FIPREX DUO S 67 mg + 60.3 mg spot-on solution for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

(S)-Methoprene; Fipronil

Available from:

Vet-Agro Multi-Trade Company Sp z o.o.

ATC code:

QP53AX65

INN (International Name):

(S)-Methoprene; Fipronil

Dosage:

67,60.3 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

fipronil, combinations

Authorization status:

Authorised

Authorization date:

2020-03-06

Summary of Product characteristics

Health Products Regulatory Authority
26 March 2020
CRN008PLN
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
FIPREX DUO S 67 mg + 60.3 mg spot-on solution for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 0.67 ml contains:
ACTIVE SUBSTANCES:
Fipronil 67.00 mg
(S)-methoprene 60.30 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.
Clear greenish-yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (> 2 -10 kg)
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_).
The product can be used as part of a treatment strategy for the
control of Flea Allergy Dermatitis (FAD), where this has been
previously diagnosed by a veterinary surgeon.
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 absence of studies, the use of the product is not recommended in
non-target species.
This pro