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

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Fipronil; (S)-methoprene

Saatavilla:

Chanelle Pharmaceuticals Manufacturing Limited

ATC-koodi:

QP53AX65

INN (Kansainvälinen yleisnimi):

Fipronil; (S)-methoprene

Annos:

50, 60 mg/pipette

Lääkemuoto:

Spot-on solution

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen ryhmä:

Cats, Ferrets

Terapeuttinen alue:

fipronil, combinations

Käyttöaiheet:

Ectoparasiticide

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-04-20

Valmisteyhteenveto

Health Products Regulatory Authority
06 November 2020
CRN009YGJ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zeronil Combo 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 amber 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).
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