Fipnil 402 mg Spot-on Solution for extra large dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fipronil

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP53AX15

INN (International Name):

Fipronil

Dosage:

402 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

fipronil

Therapeutic indications:

Ectoparasiticide

Authorization status:

Authorised

Authorization date:

2012-02-03

Summary of Product characteristics

Health Products Regulatory Authority
21 August 2018
CRN000YZ2
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fipnil 402 mg Spot-on Solution for extra 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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
Clear, pale amber solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea (_Ctenocephalides _spp.) and tick (_Rhipicephalus
sanguineus _and
_Ixodes ricinus_) infestations.
Insecticidal efficacy against new infestations with adult fleas
persists for 2 months.
The product has a persistent acaricidal efficacy for 1 month against
ticks
(_Rhipicephalus sanguineus_, _Ixodes ricinus_, _Dermacentor
reticulatus_). For _Ixodes ricinus _
and _Rhipicephalus sanguineus_, ticks will normally be killed within
the first 48 hours
following first application of the product. For established
infestations of _Dermacentor_
_reticulatus_, an immediate acaricidal effect has not been
demonstrated. However, ticks
will normally be killed within a week following first application of
the product.
The product can be used as part of a treatment strategy for the
control of Flea
Allergy Dermatitis (FAD) where this has been previously diagnosed by a
veterinary
surgeon.
Health Products Regulatory Authority
21 August 2018
CRN000YZ2
Page 2 of 7
4.3 CONTRAINDICATIONS
Do not use on puppies less than 2 months old or puppies or dogs
weighing less than
2kg.
Do not use on sick (e.g. 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 hypersensitivity to the active
substance or to
any of excipients.
4.4 SPECIAL WAR