Nouvelle déclaration d'incident
No de la demande: 2019-5094
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0051305 (Report 593407)
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: MICHIGAN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: advantageII pipette size unknown
Autre (préciser)
spot onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Autre
Cat / Chat
unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On unknown date post application, in 2019, the feline exhibited a seizure. The feline was presented to the clinic and died. No necropsy was performed. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable Serious nervous system disorders such as seizures are not anticipated with topical administration of product. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But seizures are not expected. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Unknown whether seizures were confirmed by vet or only observed by owner. Further reported death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Death may have been the result of seizures. Nevertheless, other causes must also be considered although not described. Considering low level of information regarding necropsy, time to onset and animals details, product involvement is deemed to be unassessable.