PestiGon Combo 402 mg / 361.8 mg spot-on solution for very large dogs

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Fipronil ; (S)-methoprene

Verfügbar ab:

Norbrook Laboratories Limited

ATC-Code:

QP53AX65

INN (Internationale Bezeichnung):

Fipronil ; (S)-methoprene

Dosierung:

402/361.8 mg/pipette

Darreichungsform:

Spot-on solution

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Dogs

Therapiebereich:

fipronil, combinations

Anwendungsgebiete:

Ectoparasiticide

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2017-05-12

Fachinformation

Health Products Regulatory Authority
22 January 2018
CRN000WT2
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PestiGon Combo 402 mg / 361.8 mg spot-on solution for very large dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 4.02 ml contains:
ACTIVE SUBSTANCES:
Fipronil
402
mg
(S)-methoprene
361.8
mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.8
mg
Butylhydroxytoluene (E321)
0.4
mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution
A clear, yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of dogs weighing over 40 kg bodyweight:
To be used against infestations with fleas, alone or in association
with ticks and/or
biting lice

Treatment of flea infestations _(Ctenocephalides spp.)._ Insecticidal
efficacy
against new infestations with adult fleas persists for 8 weeks.
Prevention of
the multiplication of fleas by inhibiting the development of eggs
(ovicidal
activity) and larvae and pupae (larvicidal activity) originating from
eggs laid
by adult fleas for eight weeks after application.

Treatment of tick infestations _(Ixodes ricinus, Dermacentor
variabilis, _
_Dermacentor reticulatus, Rhipicephalus sanguineus)_. The product has
a
persistent acaricidal efficacy for up to 4 weeks against ticks.

Treatment of infestations with biting lice _(Trichodectes canis)._
Health Products Regulatory Authority
22 January 2018
CRN000WT2
Page 2 of 8
The product can be used as part of a treatment strategy for the
control of Flea
Allergy Dermatitis (FAD).
4.3 CONTRAINDICATIONS
In the absence of available data, the product should not be used on
puppies less
than 8 weeks old
Do not use in rabbits, as adverse reactions with even mortality could
occur.In
absence of studies, the use of the product is not recommended in
non-target species.
Do not use on sick (e.g. systemic diseases, fever) or convalescent
animals.
This product is specifically developed for dogs. Do not use in cats
and ferret