Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Ivermectin
Chanelle Pharmaceuticals Manufacturing Limited
QP54AA01
Ivermectin
1 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 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Sumex 1% w/v solution for injection for pigs 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 Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the effective treatment of the following harmful parasites of pigs: GASTROINTESTINAL WORMS (adult and fourth stage larvae): _Ascaris suum,_ _Hyostrongylus rubidus_, _Oesophagostomum spp_, _Strongyloides ransomi_ (adult and somatic larval stage) LUNGWORMS: _Metastrongylus spp_. (adult) LICE: Haematopinus suis MANGE MITES: _Sarcoptes scabiei_ var. _suis_ Health Products Regulatory Authority 22 November 2018 CRN008PVZ Page 2 of 5 4.3 CONTRAINDICATIONS Do not administer by the intravenous or intramuscular route. Do not use in cases of known hypersensitivity to the active ingredient. Do not use in cats and dogs as severe adverse reactions may occur. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. It is important that the correct dose is given in order to minimise the risk of resistance. Assess bodyweight as accurately as possible before calculating the dose. The product has been formulated specifically for use in pigs only. Do not use in cats and dogs. Avermectins may not be well tolerated in all non-target species (cases of intolerance with fatal outcome are reported in dogs - especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises). SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDIC Lugege kogu dokumenti