Fipronil-(S)-Methoprene Ceva Spot-on Solution for Dogs 2-10 kg and Cats > 5kg

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

(S)-Methoprene, Fipronil

Available from:

Ceva Sante Animale

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, Dogs

Therapeutic area:

Ectoparasiticide

Authorization status:

Expired

Authorization date:

2015-08-24

Summary of Product characteristics

Revised: July 2020
AN: 01860/2019
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fipronil-(S)-Methoprene Ceva spot-on solution for dogs 2-10 kg and
cats > 5kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.71 ml pipette contains:
ACTIVE SUBSTANCES:
Fipronil
120.70 mg
(S)-methoprene
60.35 mg
EXCIPIENTS:
Butylhydroxyanisole E320
0.142 mg
Butylhydroxytoluene E321
0.142 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
Dogs 2-10 kg and cats > 5kg
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of flea and/or tick infestations.
The product can be used as part of a treatment strategy for the
control of Flea Allergy
Dermatitis (FAD).
In dogs:
- Treatment and prevention of flea infestations (_Ctenocephalides
_spp.). Immediate
insecticidal efficacy against new infestations with adult fleas
persists for 9 weeks.
Prevention of the multiplication of fleas by inhibiting the hatching
of flea eggs (ovicidal
activity) and the development of flea eggs into adult fleas for 8
weeks after
application.
-
Treatment
and
prevention
of
tick
infestation
(_Dermacentor _
_reticulatus_,
_Rhipicephalus sanguineus_). The product has immediate and persistent
acaricidal
efficacy for 6 weeks after application.
In cats:
-
Treatment and prevention of flea infestations (_Ctenocephalides
_spp.). Immediate
insecticidal efficacy against new infestations with adult fleas is
seen persisting for
Revised: July 2020
AN: 01860/2019
Page 2 of 8
8 weeks. Prevention of the multiplication of fleas by inhibiting the
hatching of flea
eggs (ovicidal activity) and the development of flea eggs into adult
fleas for 6
weeks after application.-Treatment
and
prevention
of
tick
infestation
(_Rhipicephalus turanicus_). The product has immediate and persistent
acaricidal
efficacy for 5 weeks after application.
4.3
CONTRAINDICATIONS
Do not use on rabbits, as adverse reactions even mortali