Fleaway 67 mg Spot-on Solution for small dogs

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Fipronil

Disponible des:

Chanelle Pharmaceuticals Manufacturing Limited

Codi ATC:

QP53AX15

Designació comuna internacional (DCI):

Fipronil

Dosis:

67 mg/pipette

formulario farmacéutico:

Spot-on solution

tipo de receta:

LR: Licensed Retailer as defined in national legislation

Grupo terapéutico:

Canine

Área terapéutica:

fipronil

indicaciones terapéuticas:

Ectoparasiticide

Estat d'Autorització:

Authorised

Data d'autorització:

2014-02-07

Fitxa tècnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fleaway 67 mg Spot-on Solution for small dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.67 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
67 mg
EXCIPIENTS:
Butyhydroxyanisole E320
0.134 mg
Butylhydroxytoluene E321
0.067 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear, pale amber solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE
Treatment of flea (
_Ctenocephalides_
spp.) and tick (
_Rhipicephalus sanguineus_
and
_Ixodes ricinus_
)
infestations.
Insecticidal efficacy against new infestations with adult fleas
persists for 2 months.
The product has a persistent acaricidal efficacy for 1 month against
ticks (
_Rhipicephalus sanguineus_
,
_Ixodes ricinus_
,
_Dermacentor reticulatus_
). For
_Ixodes ricinus_
and
_Rhipicephalus sanguineus_
, ticks will
normally be killed within the first 48 hours following first
application of the product. For established
infestations of
_Dermacentor reticulatus_
, an immediate acaricidal effect has not been demonstrated
however, ticks will normally be killed within a week following first
application of the product.
4.3
CONTRAINDICATIONS
In the absence of available data, the product should not be used on
kittens less than 2 months old
and/or weighing less than 1 kg.
Do not use on sick (e.g. systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse drug reactions and even death could
occur.
Do not use in cases of known hypersensitivity to the active substance
or to any of excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Avoid frequent swimming/bathing or shampooing the animal because the
maintenance of effectiveness
of the product in these cases has not been tested.
2
The product does not prevent ticks from attaching to the animals. If
the animal has been treated prior
to exposure to the ticks, the ticks will be killed in the first 24-48
hours after attachment. This will
usually be