Exidot 100 mg Spot-on solution for Medium 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:

100 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

imidacloprid

Authorization status:

Authorised

Authorization date:

2019-11-15

Summary of Product characteristics

Health Products Regulatory Authority
19 November 2019
CRN000XMS
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Exidot 100 mg Spot-on solution for Medium Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each 1.0 mL pipette contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Imidacloprid
​100
​
mg
​
EXCIPIENTS:
​
​
​
Butylhydroxytoluene (E 321)
​1.0
​
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
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention and treatment of flea infestations and for the
treatment of biting lice _(Trichodectes canis) _on dogs weighing
≥ 4 to < 10 kg.
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 the control of
Flea Allergy Dermatitis (FAD) where this has been
previously diagnosed by a veterinary surgeon.
4.3 CONTRAINDICATIONS
Do not treat unweaned puppies of less than 8 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,
pet rabbits and dogs in the household are treated. Treatment of
nursing bitches controls flea infestations on both dam and
offspring.
The product remains effective if the animal becomes wet, for example
after exposure to heavy rain. However,