FLUCLOXACILLIN Powder for oral solution Ref.[8148] Active ingredients: Floxacillin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom

Product name and form

Flucloxacillin 125mg/5ml Powder For Oral Solution.

Pharmaceutical Form

Powder for oral solution.

Pink free flowing powder.

Qualitative and quantitative composition

Each 5ml reconstituted solution contains Flucloxacillin Sodium equivalent to Flucloxacillin 125mg.

Excipient(s) with known effect: Contains 5.00 mg of Sodium Benzoate and 316.120 mg of Sucrose.

For a 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

Sodium benzoate (E211)
Disodium edetate
Saccharin sodium
Mono-Ammonium-Glycyrrhizinate
Sodium citrate anhydrous (E331)
Flavour pineapple
Flavour menthol
Erythrosine (E127)
Sucrose

Pack sizes and marketing

Nature: 150ml amber glass Beatson Clark container with polypropylene screw cap or 150ml high density polyethylene bottle with child resistant closure with expanded polyethylene wad: 100ml.

Marketing authorization holder

Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0043

06/11/2001

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