ZEVTERA Powder for concentrate for solution for infusion Ref.[7669] Active ingredients: Ceftobiprole medocaril

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Correvio, 15 Rue du Bicentenaire, 92800 Puteaux, France, Phone number: +44 (0)203 002 8114, Email: medinfo@cardiome.com

Product name and form

Zevtera 500 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

White, yellowish to slightly brownish, cake to broken cake or powder.

The pH of the reconstituted solution is between 4.5 and 5.5.

Qualitative and quantitative composition

Each vial contains 500 mg of ceftobiprole (as 666.6 mg ceftobiprole medocaril sodium). After reconstitution, each mL of concentrate contains 50 mg ceftobiprole (as 66.7 mg of ceftobiprole medocaril sodium).

Excipient (s) with known effect: Each vial contains approximately 1.3 mmol (29 mg) sodium.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ceftobiprole medocaril

Ceftobiprole exerts bactericidal activity through binding to important penicillin-binding proteins (PBPs) in susceptible species.

List of Excipients

Citric acid monohydrate
Sodium hydroxide

Pack sizes and marketing

20 mL clear type I glass vials fitted with a grey bromobutyl elastomeric closure and an aluminium seal with a blue plastic flip-off cap.

Pack size: 10 vials.

Marketing authorization holder

Correvio, 15 Rue du Bicentenaire, 92800 Puteaux, France, Phone number: +44 (0)203 002 8114, Email: medinfo@cardiome.com

Marketing authorization dates and numbers

PL 48998/0001

20/11/2013

Drugs

Drug Countries
ZEVTERA Austria, Canada, Ecuador, Spain, Finland, Poland, United Kingdom

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