MONURIL Granules for oral solution Ref.[6864] Active ingredients: Fosfomycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: ZAMBON S.p.A., Via Lillo Del Duca, 10, 20091 Bresso (Milan) – Italy, Tel: +39 02 665 241, Fax: +39 02 665 01 492

Product name and form

Monuril 3 g granules for oral solution.

Pharmaceutical Form

Granules for oral solution.

Qualitative and quantitative composition

One sachet contains 5.631 g of fosfomycin trometamol equivalent to 3.0 g fosfomycin.

Excipient(s) with known effect: One sachet contains 2.213 g of sucrose, see section 4.4.

For the 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

Mandarin flavour
Orange flavour
Saccharin
Sucrose

Pack sizes and marketing

Sachets are a four layer laminate: paper, polyethylene, aluminium, polyethylene.

Sachets are supplied in cardboard outer containing 1 sachet, 2 sachets or 5 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

ZAMBON S.p.A., Via Lillo Del Duca, 10, 20091 Bresso (Milan) – Italy, Tel: +39 02 665 241, Fax: +39 02 665 01 492

Marketing authorization dates and numbers

PL 31654/0006

18/03/1994 / 19/09/2008

Drugs

Drug Countries
MONURIL Austria, Brazil, Estonia, France, Ireland, Italy, Lithuania, Malta, Netherlands, Tunisia, United Kingdom, South Africa

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