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

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

(S)-methoprene; Fipronil

Tilgjengelig fra:

Norbrook Laboratories Limited

ATC-kode:

QP53AX65

INN (International Name):

(S)-methoprene; Fipronil

Dosering :

50/60 mg/pipette

Legemiddelform:

Spot-on solution

Resept typen:

LM: Licensed Merchant as defined in relevant national legislation

Terapeutisk gruppe:

Cats, Ferrets

Terapeutisk område:

fipronil, combinations

Indikasjoner:

Ectoparasiticide

Autorisasjon status:

Authorised

Autorisasjon dato:

2017-05-26

Preparatomtale

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,