AFARIS PAED 75/50 Tablet Ref.[115239] Active ingredients: Isoniazid Rifampicin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: Macleods Pharmaceuticals SA (Pty) Ltd., Ground Floor, Block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock Ext 12, Alberton, Gauteng

Product name and form

AFARIS PAED 75/50 (dispersible tablet).

Pharmaceutical Form

AFARIS PAED 75/50: Brick red mottled, 9,5 mm circular, uncoated biconvex tablets having deep score on one side and plain surface on other side.

Qualitative and quantitative composition

AFARIS PAED 75/50:

Each dispersible tablet contains rifampicin 75 mg and isoniazid 50 mg.

Sugar free.

Contains sweetener – aspartame 3,13 mg.

For the full list of excipients, see section 6.1.

Active Ingredient

Isoniazid is used mainly in the treatment of pulmonary tuberculosis but it appears to be effective also in the treatment of extrapulmonary lesions, including meningitis and genito-urinary disease.

Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing extracellular organisms and also has bactericidial activity intracellularly. Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

List of Excipients

Microcrystalline cellulose
Crospovidone
Povidone
Bleached shellac
Croscarmellose sodium
Raspberry flavour
Magnesium stearate

Contains aspartame.

Pack sizes and marketing

HDPE Container:

Tablets are packed in a transparent, self-sealing LDPE polybag and further packed in a silver coloured triple laminated aluminium sachet (LDP/PET/AL), kept in a white plastic container (HDPE), which is sealed at the mouth with an aluminium tagger and is closed with a white HDPE screw-on lid. Pack sizes include 100 tablets.

Alu-alu strip pack:

Tablets are packed in silver-metallic coloured aluminium foil (soft tempered) laminated with low density polyethylene film as the lidding and forming material. The blister is packed in a pre-printed carton. Pack sizes include 28, 56, 84 and 100 tablets.

Marketing authorization holder

Macleods Pharmaceuticals SA (Pty) Ltd., Ground Floor, Block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock Ext 12, Alberton, Gauteng

Marketing authorization dates and numbers

51/20.2.3/0852

26 October 2018

Drugs

Drug Countries
AFARIS South Africa

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