Pestigon 268 mg Spot-On Solution for large dogs

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Fipronil

MAH:

Norbrook Laboratories Limited

ATC_code:

QP53AX15

INN:

Fipronil

dosage:

268 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_indication:

Ectoparasiticide

authorization_status:

Authorised

authorization_date:

2012-07-06

SPC

Health Products Regulatory Authority
23 August 2017
CRN000VWL
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pestigon 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.
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 20 kg.
Health Products Regulatory Authority
23 August 2017
CRN000VWL
Page 2 of 8
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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product does not prevent ticks from attaching to the animals, but
ticks may be
killed in the first 24-48 hours af