FLOXAPEN Powder for solution for injection / infusion Ref.[49870] Active ingredients: Floxacillin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjördur, Iceland

Product name and form

Floxapen 250mg Powder for solution for Injection or Infusion.

Pharmaceutical Form

Powder for solution for injection or infusion.

A fine white homogeneous sterile powder for solution for injection, infusion or nebuliser solution.

Qualitative and quantitative composition

Each vial contains 250 mg flucloxacillin (as flucloxacillin sodium).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Floxacillin

Flucloxacillin is an isoxazolyl penicillin of the β-lactam group of antibiotics which exerts a bactericidal effect upon many Gram-positive organisms including β-lactamase-producing staphylococci and streptococci.

List of Excipients

None.

Pack sizes and marketing

Clear type III glass vials with butyl rubber plug, aluminium seal and green flip off cap.

Boxes of 10.

Marketing authorization holder

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjördur, Iceland

Marketing authorization dates and numbers

PA1380/011/003

Date of first authorisation: 18 January 1979
Date of last renewal: 18 January 2009

Drugs

Drug Countries
FLOXAPEN Austria, Estonia, Ireland, Malta, Netherlands

© 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.