Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - fulphila

Document Subject

Generated Narrative: MedicinalProductDefinition mpadb285ae6cc2127432af23ed8e516722

identifier: http://ema.europa.eu/identifier/EU/1/18/1329/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Fulphila 6 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-adb285ae6cc2127432af23ed8e516722

identifier: http://ema.europa.eu/identifier/EU/1/18/1329/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - fulphila

Attesters

What is in this leaflet

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

Fulphila contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own 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 a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.

Your doctor has given you Fulphila to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.

Fulphila is for use in adults aged 18 and over.

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 experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch.
• if you experience a cough, fever and difficulty breathing. This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if you have any of the following or combination of the following side effects:

• swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
  These could be symptoms of condition called Capillary Leak Syndrome which causes blood to leak from the small blood vessels into your body. See section 4. - if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a problem with your spleen (splenomegaly).

• if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration).
• if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia). Your doctor may want to monitor you more closely.
• if you have sickle cell anaemia. Your doctor may monitor your condition more closely.
• if you are a patient with breast cancer or lung cancer, Fulphila in combination with chemotherapy and/or radiation therapy may increase your risk of a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukaemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding.
• if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing, these could be signs of a severe allergic reaction.
• if you have symptoms of inflammation of the aorta (the large blood vessel which transports blood from the heart to the body); this has been reported rarely in cancer patients and healthy donors. The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor if you experience these symptoms.

Your doctor will check your blood and urine regularly as Fulphila can harm the tiny filters inside your kidneys (glomerulonephritis).

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of pegfilgrastim. Stop using Fulphila and seek medical attention immediately if you notice any of the symptoms described in section 4. You should talk to your doctor about your risks of developing cancers of the blood. If you develop or are likely to develop cancers of the blood, you should not use Fulphila, unless instructed by your doctor.

Loss of response to Fulphila If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim s activity.

Children and adolescents Fulphila is not recommended for use in children and adolescents due to insufficient data on safety and effectiveness.

Other medicines and Fulphila Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Fulphila has not been tested in pregnant women. Therefore, your doctor may decide that you should not use this medicine.

If you become pregnant during Fulphila treatment, please inform your doctor.

Unless your doctor directs you otherwise, you must stop breast-feeding if you use Fulphila.

Driving and using machines Fulphila has no or negligible effect on the ability to drive or use machines.

Fulphila contains sorbitol and sodium This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg/mL.

This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially sodium-free .

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.

Injecting Fulphila yourself Your doctor may decide that it would be more convenient for you to inject Fulphila yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.

For further instructions on how to inject yourself with Fulphila, please read the attached instructions for use.

Do not shake Fulphila vigorously as this may affect 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 inject Fulphila If you have forgotten a dose of Fulphila, you should contact your doctor to discuss when you should inject the next dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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

Please tell your doctor immediately if you have any of the following or combination of the following side effects:

• swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop in a rapid fashion.

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

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

• bone pain. Your doctor will tell you what you can take to ease the bone pain.
• nausea and headaches.

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

• pain at the site of injection.
• general aches and pains in the joints and muscles.
• some changes may occur in your blood, but these will be detected by routine blood tests. Your white blood cell count may become high for a short period of time. Your platelet count may become low which might result in bruising.
• chest pain.

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

• allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch.
• serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
• sickle cell crises in patients with sickle cell anaemia.
• increased spleen size.
• spleen rupture. Some cases of splenic rupture were fatal. It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
• breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor.
• Sweet s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role.
• cutaneous vasculitis (inflammation of the blood vessels in the skin).
• damage to the tiny filters inside your kidneys (glomerulonephritis).
• redness at the site of injection.
• 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 which transports blood from the heart to the body), see section 2. - bleeding from the lung (pulmonary haemorrhage).
• Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Fulphila if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2. Reporting of side effects
  If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 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 is accidentally frozen for a single period of less than 24 hours.

Keep the container in the outer carton in order to protect from light.

You may take Fulphila out of the refrigerator and keep it at room temperature (not above 30 C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30 C) it must either be used within 3 days or disposed of.

Do not use this medicine if you notice it is cloudy or there are particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 .

What Fulphila looks like and contents of the pack
Fulphila is a clear, colourless solution for injection (injection) in a glass pre-filled syringe with an attached stainless steel needle and needle cap. The syringe is provided with a blister wrapping.
Each pack contains 1 pre-filled syringe.

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

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Biocon Biologics Belgium BV T l/Tel: 0080008250Lietuva Biosimilar Collaborations Ireland Limited Tel: 0080008250
Biosimilar Collaborations Ireland Limited Te .: 0080008250Luxembourg/Luxemburg Biocon Biologics France S.A.S T l/Tel: 0080008250 esk republika Biocon Biologics Germany GmbH Tel: 0080008250Magyarorsz g Biosimilar Collaborations Ireland Limited
Tel: 0080008250Danmark Biocon Biologics Finland OY
Tlf: 0080008250Malta Biosimilar Collaborations Ireland Limited
Tel: 0080008250Deutschland Biocon Biologics Germany GmbH
Tel: 0080008250Nederland Biocon Biologics France S.A.S. Tel: 0080008250Eesti Biosimilar Collaborations Ireland Limited
Tel: 0080008250Norge Biocon Biologics Finland OY
Tlf: +47 800 62
Biocon Biologics Greece
. .
: 0080008250 sterreich Biocon Biologics Germany GmbH Tel: 0080008250Espa a Biocon Biologics Spain S.L. Tel: 0080008250Polska Biosimilar Collaborations Ireland Limited
Tel:.: 0080008250France Biocon Biologics France S.A.S
T l: +Te l: 0080008250Portugal Biocon Biologics Spain S.L.. Tel: 0080008250Hrvatska Biocon Biologics Germany GmbH
Tel: 0080008250Rom nia Biosimilar Collaborations Ireland Limited
Tel: 0080008250Ireland Biosimilar Collaborations Ireland Limited
Tel: 1800 777 Slovenija Biosimilar Collaborations Ireland Limited
Tel: 0080008250 sland Biocon Biologics Finland OY S mi: +345 8004Slovensk republika Biocon Biologics Germany GmbH
Tel: 0080008250Italia Biocon Biologics Spain S.L. Tel: 0080008250Suomi/Finland Biocon Biologics Finland OY Puh/Tel: 99980008250
Biosimilar Collaborations Ireland Limited
: 0080008250Sverige Biocon Biologics Finland OY
Tel: 0080008250Latvija Biosimilar Collaborations Ireland Limited
Tel: 0080008250This leaflet was last revised in {MM/YYYY}.

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: