FLEVOX 268 MG SPOT-ON SOLUTION FOR LARGE DOGS
Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Αρχείο Π.Χ.Π.
(SPC)
09-07-2016
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Δραστική ουσία:
FIPRONIL
Διαθέσιμο από:
Vetoquinol UK Limited
Φαρμακολογική κατηγορία (ATC):
QP53AX15
INN (Διεθνής Όνομα):
FIPRONIL
Δοσολογία:
268 Milligram
Φαρμακοτεχνική μορφή:
Spot On Solution
Τρόπος διάθεσης:
POM
Θεραπευτική ομάδα:
Canine
Θεραπευτική περιοχή:
Fipronil
Θεραπευτικές ενδείξεις:
Ectoparasiticide
Καθεστώς αδειοδότησης:
Authorised
Ημερομηνία της άδειας:
2011-09-30
Αρχείο Π.Χ.Π.
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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