Pestigon 67 mg Spot-On Solution for Small Dogs

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Fipronil

Beschikbaar vanaf:

Norbrook Laboratories (Ireland) Limited

ATC-code:

QP53AX15

INN (Algemene Internationale Benaming):

Fipronil

Dosering:

67 mg/pipette

farmaceutische vorm:

Spot-on solution

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutisch gebied:

fipronil

Autorisatie-status:

Authorised

Autorisatie datum:

2012-07-06

Productkenmerken

Health Products Regulatory Authority
09 April 2019
CRN008ZTX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pestigon 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.
The product can be used as part of a treatment programme for Flea
Allergy Dermatitis where this has been previously
diagnosed by a Veterinary Surgeon.
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.
Health Products Regulatory Authority
09 April 2019
CRN008ZTX
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product does not prevent ticks from a