Exidot 40 mg Spot-on solution for Small Cats, Small Pet Rabbits & Small Dogs

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Imidacloprid

Dostępny od:

Chanelle Pharmaceuticals Manufacturing Limited

Kod ATC:

QP53AX17

INN (International Nazwa):

Imidacloprid

Dawkowanie:

40 mg/pipette

Forma farmaceutyczna:

Spot-on solution

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

imidacloprid

Status autoryzacji:

Authorised

Data autoryzacji:

2019-11-15

Charakterystyka produktu

Health Products Regulatory Authority
19 November 2019
CRN000XMS
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Exidot 40 mg Spot-on solution for Small Cats, Small Pet Rabbits &
Small Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each 0.4 ml pipette contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Imidacloprid
40​
mg​
​
EXCIPIENTS:
​
​
​
Butylhydroxytoluene (E 321)
0.4​
mg​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Spot-on solution
A clear pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats, pet rabbits and dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For cats of less than 4 kg:
Prevention and treatment of flea (_Ctenocephalides felis_)
infestations.
For pet rabbits of less than 4 kg:
Treatment of flea infestations.
For dogs of less than 4 kg:
For the prevention and treatment of flea infestations and for the
treatment of biting lice (_Trichodectes canis_) on dogs.
Fleas on dogs are killed within one day following treatment.
One treatment prevents further flea infestation for four weeks on
dogs, three to four weeks on cats and up to one week on pet
rabbits.
The product can be used as part of a treatment strategy for the
control of Flea Allergy Dermatitis (FAD) where this has been
previously diagnosed by a veterinary surgeon.
4.3 CONTRAINDICATIONS
Do not treat unweaned kittens of less than 8 weeks of age.
Do not use on pet rabbits of less than 10 weeks of age.
Do not treat unweaned puppies of less than 8 weeks of age.
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Re-infestation from emergence of new fleas in the environment may
continue to occur for six weeks or longer after treatment
is initiated. More than one treatment may therefore be required,
depending on the level of fleas in the environment. To aid
reduction in environmental challenge, the additional use of a suitable
envi