FLEVOX 268 MG SPOT-ON SOLUTION FOR LARGE DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
09-07-2016
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Active ingredient:
FIPRONIL
Available from:
Vetoquinol UK Limited
ATC code:
QP53AX15
INN (International Name):
FIPRONIL
Dosage:
268 Milligram
Pharmaceutical form:
Spot On Solution
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Fipronil
Therapeutic indications:
Ectoparasiticide
Authorization status:
Authorised
Authorization date:
2011-09-30
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flevox 268 mg spot-on solution for large dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette of 2.68 ml contains:
ACTIVE SUBSTANCE:
Fipronil
268 mg
EXCIPIENTS:
Butylhydroxyanisole (E320) 1.072 mg
Butylhydroxytoluene (E321) 0.536 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution
Limpid, yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs:
Treatment of flea (_Ctenocephalides _spp.) and biting/chewing lice (_Trichodectes canis) _infestations in dogs.
Insecticidal efficacy against new infestations with adult fleas persists for up to 8 weeks. Newly arriving fleas are killed
within 48 hours of landing on the animal. 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.
The product has not demonstrated an immediate acaricidal effect against ticks but has demonstrated persistent
acaricidal efficacy for up to 4 weeks against _Rhipicephalus sanguineus _and _Dermacentor reticulatus _and up to 3 weeks
against _Ixodes Ricinus. _If ticks of these species are present when the product is applied, all the ticks may not be killed
within the first 48 hours but they may be killed within a week.
4.3 CONTRAINDICATIONS
Do not use on puppies less than 8 weeks old and/or weighing less than 2 kg, in the absence of available data.
Do not use on sick (systemic diseases, fever…) or convalescent animals.
Do not use in rabbits, as adverse drug reactions and even death could occur.
Do not use in case of hypersensitivity to fipronil or to any of the excipients.
Do not administer orally.
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