Fiprotec 50 mg Spot-On Solution for Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Fipronil

Available from:

Beaphar B.V.

ATC code:

QP53AX15

INN (International Name):

Fipronil

Pharmaceutical form:

Spot-on solution

Prescription type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Therapeutic group:

Cats

Therapeutic area:

Ectoparasiticide

Authorization status:

Authorized

Authorization date:

2014-08-08

Summary of Product characteristics

Revised: August 2019
AN: 00929/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fiprotec 50 mg Spot-On Solution for Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette of 0.5 ml contains:
ACTIVE SUBSTANCE:
Fipronil ...................................................50.0 mg
EXCIPIENTS:
Butylhydroxyanisole (E-320) ................0.100 mg
Butylhydroxytoluene (E-321)................0.050 mg
Benzyl alcohol (E-1519)...................142.500 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution
Clear colourless to slightly yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The treatment and prevention of flea infestations (_Ctenocephalides
felis_)_._ The
duration of protection against flea infestations is 5 weeks.
Treatment of tick infestations (_Ixodes ricinus_). Ticks (_Ixodes
ricinus_) on the
animal at time of treatment will be killed within 48 hours. Treatment
does not
protect against new tick infestations.
4.3
CONTRAINDICATIONS
In the absence of available data, the product should not be used on
kittens less
than 8 weeks old and/or weighing less than 1 kg
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.
Revised: August 2019
AN: 00929/2018
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For optimum control of flea problems in a multi-pet household, all
animals in the
household should be treated with a suitable insecticide.
Avoid
frequent
swimming
or
shampooing
of
the
animal
because
the
maintenance of effectiveness of the product has not been tested in
these cases.
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 infestations and at the beginning of