenia). Your doctor may wish to monitor you closely.
• if you have sickle cell disease. Your doctor may wish to monitor you closely.
• if you have breast cancer or lung cancer, Vivlipeg in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-cancerous blood condition called myelodysplastic syndrome (MDS) or a blood tumor called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, and easy bruising or bleeding.
• if you suddenly develop 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 carrying blood from the heart to the rest of the body), which has been rarely reported in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Inform your doctor if you experience such symptoms.

Your doctor will regularly check your blood and urine because Vivlipeg may damage the tiny filters in your kidneys (glomerulonephritis).
Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Vivlipeg.
If you notice any of the symptoms described in section 4, stop using Vivlipeg and seek immediate medical attention.
Talk to your doctor about the risks of developing blood cancer. If you have or may have blood cancer, you must not use Vivlipeg unless otherwise instructed by your doctor.

Loss of response to Vivlipeg
If you experience a decreased response or failure to maintain response to pegfilgrastim treatment, your doctor will investigate possible causes, including the possibility that you have developed antibodies that neutralize the activity of pegfilgrastim.

Children and adolescents
The use of Vivlipeg is not recommended in children and adolescents due to insufficient data on safety and efficacy.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Vivlipeg has not been studied in pregnant women. Therefore, your doctor may advise against using this medicine.
If you become pregnant while being treated with Vivlipeg, inform your doctor.
Unless otherwise instructed by your doctor, you must stop breastfeeding while using Vivlipeg.

Driving and using machines
Vivlipeg has no effect or negligible effect on the ability to drive vehicles or operate machinery.

Vivlipeg contains sorbitol, polysorbate, and sodium
This medicine contains 30 mg of sorbitol in each pre-filled syringe, equivalent to 50 mg/mL.
This medicine contains less than 1 mmol (23 mg) of sodium per 6 mg dose, i.e., essentially “sodium-free”.
This medicine contains 0.024 mg of polysorbate 20 in each 6 mg/0.6 mL pre-filled syringe, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Vivlipeg

Take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The usual dose is one 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 chemotherapy
cycle.
How to self-administer the Vivlipeg injection
Your doctor may consider it appropriate for you to self-administer the Vivlipeg injection.
Your doctor or nurse will show you how to inject yourself with Vivlipeg. Do not attempt to
administer the injection yourself unless you have been properly instructed.
For further instructions on how to administer the Vivlipeg injection, please read the instructions for use provided in the package.
Do not shake Vivlipeg vigorously, as this may impair its activity.
If you use more Vivlipeg than you should
If you use more Vivlipeg than you should, contact your doctor, pharmacist, or nurse.
If you forget to use Vivlipeg
If you have missed your dose of Vivlipeg, you must contact your doctor to determine when the next
injection should be given.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• swelling or puffiness, which may be associated with reduced fluid passage, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of tiredness. 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 into the body and requires urgent medical treatment.

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

• bone pain. Your doctor will advise 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 aches.
• some changes may occur in the blood, but these will be detected during routine blood tests. White blood cell levels may rise temporarily. Platelet levels may decrease, leading to bruising.
• chest pain.

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

• allergic-type reactions, including flushing and hot flushes, skin rash (skin redness), and itchy skin swellings.
• severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
• sickle cell crisis in patients with sickle cell anaemia.
• enlargement of the spleen.
• rupture of the spleen. 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 the abdomen or left shoulder, as this may indicate spleen problems.
• breathing problems. If you have cough, fever, and difficulty breathing, contact your doctor.
• cases of Sweet's syndrome (purple, raised, and painful skin lesions on limbs and sometimes on face and neck, associated with fever) have been reported, although other factors may have contributed.
• cutaneous vasculitis (inflammation of the skin blood vessels).
• damage to the tiny filters in the kidneys (glomerulonephritis).
• redness at the injection site.
• coughing up blood (haemoptysis).
• blood disorders (MDS or AML).

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Vivlipeg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and syringe label after "Exp." The expiry date refers to the last day of that month.
Store in a refrigerator (2°C-8°C).
Do not freeze. Vivlipeg may be used if it has been accidentally frozen once for less than 24 hours.
Keep the container in the outer packaging to protect the medicine from light.
Vivlipeg may be removed from the refrigerator and stored at room temperature (not above 30°C) for up to 3 days. Once the syringe has been removed from the refrigerator and has reached room temperature (not above 30°C), it must be used within 3 days or discarded.
Do not use this medicine if it appears cloudy or if particles are visible.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information What is contained in Vivlipeg

• The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL of solution.
• The other components are sodium acetate, sorbitol (E420), polysorbate 20, and water for injections. See section 2 “Vivlipeg contains sorbitol and sodium”.

Description of the appearance of Vivlipeg and contents of the pack
Vivlipeg is a clear, colourless injectable solution in a pre-filled glass syringe with a stainless steel needle and needle cap. The syringe is supplied with a sealed blister pack and an automatic needle protection device.
Each pack contains 1 pre-filled glass syringe.

Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited Unit 35/36
Grange Parade,
Baldoyle Industrial Estate, Dublin 13
DUBLIN
Ireland D13 R20R

Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne Dublin
D09 C6X8
Ireland

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Biocon Biologics Belgium BV Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910 Tel: 0080008250910

България Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited Biocon Biologics France S.A.S
Тел: 0080008250910 Tél/Tel: 0080008250910
(Belgique/Belgien)

Česká republika Magyarország
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel.: 0080008250910

Danmark Malta
Biocon Biologics Finland OY Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910 Tel.: 0080008250910

Deutschland Nederland
Biocon Biologics Germany GmbH Biocon Biologics France S.A.S
Tel: 0080008250910 Tel: 0080008250910

Eesti Norge
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tlf: +47 800 62 671

Ελλάδα Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Biocon Biologics Germany GmbH
Ι.Κ.Ε Tel: 0080008250910
Τηλ.: 0080008250910

España Polska
Biocon Biologics Spain S.L. Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910

France Portugal
Laboratories Biogaran Biocon Biologics Spain S.L.
Tél: +33 (0) 800 970 109 Tel: 0080008250910

Hrvatska România
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910

Ireland Slovenija
Biosimilar Collaborations Ireland Limited Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794 Tel: 0080008250910

Ísland Slovenská republika
Biocon Biologics Finland OY Biocon Biologics Germany GmbH
Sími: +345 800 4316 Tel: 0080008250910

Italia Suomi/Finland
Biocon Biologics Spain S.L. Biocon Biologics Finland OY
Tel: 0080008250910 Puh/Tel: 99980008250910

Κύπρος Sverige
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Τηλ: 0080008250910 Tel: 0080008250910

Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Instructions for use:
Guide to the parts
Before use
After use
Step 1: Preparation
A. Remove the syringe packaging needed for the injection: cotton swab, adhesive plaster, and a container included).	pre-filled syringe from the package and collect the materials, alcohol-impregnated swab, a cotton ball or gauze, and a container for disposal of sharp materials (not included)
For a more comfortable injection, allow the pre-filled syringe to reach room temperature for about 30 minutes before injection. Wash your hands thoroughly with soap and water. Place the new pre-filled syringe on a clean, well-lit working surface, along with the materials needed for the injection. X Do not attempt to heat the syringe using a heat source such as hot water or microwave. X Do not expose the pre-filled syringe to direct sunlight. X Do not shake the pre-filled syringe excessively.
Keep the pre-filled syringe out of sight and reach of children.
B.	Open the packaging by tearing the seal. Hold the safety shield of the pre-filled syringe to remove the pre-filled syringe from the packaging.
For safety reasons: X Do not touch the plunger. X Do not touch the gray needle cap.
C.	Inspect the medicine and the pre-filled syringe.
Medicine X Do not use the pre-filled syringe if: The medicine is cloudy or there are particles inside. It should be a clear, colorless liquid. Any parts appear cracked or broken. • The gray needle cap is missing or not securely attached. • The expiration date printed on the label has passed the last day of the month indicated. In all cases, contact your doctor or healthcare provider.
Step 2: Preparation
A.	Wash your hands thoroughly. Prepare and clean the injection site.
You may use: • The upper thigh • The abdomen, except for an area of 5 centimeters around the navel. • The outer upper arm (only if someone else is administering the injection). Clean the injection site with an alcohol-impregnated swab. Let the skin dry completely. X Do not touch the injection site before injecting. Do not inject into areas where the skin is tender, bruised, red, or hardened. Avoid injecting into areas with scars or stretch marks.
B	Carefully remove the gray needle cap by pulling it outward and away from the body.
C	Lift the injection site to create a stable surface.
It is important to keep the skin lifted during injection.
Step 3: Injection
A	Keep the skin lifted. INSERT the needle into the skin.
X Do not touch the cleaned area of the skin.
B	PUSH the plunger with slow and steady pressure until you feel or hear a "click". Push fully until the click is reached.

It is important to push fully until the "click" is heard to inject the entire dose.
Healthcare professionals only
The trade name of the administered product must be clearly recorded in the patient's file.

C	RELEASE your thumb. Then WITHDRAW the syringe from the skin.
After releasing the plunger, the safety mechanism of the pre-filled syringe will safely cover the injection needle. XDo not replace the gray needle cap on used pre-filled syringes.
Step 4: Completion
A	Dispose of the used pre-filled syringe and other materials in a sharps disposal container.
Medicines must be disposed of in accordance with local regulations. Ask your pharmacist how to discard medicines you no longer use. These measures will help protect the environment. Keep the syringe and the sharps disposal container out of the sight and reach of children. XDo not reuse the pre-filled syringe. XDo not recycle pre-filled syringes or dispose of them in household waste.
B	Examine the injection site.
If you see any bleeding, press a cotton ball or gauze onto the injection site. Do not rub the injection site. Apply a bandage if needed.