Fipronil-(S)-Methoprene Ceva Spot-on Solution for Dogs 10-20 kg

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:

Dogs

Therapeutic area:

Ectoparasiticide

Authorization status:

Expired

Authorization date:

2015-08-24

Summary of Product characteristics

Revised: July 2020
AN: 01865/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fipronil-(S)-Methoprene Ceva Spot-on Solution for Dogs 10-20 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1.41 ml pipette contains :
ACTIVE SUBSTANCES:
Fipronil
239.70 mg
(S)-methoprene
119.85 mg
EXCIPIENTS:
Butylhydroxyanisole E320
0.282 mg
Butylhydroxytoluene E321
0.282 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 10-20 kg
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
-
Treatment and prevention of flea and/or tick infestations.
-
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.
The product can be used as part of a treatment strategy for the
control of Flea Allergy
Dermatitis (FAD).
4.3
CONTRAINDICATIONS
Do not use on rabbits, as adverse reactions even mortality could
occur.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Revised: July 2020
AN: 01865/2019
Page 2 of 7
Do not use on sick (e.g. systemic disease, fever) or convalescent
animals.
This product is specifically developed for dogs. Do not use in cats,
as this could lead
to overdosing.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
All stages of fleas can infest the dog’s basket, bedding, and
regular resting areas
such as carpets and soft furnishings. In cases of massive flea
infestation and at the
beginning of the control measures these areas should be treated w