Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Imidacloprid
Chanelle Pharmaceuticals Manufacturing Limited
QP53AX17
Imidacloprid
40 mg/pipette
Spot-on solution
LM: Licensed Merchant as defined in relevant national legislation
imidacloprid
Authorised
2019-10-25
Health Products Regulatory Authority 31 January 2022 CRN00CD0F Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Imidaflea 40 mg Spot-on solution for Small Cats, Small Pet Rabbits & Small Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.4 ml pipette contains: ACTIVE SUBSTANCE: Imidacloprid 40 mg EXCIPIENTS: Butylhydroxytoluene (E 321) 0.4 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution A clear pale yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats, pet rabbits and dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For cats of less than 4 kg: Prevention and treatment of flea (_Ctenocephalides felis_) infestations. For pet rabbits of less than 4 kg: Treatment of flea infestations. For dogs of less than 4 kg: For the prevention and treatment of flea infestations and for the treatment of biting lice (_Trichodectes canis_) on dogs. Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks on dogs, three to four weeks on cats and up to one week on pet rabbits. 4.3 CONTRAINDICATIONS Do not treat unweaned kittens of less than 8 weeks of age. Do not use on pet rabbits of less than 10 weeks of age. Do not treat unweaned puppies of less than 8 weeks of age. Do not use in known cases of hypersensitivity to the active substance or to any of the excipients. Health Products Regulatory Authority 31 January 2022 CRN00CD0F Page 2 of 5 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Re-infestation from emergence of new fleas in the environment may continue to occur for six weeks or longer after treatment is initiated. More than one treatment may therefore be required, depending on the level of fleas in the environment. To aid reduction in environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developing stages is recommended. In order to reduce further the environ Les hele dokumentet