EXBLIFEP Powder for concentrate for solution for infusion Ref.[109327] Active ingredients: Cefepime

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Advanz Pharma Limited, Unit 17 Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland

Product name and form

EXBLIFEP 2 g/0.5 g powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion (powder for concentrate).

White to yellowish powder.

Qualitative and quantitative composition

Each vial contains cefepime dihydrochloride monohydrate equivalent to 2 g cefepime and 0.5 g of enmetazobactam.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cefepime

Cefepime is a broad-spectrum, bactericidal antibiotic, with activity against a wide range of Gram-positive and Gram-negative bacteria, including many strains resistant to aminoglycosides or third generation cephalosporins. It has a reduced affinity for beta-lactamases.

List of Excipients

L-arginine

Pack sizes and marketing

20 mL vial (Type I clear glass) with stopper (bromobutyl rubber) and flip-off seal.

Pack size of 10 vials.

Marketing authorization holder

Advanz Pharma Limited, Unit 17 Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland

Marketing authorization dates and numbers

EU/1/24/1794/001

Drugs

Drug Countries
EXBLIFEP Lithuania, United States

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