País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE
Pfizer Healthcare Ireland
QJ01CA04
40 Milligram
Tablets
Antibacterial
Canine
0000-00-00
IRISH MEDICINES BOARD ACT 1995 ANIMAL REMEDIES REGULATIONS, 2005 (S.I. NO. 734 OF 2005) VPA: 10019/042/001 Case No: 7002014 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) hereby grants to: PFIZER HEALTHCARE IRELAND TRADING AS PFIZER ANIMAL HEALTH, RINGASKIDDY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the Veterinary Medicinal Product: CLAMOXYL PALATABLE TABLETS 40MG The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may be specified in the said Schedule. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/11/2006_ _CRN 7002014_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Clamoxyl Palatable Tablets 40 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active Substance Amoxicillin (as amoxicillin trihydrate) 40 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Clamoxyl is a broad spectrum semi-synthetic penicillin which is bactericidal against a wide range of Gram-positive and Gram-negative bacteria found in dogs and cats and including the following: _Haemophilus _spp., _Pasteur Llegiu el document complet