Norbrook Fipronil 268 mg Spot-On Solution for Large Dogs

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Fipronil

Saadav alates:

Norbrook Laboratories Limited

ATC kood:

QP53AX15

INN (Rahvusvaheline Nimetus):

Fipronil

Annus:

268 mg/pipette

Ravimvorm:

Spot-on solution

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline rühm:

Dogs

Terapeutiline ala:

fipronil

Näidustused:

Ectoparasiticide

Volitamisolek:

Authorised

Loa andmise kuupäev:

2012-07-06

Toote omadused

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 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.
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.
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