Flevox 402 mg spot-on solution for very large dogs

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Fipronil

Prieinama:

Vetoquinol UK Limited

ATC kodas:

QP53AX15

INN (Tarptautinis Pavadinimas):

Fipronil

Dozė:

402 mg/pipette

Vaisto forma:

Spot-on solution

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Farmakoterapinė grupė:

Dogs

Gydymo sritis:

fipronil

Terapinės indikacijos:

Ectoparasiticide

Autorizacija statusas:

Authorised

Leidimo data:

2011-09-30

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flevox 402 mg spot-on solution for very large dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette of 4.02 ml contains:
ACTIVE SUBSTANCE:
Fipronil
402 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
1.608 mg
Butylhydroxytoluene (E321)
0.804 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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