Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
pegfilgrastim
Dompé Biotec S.p.A.
L03AA13
pegfilgrastim
Immunostimulants,
Neutropenia; Cancer
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Revision: 9
Withdrawn
2002-08-22
Medicinal product no longer authorised B. PACKAGE LEAFLET Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER NEUPOPEG 6 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE pegfilgrastim READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS M EDICINE. - Keep this leaf let. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What Neupop eg is and what it is used for 2. Before y ou use Neupopeg 3. How to use Neupopeg 4. Possible side effects 5. How to store Neupopeg 6. Further information 1. WHAT NEUPOPEG IS AND WHAT IT IS USED FOR Neupopeg is used to reduce the duration of neutro penia (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 Neupopeg to encourage your bo ne marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection. 2. BEFORE YOU USE NEUPOPEG DO NOT USE NEUPOPEG • if you are hypersensitive (allergic) to pegfilgrastim, filgrastim, _E. coli _ derived proteins, or any of the other ingredients of Neupopeg. TAKE SPECIAL CARE WITH NEUPOPEG Please tell your doctor: • if you experience a cough, fever and difficulty breathing; • if you Прочетете целия документ
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection. 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 c_ _oli_ 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 potenc y of another pegylated or non- pegylated protein of the same therapeutic class. For more information, see section 5.1. Excipients: Excipients known to have a recognised action: sorbitol E420, sodium acetate (see section 4.4). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. _ _ Clear, colourless solution for injection. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction in the duration of neutropenia and the incid ence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Neupopeg therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. One 6 mg dose (a single pre-filled syringe) of Neupopeg is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy. Neupopeg is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy. Renal impairment: no dose change is recommended in patients with renal impairment, including those with end stage renal disease. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Medicinal product no longer authorised 4.4 SPECIAL WARNINGS AND PRECAUTI Прочетете целия документ