Nouvelle déclaration d'incident
No de la demande: 2017-6457
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0055185 (Report 441896)
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: CALIFORNIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage (cat-unspecified)
Autre (préciser)
Spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Inconnu
15
Inconnu
Cutanée
>15 min <=2 hrs / >15 min <=2 h
>30 min <=2 hrs / >30 min <=2 h
Système
>30 min <=2 hrs / >30 min <=2 h
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 1 hour post application, the cat exhibited a seizure then died. No necropsy was performed.
Mort
N-Unlikely: Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. 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. Unknown whether seizures were confirmed by vet or only observed by owner. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. The involved animal was geriatric. Moreover, the caller contacted Bayer Animal Health to inquire about a new pet in the household and not to report this event. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 8 years). In the end, even though time to onset is short and no necropsy was performed, considering all aspects and unexpected serious outcome, a product involvement is deemed to be unlikely. The caller contacted Bayer Animal Health to inquire about a new pet in the household and not to report this event.