Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685 Customer Care: 0860 ADCOCK (232625)
NUVACO, 300 mg, 300 mg, 50 mg, film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. Orange coloured, modified capsule shaped, biconvex film-coated tablets debossed with ‘H’ on one side, and ‘D 17’ on the other side. |
Each NUVACO film-coated tablet contains:
Lamivudine 300 mg.
Tenofovir disoproxil fumarate 300 mg.
Dolutegravir sodium equivalent to dolutegravir 50 mg.
Contains sugar (140,4 mg mannitol per tablet).
For the 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 |
|---|
|
Tablet core: Croscarmellose sodium Film coating: Iron oxide red |
Pack sizes 28, 30, 56, 60, 84, 90, 100, 180 and 750 film-coated tablets: NUVACO tablets are packed in a white opaque high density polyethylene (HDPE) container with a cotton or rayon coil wadding and a desiccant canister containing silica gel. The HDPE container is closed with a white polypropylene, child-resistant cap with heat seal induction liner or pulp liner. Pack size of 30’s is packed in an outer carton.
Not all pack sizes may be marketed.
Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685
Customer Care: 0860 ADCOCK (232625)
52/20.2.8/0949
10 October 2018
| Drug | Countries | |
|---|---|---|
| NUVACO | South Africa |
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