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ZINACEF Powder for injection / infusion (2019)

Active ingredients: Cefuroxime

Product Name and Form

Zinacef for Injection or Infusion.

Pharmaceutical form

Cefuroxime is a white to cream powder to which appropriate amounts of water are added to prepare an off-white suspension for intramuscular use or a yellowish solution for intravenous administration.

Qualitative and Quantitative Composition

Vials contain either 250 mg, 750mg or 1.5g cefuroxime (as sodium).

The total quantity of sodium per vial is as follows:

Zinacef strengthAmount of sodium per vial
250 mg14 mg
750 mg42 mg
1.5 g83 mg
Chemical substance
Description
Cefuroxime

Cefuroxime 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

None.

Pack sizes and Marketing

  1. Moulded glass (type 1 or III) vials with bromobutyl or fluoro-resin laminated butyl rubber plug, overseal and flip-off cap containing either 250mg, 750mg or 1.5g Zinacef.
  2. A bulk pack of 100 vials.
  3. Monovial containing either 750mg or 1.5g Zinacef with transfer needle.

* Only the 1.5g injection pack is marketed (the infusion pack is not)

Marketing authorization holder
Authorization dates

Glaxo Operations UK Limited, 980 Great West Road,Brentford,TW8 9GS

Trading as:

GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT

28 April 2002

Marketing authorization number:

PL 00004/0263