Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVAMISOLE HYDROCHLORIDE
Univet Limited
QP52AE01
75 Mg/Ml
Solution for Injection
Endoparasiticide
Bovine
1989-10-01
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) 10990/014/001A Case No: 7002257 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 ASCARAJECT 7.5% SOLUTION FOR INJECTION 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 7002257_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ascaraject 7.5 %w/v Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Ascaraject is a broad spectrum anthelmintic for the treatment of Nematode Infections in Cattle. Ascaraject should be used in cases of parasitic gastroenteritis and lungworm caused by the following: LUNGWORMS: _Dictyocaulus spp._ TRICHOSTRONGYLIDES: _Trichostrongylus spp._ _Cooperia spp._ _Ostertagia spp. (except inhibited larvae causing Type II Winter_ _Scour)_ _Haemonchus spp._ STRONGYLES: _Bunostomum spp._ _Oesophagostomum spp. Read the complete document