Norbrook Fipronil and (S)-Methoprene 268 mg / 241.2 mg spot-on solution for large dogs

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:

268, 241.2 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 268 mg / 241.2 mg spot-on
solution for large dogs (IE)
Fleanil Duo 268 mg 241.2 mg spot-on solution for large dogs (UK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 2.68 ml contains:
ACTIVE SUBSTANCES:
Fipronil 268 mg
(S)-methoprene 241.2 mg
EXCIPIENTS:
Butylhydroxyanisole (E320) 0.54 mg
Butylhydroxytoluene (E321) 0.27 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 20 to 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 _
_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 to the active substances or to
any of the excipients.
4.4