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
Fomicyt 40 mg/ml powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. White to cream-coloured powder. |
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 |
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.
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
PL 15011/0017
19/06/2015
| Drug | Countries | |
|---|---|---|
| FOMICYT | Austria, France, Croatia, Ireland, Netherlands, Romania, United Kingdom |
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