Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PENETHAMATE HYDRIODIDE BENETHAMINE PENICILLIN FRAMYCETIN SULFATE
Boehringer Ingelheim Ltd
QJ51R
intramammary Suspension
Antibacterial
Bovine
2006-02-10
IRISH MEDICINES BOARD ACT 1995 ANIMAL REMEDIES REGULATIONS, 2005 (S.I. NO. 734 OF 2005) VPA: 10007/044/001 Case No: 7002927 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) hereby grants to: BOEHRINGER INGELHEIM LTD ELLESFIELD AVENUE, BRACKNELL, BERKSHIRE RG12 8YS, ENGLAND 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: BENESTERMYCIN DRY COW 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. 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 01/03/2007_ _CRN 7002927_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT BENESTERMYCIN Dry Cow Intramammary Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Intramammary suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For routine treatment of subclinical infection present at drying off and to assist in the prevention of new infections during the dry period. In vitro efficacy has been demonstrated against: Staphylococcus spp Streptococcus spp Actinomyces (Corynebacterium) Escherichia coli Klebsiella spp Pseudomonas spp 4.3 CONTRAINDICATIONS Do not Read the complete document