Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
AMPICILLIN
Franklin Pharmaceuticals Ltd.
QJ01CA01
AMPICILLIN
2 Grams
Pdr for Soln for Injection
POM
Equine - Food
Ampicillin
Antibacterial
Authorised
1991-12-18
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10976/013/001 Case No: 7001932 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: FRANKLIN PHARMACEUTICALS LTD. ATHBOY ROAD, TRIM, CO. MEATH, 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: AMPISOL 2 G 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. The authorisation, unless previously revoked, shall continue in force from 17/12/2006. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/06/2009_ _CRN 7001932_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ampisol 2g 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Ampicillin (as Ampicillin Sodium Ph. Eur) 2g/vial Excipients: None For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection A white or off-white powder 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and control of respiratory tract, alimentary tract and urogenital tra Olvassa el a teljes dokumentumot