Norbrook Fipronil 67 mg Spot-On Solution for Small Dogs

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Fipronil

Tilgængelig fra:

Norbrook Laboratories Limited

ATC-kode:

QP53AX15

INN (International Name):

Fipronil

Dosering:

67 mg/pipette

Lægemiddelform:

Spot-on solution

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Dogs

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 the 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.
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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,