Flevox 134 mg spot-on solution for medium dogs

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Fipronil

Disponible des:

Vetoquinol UK Limited

Codi ATC:

QP53AX15

Designació comuna internacional (DCI):

Fipronil

Dosis:

134 mg/pipette

formulario farmacéutico:

Spot-on solution

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Dogs

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 134 mg spot-on solution for medium dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette of 1.34 ml contains:
ACTIVE SUBSTANCE:
Fipronil
134 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.536 mg
Butylhydroxytoluene (E321)
0.268 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.
This product has been developed specifically for dogs. Do not use on
cats as this could lead to overdosing.
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