Fyperix 134 mg Spot-on Solution for Dogs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Fipronil

Commercializzato da:

Krka d.d., Novo Mesto

Codice ATC:

QP53AX15

INN (Nome Internazionale):

Fipronil

Forma farmaceutica:

Spot-on solution

Tipo di ricetta:

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

Gruppo terapeutico:

Dogs

Area terapeutica:

Ectoparasiticide

Stato dell'autorizzazione:

Expired

Data dell'autorizzazione:

2012-09-19

Scheda tecnica

Revised: May 2017
AN: 00885/2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fyperix 134 mg spot-on solution for dogs
Fyperix vet 134 mg spot-on solution for dogs
Fyperix 134 mg spot-on solution for dogs (United Kingdom, France,
Germany,
Portugal, Spain, Netherlands, Italy)
Fyperix vet 134 mg spot-on solution for dogs (Denmark, Finland,
Sweden, Norway)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette (1.34 ml) contains:
ACTIVE SUBSTANCE:
Fipronil
134 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.268 mg
Butylhydroxytoluene (E321)
0.134 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
Dogs (weighing over 10 kg, up to a maximum of 20 kg)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea (_Ctenocephalides_ spp.) and tick (_Dermacentor
reticulatus_)_ _
infestations.
For treatment of _Trichodectes canis_ biting lice infestations on
dogs. Most lice are
killed within 2 days.
Insecticidal efficacy against new infestations with adult fleas
persists for up to 8
weeks.
The product has a persistent acaricidal efficacy for up to 3 weeks
against _Ixodes _
_ricinus_ and up to 4 weeks against _Rhipicephalus_ _sanguineus_ and_
Dermacentor _
_reticulatus_. If ticks of some species (_Ixodes ricinus,
Rhipicephalus_ _sanguineus_) are
present when the product is applied, all the ticks may not be killed
within the first 48
hours.
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: 00885/2016
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use on puppies less than 2 months old and/or weighing less than
2 kg in the
absence of available data.
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.
This product is specif