Duoflect Spot-on Solution for Dogs 10-20 kg

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

(S)-Methoprene, Fipronil

Available from:

Ceva Animal Health Ltd

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:

2014-05-07

Summary of Product characteristics

                                Revised: September 2022
AN: 01491/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duoflect spot-on solution for dogs 10-20 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 1.4 ml pipette contains:
ACTIVE SUBSTANCES:
Fipronil
240 mg
(S)-methoprene120 mg
EXCIPIENTS:
Butylhydroxyanisole E320 0.28 mg
Butylhydroxytoluene E321 0.28 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) in dogs when previously diagnosed by a veterinary
surgeon.
4.3
CONTRAINDICATIONS
Do not use in rabbits, as adverse reactions, even mortality, could
occur.
Revised: September 2022
AN: 01491/2022
Page 2 of 7
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use on sick (e.g. systemic disease, fever) or convalescent
animals.
4.4
SPECIAL WARNINGS
The attachment of single ticks after treatment cannot be ruled out.
Therefore the
transmission of infectious disease cannot be completely excluded if
conditions are
unfavourable.
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
in
                                
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