Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
filgrastim
Accord Healthcare S.L.U.
L03AA02
filgrastim
Immunostimulants,
Neutropenia
Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy.Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Revision: 14
Authorised
2014-09-17
102 B. PACKAGE LEAFLET 103 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ACCOFIL 30 MU/0.5 ML (0.6 MG/ML) SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE filgrastim 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, nurse or pharmacist. 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 Accofil is and what it is used for 2. What you need to know before you use Accofil 3. How to use Accofil 4. Possible side effects 5. How to store Accofil 6. Contents of the pack and other information 1. WHAT ACCOFIL IS AND WHAT IT IS USED FOR WHAT ACCOFIL IS Accofil is a white blood cell growth factor (granulocyte-colony stimulating factor) and belong to a group of medicines called cytokines. Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine. Accofil works by encouraging the bone marrow to produce more white blood cells. A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. Accofil stimulates the bone marrow to produce new white cells quickly. Accofil can be used: - to increase the number of white blood cells after treatment with chemotherapy to help prevent infections; - to increase the number of white blood cells after a bone marrow transplant to help prevent infections; - before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment. These can be taken from you or from a donor. The stem cells will then go b Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Accofil 30 MU/0.5 ml solution for injection/infusion in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 30 million units (MU)/300 micrograms of filgrastim in 0.5 ml (0.6 mg/ml) solution for injection or infusion. Filgrastim is a recombinant methionyl human granulocyte-colony stimulating factor produced in _Escherichia coli _ (BL21) by recombinant DNA technology. Excipient with known effect: Each ml of solution contains 50 mg of sorbitol (E420). _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe Concentrate for solution for infusion in pre-filled syringe Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy. Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 10 9 /L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Accofil is indicated f or the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 10 9 /L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infec Lugege kogu dokumenti