MEDOCEF Powder for solution for injection / infusion Ref.[50940] Active ingredients: Cefoperazone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Medocef 1g powder for solution for injection or infusion.

Medocef 2g powder for solution for injection or infusion.

Pharmaceutical Form

White or slightly yellow, hygroscopic powder.

Powder for solution for injection or infusion.

Qualitative and quantitative composition

Each vial contains Cefoperazone 1g or 2g as Cefoperazone sodium.

Excipient with known effect: sodium.

Each 1g vial contains 34.4 mg sodium.

Each 2g vial contains 68.8 mg sodium.

Active Ingredient Description
Cefoperazone

Cefoperazone, a third-generation cephalosporin, interferes with cell wall synthesis by binding to the penicillin-binding proteins (PBPs), thus preventing cross-linking of nascent peptidoglycan. Cefoperazone is stable to penicillinases and has a high degree of stability to many beta-lactamases produced by gram-negative bacteria.

List of Excipients

None.

Pack sizes and marketing

Colourless moulded type I glass vials of 20ml capacity, sealed with a rubber stopper and aluminium overcap. Each vial contains either 1g or 2g of cefoperazone as cefoperazone sodium.

Cartons of 1, 10 or 25, 50 and 100 vials are available.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

Medocef 1g: 12622
Medocef 2g: 12621

Date of first authorization

Medocef 1g: 29/01/1990
Medocef 2g: 29/01/1990

Renewal of Authorization:

Medocef 1g: 17/10/2011
Medocef 2g: 17/10/2011

Drugs

Drug Countries
MEDOCEF Cyprus, Romania

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