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

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Fipronil; (S)-methoprene

Tersedia dari:

Norbrook Laboratories (Ireland) Limited

Kode ATC:

QP53AX65

INN (Nama Internasional):

Fipronil; (S)-methoprene

Dosis:

402, 361.8 mg/pipette

Bentuk farmasi:

Spot-on solution

Jenis Resep:

LR: Licensed Retailer as defined in national legislation

Area terapi:

fipronil, combinations

Status otorisasi:

Authorised

Tanggal Otorisasi:

2017-05-26

Karakteristik produk

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 _
_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
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Bathing/immersion in wate