Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa
Lanograv.
Pharmaceutical Form |
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Film coated tablet. White to off-white film coated, caplet shaped tablets plain on both side. |
Each film coated tablet contains:
Dolutegravir sodium equivalent to dolutegravir 50 mg
Lamivudine 300 mg
Tenofovir disoproxil fumarate 300 mg
Contains sugar: Mannitol 144,5 mg per tablet.
For full list of excipients, see section 6.1.
Active Ingredient | Description | |
---|---|---|
Dolutegravir |
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 |
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. |
|
Tenofovir disoproxil |
Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. |
List of Excipients |
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Croscarmellose sodium Coating material: Opadry II 85F580019 (White) Macrogol/PEG |
The film coated tablets are packed in a white opaque HDPE bottle pack of 28’s, 30’s and 90’s with 3 g silica or 5 g silica as desiccant and a white opaque polypropylene screw cap with an induction seal liner; with or without a carton.
Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa
52/20.2.8/0718
26 October 2018
Drug | Countries | |
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LANOGRAV | South Africa |
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