Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Imidacloprid
Chanelle Pharmaceuticals Manufacturing Limited
QP53AX17
Imidacloprid
80 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 80 mg Spot-on solution for Large Cats and Large Pet Rabbits 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.8 ml pipette contains: ACTIVE SUBSTANCE: Imidacloprid 80 mg EXCIPIENTS: Butylhydroxytoluene (E 321) 0.8 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 and pet rabbits 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For cats of 4 kg and greater: Prevention and treatment of flea (_Ctenocephalides felis_) infestations. For pet rabbits of 4 kg and greater: Treatment of flea infestations. Fleas are killed within one day following treatment. One treatment prevents further flea infestation for 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 use in case of hypersensitivity to the active substance or to any of the excipients. 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 environmental challenge, it is recommended that all cats and pet rabbits in the household are treated. Treatment of nursing queens and does control flea infestations on both dam and offspring. The product remains effective if the animal becomes wet, for example after exposure to heavy rain. However, re-treatment may become necessary, dep Read the complete document