Nouvelle déclaration d'incident
No de la demande: 2017-7472
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0065156 (Report 450820)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: OKLAHOMA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-152
Nom du produit: Advantage II Large Cat
Autre (préciser)
Spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in approximately 2017, a cat, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. Approximately 5 minutes post application, the cat self groomed and licked some of the product. On an unspecified date in approximately 2017, approximately 3 months post application, the cat was examined by a veterinarian who diagnosed an unspecified stomach cancer and the cat died. No known necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss product use on another cat in the household and not to report the death in this event. No further information is expected. This case is closed.
Mort
N - Unlikely The reported digestive tract neoplasm and consequent fatal outcome are not expected as they are inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. A 24-fold overdosage tolerated by cats without showing any side effect. Even with oral product exposure, signs would not be expected, but rather hypersalivation. Signs appeared 3 months after product application, but considering a sign such as neoplasm, development of sign likely began even prior to product application. Moreover, the reason for the initial phone call was to discuss product use on another cat in the household and not to report the death in this event. Finally considering other more probable underlying causes, intent of call and known product profile, a product relation is considered unlikely.