AXETINE Powder for solution for injection / infusion Ref.[28134] Active ingredients: Cefuroxime

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Axetine 250 mg powder for solution for injection or infusion.

Axetine 750 mg powder for solution for injection or infusion.

Axetine 1.50 g powder for solution for injection or infusion.

Pharmaceutical Form

Powder for solution for injection or infusion.

White or almost white to yellowish powder.

Qualitative and quantitative composition

Each vial contains 250mg or 750mg or 1.5g cefuroxime as cefuroxime sodium.

Axetine strengthAmount of sodium per vial
250 mg13.55 mg (0.589 mmol)
750 mg40.65 mg (1.77 mmol)
1.5 g 81.45 mg(3.54 mmol)
Active Ingredient 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

Axetine 250mg powder for solution for injection or infusion:

Type I clear glass vials having a nominal capacity of 10ml that are sealed with a 20mm bromobutyl rubber stopper and an aluminium cap.

Axetine 750mg powder for solution for injection or infusion:

Type I clear glass vials having a nominal capacity of 15ml that are sealed with a 20mm bromobutyl rubber stopper and an aluminium cap.

Axetine 1.5g powder for solution for injection or infusion:

Type I clear glass vials having a nominal capacity of 15ml that are sealed with a 20mm bromobutyl rubber stopper and an aluminium cap.

Boxes of 1, 10, 50 or 100 vials.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Axetine 250 mg: 13413
Axetine 750 mg: 13412
Axetine 1.5 g: 14882

Axetine 250 mg: 26.06.1991 / 29.10.2012
Axetine 750 mg: 25.06.1991 / 29.10.2012
Axetine 1.5 g: 14.07.1994 / 11.10.2010

Drugs

Drug Countries
AXETINE Cyprus, Estonia, Hong Kong, Croatia, Lithuania, Malta, Romania, Singapore

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