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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fipronil; (S)-methoprene

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QP53AX65

INN (International Name):

Fipronil; (S)-methoprene

Dosage:

50, 60 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

LR: Licensed Retailer as defined in national legislation

Therapeutic area:

fipronil, combinations

Authorization status:

Authorised

Authorization date:

2017-05-26

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil and (S)-Methoprene 50 mg / 60 mg spot-on solution
for cats and ferrets (IE)
Fleanil Duo 50 mg / 60 mg spot-on solution for cats and ferrets (UK)
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.

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, the product should not be used