Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ERYTHROMYCIN
Ceva Animal Health Limited
QJ51FA01
300 Milligram
intramammary Solution
Antibacterial
Bovine
1988-10-01
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) 10995/010/001 Case No: 7002385 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CEVA ANIMAL HEALTH LIMITED 90 THE BROADWAY, CHESHAM, BUCKS HP15 1EG, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ERYTHROCIN INTRAMAMMARY SOLUTION 300MG 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 15/12/2006 until . Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/12/2006_ _CRN 7002385_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Erythrocin Intramammary Solution 300mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Intramammary solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of clinical and subclinical mastitis in cattle due to erythromycin-sensitive: _Staphlococcus aureus_ _Streptococcus agalactia_ _S. dysgalactia_ _S. uberis_ 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE None. Each 6ml syringe contains : Active substance Er Read the complete document