ZEPILEN Powder for solution for injection/infusion Ref.[28167] Active ingredients: Cefazolin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Medochemie Ltd, 1–10 Constantinoupoleus Street 3011 Limassol, Cyprus

Product name and form

Zepilen 500 mg powder for solution for injection/infusion.

Zepilen 1g powder for solution for injection/infusion.

Pharmaceutical Form

Powder for solution for injection/infusion.

White or almost white, very hygroscopic powder for solution for injection/infusion.

Qualitative and quantitative composition

Each vial of Zepilen 500 mg contains 500 mg of cefazolin as cefazolin sodium.

Each vial of Zepilen 1 g contains 1 g of cefazolin as cefazolin sodium.

Excipient with known effect: sodium.

Zepilen 1g contains 2.2 mmol (50.72 mg) sodium per vial.

Zepilen 500 mg contains 1.1 mmol (25.36 mg) sodium per vial.

Active Ingredient Description
Cefazolin

Cefazolin is a bactericidal cephalosporin antibiotic of the first generation for parenteral administration. Cephalosporins inhibit cell wall synthesis (in the growth stage) through blocking the penicillin-binding proteins (PBPs) like transpeptidases. The outcome is a bactericidal action.

List of Excipients

Zepilen contains no excipients.

Pack sizes and marketing

Clear, colourless type I glass vials, sealed with a grey bromobutyl stopper and an aluminium overcap.

Each vial contains either 500 mg, or 1 g of cefazolin as cefazolin sodium. Cartons containing 1, 10, 50 or 100 vials are available.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd, 1–10 Constantinoupoleus Street 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Zepilen 500mg: 12523
Zepilen 1g: 12771

Zepilen 500mg: 14.12.1989 / 17.12.2012
Zepilen 1g: 06.07.1990 / 30.07.2013

Drugs

Drug Countries
ZEPILEN Cyprus, Estonia, Spain, Lithuania, Malta, Singapore

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