Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Fipronil

Disponible depuis:

Krka, d.d., Novo mesto

Code ATC:

QP53AX15

DCI (Dénomination commune internationale):

Fipronil

Dosage:

2.5 milligram(s)/millilitre

forme pharmaceutique:

Cutaneous spray, solution

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Cats, Dogs

Domaine thérapeutique:

fipronil

indications thérapeutiques:

Ectoparasiticide

Statut de autorisation:

Authorised

Date de l'autorisation:

2013-02-22

Résumé des caractéristiques du produit

Health Products Regulatory Authority
09 August 2017
CRN000V42
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains
ACTIVE SUBSTANCE:
Fipronil 2.5 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous spray, solution
Clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea (_Ctenocephalides_ spp.) and tick (_Ixodes ricinus_,
_Rhipicephalus _
_sanguineus_) infestations in dogs and cats.
Treatment of biting lice infestations in dogs (_Trichodectes canis_)
and cats (_Felicola _
_subrostratus_).
The product can be used as part of a treatment strategy for the
control of Flea
Allergy Dermatitis (FAD).
Insecticidal efficacy against new infestations with adult fleas
persists for up to 2
months in cats and up to 3 months in dogs, depending on environmental
challenge.
The product has a persistent acaricidal efficacy for up to 4 weeks
against ticks,
depending on the level of environmental challenge.
4.3 CONTRAINDICATIONS
Do not use on sick (systemic diseases, fever) or convalescent animals
Do not use in rabbits, as adverse reactions and even death could
occur.
Do not use in cases of hypersensitivity to the active substance or to
any of the
Health Products Regulatory Authority
09 August 2017
CRN000V42
Page 2 of 7
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed the recommended dosage.
Allow treated animals to dry in a well ventilated room (see also
section 4.5(ii)).
Do not confine animals in an enclosed space or pet carrier until the
coat is totally dry.
In the absence of specific tolerance and efficacy data, the product is
not
recommended for the treatment of species other than cats and dogs.
For optimum control of flea problems in a multi-pet household, all
dogs and cats in
the household should be treated with a suitable insecticide.
When used a