TRELAVUE Film-coated tablet Ref.[115292] Active ingredients: Abacavir Dolutegravir Lamivudine

Source: Health Products Regulatory Authority (ZA)  Publisher: GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460

Product name and form

TRELAVUE.

Pharmaceutical Form

Purple, biconvex, oval, film-coated tablets, debossed with "572 Trı" on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg of dolutegravir as dolutegravir sodium, 600 mg of abacavir as abacavir sulphate and 300 mg of lamivudine.

Active Ingredient

Abacavir is a NRTI. It is a potent selective inhibitor of HIV-1 and HIV-2. 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.

Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.

Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription.

List of Excipients

Tablet Core:

D-Mannitol
Magnesium stearate
Microcrystalline cellulose
Povidone K29/32
Sodium starch glycolate

Tablet coating:

Opadry II Purple 85F90057 containing:

Polyvinyl alcohol – part hydrolysed
Titanium oxide
Macrogol/PEG
Talc
Iron oxide black
Iron oxide red

Pack sizes and marketing

TRELAVUE tablets are packed into opaque, white High Density Polyethylene (HDPE) bottles and closed with white polypropylene child resistant closures, with a polyethylene faced induction heat seal liner. A silica gel desiccant is included in each bottle. The HDPE bottle is pigmented white with titanium dioxide and is packed into an outer cardboard carton.

Marketing authorization holder

GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460

Marketing authorization dates and numbers

49/20.2.8/0097

Drugs

Drug Countries
TRELAVUE South Africa

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