Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
Chem-Pharm
QJ01AA06
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
200 Mg/Ml
Solution for Injection
POM
Bovine, Ovine, Porcine
Oxytetracycline
Antibacterial
Authorised
1998-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10823/007/001 Case No: 7007114 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: CHEM-PHARM BALLYVAUGHAN, CO. CLARE, 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: MAXOJECT LA 200 MG/ML SOLUTION FOR INJECTION 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 30/09/2008. 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 22/12/2009_ _CRN 7007114_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Maxoject LA 200 mg/ml 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, pigs and piglets. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Oxytetracycline is active against a wide range of Gram-positive and Gram-negative pathogenic bacteria, certain rickettsia and the larger viruses. Maxoject LA Injec Izlasiet visu dokumentu