Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FIPRONIL
Merial Animal Health Limited
QP53AX15
FIPRONIL
10 %w/v
Spot On Solution
POM
Canine
Fipronil
Ectoparasiticide
Authorised
1998-06-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Frontline Spot On Dog. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution. Clear to light brownish-yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The treatment and prevention of infestations by fleas and ticks in dogs. Frontline Spot On Dog has been shown to significantly reduce the incidence of Flea Allergy Dermatitis. Ticks will usually detach from the treated host within 24 to 48 hours after infestation, without having had a blood meal. Frontline Spot On Dog rapidly controls infestations with _Trichodectes canis _(biting lice) on dogs. 4.3 CONTRAINDICATIONS In the absence of available data, the product should not be used on puppies less than 8 weeks old and/or weighing less than 2 kg. Do not use on sick (systemic diseases, fever….) or convalescent animals. Do not use in rabbits, as adverse reactions and even death could occur. This product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing. Each pipette contains: Active Substance Fipronil 10 % w/v Excipients Butylhydroxyanisole (E320) 0.02 % w/v Butylhydroxytoluene (E321) 0.01 % w/v Non-aqueous vehicle q.s. to 100 % w/v IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/02/2014_ _CRN 7017210_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Avoid contact with the animal's eyes. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/02/2014_ _CRN 7017210_ _page number: 2_ 4.5 SPECIAL P Read the complete document