Eliminall 67 mg spot-on solution for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fipronil

Available from:

Krka, d.d., Novo mesto

ATC code:

QP53AX15

INN (International Name):

Fipronil

Dosage:

67 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

fipronil

Therapeutic indications:

Ectoparasiticide

Authorization status:

Authorised

Authorization date:

2011-11-25

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eliminall 67 mg spot-on solution for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette (0.67 ml) contains:
ACTIVE SUBSTANCE:
Fipronil
67 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.134 mg
Butylhydroxytoluene (E321)
0.067 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
Light yellow to yellow, clear liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea (_Ctenocephalides_ spp.) and tick (_Dermacentor
reticulatus_) infestations.
For treatment of_ Trichodectes canis_ biting lice infestations on
dogs. Most lice are killed within 2 days.
Insecticidal efficacy against new infestations with adult fleas
persists for up to 8 weeks.
The product has a persistent acaricidal efficacy for up to 3 weeks
against_ Ixodes ricinus_ and up to 4 weeks against
_Rhipicephalus sanguineus_ and_ Dermacentor reticulatus_. If ticks of
some species (_Ixodes ricinus_,_ Rhipicephalus_
_sanguineus_) are present when the product is applied, all the ticks
may not be killed within the first 48 hours.
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 use on puppies less than 2 months old and/or weighing less than
2 kg in the absence of available data.
Do not use on sick (e.g. systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse reactions and even death could
occur.
This product is specifically developed for dogs. Do not use in cats,
as this could lead to overdosing.
Do not use in cases of hypersensitivity to the active substance,
dimethyl sulphoxide or to any of other excipients.
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