Fulphila

Package leaflet: Information for the user

Fulphila 6 mg solution for injection in pre-filled syringe

pegfilgrastim
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 pass it on to other people, even if they have the same symptoms as yours, 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:

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

1. What Fulphila is and what it is used for

Fulphila contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by 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 our body.
Fulphila is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with fever) that 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 lead to a reduction 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 off bacteria, and you may be at increased risk of developing an infection.
Your doctor has prescribed Fulphila 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.
Fulphila is intended for adults aged 18 years and older.

2. What you should know before using Fulphila

Do not use Fulphila

• 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 Fulphila:

• if you have an allergic reaction, including weakness, low blood pressure, difficulty breathing, facial swelling (anaphylaxis), 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 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 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 reduce the 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, Fulphila 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 reported rarely in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Inform your doctor if such symptoms occur. Your doctor will regularly monitor your blood and urine, as Fulphila may damage the tiny filters in your kidneys (glomerulonephritis). Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Fulphila. If you notice any of the symptoms described in section 4, stop using Fulphila 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 Fulphila unless otherwise directed by your doctor. Loss of response to Fulphila 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 neutralizing antibodies to pegfilgrastim.

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

Other medicines and Fulphila
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, consult your doctor or pharmacist before taking this medicine.
Fulphila has not been studied in pregnant women. Therefore, your doctor may advise against using this medicine.
If you become pregnant while being treated with Fulphila, inform your doctor.
Unless otherwise instructed by your doctor, you must stop breastfeeding while using Fulphila.

Driving and using machines
Fulphila does not affect or has negligible influence on the ability to drive or use machinery.

Fulphila contains sorbitol 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”.

3. How to use Fulphila

Take this medicine exactly as your doctor has told you. 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 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 Fulphila injection
Your doctor may consider it appropriate for you to self-inject Fulphila. Your doctor or nurse will show you how to administer the injection. Do not attempt to inject yourself unless you have been properly instructed.
For further instructions on how to self-administer the Fulphila injection, please read the instructions for use provided in the package leaflet.
Do not shake Fulphila vigorously, as this may impair its activity.
If you use more Fulphila than you should
If you use more Fulphila than prescribed, contact your doctor, pharmacist, or nurse.
If you forget to use Fulphila
If you have missed your dose of Fulphila, 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 everyone experiences them.
Immediately inform your doctor if you experience any one or a combination of the following side effects:

• 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.
• certain 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 (reddening of the skin), and skin swelling with itching.
• severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
• 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 to contact your doctor immediately if you feel pain in the upper left part of the abdomen or in the 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-coloured, raised and painful skin lesions on limbs and sometimes on the face and neck, associated with fever), although other factors may have contributed.
• cutaneous vasculitis (inflammation of the skin blood vessels).
• damage to the tiny filters within 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 Fulphila 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulphila

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. Fulphila may be used if it has been accidentally frozen only once for less than 24 hours.
Keep the container in the outer packaging to protect the medicine from light.
Fulphila can be removed from the refrigerator and kept at room temperature (not above 30°C) for no more than 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 must be discarded.
Do not use this medicine if you notice that it is 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 Fulphila 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, and water for injections. See section 2 “Fulphila contains sorbitol and sodium”.

Description of the appearance of Fulphila and contents of the pack
Fulphila is a clear, colourless injectable solution in a glass pre-filled syringe with a stainless steel needle and a needle cap. The syringe is supplied in a blister pack. 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, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Biocon Biologics Belgium BV
Tél/Tel: 0080008250910

България (Bulgaria)
Biosimilar Collaborations Ireland Limited
Teл.: 0080008250910

Česká republika (Czech Republic)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Danmark (Denmark)
Biocon Biologics Finland OY
Tlf: 0080008250910

Deutschland (Germany)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Eesti (Estonia)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Ελλάδα (Greece)
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Ι.Κ.Ε
Τηλ: 0080008250910

España (Spain)
Biocon Biologics Spain S.L.
Tel: 0080008250910

France
Biocon Biologics France S.A.S
Tél: +33 1 70 70 76 10

Hrvatska (Croatia)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Ireland
Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794

Ísland (Iceland)
Biocon Biologics Finland OY
Sími: +345 8004316

Italia (Italy)
Biocon Biologics Spain S.L.
Tel: 0080008250910

Κύπρος (Cyprus)
Biosimilar Collaborations Ireland Limited
Τηλ: 0080008250910

Latvija (Latvia)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Lietuva (Lithuania)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Luxembourg/Luxemburg
Biocon Biologics France S.A.S
Tél/Tel: 0080008250910

Magyarország (Hungary)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Malta
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Nederland (Netherlands)
Biocon Biologics France S.A.S.
Tel: 0080008250910

Norge (Norway)
Biocon Biologics Finland OY
Tlf: +47 800 62 671

Österreich (Austria)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Polska (Poland)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Portugal
Biocon Biologics Spain S.L.
Tel: 0080008250910

România (Romania)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Slovenija (Slovenia)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Slovenská republika (Slovakia)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Suomi/Finland (Finland)
Biocon Biologics Finland OY
Puh/Tel: 0080008250910

Sverige (Sweden)
Biocon Biologics Finland OY
Tel: 0080008250910

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

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Instructions for injecting Fulphila from a pre-filled syringe
This section contains information on how to self-administer an injection of Fulphila. It is important that you do not attempt 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 this medicine, please consult your doctor, nurse, or pharmacist.

How you, or the person administering the injection, should use Fulphila in the pre-filled syringe
You must inject the medicine just under the skin. This type of injection is called a subcutaneous injection.

What you need
To give a subcutaneous injection, you will need:

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

What should I do before giving myself a subcutaneous injection of Fulphila?

1. Remove the medicine from the refrigerator.
2. Do not shake the pre-filled syringe.
3. Do not remove the needle cap from the syringe until you are ready to give the injection.
4. Check the expiry date on the label of the pre-filled syringe (Exp.). Do not use it after the last day of the month indicated.
5. Check the appearance of Fulphila. It should be a clear, colourless liquid. If you see particles, do not use it.
6. For a more comfortable injection, allow the pre-filled syringe to warm up to room temperature by leaving it outside the refrigerator for about 30 minutes, or hold it gently in your hands 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).
7. Wash your hands thoroughly.
8. Find a comfortable, well-lit, clean surface and keep everything you need within easy reach.

How do I prepare the Fulphila injection?
Before giving yourself the Fulphila injection, perform the following steps:

1. 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.

2. 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.
3. The pre-filled syringe is now ready for use.

Where should I give myself the injection?

The most suitable injection sites 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 swab.
2. Pinch the skin between your thumb and index finger (without squeezing it tightly). Insert the needle into the skin.
3. Push the plunger down slowly and steadily. Continue pushing until the plunger is fully depressed and all the liquid has been injected.
4. After injecting the liquid, withdraw the needle and release the skin.
5. If you see a small drop of blood at the injection site, gently wipe it away with a cotton ball or gauze pad. Do not rub the injection site. If needed, you may cover the injection site with a plaster.
6. Do not reuse any remaining Fulphila left in the syringe.

Remember
Use each syringe only once. If you have any difficulties, 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 the 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

Fulphila 6 mg solution for injection in pre-filled syringe

pegfilgrastim
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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Fulphila is and what it is used for

Fulphila 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 natural protein (granulocyte colony-stimulating factor) produced by our body.
Fulphila 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 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 reduction 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 increased risk of developing an infection.
Your doctor has prescribed Fulphila 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.
Fulphila is intended for adults aged 18 years and older.

2. What you should know before using Fulphila

Do not use Fulphila

• 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 Fulphila:

• if you have an allergic reaction, including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), flushing, skin redness, rash, or itchy skin areas.
• if you have cough, fever, and difficulty breathing. These may be signs 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 sense 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 part 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 reduced platelet levels, which decreases the 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, Fulphila 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 body parts, shortness of breath, wheezing, or difficulty breathing—these could be signs of a serious 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 reported rarely in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and elevated markers of inflammation. Inform your doctor if such symptoms occur. Your doctor will regularly monitor your blood and urine, as Fulphila may damage the tiny filters in your kidneys (glomerulonephritis). Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Fulphila. If you notice any of the symptoms described in section 4, stop using Fulphila and seek immediate medical attention. Discuss with your doctor the risks of developing blood cancer. If you have or may have blood cancer, you must not use Fulphila unless otherwise directed by your doctor.

Loss of response to Fulphila
If you experience a reduced 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 Fulphila is not recommended in children and adolescents due to insufficient data on safety and efficacy.

Other medicines and Fulphila
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 a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Fulphila has not been studied in pregnant women. Therefore, your doctor may advise against using this medicine.
If you become pregnant during treatment with Fulphila, inform your doctor.
Unless otherwise instructed by your doctor, you must stop breastfeeding while using Fulphila.

Driving and using machines
Fulphila does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.

Fulphila contains sorbitol 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".

3. How to use Fulphila

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The usual dose is one subcutaneous injection (an 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 Fulphila injection
Your doctor may decide that it is better for you to self-inject Fulphila. Your doctor or nurse will show you how to administer the Fulphila injection. Do not attempt to inject yourself unless you have been properly instructed.
For further instructions on how to administer the injection of Fulphila, please read the instructions for use provided in the package.
Do not shake Fulphila vigorously, as this may impair its activity.

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

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

If you have any doubts about how to use this medicine, speak to 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 one or a combination of the following side effects:

• swelling or fluid retention, which may be associated with reduced passage of fluids, 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.
• certain 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 reactions, including flushing and hot flushes, skin rash (reddening of the skin), and itchy skin swellings.
• severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
• sickle cell crises 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 have cough, fever, and difficulty breathing, contact your doctor.
• cases of Sweet’s syndrome (tender, raised, purple-coloured skin lesions on the limbs and sometimes on the face and neck, associated with fever), although other factors may have contributed.
• cutaneous vasculitis (inflammation of the blood vessels in the skin).
• 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 ulcers in the throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. If you develop these symptoms, stop using Fulphila and contact your doctor or seek immediate medical assistance immediately. 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 through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulphila

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, on the blister, 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).
Do not freeze. Fulphila may be used if it has been accidentally frozen only once for less than
24 hours.
Keep the container in the outer packaging to protect the medicine from light.
You may remove Fulphila from the refrigerator and keep it at room temperature (not above 30°C) for no more than
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 must be discarded.
Do not use this medicine if you notice that 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Fulphila 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 “Fulphila contains sorbitol and sodium”.

Description of the appearance of Fulphila and contents of the pack
Fulphila is a clear, colourless injectable solution in a pre-filled glass syringe with a stainless steel needle and a needle cap. The syringe is supplied with a surrounding blister 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Biocon Biologics Belgium BV
Tél/Tel: 0080008250910

България
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Česká republika
Biocon Biologics Germany GmbH
Tel: 0080008250910

Danmark
Biocon Biologics Finland OY
Tlf: 0080008250910

Deutschland
Biocon Biologics Germany GmbH
Tel: 0080008250910

Eesti
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Ελλάδα
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Ι.Κ.Ε
Τηλ: 0080008250910

España
Biocon Biologics Spain S.L.
Tel: 0080008250910

France
Biocon Biologics France S.A.S
Tél: +33 1 70 70 70 70

Hrvatska
Biocon Biologics Germany GmbH
Tel: 0080008250910

Ireland
Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794

Ísland
Biocon Biologics Finland OY
Sími: +354 800 4316

Italia
Biocon Biologics Spain S.L.
Tel: 0080008250910

Κύπρος
Biosimilar Collaborations Ireland Limited
Τηλ: 0080008250910

Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Lietuva
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Luxembourg/Luxemburg
Biocon Biologics France S.A.S
Tél/Tel: 0080008250910

Magyarország
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Malta
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Nederland
Biocon Biologics France S.A.S.
Tel: 0080008250910

Norge
Biocon Biologics Finland OY
Tlf: +47 800 62 671

Österreich
Biocon Biologics Germany GmbH
Tel: 0080008250910

Polska
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Portugal
Biocon Biologics Spain S.L.
Tel: 0080008250910

România
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Slovenija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Slovenská republika
Biocon Biologics Germany GmbH
Tel: 0080008250910

Suomi/Finland
Biocon Biologics Finland OY
Puh/Tel: +358 800 8250910

Sverige
Biocon Biologics Finland OY
Tel: 0080008250910

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

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Instructions for use:
Guide to parts

Before use

After use

Important
Before using a pre-filled syringe of Fulphila with automatic needle protection device,
please read these important instructions:

• It is important that you do not attempt to administer the injection unless you have received proper instructions from your doctor or healthcare professional.
• Fulphila is administered as an injection into the tissue just beneath the skin (subcutaneous injection).
  X Do not remove the grey needle cap from the pre-filled syringe until you are ready to administer the injection.
  X Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new pre-filled syringe and contact your doctor or healthcare professional.
  X Do not attempt to activate the pre-filled syringe before the injection.
  X Do not attempt to remove the transparent safety shield from the pre-filled syringe.

Contact your doctor or healthcare professional if you have any questions.

Healthcare professionals only
The trade name of the administered product must be clearly recorded in the patient's file.