FIPREX DUO 50 mg+ 60 mg spot-on solution for cats and ferrets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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12-01-2024

Active ingredient:

Fipronil; (S)-methopene

Available from:

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

ATC code:

QP53AX65

INN (International Name):

Fipronil; (S)-methopene

Dosage:

50,60 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
13 May 2021
CRN00C8R5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
FIPREX DUO 50 mg+ 60 mg spot-on solution for cats and ferrets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 0.5 ml contains
ACTIVE SUBSTANCES:
Fipronil 50.00 mg
(S)-methoprene 60.00 mg
EXCIPIENTS:
Butylhydroxyanisole (E320) 0.10 mg
Butylhydroxytoluene (E321) 0.05 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
Cats and ferrets
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cats:

To be used against infestations with fleas, alone or in association
with ticks and/or biting lice.

Elimination of fleas (_Ctenocephalides spp_.). Insecticidal efficacy
against new infestations with adult fleas persists for
4 weeks. Prevention of the multiplication of fleas by inhibiting the
development of eggs (ovicidal activity), larvae
and pupae (larvicidal activity) originating from eggs laid by adult
fleas for six weeks after application.

Elimination of ticks (_Ixodes ricinus, Dermacentor variabilis,
Rhipicephalus sanguineus_). The product has a persistent
acaricidal efficacy for up to 2 weeks against ticks (based on
experimental data).

Elimination of biting lice (_Felicola subrostratus_).
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.
In ferrets:

To be used against infestations with fleas, alone or in association
with ticks.

Elimination of fleas (_Ctenocephalides spp_.). Insecticidal efficacy
against new infestations with adult fleas persists for
4 weeks. Prevention of the multiplication of fleas by inhibiting the
development of eggs (ovicidal activity), larvae
and pupae (larvicidal activity) originating from eggs laid by adult
fleas.

Elimination of ticks (_Ixodes ricinus_). The product has a pers
                                
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