Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
LEVAMISOLE HYDROCHLORIDE
Univet Limited
QP52AE01
1.5 %w/v
Endoparasiticide
Bovine
1989-10-01
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) 10990/017/001 Case No: 7002259 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to UNIVET LIMITED TULLYVIN, COOTEHILL, CO. CAVAN., IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ASCARA WORM DRENCH 1.5%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 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 7002259_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ascara Worm Drench 1.5% w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral Solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _ASCARA WORM DRENCH 1.5% w/v _is a broad spectrum anthelmintic for the treatment of Nematode Infections in Cattle. _Ascara Worm Drench 1.5% w/v _should be used in cases of parasitic gastro-enteritis and lungworm caused by the following: Each ml contains: Active Substance Levamisole Hydrochloride 15.0 mg Excipients Methyl Parahydroxybenzoate 1.0 mg Sodium Metabisulphite 0.5 mg Quinoline Yellow (E104) 0.132 mg For a full list of excipients, see section 6.1 Lun Prečítajte si celý dokument