Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Ivermectin
Norbrook Laboratories (Ireland) Limited
QP54AA01
Ivermectin
1 percent weight/volume
Solution for injection
LM: Licensed Merchant as defined in relevant national legislation
ivermectin
Authorised
2002-09-27
Health Products Regulatory Authority 13 February 2019 CRN008WD8 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Noromectin 1.0% w/v Solution for Injection for Pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance Ivermectin 1.0 % w/v For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. A colourless to pale yellow, clear solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Noromectin Injection for Pigs is indicated for the treatment and control of parasitic diseases of pigs caused by the following parasites: Gastrointestinal roundworms: _Ascaris suum_ (adults and fourth-stage larvae) _Hyostrongylus rubidus_ (adults and fourth-stage larvae) _Oesophagostomum_ spp. (adults and fourth-stage larvae) _Strongyloides ransomi_ (adults and somatic larval stages) Lungworms: _Metastrongylus_ spp (adults) Lice: _Haematopinus suis_ Mange mites: _Sarcoptes scabiei var suis_ Health Products Regulatory Authority 13 February 2019 CRN008WD8 Page 2 of 5 Noromectin Injection for Pigs may also be used as an aid in the control of adult whipworm (_Trichuris suis_). 4.3 CONTRAINDICATIONS Noromectin Injection for Pigs is not for intravenous or intramuscular use. Do not use in animals known to be hypersensitive to the active substance 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS 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 and tortoises). SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS Do not smoke or eat while handling the product. Direct contact of the product with the skin should be kept to a minimum.Wash hands after use 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None known. 4.7 USE DURING PREGNA Læs hele dokumentet