Norbrook Fipronil and (S)-Methoprene 50 mg / 60 mg spot-on solution for cats and ferrets

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:

50/60 mg/pipette

formulario farmacéutico:

Spot-on solution

tipo de receta:

LM: Licensed Merchant as defined in relevant national legislation

Grupo terapéutico:

Cats, Ferrets

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 50 mg / 60 mg spot-on solution
for cats and
ferrets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 0.5 ml contains:
ACTIVE SUBSTANCES:
Fipronil
50
mg
(S)-Methoprene
60
mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.10 mg
Butylhydroxytoluene (E321)
0.05 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
Cats and ferrets.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cats:
To be used against infestations with fleas, alone or in association
with ticks and/or
biting lice.

Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy
against new
infestations with adult fleas persists for 4 weeks. Prevention of the
multiplication of fleas by inhibiting the development of eggs
(ovicidal
activity), larvae and pupae (larvicidal activity) originating from
eggs laid by
adult fleas for six weeks after application.
Health Products Regulatory Authority
17 July 2017
CRN000TS2
Page 2 of 8

Elimination of ticks (Ixodes ricinus, Dermacentor variabilis,
Rhipicephalus
sanguineus). The product has a persistent acaricidal efficacy for up
to 2
weeks against ticks (based on experimental data).

Elimination of biting lice (Felicola subrostratus)
In ferrets:
To be used against infestations with fleas, alone or in association
with ticks.

Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy
against new
infestations with adult fleas persists for 4 weeks. Prevention of the
multiplication of fleas by inhibiting the development of eggs
(ovicidal
activity), larvae and pupae (larvicidal activity) originating from
eggs laid by
adult fleas.

Elimination of ticks (Ixodes ricinus). The product has a persistent
acaricidal
efficacy for 4 weeks against ticks (based on experimental data).
4.3 CONTRAINDICATIONS
In the absence of available data,