TRACTINFECT Powder for oral solution Ref.[51232] Active ingredients: Fosfomycin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191

Product name and form

TRACTINFECT 3 g powder.

Pharmaceutical Form

Powder for oral solution.

Single dose sachet containing white to off-white powder with orange flavour.

Qualitative and quantitative composition

Each sachet of TRACTINFECT contains fosfomycin trometamol equivalent to 3 g fosfomycin.

Contains sugar: Sucrose 2,193 g

Contains sweetener: Saccharin sodium 16 mg

For full list of excipients, see section 6.1.

Active Ingredient Description
Fosfomycin

Fosfomycin exerts a bactericidal effect on proliferating pathogens by preventing the enzymatic synthesis of the bacterial cell wall. Fosfomycin inhibits the first stage of intracellular bacterial cell wall synthesis by blocking peptidoglycan synthesis.

List of Excipients

Orange flavour
Saccharin sodium
Sucrose

Pack sizes and marketing

The powder is packed in sachets made of paper, low density polyethylene and aluminium foil.

Each sachet is packed in an outer cardboard carton.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191

Marketing authorization dates and numbers

48/20.1.1/0482

02 February 2021

Drugs

Drug Countries
TRACTINFECT South Africa

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