NORBROOK FIPRONIL 402 MG SPOT-ON SOLUTION FOR VERY LARGE DOGS
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
14-06-2024
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Virkt innihaldsefni:
FIPRONIL
Fáanlegur frá:
Norbrook Laboratories Limited
ATC númer:
QP53AX15
INN (Alþjóðlegt nafn):
FIPRONIL
Skammtar:
402 Milligram
Lyfjaform:
Spot On Solution
Gerð lyfseðils:
POM
Meðferðarhópur:
Canine
Lækningarsvæði:
Fipronil
Ábendingar:
Ectoparasiticide
Leyfisstaða:
Authorised
Leyfisdagur:
2012-07-06
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil 402 mg Spot-On Solution for Very Large Dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 4.02 ml pipette contains
ACTIVE SUBSTANCE:
Fipronil
402 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.804 mg
Butylhydroxytoluene (E321)
0.402 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 40 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 n
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