CEFAGER Powder for Oral Suspension 250 MG/5ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
CEFACLOR MONOHYDRATE
Available from:
McDermott Laboratories Ltd t/a Gerard Laboratories
Dosage:
250 MG/5ml
Pharmaceutical form:
Powder for Oral Suspension
Authorization date:
2002-03-08
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)
PA0577/045/002
Case No: 2051195
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MCDERMOTT LABORATORIES LTD T/A GERARD LABORATORIES
35/36 BALDOYLE INDUSTRIAL ESTATE, GRANGE ROAD, DUBLIN 13, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CEFAGER POWDER FOR ORAL SUSPENSION 250 MG/5 ML
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 18/02/2009 until 12/12/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/02/2009_
_CRN 2051195_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefager Powder for Oral Suspension 250 mg/5 ml.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted as directed in section 6.6, each 5ml dose contains cefaclor (as monohydrate) 250mg.
Cefager Powder for Oral Suspension also contains Sorbitol (E420).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
An off-white, sugar-free, strawberry-flavoured product.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefaclor is indicated for the treatment of the following infections due to susceptible micr
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