Norbrook Fipronil and (S)-Methoprene 402 mg / 361.8 mg spot-on solution for very large dogs

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

(S)-methoprene; Fipronil

Disponible desde:

Norbrook Laboratories Limited

Código ATC:

QP53AX65

Designación común internacional (DCI):

(S)-methoprene; Fipronil

Dosis:

402/361.8 mg/pipette

formulario farmacéutico:

Spot-on solution

tipo de receta:

LM: Licensed Merchant as defined in relevant national legislation

Grupo terapéutico:

Dogs

Área terapéutica:

fipronil, combinations

indicaciones terapéuticas:

Ectoparasiticide

Estado de Autorización:

Authorised

Fecha de autorización:

2017-05-26

Ficha técnica

Health Products Regulatory Authority
17 July 2017
CRN000TS2
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil and (S)-Methoprene 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)
0.80
mg
Butylhydroxytoluene (E321)
0.40
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 of 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 _
Health Products Regulatory Authority
17 July 2017
CRN000TS2
Page 2 of 8
_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_).
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 on sick (e.g. systemic diseases, fever) or convalescent
animals.
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.
This product is specifically developed for dogs. Do not use in cats or
ferrets, as this
could lead to overdosing.
Do not use in cases of hypersensitivity t