Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
NOVOBIOCIN SODIUM NEOMYCIN SULFATE PROCAINE BENZYLPENICILLIN DIHYDROSTREPTOMYCIN SULFATE PREDNISOLONE
Pfizer Healthcare Ireland
QJ51RV01
intramammary Suspension
Antibacterial
Bovine
2006-01-20
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10019/098/001 Case No: 7006670 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: PFIZER HEALTHCARE IRELAND TRADING AS PFIZER ANIMAL HEALTH, RINGASKIDDY, CO. CORK, 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: TETRA-DELTA MILKING COW 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 revoked, shall continue in force from 09/09/2009. 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 10/09/2009_ _CRN 7006670_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tetra-Delta Milking Cow 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Intramammary suspension. Off white oily suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Lactating cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of bovine mastitis in lactating cows. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES If redness, Прочетете целия документ