Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Filgrastim
HOSPIRA MALAYSIA SDN BHD
Filgrastim
0.5ml mL
Hospira Zagreb d.o.o
Pfizer Confidential _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ NIVESTIM ® SOLUTION FOR INJECTION Filgrastim (12 MU/0.2 mL, 30 MU/0.5 mL, 48 MU/0.5 mL) 1 WHAT IS IN THIS LEAFLET 1. What Nivestim is used for 2. How Nivestim works 3. Before you use Nivestim 4. How to use Nivestim 5. While you are using it 6. Side effects 7. Storage and Disposal of Nivestim 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT NIVESTIM IS USED FOR Nivestim is used mainly for reducing the duration of neutropenia and to prevent the occurrence of neutropenia associated with fever for those who undergo treatment with medicines for cancer. Neutropenia means reduction in neutrophils (type of white blood cell important in the body’s fight against infection). It is also used for reducing the duration of neutropenia in patients undergoing myeloablative therapy (therapy aimed at reducing the bone marrow cells) which is followed by bone marrow cell transplantation. It is used for mobilization of blood progenitor cells (progenitor cells are nothing but the cells that can differentiate into a specific type of cells). It is also used for reducing the duration of neutropenia in patients (children or adults), with neutropenia less than or equal to the count of 0.5 x 10 9 /L who present this condition by birth and those who have severe infections. It is also used in patients with persistent neutropenia whose count is less than or equal to 1.0 x 10 9 /L like in patients with HIV infection. HOW NIVESTIM WORKS Nivestim is a man-made form of granulocyte colony-stimulating factor (G-CSF). Human G-CSF is a substance produced by our body which regulates the production and release of neutrophils from the bone marrow. Nivestim stimulates the growth of neutrophils along with a minor increase in other type of blood cells like monocytes, eosinophils and basophils. BEFORE YOU USE NIVESTIM - _When you must not use it _ Do not take Nivestim if you are allergic to filgrastim or any of the ot Przeczytaj cały dokument
Pfizer Confidential NIVESTIM ® FILGRASTIM 1. NAME OF THE MEDICINAL PRODUCT Nivestim 12 MU/0.2 ml solution for injection/infusion Nivestim 30 MU/0.5 ml solution for injection/infusion Nivestim 48 MU/0.5 ml solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nivestim 12 MU/0.2 ml and 30 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 60 million units [MU] (600 micrograms [ µ g]) of filgrastim*. Each pre-filled syringe contains 12 million units (MU) (120 micrograms [ µ g]) of filgrastim in 0.2 ml (0.6 mg/ml). Each pre-filled syringe contains 30 million units (MU) (300 micrograms [ µ g]) of filgrastim in 0.5 ml (0.6 mg/ml). Nivestim 48 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 96 million units [MU] (960 micrograms [ µ g]) of filgrastim*. Each pre-filled syringe contains 48 million units (MU) (480 micrograms [ µ g]) of filgrastim in 0.5 ml (0.96 mg/ml). *Recombinant methionyl granulocyte-colony stimulating factor [G-CSF] produced in _ Escherichia coli _ (BL21) by recombinant DNA technology. Excipient with known effect Each ml of solution contains 50 mg of sorbitol (E420) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion (injection/infusion). Clear, colourless solution. Pfizer Confidential 1 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Filgrastim 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 filgrastim are similar in adults and children receiving cytotoxic chemotherapy. F Przeczytaj cały dokument