FOMICYT Powder for solution for infusion Ref.[6865] Active ingredients: Fosfomycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: INFECTOPHARM Arzneimittel und Consilium GmbH, Von-Humboldt-Str. 1, 64646 Heppenheim, Germany Distributor: Nordic Pharma UK Ltd, Abbey House, 1650 Arlington Business Park, Theale, Berkshire, RG7 4SA

Product name and form

Fomicyt 40 mg/ml powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion.

White to cream-coloured powder.

Qualitative and quantitative composition

One ml of reconstituted solution contains 40 mg fosfomycin.

Each bottle with 2.69 g of powder contains 2.64 g disodium fosfomycin, corresponding to 2 g fosfomycin and 0.64 g sodium, for reconstitution in 50 ml of solvent.

Each bottle with 5.38 g of powder contains 5.28 g disodium fosfomycin, corresponding to 4 g fosfomycin and 1.28 g sodium, for reconstitution in 100 ml of solvent.

Each bottle with 10.76 g of powder contains 10.56 g disodium fosfomycin, corresponding to 8 g fosfomycin and 2.56 g sodium, for reconstitution in 200 ml of solvent.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Fosfomycin

Fosfomycin exerts a bactericidal effect on proliferating pathogens by preventing the enzymatic synthesis of the bacterial cell wall. Fosfomycin inhibits the first stage of intracellular bacterial cell wall synthesis by blocking peptidoglycan synthesis.

List of Excipients

Succinic acid

Pack sizes and marketing

Clear type-II glass bottles with a rubber stopper (bromobutyl rubber) and pull-off cap containing 2 g (in 100 ml bottle), 4 g (in 100 ml bottle) or 8 g (in 250 ml bottle) of Fomicyt, respectively, in packs of 10 bottles each.

Not all pack sizes may be marketed.

Marketing authorization holder

INFECTOPHARM Arzneimittel und Consilium GmbH, Von-Humboldt-Str. 1, 64646 Heppenheim, Germany

Distributor: Nordic Pharma UK Ltd, Abbey House, 1650 Arlington Business Park, Theale, Berkshire, RG7 4SA

Marketing authorization dates and numbers

PL 15011/0017

19/06/2015

Drugs

Drug Countries
FOMICYT Austria, France, Croatia, Ireland, Netherlands, Romania, United Kingdom

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