RENAPIME Powder for solution for injection / infusion

Active ingredients: Cefepime

Product name and form

Renapime 1 g powder for solution for injection/infusion.

Renapime.

Pharmaceutical Form

Powder for solution for injection/infusion.

White to pale yellow powder.

Qualitative and quantitative composition

Renapime 1 g powder for solution for injection or infusion: One vial contains 1 g of cefepime (as dihydrochloride monohydrate).

Renapime.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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

Colourless type II 20 ml glass vial closed with chlorobutyl rubber stopper and sealed with an aluminium cap and a plastic flip-off.

Pack size: 1, 5, 10, 20, 25, 50 and 100 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Renascience Pharma Ltd, 11 George Street West, Luton, Bedfordshire, LU1 2BJ, United Kingdom

Marketing authorization dates and numbers

PL 44696/0001

08/12/2017

Drugs

Drug
Countries
United Kingdom