Ataxxa 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Permethrin; Imidacloprid

MAH:

Krka, d.d., Novo mesto

ATC_code:

QP53AC54

INN:

Permethrin; Imidacloprid

dosage:

1250, 250 mg/pipette

pharmaceutical_form:

Spot-on solution

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Dogs

therapeutic_area:

permethrin, combinations

therapeutic_indication:

Ectoparasiticide

authorization_status:

Authorised

authorization_date:

2015-10-30

SPC

_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ataxxa 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 ml pipette contains:
ACTIVE SUBSTANCES:
Permethrin 1250.0 mg
Imidacloprid 250.0 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
QUANTITATIVE
COMPOSITION
IF THAT
INFORMATION IS ESSENTIAL
FOR PROPER
ADMINISTRATION OF THE VETERINARY MEDICINAL
PRODUC
t
_ _
Butylhydroxytoluene (E321)
_ _
2.5 mg
Triglycerides, Medium-Chain
N-methylpyrrolidone
Citric acid (E330)
Dimethyl sulfoxide
Clear yellowish to brownish spot on solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs
3.2
INDICATIONS FOR USE FOR EACH 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 veterinary medicinal product can
be used as part of a
treatment strategy for flea allergy dermatitis (FAD).
The veterinary medicinal 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.
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.
Reduction of the risk of infection with
_Leishmania infantum_
via transmission by sandflies
(
_Phlebotomus perniciosus_
) for up to 3 weeks. The effect is indirect due to the veterinary
medicinal product's ac