Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
fipronil 67 mg
IDT Biologika GmbH
QP53AX15
Spot-on solution
fipronil
Dogs
2010-11-25
November 2010 1 DRAFT SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FIPROSPOT 67 mg spot-on solution for small dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.67 ml pipette contains ACTIVE SUBSTANCE: Fipronil 67.00 mg EXCIPIENTS Butylhydroxyanisole (E 320) 0.134 mg Butylhydroxytoluene (E 321) 0.067 mg For full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Spot-on solution Clear, colourless to yellowish solution 4. CLINICAL PARTICULARS 4.1 Target species Dog (2 – 10 kg) 4.2 Indications for use, specifying the target species F or the treatment of dogs against flea infestations ( Ctenocephalides spp.) Insecticidal efficacy against new infestation with fleas persists for up to 6 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. November 2010 2 Although the product does not consistently show an immediate acaricidal efficacy (several ticks may be present after 48 hours), it has a persistent acaricidal efficacy for up to 4 weeks against Dermacentor variabilis and up to 3 weeks against Rhipicephalus sanguineus. 4.3 Contraindication In the absence of available data, the veterinary medicinal product should not be used on puppies less than 2 months old and/or weighing less than 2 kg. Do not use on sick (systemic disease, fever, etc.) or convalescent animals. Do not use on rabbits, as adverse drug reactions and even death Read the complete document