ROXIPIME Sterile powder for injection Ref.[49964] Active ingredients: Cefepime

Source: Health Sciences Authority (SG)  Revision Year: 2020  Publisher: United Italian Trading Corporation (Pte) Ltd, 28 Tai Seng Street, #06-01 Singapore, 534106, Tel: +65 6284 8889 Name and adress of manufacturer: Pharma Vision San. Ve Tic. A.Ş., Davutpaşa Caddesi No: 145, ...

Product name and form

ROXIPIME 2 g Powder for Solution for IV Injection.

Pharmaceutical Form

Sterile Powder for injection.

Light yellow-white coloured powder.

Qualitative and quantitative composition

Active Substance: Each vial contains cefepime hydrochloride equivalent to 2 g cefepime as powder.

Excipients: For excipients, see 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
Water for injection

Pack sizes and marketing

25 ml type II transparent glass vial with gray coloured bromobutyl rubber stopper fixed with transparent aluminum/plastic flip-off cap and ampoule containing 10 ml water for injection.

In addition, 10 vials hospital packaging is also available.

Marketing authorization holder

United Italian Trading Corporation (Pte) Ltd, 28 Tai Seng Street, #06-01 Singapore, 534106, Tel: +65 6284 8889

Name and adress of manufacturer: Pharma Vision San. Ve Tic. A.Ş., Davutpaşa Caddesi No: 145, Topkapı-İSTANBUL, TURKEY

Marketing authorization dates and numbers

2014/658

Date of first authorisation: 09.09.2014
Renewal of the authorisation: 07.12.2017

Drugs

Drug Countries
ROXIPIME Singapore, Turkey

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.