NORBROOK FIPRONIL 268 MG SPOT-ON SOLUTION FOR LARGE DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
FIPRONIL
Available from:
Norbrook Laboratories Limited
ATC code:
QP53AX15
INN (International Name):
FIPRONIL
Dosage:
268 Milligram
Pharmaceutical form:
Spot On Solution
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Fipronil
Therapeutic indications:
Ectoparasiticide
Authorization status:
Authorised
Authorization date:
2012-07-06
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil 268 mg Spot-On Solution for Large Dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 2.68 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
268 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.536 mg
Butylhydroxytoluene (E321)
0.268 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 20 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
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_Date Printed 26/10/2013_
_CRN 7015899_
_page number
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