Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Mylan (Pty) Ltd, 4 Brewery Street, Isando, Johannesburg, 1609, Republic of South Africa
ENVUTEG Film coated tablet.
| Pharmaceutical Form |
|---|
|
Film coated tablets. White to off white, film coated, capsule shaped, biconvex, bevelled edge tablet debossed with “M” on one side of the tablet and “LD” on the other side. |
Each ENVUTEG film coated tablet contains:
Lamivudine 300 mg.
Tenofovir alafenamide 25 mg.
Dolutegravir sodium (equivalent to dolutegravir) 50 mg.
Contains sugar: mannitol 131,40 mg and lactose monohydrate 60 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 |
|---|
|
Croscarmellose sodium |
The product is presented in the following marketable packs:
30’s Bottle Pack (with 4 g Molecular Sieve):
| Pack Type | Config-uration | Primary packaging components |
|---|---|---|
| HDPE Bottle Pack (with desiccant) | 30’s count | Container: Bottle HDPE 60 ml 33 mm Blue round (12 G) TP Closure: Closure 33 mm Blue screw with SG100 SP. Desiccant: 2 g Molecular Sieve Canister-SC (2 No.s) |
Mylan (Pty) Ltd, 4 Brewery Street, Isando, Johannesburg, 1609, Republic of South Africa
03/08/2021
| Drug | Countries | |
|---|---|---|
| ENVUTEG | South Africa |
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