Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZIDOVUDINE/AZIDOTHYMIDINE; LAMIVUDINE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
ZIDOVUDINE/AZIDOTHYMIDINE; LAMIVUDINE
60Tablet Tablets
GLAXOSMITHKLINE PHARMACEUTICALS SA
_Consumer Medication Information Leaflet (RiMUP)_ COMBIVIR TABLET _ _ _ _ Lamivudine/Zidovudine (150 mg/300 mg) 1 WHAT IS IN THIS LEAFLET 1. What Combivir is used for 2. How Combivir works 3. Before you use Combivir 4. How to use Combivir 5. While you are using it 6. Side Effects 7. Storage and Disposal of Combivir 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT COMBIVIR IS USED FOR Combivir is used to treat HIV (human immunodeficiency virus) infection in adults and in children. HOW COMBIVIR WORKS Combivir contains two active ingredients that are used to treat HIV infection: lamivudine and zidovudine. Both of these belong to a group of anti- retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs). Combivir does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Not everyone responds to treatment with Combivir in the same way. Your doctor will monitor the effectiveness of your treatment. BEFORE YOU USE COMBIVIR - _When you must not use it _ Do not take this medicine: • If you are allergic (hypersensitive) to lamivudine or zidovudine, or any other ingredients of Combivir tablets. • If you have a very low red blood cell count ( _anaemia_ ) or a very low white blood cell count ( _neutropenia_ ). If you think any of these apply to you, don’t take Combivir until you have checked with your doctor. - _Before you start to use it _ Before you take Combivir your doctor needs to know: • If you have ever had liver disease, including hepatitis B or C • If you have kidney disease • If you have a blood disorder Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you’re taking your medication. Conditions you need to look out for: Combivir can cause serious side effects. You must loo Baca dokumen lengkap
CONFIDENTIAL COMBIVIR Lamivudine-Zidovudine QUALITATIVE AND QUANTITATIVE COMPOSITION COMBIVIR tablets contain 150 mg lamivudine and 300 mg zidovudine and are white to off- white capsule-shaped, scored tablets, engraved with GX FC3 on both faces. CLINICAL INFORMATION Indications COMBIVIR is indicated for the treatment of HIV infection. Dosage and Administration Pharmaceutical Form: Film-coated tablets. COMBIVIR therapy should be initiated and monitored by a physician experienced in the management of HIV infection. COMBIVIR may be administered with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. For patients who are unable to swallow tablets, they may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see Pharmacokinetics). Populations Adults and adolescents weighing at least 30 kg: The recommended dose of COMBIVIR is one tablet twice daily. • Children weighing between 21 kg and 30 kg The recommended oral dose of COMBIVIR is one-half tablet taken in the morning and one whole tablet taken in the evening. • Children weighing from 14 kg to 21 kg The recommended oral dose of COMBIVIR is one-half tablet taken twice daily. For children weighing less than 14 kg, lamivudine (3TC) and zidovudine (RETROVIR) should be taken as separate formulations according to the prescribed dosing for these products. If a reduction in dose of COMBIVIR appears clinically indicated, or if one of the components of COMBIVIR (lamivudine or zidovudine) requires reduction or discontinuation, separate CONFIDENTIAL preparations of lamivudine (3TC) and zidovudine (RETROVIR) are available in tablets/capsules and oral solution. Elderly No specific data are available, however special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters. Renal impairment Dosage adjustment of lamivudine is required in patients wi Baca dokumen lengkap