Fipronil Pyriproxyfen Virbac 50 mg/60 mg Spot-on Solution for Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Fipronil, Pyriproxyfen

Available from:

Virbac

ATC code:

QP53AX65

INN (International Name):

Fipronil, Pyriproxyfen

Pharmaceutical form:

Spot-on solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats

Therapeutic area:

Ectoparasiticide; Insect Growth Regulator

Authorization status:

Authorized

Authorization date:

2015-12-09

Summary of Product characteristics

Revised: August 2021
Divergence from GB MA following AN: 01838/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fipronil Pyriproxyfen Virbac 50 mg/ 60 mg spot-on solution for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml pipette contains:
ACTIVE SUBSTANCES:
Fipronil
50 mg
Pyriproxyfen
60 mg
EXCIPIENTS:
Butylhydroxyanisole E320
0.1 mg
Butylhydroxytoluene E321
0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear, colourless to yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cats, to be used against infestations with fleas alone or in
association with ticks.
Against fleas:
Treatment and prevention of infestations by fleas _(Ctenocephalides
felis)._ One treatment
prevents further infestations for 5 weeks.
Prevention of the multiplication of fleas by preventing flea eggs
developing into adult fleas
for 12 weeks after application.
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.
Against ticks:
Treatment of infestations by ticks (_Ixodes ricinus _and_
Rhipicephalus turanicus_).
One treatment provides persistent acaricidal efficacy for one week.
If ticks are present at the time of application, not all ticks may be
killed within 48 hours.
Revised: August 2021
Divergence from GB MA following AN: 01838/2017
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use in rabbits, as adverse reactions and even death could
occur.
Do not use in cases of known hypersensitivity to the active substances
or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Wetting of the haircoat with water 2 hours before product application
and twice during the
claimed period of efficacy against fleas (at two week intervals
against adult fleas or four
week intervals against developing flea stages) was investigated during
two laborato