Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ABACAVIR SULFATE
UNIMED SDN BHD
ABACAVIR SULFATE
240ml mL
Aurobindo Pharma Limited Unit - III
ABACAVEX TABLET/ORAL SOLUTION (Abacavir Sulfate 300mg USP Tablet, 20mg/ml Oral solution) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Abacavir Sulfate is used for 2. How Abacavir Sulfate works 3. Before you use Abacavir Sulfate 4. How to use Abacavir Sulfate 5. While you are using it 6. Side effects 7. Storage and Disposal of Abacavir Sulfate 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ABACAVIR SULFATE IS USED FOR Abacavir Sulfate is used in antiretroviral combination therapy, for, the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children. HOW ABACAVIR SULFATE WORKS The active ingredient Abacavir Sulfate is a potent selective inhibitor of HIV. It works by inhibiting HIV reverse transcriptase enzyme. Reverse transcriptase is an enzyme that HIV needs in order to multiply. Abacavir penetrates the cerebrospinal fluid, and has been shown to reduce HIV-1 RNA levels. BEFORE YOU USE ABACAVIR SULFATE - _When you must not use it_ Do not take Abacavir Sulfate if: • You are allergic or hypersensitive to Abacavir Sulfate or any of the other ingredients of this product. • You suffer from severe liver impairment _Pregnancy and lactation _ Do not take Abacavir Sulfate if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Abacavir Sulfate if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Do not take Abacavir Sulfate if you have: • Buildup of lactate • Mitochondrial dysfunction (important part of the cell which fails to produce enough energy for cell or organ function) • Lipodystrophy (abnormal distribution of fat in the body) • Pancreatitis (inflammation in the pancreas) • Liver disease • Kidney disease • Hereditary problems of fructose intolerance • Immune Reactivation Syndrome (some cases of AIDS or immunosuppression, in which the immune system begins to recover, but then responds to Preberite celoten dokument
ABACAVEX (ABACAVIR ORAL SOLUTION USP 20 MG/ML) ABACAVEX (ABACAVIR TABLETS USP 300 MG) ABACAVIR SULFATE ORAL SOLUTION 20MG/ML: DESCRIPTION AND COMPOSITION: Clear to opalescent yellowish, strawberry-banana flavoured liquid. Each ml contains abacavir 20mg as abacavir sulfate. ABACAVIR SULFATE TABLETS USP 300MG DESCRIPTION AND COMPOSITION: Yellow colored, biconvex, capsule shaped, coated tablet, debossed with ‘D’ and ‘88’ on either side of the score line on one side and plain with a score line on other side. Each film coated tablet contains: Abacavir Sulfate equivalent to Abacavir 300mg. PHARMACODYNAMICS: Pharmacotherapeutic group: Nucleoside reverse transcriptase inhibitors, ATC Code: J05A F06 Abacavir is a NRTI. It is a potent selective inhibitor of HIV-1 and HIV-2, including HIV-1 isolates with reduced susceptibility to zidovudine, lamivudine, zalcitabine, didanosine or nevirapine. Abacavir is metabolised intracellularly to the active moiety, carbovir 5’- triphosphate (TP). In vitro studies have demonstrated that its mechanism of action in relation to HIV is inhibition of the HIV reverse transcriptase enzyme, an event which results in chain termination and interruption of the viral replication cycle. Abacavir shows synergy in vitro in combination with nevirapine and zidovudine. It has been shown to be additive in combination with didanosine, zalcitabine, lamivudine and stavudine. Abacavir-resistant isolates of HIV-1 have been selected in vitro and are associated with specific genotypic changes in the reverse transcriptase (RT) codon region (codons M184V, K65R, L74V and Y115F). Viral resistance to abacavir develops relatively slowly in vitro and in vivo, requiring multiple mutations to reach an eight-fold increase in IC50 over wild-type virus, which may be a clinically relevant level. Isolates resistant to abacavir may also show reduced sensitivity to lamivudine, zalcitabine and/or didanosine, but remain sensitive to zidovudine and stavudine. Cross-resistance between abacavir and PIs or NNRTIs is unl Preberite celoten dokument