País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ABACAVIR SULFATE; LAMIVUDINE
CAMBER LABORATORIES SDN. BHD.
ABACAVIR SULFATE; LAMIVUDINE
3 x 10s Tablets
Hetero Labs Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ABALAM TABLETS ABACAVIR SULFATE/LAMIVUDINE (600MG/300MG) 1 WHAT IS IN THIS LEAFLET? 1. What ABALAM is used for? 2. How ABALAM works 3. Before you take ABALAM 4. How to use ABALAM 5. While you are using it 6. Side effects 7. Storage and disposal of ABALAM 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 11. Serial Number WHAT ABALAM IS USED FOR ABALAM is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and in children weighing at least 25 kg. ABALAM contains two active ingredients that are used to treat HIV infection: abacavir and lamivudine. These belong to a group of anti-retroviral medicines called _nucleoside _ _analogue _ _reverse transcriptase inhibitors (NRTIs)_ . HOW ABALAM WORKS ABALAM does not completely 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 ABALAM in the same way. Your doctor will monitor the effectiveness of your treatment. BEFORE YOU TAKE ABALAM _-When you must not use it _ Do not take ABALAM: • If you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir – (e.g., Ziagen), lamivudine or any of the other ingredients of this medicine. You are more likely to develop this reaction if you have a gene called HLA- B*5701 (but you can get a reaction even if you do not have this gene). You should have been tested for this gene before ABALAM was prescribed for you. If you know you have this gene, tell your doctor before you take ABALAM. Carefully read all the information about hypersensitivity reactions in section “Side Effect”. Check with your doctor if you think this applies to you. Do not take ABALAM. _Pregnancy _ ABALAM is not recommended for use during pregnancy. ABALAM and similar medicines may cau Leia o documento completo
----- ABALAM (ABACAVIR SULFATE AND LAMIVUDINE TABLET 600MG/ 300MG) Font size: 7 NAME OF ACTIVE INGREDIENT Each film-coated tablet contains Abacavir 600mg and Lamivudine 300mg. DOSAGE FORM Film coated tablet. PRODUCT DESCRIPTION The tablets are orange, modified capsule shaped, film coated tablets, debossed with ‘H’ on one side and ‘A1’ on the other side. 702 mg of Abacavir Sulfate is equivalent to 600 mg of Abacavir. PHARMACODYNAMICS Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations. ATC code: J05AR02. _Mechanism of action: _ Abacavir and lamivudine are NRTIs and are potent selective inhibitors of HIV-1 and HIV-2 (LAV2 and EHO) replication. Both abacavir and lamivudine are metabolised sequentially by intracellular kinases to the respective 5'-triphosphate (TP) which are the active moieties. Lamivudine-TP and carbovir-TP (the active triphosphate form of abacavir) are substrates for and competitive inhibitors of HIV reverse transcriptase (RT). However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination. Abacavir and lamivudine triphosphates show significantly less affinity for host cell DNA polymerases. No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents: didanosine, nevirapine and zidovudine). The antiviral activity of abacavir in cell culture was not antagonized when combined with the nucleoside reverse transcriptase inhibitors (NRTIs) didanosine, emtricitabine, stavudine, tenofovir or zidovudine, the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, or the protease inhibitor (PI) amprenavir. Antiviral Activity in vitro Both abacavir and lamivudine have been shown to inhibit replication of laboratory strains and clinical isolates of HIV in a number of cell types, including transformed T cell lines, monocyte/macrophage derived lines and primary cultures of activated peripheral blood lymphocytes ( Leia o documento completo