TAFBIN Film-coated tablet Ref.[115238] Active ingredients: Emtricitabine Tenofovir alafenamide

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530 Customer Care: 080 222 6662

Product name and form

TAFBIN.

(Emtricitabine 200 mg and tenofovir alafenamide 25 mg film-coated tablets)

Pharmaceutical Form

Film-coated tablet.

White to off white coloured, capsule shaped, biconvex film-coated tablet debossed with 'Cipla' on one side and plain on other side.

Qualitative and quantitative composition

Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.

Sugar free.

For full list of excipients, see section 6.1.

Active Ingredient

Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2 and HBV. Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination. Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.

Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir. Tenofovir alafenamide enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3. Tenofovir alafenamide is primarily hydrolysed to form tenofovir by carboxylesterase 1 in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination. Tenofovir has activity that is specific to HBV and HIV (HIV-1 and HIV-2).

List of Excipients

Croscarmellose sodium
Magnesium stearate
Microcrystalline cellulose
Opadry II white 85F18422

Contents of the Opadry White II 85F18422 film-coating solution:

Macrogol (polyethylene glycol) (E1521)
Polyvinyl alcohol-part hydrolysed (E1203)
Talc (E553b)
Titanium dioxide (E171)

Pack sizes and marketing

TAFBIN is packed in a white high-density polyethylene (HDPE) bottle that is fitted with a white HDPE closure, containing 28, 30 or 90 film-coated tablets and silica gel desiccants.

Marketing authorization holder

CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530
Customer Care: 080 222 6662

Marketing authorization dates and numbers

TAFBIN: 55/20.2.8/0080.079

30 November 2021

Drugs

Drug Countries
TAFBIN South Africa

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