FLEVOX 50 MG SPOT-ON SOLUTION FOR CATS
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:
50 Milligram
Pharmaceutical form:
Spot On Solution
Prescription type:
POM
Therapeutic group:
Feline
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 50 mg spot-on solution for cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette of 0.5 ml contains:
ACTIVE SUBSTANCE:
Fipronil
50 mg
EXCIPIENTS:
Butylhydroxyanisole (E320) 0.2 mg
Butylhydroxytoluene (E321) 0.1 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
Cat
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cats:
Treatment of flea (_Ctenocephalides _spp_._) and tick (_Rhipicephalus sanguineus_) infestations.
Insecticidal efficacy against new infestations with adult fleas persists for up to 4 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 flea allergy
dermatitis (FAD) where this has previously been diagnosed by a veterinary surgeon.
The product has a persistent acaricidal efficacy for up to 1 week against ticks (_Rhipicephalus sanguineus _and
_Dermacentor reticulatus)_. If ticks of _Dermacentor reticulatus _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 kittens less than 8 weeks old and/or weighing less than 1 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 2
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