Amflee 268 mg Spot-on Solution for Large Dogs

Summary of Product characteristics

                                Revised: March 2020
AN: 00565/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amflee 268 mg spot-on solution for large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pipette (2.68 ml) contains:
ACTIVE SUBSTANCE:
Fipronil
268 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.54 mg
Butylhydroxytoluene (E321)
0.27 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.
Revised: March 2020
AN: 00565/2019
Page 2 of 6
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 sulfoxide or
to any of other excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Bathing/immersion in water with
                                
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