Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Ark Animal Care Ltd
QD08AG
0.5 %w/v
Cutaneous Spray Solution
Antiseptics
Bovine
0000-00-00
IRISH MEDICINES BOARD ACT 1995 ANIMAL REMEDIES REGULATIONS, 2005 (S.I. NO. 734 OF 2005) VPA: 10900/012/001 Case No: 7001755 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: ARK ANIMAL CARE LTD NEWBRIDGE, CO. KILDARE, 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: ARK IODINE SPRAY 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 03/11/2006_ _CRN 7001755_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ark Iodine Spray. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Iodinated povidone 5 % w/v equivalent to 0.5 % w/v iodine. Excipients Isoproponol Purified water For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Farm animals. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For use as a general topical and quick drying antiseptic on farm animals in the prevention and control of infections susceptible to iodine. 4.3 CONTRAINDICATIONS Do not use on cats. In rare instances of hypersensitivity discontinue treatment. 4.4 Soma hati kamili