Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
AMPICILLIN TRIHYDRATE
Norbrook Laboratories Limited
QJ51RC
AMPICILLIN TRIHYDRATE
7
intramammary Suspension
POM
Bovine
Beta-lactam antibacterials, penicillins, combinations with other antibacterials
Antibacterial
Authorised
1987-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/003/001 Case No: 7003115 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: NORBROOK LABORATORIES LIMITED STATION WORKS, CAMLOUGH ROAD, CO. DOWN BT35 6JP 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: BOVACLOX DC INTRAMAMMARY SUSPENSION 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 30/09/2007. 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 28/08/2008_ _CRN 7003115_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bovaclox DC Intramammary Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4.5 g syringe contains: Cloxacillin (as Cloxacillin Benzathine) 500 mg and Ampicillin (as Ampicillin Trihydrate) 250 mg. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Intramammary suspension. An off-white suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dairy cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET Leggi il documento completo