国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Imidacloprid
Chanelle Pharmaceuticals Manufacturing Limited
QP53AX17
Imidacloprid
250 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 250 mg Spot-on solution for Large Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 ml pipette contains: ACTIVE SUBSTANCE: Imidacloprid 250 mg EXCIPIENTS: Butylhydroxytoluene (E 321) 2.5 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 Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the prevention and treatment of flea infestations and for the treatment of biting lice _(Trichodectes canis) _on dogs weighing ≥ 10 to < 25 kg. Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. 4.3 CONTRAINDICATIONS Do not treat unweaned puppies of less than 8 weeks of age. Do not use in case of hypersensitivity to the active substance or to any of the excipients. This product is specifically developed for dogs. Do not use in cats or pet rabbits as this could lead to overdosing. 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, pet rabbits and dogs in the household are treated, with a product approved for the species. Treatment of nursing bitches controls 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 阅读完整的文件