Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
lipegfilgrastim
Teva B.V.
L03AA14
lipegfilgrastim
Immunostimulants, , Colony stimulating factors
Neutropenia
Lonquex is indicated in adults and in children 2 years of age and older for 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: 27
Authorised
2013-07-25
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LONQUEX 6 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE lipegfilgrastim 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 Lonquex is and what it is used for 2. What you need to know before you use Lonquex 3. How to use Lonquex 4. Possible side effects 5. How to store Lonquex 6. Contents of the pack and other information 1. WHAT LONQUEX IS AND WHAT IT IS USED FOR WHAT LONQUEX IS Lonquex contains the active substance lipegfilgrastim. Lipegfilgrastim is a long-acting modified protein produced by biotechnology in bacteria called _Escherichia coli_ . It belongs to a group of proteins called cytokines and is similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body. WHAT LONQUEX IS USED FOR Lonquex is used in adults and in children aged 2 years and older. Your doctor has prescribed Lonquex for you or for your child in order to reduce the duration of a condition called neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever). These can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly-growing cells). HOW LONQUEX WORKS Lipegfilgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood 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 ca Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lonquex 6 mg solution for injection in pre-filled syringe Lonquex 6 mg/0.6 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe Each pre-filled syringe contains 6 mg of lipegfilgrastim* in 0.6 ml solution. Vial Each vial contains 6 mg of lipegfilgrastim* in 0.6 ml solution. Each ml of solution for injection contains 10 mg of lipegfilgrastim. The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker. *This is based on protein content only. The concentration is 20.9 mg/ml (i.e. 12.6 mg per pre-filled syringe or vial) if the PEG moiety and the carbohydrate linker are included. **Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor [G-CSF]) is produced in _Escherichia coli _ cells by recombinant DNA technology. The potency of this medicinal 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. Excipients with known effect Each pre-filled syringe or vial contains 30 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lonquex is indicated in adults and in children 2 years of age and older for 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). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology. _ _ 3 Posology _Adults _ The recommended dose is 6 mg (0.6 ml solution in a single pre-filled syringe or vial) of Lonquex for each chemotherapy cycle, given approximately 24 hours after cytotoxic ch Lesen Sie das vollständige Dokument