CEFTAL Coated Tablets 125 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
CEFUROXIME AXETIL
Available from:
Rowex Ltd
Dosage:
125 Milligram
Pharmaceutical form:
Coated Tablets
Authorization date:
2006-10-13
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0711/101/001
Case No: 2082950
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CEFTAL 125MG COATED TABLETS
the particulars of which are set out in 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 28/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/07/2010_
_CRN 2082950_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftal 125mg coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftal 125 mg contains 150.36 mg cefuroxime axetil which is equivalent to 125 mg cefuroxime per tablet
Excipients: aspartame (E951) 0.2mg
For a full list of excipients: see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablets
White to slightly yellowish, biconvex, oblong tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime axetil is indicated for the treatment of mild to moderately severe infections caused by micro-organisms
susceptible to cefuroxime, such as:
-
upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
-
acute bronchitis, acute exacerbations of chronic bronch
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