MONURIL Granules for oral solution 2g Grams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-05-2024
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Active ingredient:
FOSFOMYCIN TROMETAMOL
Available from:
Zambon S.p.A.
Dosage:
2g Grams
Pharmaceutical form:
Granules for oral solution
Authorization date:
2007-12-07
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1441/002/001
Case No: 2045284
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ZAMBON S.P.A.
VIA LILLO DEL DUCA, 10, 20091-BRESSO, MILANO, ITALY
an authorisation, subject to the provisions of the said Regulations, in respect of the product
MONURIL 2G GRANULES FOR ORAL SOLUTION
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 26/02/2008 until 12/11/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/03/2008_
_CRN 2045284_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monuril 2 g Granules for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 6 g sachet contains 3.754 g fosfomycin-trometamol (1:1) equivalent to 2 g fosfomycin.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral solution.
Orange- mandarin flavoured granules
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of acute uncomplicated urinary tract infections due to sensitive organisms in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults only:
A single dose of 2 g taken on an empty stomach, preferably before bedtime, after bladder emptying. The contents of
the
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