Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Ivermectin
Chanelle Pharmaceuticals Manufacturing Limited
QP54AA01
Ivermectin
1.0 percent weight/volume
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
ivermectin
Authorised
2002-06-28
Health Products Regulatory Authority 22 November 2018 CRN008PVZ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Sumex 1 %w/v solution for injection for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Ivermectin 1.0 % w/v (10 mg/ml) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless to slightly yellow solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (Beef and non lactating cattle) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the effective treatment of the following harmful parasites of cattle: GASTRO-INTESTINAL ROUNDWORMS: _Ostertagia_ spp (including inhibited _O. ostertagi (adult and L4_)), _Haemonchus placei (adult and L4_), _Trichostrongylus spp (adult and L4_), _Cooperia_ spp _(adult and L4_), _Nematodirus spp (adult_), LUNGWORMS (adult and fourth stage larvae): _Dictyocaulus viviparus_ WARBLES (parasitic stages): _Hypoderma spp _ MANGE MITES: _Psoroptes bovis_ _Sarcoptes scabiei_ var. _bovis_. Health Products Regulatory Authority 22 November 2018 CRN008PVZ Page 2 of 6 SUCKING LICE: _Linognathus vituli_, _Haematopinus eurysternus_ PERSISTENT ACTIVITY Treatment at the recommended dose rate controls re-infection with _Haemonchusplacei_ and _Cooperia spp. _acquired up to 14 days after treatment, _Ostertagia ostertagi_ acquired up to 21 days after treatment and _Dictyocaulus _ _viviparus_ acquired up to 28 days after treatment. To obtain maximum benefit from the persistent activity of the product for grazing animals it is recommended that calves which are set-stocked in their first grazing season should be treated 3, 8 and 13 weeks after the day of turn-out. This can protect the animals from parasitic gastroenteritis and lungworm disease throughout the grazing season, provided they are set-stocked, all the calves are included in the programme and that no untreated cattle are added to the pasture. Treated calves should always be monitored according t Prečítajte si celý dokument