Fiprotec 67 mg Spot On Solution for Small Dogs

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:

Dogs

Therapeutic area:

Ectoparasiticide

Authorization status:

Authorized

Authorization date:

2014-08-08

Summary of Product characteristics

Revised: August 2019
AN: 00930/2018
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fiprotec 67 mg Spot On Solution for Small Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette of 0.67 ml contains:
ACTIVE SUBSTANCE:
Fipronil ...................................................67.0 mg
EXCIPIENTS:
Butylhydroxyanisole (E320) .................0.134 mg
Butylhydroxytoluene (E321).................0.067 mg
Benzyl alcohol (E1519) ...................190.950 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
Dogs.
This product is suitable for dogs weighing 2 to 10 kg.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of flea infestations (_Ctenocephalides
felis_) in dogs.
The duration of protection against flea infestations is 5 weeks.
The product protects against new tick infestations (_Dermacentor
reticulatus, _
_Rhipicephalus sanguineus_) in dogs from day 7 to day 28 after
application of the
product.
4.3
CONTRAINDICATIONS
Do not use on dogs less than 8 weeks old and/or weighing less than 2
kg.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use on sick (e.g. systemic disease, fever) or convalescent
animals.
Do not use in rabbits, as adverse reactions and even death could
occur.
Revised: August 2019
AN: 00930/2018
Page 2 of 7
Do not use in cats, as this could lead to overdosing.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For optimal control of flea infestations in multi-pet households, all
animals in the
household should be treated with a suitable insecticide.
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 the control measures,
with a
suitable insecticide and vacuumed regularly.
No data on the effect of bathin