Flevox 50 mg Spot-on Solution for Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Fipronil

Available from:

Vetoquinol UK Ltd

ATC code:

QP53AX15

INN (International Name):

Fipronil

Pharmaceutical form:

Spot-on solution

Prescription type:

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

Therapeutic group:

Cats

Therapeutic area:

Ectoparasiticide

Authorization status:

Authorized

Authorization date:

2011-10-03

Summary of Product characteristics

Revised: September 2018
AN: 00540/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flevox 50 mg spot-on solution for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette of 0.5 ml contains:
ACTIVE SUBSTANCE:
Fipronil
50 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.2 mg
Butylhydroxytoluene (E321)
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution
Limpid, yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cat
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cats:
Treatment of flea (_Ctenocephalides spp._) and tick (_Rhipicephalus
sanguineus_)
infestations.
Insecticidal efficacy against new infestations with adult fleas
persists for up to 4
weeks. Newly arriving fleas are killed within 48 hours of landing on
the animal. The
product can be used as part of a treatment strategy for flea allergy
dermatitis (FAD)
where this has previously been diagnosed by a veterinary surgeon.
The product has a persistent acaricidal efficacy for up to 1 week
against ticks
(_Rhipicephalus sanguineus_ and _ Dermacentor reticulatus)_. If ticks
of _ Dermacentor _
_reticulatus_ 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.
4.3
CONTRAINDICATIONS
Do not use on kittens less than 8 weeks old and/or weighing less than
1 kg in the
absence of available data.
Do not use on sick (systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse drug reactions and even death could
occur.
Do not use in case of hypersensitivity to fipronil or to any of the
excipients.
Do not administer orally.
Revised: September 2018
AN: 00540/2018
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Fleas from pets often infest the animal’s basket, bedding and
regular resting areas
such as carpets and soft furnishings which should be treated, in case
of massive
infestation and at the beginning of the control measures, with a
suitable inse