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

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Permethrin (Cis:Trans 40:60); Imidacloprid for veterinary use

Tilgængelig fra:

Krka, d.d., Novo mesto

ATC-kode:

QP53AC54

INN (International Name):

Permethrin (Cis:Trans 40:60); Imidacloprid for veterinary use

Lægemiddelform:

Spot-on solution

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

permethrin, combinations

Autorisation status:

Authorised

Autorisation dato:

2022-04-01

Produktets egenskaber

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DACLOTRIX 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 (40:60)
500.0 mg
Imidacloprid
100.0 mg
EXCIPIENTS:
Butylhydroxytoluene (E321)
1.0 mg
N-methylpyrrolidone
200.0 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) where this has been previously diagnosed by a
veterinary surgeon.
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.
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 product's activity
against the vector.
4.3
CONTRAINDICATIONS
In the absence of available data do not use the product on puppies of
less than 7 weeks of age,
or 4 kg of weight.
Do not use in known cases of h