Flevox 67 mg Spot-on Solution for Small Dogs

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:

Dogs

Therapeutic area:

Ectoparasiticide

Authorization status:

Authorized

Authorization date:

2011-10-03

Summary of Product characteristics

Revised: September 2018
AN: 00540/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flevox 67 mg spot-on solution for small dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette of 0.67 ml contains:
ACTIVE SUBSTANCE:
Fipronil
67 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
Limpid, yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs:
Treatment of flea (Ctenocephalides spp.) and biting/chewing lice
(_Trichodectes canis)_
infestations in dogs.
Insecticidal efficacy against new infestations with adult fleas
persists for up to 8
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 the control of
Flea Allergy
Dermatitis (FAD) where this has been previously diagnosed by a
veterinary surgeon.
The product has not demonstrated an immediate acaricidal effect
against ticks but
has demonstrated persistent acaricidal efficacy for up to 4 weeks
against
_Rhipicephalus sanguineus and_ _Dermacentor reticulatus_ and up to 3
weeks against
_Ixodes Ricinus._ If ticks of these species 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 puppies less than 8 weeks old and/or weighing less than
2 kg in the
absence of available data.
Do not use on sick (systemic diseases, fever…) or convalescent
animals.
Revised: September 2018
AN: 00540/2018
Page 2 of 6
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.
This product has been developed specifically for dogs. Do not use on
cats as this
could lead to overdosing.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECI