Effipro 10% w/v Spot-On Solution for Cats
Country: Malta
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
10-05-2013
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Active ingredient:
fipronil 10 mg
Available from:
Virbac S.A.
ATC code:
QP53AX15
Pharmaceutical form:
Spot-on solution
Therapeutic group:
fipronil
Therapeutic area:
Cats
Authorization date:
2011-02-09
Summary of Product characteristics
Revised: September 2011
AN: 00356/2011
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
EFFIPRO 50 mg spot-on solution for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.5 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
50 mg
EXCIPIENTS:
Butylhydroxyanisole E320 0.1 mg/pipette
Butylhydroxytoluene E321 0.05 mg/pipette
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear, colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE
Treatment of flea (_Ctenocephalides_ spp.) and tick (_Dermacentor reticulatus_)
infestations.
The product has a persistent insecticidal efficacy for up to 5 weeks against fleas
(_Ctenocephalides_ _felis_).
The product has a persistent acaricidal efficacy for up to 2 weeks against ticks
(_Rhipicephalus sanguineus, Ixodes ricinus,_ _Dermacentor reticulatus_). If ticks of
some species (_Rhipicephalus sanguineus_ and _Ixodes ricinus_) 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.
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
CONTRAINDICATIONS
In the absence of available data, the product should not be used on kittens less than
2 months old and/or weighing less than 1 kg.
Revised: September 2011
AN: 00356/2011
Page 2 of 8
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
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