Norofip 67 mg Spot-On Solution for Small Dogs
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
19-09-2013
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Active ingredient:
fipronil 67 mg
Available from:
Norbrook Laboratories Limited
ATC code:
QP53AX15
Pharmaceutical form:
Spot-on
Therapeutic group:
fipronil
Therapeutic area:
Dogs
Authorization date:
2013-02-20
Summary of Product characteristics
Dokument1
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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Dokument1
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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fleanil 67 mg Spot-On Solution for Small Dogs
Fleanil vet 67 mg Spot-On Solution for Small Dogs (FI)
Fipronil Norbrook 67 mg Spot-On Solution for Small Dogs (NO)
Fleanil (DK)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.67 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil 67 mg
EXCIPIENTS:
Butylhydroxyanisole (E320) 0.134 mg
Butylhydroxytoluene (E321) 0.067 mg
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
A clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infestations by fleas (_Ctenocephalides_ _felis_). The product shows
immediate insecticidal effect and persistent insecticidal activity against new infestations by
adult fleas for up to 8 weeks.
The product has a persistent acaricidal efficacy against _Ixodes ricinus_ for up to 2 weeks,
_Rhipicephalus sanguineus_ for up to 3 weeks and _Dermacentor reticulatus_ for up to 4 weeks. If
ticks of these species are present when the product is applied, all ticks will not be killed within
the first 48 hours but they may
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