Ataxxa 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Permethrin; Imidacloprid

Tillgänglig från:

Krka, d.d., Novo mesto

ATC-kod:

QP53AC54

INN (International namn):

Permethrin; Imidacloprid

Dos:

500, 100 mg/pipette

Läkemedelsform:

Spot-on solution

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk grupp:

Dogs

Terapiområde:

permethrin, combinations

Terapeutiska indikationer:

Ectoparasiticide

Bemyndigande status:

Authorised

Tillstånd datum:

2015-10-30

Produktens egenskaper

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
CONFIDENTIAL
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ataxxa 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1.0 ml pipette contains:
ACTIVE SUBSTANCES:
Permethrin 500.0 mg
Imidacloprid 100.0 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY MEDICINAL
PRODUCt
Butylhydroxytoluene (E321)
1.0 mg
Triglycerides, Medium-Chain
N-methylpyrrolidone
200.0 mg
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.
CONFIDENTIAL
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 pro