Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
pegfilgrastim
Biosimilar Collaborations Ireland Limited
L03AA13
pegfilgrastim
Immunostimulants,
Neutropenia
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Revision: 12
Authorised
2018-11-20
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER FULPHILA 6 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE pegfilgrastim 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 further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. 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 1. WHAT FULPHILA IS AND WHAT IT IS USED FOR 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 he Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fulphila 6 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**. *Produced in _Escherichia coli _ cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/mL if the PEG moiety is included. The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. For more information, see section 5.1 Excipient with known effect Each pre-filled syringe contains 30 mg sorbitol (E420) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. Posology One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. Special populations _Patients with renal impairment _ No dose change is recommended in patients with renal impairment, including those with end stage renal disease. 3 _Paediatric population _ The safety and efficacy of pegfilgrastim in children has not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made. Method of administration Fulphila is injected subcutaneously. The injections should be given Aqra d-dokument sħiħ