Fipronil KRKA 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs

Land: Storbritannien

Språk: engelska

Källa: VMD (Veterinary Medicines Directorate)

Aktiva substanser:

Fipronil

Tillgänglig från:

Krka d.d., Novo Mesto

ATC-kod:

QP53AX15

INN (International namn):

Fipronil

Läkemedelsform:

Cutaneous spray, solution

Receptbelagda typ:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk grupp:

Cats, Dogs

Terapiområde:

Ectoparasiticide

Bemyndigande status:

Expired

Tillstånd datum:

2015-09-30

Produktens egenskaper

Issued: September 2015
AN: 01274/2014
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Fipronil KRKA 2.5 mg/ml cutaneous spray, solution for cats and dogs
(UK)
Fypryst 2.5 mg/ml cutaneous spray, solution for cats and dogs (CZ)
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
excipients.
Issued: September 2015
AN: 01274/2014
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
When used as part of a strategy for the treatment of flea allergy
dermatitis, monthly
applications to the allergic patient and to other cats and dogs in the
household are
recommended.
Treatment of bedding, carpets and soft furnishings with a suitable
insecticide will aid
reduction in environmental challenge and maximise the duration of
protection against
re-infestation provided by the product.
The product is not suitable for direct trea