Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
pegfilgrastim
ERA Consulting GmbH
L03AA13
pegfilgrastim
Immunostimulants, , Colony stimulating factors
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: 3
Withdrawn
2018-09-21
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER UDENYCA 6 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE pegfilgrastim This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 UDENYCA is and what it is used for 2. What you need to know before you use UDENYCA 3. How to use UDENYCA 4. Possible side effects 5. How to store UDENYCA 6. Contents of the pack and other information 1. WHAT UDENYCA IS AND WHAT IT IS USED FOR UDENYCA contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria called _E. coli _ followed by conjugation with polyethylene glycol (PEG) It belongs to a group of proteins called cytokines. The protein part is very similar to a natural protein produced by your own body. The medicinal product is used to reduce the duration of low white blood cell count (neutropenia) and the occurrence of low white blood cell count with a fever (febrile neutropenia) 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 le Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT UDENYCA 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 content only**. *The active substance is a covalent conjugate of filgrastim produced in _Escherichia coli_ cells by recombinant DNA technology with polyethylene glycol (PEG). ** The concentration is 20 mg/ml if the PEG moiety is included. 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 Excipient with known effect Each pre--filled syringe contains 30 mg sorbitol For the 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 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. _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 Aqra d-dokument sħiħ