Fipronil Spot-on Solution by Virbac 134 mg for Medium Dogs

Summary of Product characteristics

                                Revised: March 2019
AN: 01420/2018
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FIPRONIL spot-on solution by Virbac 134 mg for medium dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 1.34 ml pipette contains :
ACTIVE SUBSTANCE:
Fipronil
134 mg
EXCIPIENTS:
Butyhydroxyanisole E320 0.268 mg
Butylhydroxytoluene E321 0.134 mg
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
Dogs.
4.2
INDICATIONS FOR USE
Treatment
of
flea
(_Ctenocephalides_
spp.)
and
tick
(_Dermacentor_
_reticulatus_)
infestations.
Insecticidal efficacy against new infestations with adult fleas
persists for up to 8
weeks.
The product has a persistent acaricidal efficacy for up to 4 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
Revised: March 2019
AN: 01420/2018
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Do not use on puppies less than 2 months old and /or weighing less
than 2kg in the
absence of available data.
Do not use on sick (e.g. systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse reactions and even death could
occur.
This product is specifically developed for dogs. Do not use in cats,
as this could lead
to overdosing.
Do not use in cases of hypersensitivity to the active substance or to
any of excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Shampooing an hour prior to treatment does not affect the efficacy of
the product
against fleas.
Bathing/immersion in water within two days after application of the
product should
                                
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