Nouvelle déclaration d'incident
No de la demande: 2019-5936
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0056960 (Report 600278)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson Blvd
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L4W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: PENNSYLVANIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: K9advantixII pipette size unknown
Liquide
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Bichon Frise
1
Inconnu
11
Inconnu
Cutanée
Unknown / Inconnu
<=30 min / <=30 min
Système
Unknown / Inconnu
Non
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Immediately post application, the canine exhibited an allergic reaction and behavioral change. The canine was examined by a veterinarian who recommended they discontinue use. The canine had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. The canine's clinical signs resolved. On an unknown date in 2018, the canine died. No known necropsy was performed.
Mort
Advantix Plus Spot-on pipette size unknown O - Unclassifiable/unassessable Product has very low allergic potential. However, in individual cases, a hypersensitivity reaction to the product is possible in animals that are particularly sensitive (as with any substance). Time to onset is short. No other possible cause reported. Reported behavioral change may be a response to the feeling caused by the applied product and/or allergic reaction. Later reported death is not expected after product application as it is inconsistent with the pharmaco-toxicological profile of the product. Other etiologies are likely. The animal involved in this case is geriatric. No necropsy was performed. Considering all aspects, a product relation for the case remains unassessable. Seresto Collar unknown O - Unclassifiable/unassessable An allergic reaction and behavioural change were reported prior to collar administration. Hence, signs are not product related. Later reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. The animal involved in this case geriatric. No necropsy was performed. Time to onset is unknown. Considering the known product profile, sufficient information exists to conclude that the product did not cause the event. In the end, product involvement was considered unassessable.