Држава: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Nevirapine (Anhydrous)
DUOPHARMA (M) SDN. BHD.
Nevirapine (Anhydrous)
60 Tablet Tablets
DUOPHARMA (M) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 HIRAPINE TABLET Nevirapine (200mg) WHAT IS IN THIS LEAFLET 1. What HIRAPINE TABLET is used for 2. How HIRAPINE TABLET works 3. Before you use HIRAPINE TABLET 4. How to use HIRAPINE TABLET 5. While you are using HIRAPINE TABLET 6. Side effects 7. Storage and disposal of HIRAPINE TABLET 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT HIRAPINE TABLET IS USED FOR HIRAPINE TABLET is used for the treatment of Human Immunodeficiency Virus (HIV-1) infection in adults and children over the age of 12 months. HOW HIRAPINE TABLET WORKS HIRAPINE TABLET contains Nevirapine which belongs to a class of anti-HIV medicines. Nevirapine decrease HIV-1 activities and production. BEFORE YOU USE HIRAPINE TABLET _-_ _ _ _When you must not use it _ You must not use HIRAPINE TABLET if you are hypersensitive to the Nevirapine or to any of the excipients. You must not use HIRAPINE TABLET if you have liver impairment. _-_ _ _ _Before you start to use it _ Before taking HIRAPINE TABLET, you must tell your doctor or pharmacist if you have, or have had, any of the following conditions: Liver disease Post-exposure prophylaxis (taking antiviral medicines after being potentially exposed to HIV to prevent becoming infected) Kidney dysfunction If you are not sure if you have, or have had, any of these conditions, you should raise those concerns with your doctor or pharmacist. _Pregnancy _ Ask for your doctor’s advice if you are pregnant, or likely to become pregnant during your course of medication. _Breast-feeding _ HIRAPINE TABLET was excreted in the breast milk. Women who are infected HIV- 1 is generally recommended not to breastfeed infants regardless of the use of medicine, to avoid post-natal transmission of HIV-1. _-_ _ _ _Taking other medicines _ Inform your doctor or pharmacist before taking HIRAPINE TABLET. Before using HIRAPINE TABLET, it is important to tell your doctor or pharmacist if you are taking or about to take any o Прочитајте комплетан документ
Page 1 of 4 [REVISION DATE: 12.06.2019] [DUOPHARMA (M) SDN BHD] HIRAPINE TABLET 200MG DESCRIPTION: A round 9mm, scored tablet white to off-white in colour with markings ‘DUO 3’ on the scored side and ‘DUO 4’ on the other side. COMPOSITION: Each tablet contains Nevirapine 200mg. PHARMACODYNAMICS: Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1. Nevirapine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. The activity of nevirapine does not compete with template or nucleoside triphosphates. HIV-2 RT and eukaryotic DNA polymerases (such as human DNA polymerases a, b, gamma or delta) are not inhibited by nevirapine. PHARMACOKINETICS: Nevirapine is readily absorbed following oral administration and absorption is not affected by food. Peak plasma concentration occurs up to 4 hours after a single dose. Nevirapine is about 60% bound to plasma proteins. Concentrations in the CNS are about 45% of those in plasma. Nevirapine crosses the placenta and is distributed into breast milk. It is extensively metabolised by hepatic microsomal enzymes, principally by cytochrome P450 isoenzymes of the CYP3A family. Autoinduction of these enzymes results in a 1.5- to 2-fold increase in apparent oral clearance after 2 to 4 weeks administration of usual doses, and a decrease in terminal half-life from 45 hours to 25 to 30 hours over the same period. Nevirapine is mainly excreted in the urine as glucoronide conjugates of the hydroxylated metabolites. INDICATION: Nevirapine in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and children over the age of 2 months. Resistant virus emerges rapidly when Nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. Therefore, Nevirapine should always be administered in combination with at least two additional antiretroviral agents. Avoid usage o Прочитајте комплетан документ