Flevox 50 mg spot-on solution for cats

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

Compra'l ara

Descargar Fitxa tècnica (SPC)
12-06-2017

ingredients actius:

Fipronil

Disponible des:

Vetoquinol UK Limited

Codi ATC:

QP53AX15

Designació comuna internacional (DCI):

Fipronil

Dosis:

50 mg/pipette

formulario farmacéutico:

Spot-on solution

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cats

Área terapéutica:

fipronil

indicaciones terapéuticas:

Ectoparasiticide

Estat d'Autorització:

Authorised

Data d'autorització:

2011-09-30

Fitxa tècnica

                                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.
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