Damtix 2000 mg/400 mg spot-on solution for dogs over 25 kg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Krka, d.d., Novo mesto

ATC code:

QP53AC54

INN (International Name):

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

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

permethrin, combinations

Authorization status:

Authorised

Authorization date:

2022-04-01

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
CONFIDENTIAL
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DAMTIX 2000 mg/400 mg spot-on solution for dogs over 25 kg (IE, DE,
EL, ES, IT, PT)
ATAXXA VET 2000 mg/400 mg spot-on solution for dogs over 25 kg (FI)
Permetrix biocanina 2000 mg/400 mg spot-on solution for dogs over 25
kg (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4.0 ml pipette contains:
ACTIVE SUBSTANCES:
Permethrin (40:60) 2000.0 mg
Imidacloprid 400.0 mg
EXCIPIENTS:
Butylhydroxytoluene (E321) 4.0 mg
N-methylpyrrolidone
800.0 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.
CONFIDENTIAL
Reduction of the risk of infection with _Leishmania infantum_ via
transmission by sandflies
(_Phlebotomus perniciosus_) for up to 3 weeks. The effect is indirec