Eliminall 402 mg spot-on solution for dogs

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Fipronil

Dostupné z:

Krka, d.d., Novo mesto

ATC kód:

QP53AX15

INN (Medzinárodný Name):

Fipronil

Dávkovanie:

402 mg/pipette

Forma lieku:

Spot-on solution

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

fipronil

Terapeutické indikácie:

Ectoparasiticide

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2011-11-25

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eliminall 402 mg spot-on solution for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette (4.02 ml) contains:
ACTIVE SUBSTANCE:
Fipronil
402 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.80 mg
Butylhydroxytoluene (E321)
0.40 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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