Fleanil Combo 268 mg / 241.2 mg spot-on solution for large dogs

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Fipronil; (S)-methopene

थमां उपलब्ध:

Norbrook Laboratories (Ireland) Limited

ए.टी.सी कोड:

QP53AX65

INN (इंटरनेशनल नाम):

Fipronil; (S)-methopene

डोज़:

268, 241.2 mg/pipette

फार्मास्यूटिकल फॉर्म:

Spot-on solution

प्रिस्क्रिप्शन प्रकार:

LR: Licensed Retailer as defined in national legislation

चिकित्सीय क्षेत्र:

fipronil, combinations

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2017-05-26

उत्पाद विशेषताएं

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fleanil Combo 268 mg / 241.2 mg spot-on solution for large dogs (IE)
Fiproclear Combo 268 mg / 241.2 mg spot-on solution for large dogs
(IT, PT)
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 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 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 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.
Do not use on sick (e.g. systemic diseases, fever) or convalescent
animals.
This product is specifically developed for dogs. Do not use in cats
and 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