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

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Krka, d.d., Novo mesto

ATC kanuni:

QP53AC54

INN (Jina la Kimataifa):

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

Dawa fomu:

Spot-on solution

Dawa ya aina:

POM: Prescription Only Medicine as defined in relevant national legislation

Eneo la matibabu:

permethrin, combinations

Idhini hali ya:

Authorised

Idhini ya tarehe:

2022-04-01

Tabia za bidhaa

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
CONFIDENTIAL
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DAMTIX 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg (
IE
,
DE, EL, ES,
IT, PT
)
ATAXXA VET 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10
kg (FI)
Permetrix biocanina 500 mg/100 mg spot-on solution for dogs over 4 kg
up to 10 kg (FR)
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.
CONFIDENTIAL
Reduction of the risk of infection with _Leishmania infantum_ via
transmission by sandflies
(_Phlebotomus perniciosus_) for up to