Prectival 268 mg Spot-on Solution for Dogs
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
24-01-2013
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Active ingredient:
fipronil 0 mg/ml
Available from:
Krka d.d.
ATC code:
QP53AX15
Pharmaceutical form:
Spot-on solution
Therapeutic group:
fipronil
Therapeutic area:
Dogs
Authorization date:
2011-09-28
Summary of Product characteristics
Issued: November 2011
AN: 00586/2010
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Eliminall 268 mg spot-on solution for dogs
Exproline vet 268 mg spot-on solution for dogs
Eliminall 268 mg spot-on solution for dogs (Austria, France, Germany, Greece, Italy,
Ireland, Luxemburg, Netherlands, United Kingdom, Portugal, Spain)
Exproline vet 268 mg spot-on solution for dogs (Norway, Denmark, Finland, Sweden)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette (2.68 ml) contains:
ACTIVE SUBSTANCE:
Fipronil
268 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.54 mg
Butylhydroxytoluene (E321)
0.27 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Light yellow to yellow, clear liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea (_Ctenocephalides_ spp.) and tick (_Dermacentor_ _reticulatus_)_ _
infestations.
For treatment of _Trichodectes canis_ biting lice infestations on dogs. Most lice are
killed within 2 days.
Insecticidal efficacy against new infestations with adult fleas persists for up to 8
weeks.
Issued: November 2011
AN: 00586/2010
Page 2 of 7
The product has a persistent acaricidal efficacy for up to 3 weeks against _Ixodes _
_ricinus_ and_ _up to_ _4 weeks against _Rhipicephalus_ _sanguineus_ and _Dermacentor _
_reticulatus_. If ticks of some species (_Ixodes ricinus_, _Rhipicephalus sanguineus_) are
present when the product is applied, all the ticks may not be killed within the fir
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