Ataxxa 2000 mg/400 mg Spot-on Solution for Dogs Over 25 kg

Summary of Product characteristics

                                Revised: October 2021
AN: 01901/2020, 01967/2020, 00343/2021 & 00345/2021
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ataxxa 2000 mg/400 mg spot-on solution for dogs over 25 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4.0 ml pipette contains:
ACTIVE SUBSTANCES:
Permethrin 2000.0 mg
Imidacloprid 400.0 mg
EXCIPIENTS:
Butylhydroxytoluene (E321) 4.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear yellowish to brownish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and prevention of flea (_Ctenocephalides felis_)
infestation.
Fleas on dogs are killed within one day following treatment. One
treatment prevents
further flea infestation for four weeks. The product can be used as
part of a treatment
strategy for flea allergy dermatitis (FAD).
The product has persistent acaricidal efficacy against tick
infestations (_Rhipicephalus _
_sanguineus_ and _Ixodes ricinus _ for four weeks, and _Dermacentor
reticulatus _for three
weeks) and persistent repellent efficacy (_Ixodes ricinus_) for three
weeks.
Ticks already on the dog may not be killed within two days after
treatment and may
remain attached and visible. Therefore the removal of ticks already on
the dog at the
time of treatment is recommended, in order to prevent them from
attaching and
having a blood meal.
Revised: October 2021
AN: 01901/2020, 01967/2020, 00343/2021 & 00345/2021
Page 2 of 9
One treatment provides repellent (anti-feeding) activity against the
sand fly
_Phlebotomus perniciosus_ for three weeks and against the mosquito
_Aedes aegypti_
from 7 days up to 14 days after treatment.
4.3
CONTRAINDICATIONS
In the absence of available data do not use the product on puppies of
less than 7
weeks of age, or 25 kg of weight.
Do not use in known cases of hypersensitivity to the active substances
or to any of
the excipients.
Do not use on cats. (Refer to section 4.5 – Special preca
                                
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