देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN
Vetoquinol Ireland Limited
QJ01MA93
5 Milligram
Tablets
Antibacterial
Canine
1995-12-19
IRISH MEDICINES BOARD ACT 1995 ANIMAL REMEDIES REGULATIONS, 2005 (S.I. NO. 734 OF 2005) VPA: 10983/028/001 Case No: 7003107 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: VETOQUINOL IRELAND LIMITED WILTON PLACE, DUBLIN 2, 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: MARBOCYL 5MG TABLETS 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 10/03/2007_ _CRN 7003107_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocyl 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance Marbofloxacin 5mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White, circular divisible tablets. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _IN DOGS_ Marbofloxacin tablet is indicated in the treatment of: - skin and soft tissue infections (intertrigo, folliculitis, impetigo, furunculosis, cellulitis) caused by susceptible strains. - lower and upper urinary tract infections (UTI) associated or not with prostatiti पूरा दस्तावेज़ पढ़ें