TRICHAZOLE Solution for infusion Ref.[50447] Active ingredients: Methronidazole

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Fresenius Kabi Manufacturing SA (Pty) Ltd, 6 Gibaud Road, Korsten, Port Elizabeth 6020, South Africa

Product name and form

Trichazole 500 mg/100 ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

A clear, colourless to pale straw-coloured, sterile solution.

Qualitative and quantitative composition

Each 100 ml of the solution contains: 500 mg metronidazole.

Sugar free.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methronidazole

Metronidazole is an anti-infectious drug belonging to the pharmacotherapeutic group of nitroimidazole derivatives, which have effect mainly on strict anaerobes. This effect is probably caused by interaction with DNS and different metabolites.

List of Excipients

Citric acid (for pH-adjustment)
Disodium phosphate (E339ii) (for pH-adjustment)
Sodium chloride
Water for injection

Pack sizes and marketing

100 ml freeflex or PVC bags.

Pack size: 1, 40 or 50.

Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Manufacturing SA (Pty) Ltd, 6 Gibaud Road, Korsten, Port Elizabeth 6020, South Africa

Marketing authorization dates and numbers

Q/20.2/92

15 June 1982

Drugs

Drug Countries
TRICHAZOLE Hong Kong, South Africa

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