Fiprex Duo M 134 mg + 120.6 mg spot-on solution for dogs

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

(S)-Methoprene; Fipronil

Disponibil de la:

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

Codul ATC:

QP53AX65

INN (nume internaţional):

(S)-Methoprene; Fipronil

Dozare:

134,120.6 mg/pipette

Forma farmaceutică:

Spot-on solution

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Zonă Terapeutică:

fipronil, combinations

Statutul autorizaţiei:

Authorised

Data de autorizare:

2020-03-06

Caracteristicilor produsului

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 M 134 mg + 120.6 mg spot-on solution for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 1.34 ml contains
ACTIVE SUBSTANCES:
Fipronil 134.00 mg
(S)-methoprene 120.60 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
Clear greenish-yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (>10-20 kg)
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
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.
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