Amflee Combo 50 mg/60 mg Spot-on Solution for Cats and Ferrets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

(S)-Methoprene, Fipronil

Available from:

Krka d.d., Novo Mesto

ATC code:

QP53AX65

INN (International Name):

(S)-Methoprene, Fipronil

Pharmaceutical form:

Spot-on solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Ferrets

Therapeutic area:

Ectoparasiticide; Insect Growth Regulator

Authorization status:

Authorized

Authorization date:

2016-07-13

Summary of Product characteristics

                                Revised: April 2021
AN: 00999/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AMFLEE combo 50 mg/60 mg spot-on solution for cats and ferrets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml pipette contains:
ACTIVE SUBSTANCES:
Fipronil
50 mg
S-Methoprene
60 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.1 mg
Butylhydroxytoluene (E321)
0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats, 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:
-
Treatment of flea infestations (_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.
-
Treatment of tick infestations (_Ixodes ricinus, Dermacentor
variabilis, _
_Rhipicephalus sanguineus_). The product has a persistent acaricidal
efficacy for up
to 2 weeks against ticks.
-
Treatment of infestations with biting lice (_Felicola subrostratus_).
Revised: April 2021
AN: 00999/2020
Page 2 of 7
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:
-
Treatment of flea infestations (_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.
-
Treatment of tick infestations (_Ixodes ricinus_). The 
                                
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