REPOCEF Powder for suspension Ref.[115774] Active ingredients: Cefprozil

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Aurogen South Africa (Pty) Ltd, 53 Phillip Engelbrecht Avenue, Woodhill Office Park, Building 1, Meyersdal, Extension 12, 1448, Johannesburg, South Africa

Product name and form

REPOCEF SUSPENSION 125 mg/5 ml (Powder for suspension).

REPOCEF SUSPENSION 250 mg/5 ml (Powder for suspension).

Pharmaceutical Form

REPOCEF SUSPENSION 125 mg/5 ml

For Dry Powder: White to off white granular powder with bubble gum flavour.

For Reconstituted Suspension: Light orange suspension with bubble gum flavour.

REPOCEF SUSPENSION 250 mg/5 ml

For Dry Powder: White to off white granular powder with bubble gum flavour.

For Reconstituted Suspension: Light orange suspension with bubble gum flavour.

Qualitative and quantitative composition

REPOCEF SUSPENSION 125 mg/5 ml: Each 5 ml (after reconstitution) contains cefprozil monohydrate equivalent to 125 mg anhydrous cefprozil and sodium benzoate 0,064% m/v as preservative.

REPOCEF SUSPENSION 250 mg/5 ml: Each 5 ml (after reconstitution) contains cefprozil monohydrate equivalent to 250 mg anhydrous cefprozil and sodium benzoate 0,064% m/v as preservative.

The other ingredients of the formulation are sucrose, sodium chloride, citric acid monohydrate, simethicone emulsion, polysorbate 80, aspartame, glycine, carmellose sodium, microcrystalline cellulose/carboxy methyl cellulose sodium, silica colloidal anhydrous, Bubble Gum Flavour (PWD # 730) and Colour FD&C Yellow No.6 (C.I. No: 15985).

Active Ingredient

Cefprozil belongs to a sub-group of beta-lactam antibiotics, cephalosporins. It is bactericidal and acts by inhibiting synthesis of bacterial cell wall. The bactericidal action of cefprozil results from inhibition of cell-wall synthesis.

List of Excipients

Pack sizes and marketing

REPOCEF SUSPENSION 125 mg/5 ml

The granules are packed in a colourless 115 ml HDPE translucent, round bottle with a 28 mm neck closed with a white opaque 28 mm child resistant closure with an induction sealing wad, together with a 20 ml measuring cup.

Pack size: 60 ml of suspension after reconstitution.

REPOCEF SUSPENSION 250 mg/5 ml

The granules are packed in a colourless 115 ml HDPE translucent, round bottle with a 28 mm neck closed with a white opaque 28 mm child resistant closure with an induction sealing wad, together with a 20 ml measuring cup.

Pack size: 60 ml of suspension after reconstitution.

Marketing authorization holder

Aurogen South Africa (Pty) Ltd, 53 Phillip Engelbrecht Avenue, Woodhill Office Park, Building 1, Meyersdal, Extension 12, 1448, Johannesburg, South Africa

Drugs

Drug Countries
REPOCEF South Africa

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