Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
CHLORHEXIDINE
Dairygold Co-op Society Ltd.
QD08AC02
CHLORHEXIDINE
0.5 %w/v
Teat Dip
LM-Licensed Merchant
Bovine
Chlorhexidine
Antiseptics
Authorised
2006-05-26
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) 10845/002/001 Case No: 7002585 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to DAIRYGOLD CO-OP SOCIETY LTD. WEST END, MALLOW, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product SUPERGOLD CHLORHEXIDINE READY TO USE TEAT DIP/SPRAY 0.5%W/V The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 20/12/2006 until . Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/12/2006_ _CRN 7002585_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Super Gold Chlorhexidine Ready To Use Teat Dip / Spray 0.5%w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Chlorhexidine gluconate 0.5%w/v (as Chlorhexidine gluconate solution) EXCIPIENTS For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Teat Dip solution/spray 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Lactating dairy cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES As an aid in the prevention of mastitis in dairy cattle 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Teat dip Leggi il documento completo