国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
AMPICILLIN TRIHYDRATE
Norbrook Laboratories Limited
QJ51CR50
AMPICILLIN TRIHYDRATE
Unknown
intramammary Suspension
POM
Bovine
Combinations of penicillins
Antibacterial
Authorised
1993-06-11
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/056/001 Case No: 7004318 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, NEWRY, 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 XTRA 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 10/06/2008. 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 04/04/2009_ _CRN 7004318_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bovaclox DC Xtra 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: The active ingredients of Bovaclox DC Xtra are Ampicillin and Cloxacillin, semi-synthetic penicillin’s derived from 6- aminopencillanic acid. Each single dose 5.4g syringe contains 600 mg Cloxacillin (as benzathine salt) and 300mg Ampicillin (as the trihydrate) in a long acting base. EXCIPIENT: Aluminium stearate For a full list of excipients see section 6.1. 3 PHARMA 完全なドキュメントを読む