Fleanil Combo 67 mg / 60.3 mg spot-on solution for small 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:

67, 60.3 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
Fleanil Combo 67 mg / 60.3 mg spot-on solution for small dogs (IE)
Fiproclear Combo 67 mg / 60.3 mg spot-on solution for small dogs (IT,
PT)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 0.67 ml contains:
ACTIVE SUBSTANCES:
Fipronil 67 mg
(S)-methoprene 60.3 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
..............................................................................................
0.13 mg
Butylhydroxytoluene (E321)
..............................................................................................
0.07 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 2 to 10 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 persist for 8 weeks. Prevention of the
multiplication of fleas by
inhibiting 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
and/or weighing less than 2 kg.
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 the absence of studies,
the use of the product is not recommended in non-target species.
This product is