Fyperix 50 mg Spot-on Solution for Cats

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Fipronil

Tilgængelig fra:

Krka d.d., Novo Mesto

ATC-kode:

QP53AX15

INN (International Name):

Fipronil

Lægemiddelform:

Spot-on solution

Recept type:

NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person

Terapeutisk gruppe:

Cats

Terapeutisk område:

Ectoparasiticide

Autorisation status:

Expired

Autorisation dato:

2012-09-20

Produktets egenskaber

Revised: May 2017
AN: 00882/2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fyperix 50 mg spot-on solution for cats
Fyperix vet 50 mg spot-on solution for cats
Fyperix 50 mg spot-on solution for cats (United Kingdom, France,
Germany,
Portugal, Spain, Netherlands, Italy)
Fyperix vet 50 mg spot-on solution for cats (Denmark, Finland, Sweden,
Norway)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.5 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
50 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.10 mg
Butylhydroxytoluene (E321)
0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Light yellow to yellow, clear liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of fleas (_Ctenocephalides_ spp.) and tick (_Ixodes
ricinus_)_ _infestations in
cats.
The product has a persistent insecticidal efficacy for up to 4 weeks
against fleas
(_Ctenocephalides_ spp.) and acaricidal efficacy for up to 4 weeks
against _Ixodes _
_ricinus_ and for up to 1 week against _Dermacentor reticulatus _and
_Rhipicephalus _
_sanguineus_. If ticks of some species (_Dermacentor reticulatus _and
_Rhipicephalus _
_sanguineus_) 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.
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.
Revised: May 2017
AN: 00882/2016
Page 2 of 6
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 reactions and even death could
occur.
Do not use in known cases of hypersensitivity to fipronil, dimethyl
sulphoxide or to
any of the excipients.
4.4
SPECIAL W