Norbrook Fipronil and (S)-Methoprene 67 mg / 60.3 mg spot-on solution for small dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fipronil ; (S)-methoprene

Available from:

Norbrook Laboratories Limited

ATC code:

QP53AX65

INN (International Name):

Fipronil ; (S)-methoprene

Dosage:

67/60.3 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

fipronil, combinations

Therapeutic indications:

Ectoparasiticide

Authorization status:

Authorised

Authorization date:

2017-05-26

Summary of Product characteristics

Health Products Regulatory Authority
17 July 2017
CRN000TS2
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil and (S)-Methoprene 67 mg / 60.3 mg spot-on solution
for small
dogs
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).
Health Products Regulatory Authority
17 July 2017
CRN000TS2
Page 2 of 7
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 specifically developed for dogs. Do not use in cats or
ferrets, as this
could lead to overdosing.
Do not use in cases of hypersens