Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Ivermectin
Cross Vetpharm Group Limited
QP54AA01
Ivermectin
10 milligram(s)/millilitre
Solution for injection
LM: Licensed Merchant as defined in relevant national legislation
Pigs
ivermectin
Endectoparasiticides
Authorised
2006-08-18
Health Products Regulatory Authority 20 March 2018 CRN000WYW Page 1 of 5 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcimec 10 mg/ml 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 solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs The product can be given to all ages of animals including piglets. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the effective treatment and control of the following harmful parasites of pigs: GASTROINTESTINAL ROUNDWORMS:(Adults and fourth stage larvae): _Ascaris suum _ _Hyostrongylus rubidus_ _Oesophagostomum _spp. _Strongyloides ransomi (_adults and somatic larval stages) LUNGWORMS: _Metastrongylus _spp. (adult) LICE: _Haematopinus suis_ MANGE MITES: _Sarcoptes scabiei _var. _suis_ Health Products Regulatory Authority 20 March 2018 CRN000WYW Page 2 of 5 4.3 CONTRAINDICATIONS Do not use in case of known hypersensitivity to the active ingredient. Do not administer by the intravenous or intramuscular route. 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 The product has been formulated specifically for use in pigs only. It should not be administered to other species as severe adverse reactions may occur. 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. 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 dosage. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTE Read the complete document