METRONIDAZOLE Solution for infusion Ref.[6987] Active ingredients: Methronidazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, UK

Product name and form

Metronidazole 500 mg/100 ml Intravenous Infusion.

Pharmaceutical Form

Solution for infusion.

A clear, almost colourless to pale yellow solution.

Qualitative and quantitative composition

Metronidazole 5 mg/ml.

100 ml of solution for infusion containing 500 mg of Metronidazole.

For excipients see 6.1.

Osmolarity: 308 mOsm/l

pH: 4.5 to 6.0

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

Disodium phosphate dodecahydrate
Citric acid monohydrate
Sodium chloride
Water for injections

Pack sizes and marketing

The bags are composed of polyolefin/polyamide co-extruded plastic (PL 2442) known as Viaflo.

The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene, which serves only to provide physical protection to the bags.

The bag size is 100ml.

Outer carton contents: 20 bags of 100ml, 50 bags of 100ml and 60 bags of 100ml.

Marketing authorization holder

Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, UK

Marketing authorization dates and numbers

PL 00116/0353

12/11/2006

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