FIPROCAT (FIPROSPOT) 50 mg spot-on solution for cats
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
19-03-2013
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Active ingredient:
fipronil 50 mg
Available from:
IDT Biologika GmbH
ATC code:
QP53AX15
Pharmaceutical form:
Spot-on solution
Therapeutic group:
fipronil
Therapeutic area:
Cats
Authorization date:
2011-04-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FIPROCAT (FIPROSPOT) 50 mg spot-on solution for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml pipette contains
ACTIVE SUBSTANCE:
Fipronil
50.00 mg
EXCIPIENTS
Butylhydroxyanisole ( E 320)
0.10 mg
Butylhydroxytoluene ( E 321)
0.05 mg
For 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
Cat
4.2
Indications for use, specifying the target species
For the treatment of cats against flea infestations (_Ctenocephalides_ spp.)
Insecticidal efficacy against new infestation with fleas persists for up to 4 weeks.
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.
4.3
Contraindication
In the absence of available data, the veterinary medicinal 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 disease, fever, etc.) or convalescent animals.
Do not use on rabbits, as adverse drug reactions and even death could occur.
Do not use on animals with hypersensitivity to the active substance or any other excipients.
4.4
Special warnings for each target species
For the optimal control of flea problems in households with several animals all dogs and cats
should be treated with an authorised insecticide.
Fleas from pets often infest animal's baskets, bedding and regular resting ar
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