Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
fipronil 268 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 FIPRODOG 268 mg spot-on solution for large dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.68 ml pipette contains ACTIVE SUBSTANCE: Fipronil 268.00 mg EXCIPIENTS Butylhydroxyanisole (E 320) 0.536 mg Butylhydroxytoluene (E 321) 0.268 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 (20 – 40 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. Although the product does not consistently show an immediate acaricidal efficacy (several ticks may be present after 48 hours), it has a persistent November 2010 2 acaricidal efficacy for up to 4 weeks against Dermacentor variabilis and up to 3 weeks against Rhipicephalus sanguineus. 4.3 Contraindication Do not use on sick (systemic disease, fever, etc.) or convalescent animals. Do not use on rabbits, as adverse drug reactions and even death could occur. This veterinary medicinal product has been developed specifically for dogs. Do not use on cats as this could lead to overdosing. Do not use Read the complete document