FLUCLOXACILLIN Powder for solution for injection / infusion Ref.[8149] Active ingredients: Floxacillin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Product name and form

Flucloxacillin 250mg Powder for Solution for Injection or Infusion.

Pharmaceutical Form

Powder for solution for injection or infusion (Powder for injection or infusion).

Flucloxacillin sodium is supplied as a white or almost white crystalline powder.

Qualitative and quantitative composition

Sodium flucloxacillin monohydrate equivalent to flucloxacillin 250mg.

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

Flucloxacillin for Injection is supplied in Type II clear glass vials containing 250mg of flucloxacillin equivalent. The vials are closed with a Type I chlorobutyl rubber stopper, sealed with an aluminium ring. The vials are packed in cartons of 10 vials.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Marketing authorization dates and numbers

PL 29831/0091

Date of first authorisation: 30/10/1998
Date of latest renewal: 20/09/2008

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