Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE HYDROCHLORIDE
Alfa Med Limited
QJ01AA06
10 Per Cent
Solution for Injection
Antibacterial
Bovine
1994-10-05
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10894/001/001 Case No: 7008119 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: ALFA MED LIMITED UNIT 6, FERMOY ENTERPRISE PARK, 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: ALFACYCLINE 10% SOLUTION FOR INJECTION The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in the Schedule. The authorisation,unless revoked, shall continue in force from 16/07/2010. 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 20/07/2010_ _CRN 7008119_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Alfacycline 10% Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. A clear amber solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES GENERAL INDICATIONS The product is recommended in the treatment of a wide range of common systemic, respiratory and local infections caused by, or associated with, organisms sensitive to Oxytetracycline. 4.3 CONTRAINDICATIONS Do not use Read the complete document