NORBROOK FIPRONIL 67 MG SPOT-ON SOLUTION FOR SMALL DOGS
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
24-05-2024
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Aktiv bestanddel:
FIPRONIL
Tilgængelig fra:
Norbrook Laboratories Limited
ATC-kode:
QP53AX15
INN (International Name):
FIPRONIL
Dosering:
67 Milligram
Lægemiddelform:
Spot On Solution
Recept type:
POM
Terapeutisk gruppe:
Canine
Terapeutisk område:
Fipronil
Terapeutiske indikationer:
Ectoparasiticide
Autorisation status:
Authorised
Autorisation dato:
2012-07-06
Produktets egenskaber
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil 67 mg Spot-On Solution for Small Dogs.
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 be killed within a week.
4.3 CONTRAINDICATIONS
Do not use in dogs weighing less than 2 kg.
In the absence of available data, the product should not be used in puppies less than 8 weeks old.
Do not use in sick (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 known hypersensitivity to the active or to any of the excipients.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/10/2013_
_CRN 7015899_
_page number: 1
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