FORTUM Powder for solution for injection or infusion Ref.[27719] Active ingredients: Ceftazidime

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Glaxo Operations UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom Trading as GlaxoSmithKline UK

Product name and form

Fortum 1 g powder for solution for injection or infusion.

Pharmaceutical Form

Powder for solution for injection or infusion.

Vials containing white to cream sterile powder.

Qualitative and quantitative composition

Each vial contains 1 g ceftazidime (as pentahydrate) with sodium carbonate (118 mg per gram of ceftazidime).

Excipient with known effect:

Each vial contains 52 mg (2.3 mmol) of sodium per vial.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ceftazidime

Ceftazidime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

List of Excipients

Sodium carbonate (anhydrous sterile)

Pack sizes and marketing

Fortum 1 g powder for solution for injection or infusion is packaged in clear Ph.Eur.Type III glass 17 ml, 26 ml, 60 ml or 77 ml vial with a bromobutyl rubber plug and a flip-off type aluminium overseal.

Packs of 1, 5, 10, 50 or 100 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Glaxo Operations UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Trading as

GlaxoSmithKline UK

Marketing authorization dates and numbers

PL 00004/0293

Date of first authorisation: 17 October 1983
Date of latest renewal: 17 January 2011

Drugs

Drug Countries
FORTUM Austria, Cyprus, Estonia, France, Hong Kong, Ireland, Israel, Lithuania, Malta, Mexico, New Zealand, Poland, Singapore, United Kingdom, South Africa

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