Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
trimethoprim sulfamethoxazole
Eurovet Animal Health B.V.
QJ01EW11
40 Mg/Ml
Solution for Injection
Bovine
Antibacterial
Authorised
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10989/009/001 Case No: 7004641 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: EUROVET ANIMAL HEALTH B.V. HANDELSWEG 25, 5531 AE BLADEL, NETHERLANDS 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: VETRISUL 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 25/11/2008_ _CRN 7004641_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisul Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Infections caused by micro-organisms susceptible to trimethoprim and/or sulfamethoxazole. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active s Preberite celoten dokument