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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Imidacloprid

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP53AX17

INN (International Name):

Imidacloprid

Dosage:

40 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic area:

imidacloprid

Authorization status:

Authorised

Authorization date:

2019-10-25

Summary of Product characteristics

Health Products Regulatory Authority
31 January 2022
CRN00CD0F
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Imidaflea 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.
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.
Health Products Regulatory Authority
31 January 2022
CRN00CD0F
Page 2 of 5
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
environ