Norbrook Fipronil and (S)-Methoprene 50 mg / 60 mg spot-on solution for cats and ferrets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

(S)-methoprene; Fipronil

Διαθέσιμο από:

Norbrook Laboratories Limited

Φαρμακολογική κατηγορία (ATC):

QP53AX65

INN (Διεθνής Όνομα):

(S)-methoprene; Fipronil

Δοσολογία:

50/60 mg/pipette

Φαρμακοτεχνική μορφή:

Spot-on solution

Τρόπος διάθεσης:

LM: Licensed Merchant as defined in relevant national legislation

Θεραπευτική ομάδα:

Cats, Ferrets

Θεραπευτική περιοχή:

fipronil, combinations

Θεραπευτικές ενδείξεις:

Ectoparasiticide

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-05-26

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
17 July 2017
CRN000TS2
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil and (S)-Methoprene 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
mg
(S)-Methoprene
60
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
A clear, 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.
Health Products Regulatory Authority
17 July 2017
CRN000TS2
Page 2 of 8

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)
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 persistent
acaricidal
efficacy for 4 weeks against ticks (based on experimental data).
4.3 CONTRAINDICATIONS
In the absence of available data,