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

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

(S)-methoprene; Fipronil

Saatavilla:

Norbrook Laboratories Limited

ATC-koodi:

QP53AX65

INN (Kansainvälinen yleisnimi):

(S)-methoprene; Fipronil

Annos:

134/120.6 mg/pipette

Lääkemuoto:

Spot-on solution

Prescription tyyppi:

LM: Licensed Merchant as defined in relevant national legislation

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

fipronil, combinations

Käyttöaiheet:

Ectoparasiticide

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-05-26

Valmisteyhteenveto

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