Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Imidacloprid
Chanelle Pharmaceuticals Manufacturing Limited
QP53AX17
Imidacloprid
400 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
imidacloprid
Authorised
2019-11-15
Health Products Regulatory Authority 19 November 2019 CRN000XMS Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Exidot 400 mg Spot-on solution for Extra Large Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4.0 ml pipette contains: ACTIVE SUBSTANCE: Imidacloprid 400 mg EXCIPIENTS: Butylhydroxytoluene (E 321) 4.0 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 25kg and greater. Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) where this has been previously diagnosed by a veterinary surgeon. 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. 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, rabbits and dogs in the household are treated. 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 Aqra d-dokument sħiħ