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

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Fipronil; (S)-methoprene

Fáanlegur frá:

Norbrook Laboratories (Ireland) Limited

ATC númer:

QP53AX65

INN (Alþjóðlegt nafn):

Fipronil; (S)-methoprene

Skammtar:

67, 60.3 mg/pipette

Lyfjaform:

Spot-on solution

Gerð lyfseðils:

LR: Licensed Retailer as defined in national legislation

Lækningarsvæði:

fipronil, combinations

Leyfisstaða:

Authorised

Leyfisdagur:

2017-05-26

Vara einkenni

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