Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Filgrastim
ACCORD HEALTHCARE SDN.BHD.
Filgrastim
0.5 ml x 1 PFS ml; 0.5 ml x 3 PFS ml; 0.5 ml x 5 PFS ml
Intas Pharmaceuticals Limited Biopharma Division
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ACCOFIL 30 MU/0.5 ML & 48 MU/0.5 ML (0.6 MG/ML) SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE Filgrastim 30 MU/0.5 ml & 48 MU/0.5 ml (0.6 mg/ml) WHAT IS IN THIS LEAFLET 1. What Accofil is used for 2. How Accofil works 3. Before you use Accofil 4. How to use Accofil 5. Possible side effects 6. How to store and dispose Accofil 7. Product Description 8. Manufacturer and Product Registration Holder 9. Date of Revision 10. Serial Number WHAT ACCOFIL IS AND HOW IT WORKS 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 back into the bone marrow and produce blood cells; • to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections; • in patients with advanced HIV infection which will help reduce the risk of infections BEFORE YOU USE ACCOFIL DO NOT USE ACCOFIL • If you are allergic (hypersensitive) to filgrastim or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or Прочетете целия документ
ACCOFIL FRONT 450 mm 866 mm 124 mm 38 mm 1. NAME OF THE MEDICINAL PRODUCT Accofil 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe. Accofil 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim. Each ml of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) of filgrastim. Each pre-filled syringe contains 30 MU (equivalent to 300 micrograms of filgrastim in 0.5 ml solution for injection or infusion. Each pre-filled syringe contains 48 MU (equivalent to 480 micrograms of filgrastim in 0.5 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 or infusion Clear, colourless solution 4. CLINCAL 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 9 absolute neutrophil count (ANC) of ≤ 0.5 x 10 /L, and a history of severe or recurrent infections, long term Прочетете целия документ