Norbrook Fipronil and (S)-Methoprene 134 mg / 120.6 mg spot-on solution for medium dogs

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

(S)-methoprene; Fipronil

थमां उपलब्ध:

Norbrook Laboratories Limited

ए.टी.सी कोड:

QP53AX65

INN (इंटरनेशनल नाम):

(S)-methoprene; Fipronil

डोज़:

134/120.6 mg/pipette

फार्मास्यूटिकल फॉर्म:

Spot-on solution

प्रिस्क्रिप्शन प्रकार:

LM: Licensed Merchant as defined in relevant national legislation

चिकित्सीय समूह:

Dogs

चिकित्सीय क्षेत्र:

fipronil, combinations

चिकित्सीय संकेत:

Ectoparasiticide

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2017-05-26

उत्पाद विशेषताएं

Health Products Regulatory Authority
17 July 2017
CRN000TS2
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil and (S)-Methoprene 134 mg / 120.6 mg spot-on
solution for
medium dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 1.34 ml contains:
ACTIVE SUBSTANCES:
Fipronil 134 mg
(S)-methoprene 120.6 mg
EXCIPIENTS:
Butylhydroxyanisole (E320) 0.27 mg
Butylhydroxytoluene (E321) 0.13 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 10 to 20 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.
Health Products Regulatory Authority
17 July 2017
CRN000TS2
Page 2 of 8
·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 t