APROKAM Powder for solution for injection Ref.[27679] Active ingredients: Cefuroxime

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: LABORATOIRES THEA, 12 rue Louis Blériot, 63017 CLERMONT-FERRAND Cedex 2, France

Product name and form

APROKAM 50 mg powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection [powder for injection].

White to almost white powder.

Qualitative and quantitative composition

Each vial contains 50 mg of cefuroxime (as 52.6 mg of cefuroxime sodium).

After reconstitution with 5 ml of solvent (see section 6.6), 0.1 ml solution contains 1 mg of cefuroxime.

For the full list of excipients, see section 6.1.

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

8ml type I glass vial, stoppered with bromobutyl stopper and sealed with flip-off cap. Box of 1×50mg, 10×50mg or 20×50mg vials.

Box of 10×50mg vials together with 10 5-micron sterile filter needles.

Not all pack sizes may be marketed.

Marketing authorization holder

LABORATOIRES THEA, 12 rue Louis Blériot, 63017 CLERMONT-FERRAND Cedex 2, France

Marketing authorization dates and numbers

PL 20162/0014

08/10/2012

Drugs

Drug Countries
APROKAM Austria, Finland, France, Hong Kong, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom

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