Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Emcure Pharmaceuticals SA (Pty) Ltd., Arizona House, First floor, South Wing, Aspen Business Park, 1 Madison Avenue, Aspen Lakes, Extension 13, Johannesburg South, 2190
LAVEM, tablets.
| Pharmaceutical Form |
|---|
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Tablets. White to off white, capsule shaped, film-coated tablets, debossed with “HP553” on one side and plain on the other side. |
Each LAVEM tablet contains:
Lamivudine 300 mg
Tenofovir disoproxil fumarate 300 mg
Dolutegravir sodium equivalent to dolutegravir 50 mg
Excipient(s) with known effect:
Sugar content: Contains sugar (lactose monohydrate 153 mg and mannitol 184,38 mg).
For full list of excipients, see section 6.1.
WARNING:
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE SECTION 4.4). LAVEM IS NOT INDICATED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION. SAFETY AND EFFICACY OF LAVEM HAS NOT BEEN ESTABLISHED IN PATIENTS CO-INFECTED WITH HBV AND HIV. SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE CO-INFECTED WITH HBV AND HIV AND HAVE DISCONTINUED THE COMBINATION TABLET. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE LAVEM AND ARE CO-INFECTED WITH HIV AND HBV. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED (SEE SECTION 4.4).
| Active Ingredient |
|---|
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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. |
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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 |
|---|
|
The other ingredients are: Core tablet: Microcrystalline cellulose Film coat: Polyvinyl alcohol partially hydrolysed |
28 or 30 tablets are packed in a 100 cc, white opaque, HDPE container and closed with a 38 mm, white opaque, polypropylene closure. Each HDPE container contains a HDPE canister containing silica gel.
84 or 90 tablets are packed in a 200 cc, white opaque, HDPE container and closed with a 38 mm, white opaque, polypropylene closure. Each HDPE container contains a HDPE canister containing silica gel.
180 tablets are packed in a 400 cc, white opaque, HDPE container and closed with a 53 mm, white opaque, polypropylene closure. Each HDPE container contains a HDPE canister containing silica gel.
Not all pack sizes may be marketed.
Emcure Pharmaceuticals SA (Pty) Ltd., Arizona House, First floor, South Wing, Aspen Business Park, 1 Madison Avenue, Aspen Lakes, Extension 13, Johannesburg South, 2190
Registration number: 53/20.2.8/0090
Date of Registration: 10 October 2018
| Drug | Countries | |
|---|---|---|
| LAVEM | South Africa |
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