Source: Health Products Regulatory Authority (ZA) Revision Year: 2018 Publisher: Macleods Pharmaceuticals SA (Pty) Ltd, Office block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext.12, Alberton, South Africa
Kovatrax Tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. White to off white, capsule shaped, film coated tablets, debossed with ‘F67’ on one side and plain on the other side. |
Each film-coated tablet contains: Dolutegravir sodium equivalent to dolutegravir 50 mg, Lamivudine 300 mg and Tenofovir disoproxil fumarate 300 mg.
Contains sugar (120,0 mg mannitol).
| 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 |
|---|
|
Microcrystalline cellulose, sodium starch glycolate, povidone, sodium stearyl fumarate, ferric oxide yellow, pregelatinized starch, croscarmellose sodium, isopropyl alcohol, magnesium stearate and coating agent containing hypromellose, triacetin and titanium dioxide (C.I. No. 77891). |
HDPE container pack of 28 or 30 tablets: Tablets are packed in a 120 ml, round white HDPE bottle with 38-400 neck finish closed with 38 mm white, continuous thread polypropylene closure with pulp and heat seal 123 white printed liner. Each HDPE container contains a 3 g silica gel sachet. The labelled HDPE container is packed in a pre- printed unit carton.
HDPE container pack of 90 or 100 tablets: Tablets are packed in a 250 ml, round white HDPE bottle with 53-400 neck finish closed with 53 mm white, continuous thread polypropylene closure with pulp and heat seal 123 white printed liner. Each HDPE container contains a 3 g silica gel sachet. The labelled HDPE container is packed in a pre- printed unit carton.
HDPE container pack of 180 tablets: Tablets are packed in a 400 ml, round white HDPE bottle with 53-400 neck finish closed with 53 mm white, continuous thread polypropylene closure with pulp and heat seal 123 white printed liner. Each HDPE container contains a 3 g silica gel sachet. The labelled HDPE container is packed in a pre- printed unit carton.
Macleods Pharmaceuticals SA (Pty) Ltd, Office block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext.12, Alberton, South Africa
52/20.2.8/0772.770
| Drug | Countries | |
|---|---|---|
| KOVATRAX | South Africa |
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