Exidot 80 mg Spot-on solution for Large Cats and Large Pet Rabbits

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Imidacloprid

Disponible des:

Chanelle Pharmaceuticals Manufacturing Limited

Codi ATC:

QP53AX17

Designació comuna internacional (DCI):

Imidacloprid

Dosis:

80 mg/pipette

formulario farmacéutico:

Spot-on solution

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

imidacloprid

Estat d'Autorització:

Authorised

Data d'autorització:

2019-11-15

Fitxa tècnica

Health Products Regulatory Authority
19 November 2019
CRN000XMS
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Exidot 80 mg Spot-on solution for Large Cats and Large Pet Rabbits
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each 0.8 ml pipette contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Imidacloprid
​80
​
mg
​
EXCIPIENTS:
​
​
​
Butylhydroxytoluene (E 321)
​0.8
​
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 and pet rabbits
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For cats of 4 kg and greater:
Prevention and treatment of flea (_Ctenocephalides felis_)
infestations.
For pet rabbits of 4 kg and greater:
Treatment of flea infestations.
Fleas are killed within one day following treatment.
One treatment prevents further flea infestation for 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) in cats, 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 use in case 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
environmental treatment against adult fleas and their
developing stages is recommended. In order to reduce further the
environmental challenge, it is recommended that all cats
and pet rabbits in the household are treated. Treatment of nursing
queens