Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NEVIRAPINE
Paxten Sdn Bhd
NEVIRAPINE
60tablet Tablets
Macleods Pharmaceuticals Ltd.
_Consumer Medication Information Leaflet (RiMUP) _ NEVIHOPE 200MG TABLET (NEVIRAPINE TABLETS USP 200 MG) Nevirapine (200mg) . 1 WHAT IS IN THIS LEAFLET 1. What Nevihope is used for 2. How Nevihope works 3. Before you use Nevihope 4. How to take Nevihope 5. While you are using Nevihope 6. Side Effects 7. Storage and Disposal of Nevihope 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT NEVIHOPE IS USED FOR Nevihope belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV- 1) infection. Nevihope is indicated for the treatment of HIV-1 infected adults and for larger children. You must take Nevihope together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. HOW NEVIHOPE WORKS The active substance of your medicine is called nevirapine. Nevirapine reduces the amount of viruses in the blood thus improving your medical condition. Nevirapine belongs to a class of anti-HIV medicines called non- nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to multiply. Nevirapine stops reverse transcriptase from working. By stopping reverse transcriptase from working, Nevihope helps control HIV-1 infection. BEFORE YOU USE NEVIHOPE _-When you must not take it _ Do not take Nevihope if: - you are allergic to nevirapine or any of the other ingredients of this medicine - you have taken Nevihope before and had to stop the treatment because you suffered from severe rashes, allergy reactions or liver problems - you are taking St. John's wort as this can affect the efficacy of Nevihope - you have severe liver problems _-Before you start to take it _ _Warnings and precautions _ Talk to your doctor or pharmacist before taking Nevihope. During the first 18 weeks of treatment with Nevihope it is very important that you and your doctor watch out for signs of liver or skin reactions. These can become severe and even life threatening. You are a Prečítajte si celý dokument
SECTION D ARTWORKS _ _ NEVIHOPE 200MG TABLET NEVIRAPINE TABLETS USP 200 MG MACLEODS PHARMACEUTICALS LTD. D3 PACKAGE INSERT For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory NEVIHOPE 200MG TABLET NEVIRAPINE TABLETS USP 200 MG COMPOSITION: Each uncoated tablet contains: Nevirapine USP……………….200 mg DOSAGE FORM: Uncoated Tablet PRODUCT DESCRIPTION: White to off white, oval , biconvex uncoated tablets having “M” and “L” debossed on upper punches separated by a deep score separating the “M” and “L” and “1” and “1” debossed on the other side with a breakline separating “1” and “1”. PHARMACOLOGY: THERAPEUTIC CODE: _ATC CODE:_ J05A G01 Mechanism of Action: 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 α, β, γ, or δ) are not inhibited by nevirapine. Nevirapine in combination with efavirenz exhibited strong antagonistic anti-HIV-1 activity in cell culture and was additive to antagonistic with the protease inhibitor ritonavir or the fusion inhibitor enfuvirtide. Nevirapine exhibited additive to synergistic anti-HIV-1 activity in combination with the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, SECTION D ARTWORKS _ _ NEVIHOPE 200MG TABLET NEVIRAPINE TABLETS USP 200 MG MACLEODS PHARMACEUTICALS LTD. nelfinavir, saquinavir and tipranavir, and the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir and zidovudine. PHARMACOKINETICS: ABSORPTION Nevirapine is readily absorbed (> 90%) after oral administration in healthy volunteers and in adults with HIV-1 infection. Peak plasma nevirapine concentrations of 2 ± 0.4 µg/ml (7.5 µM) wer Prečítajte si celý dokument