Nouvelle déclaration d'incident
No de la demande: 2017-4472
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0028565
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: FLORIDA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-127
Nom du produit: advantage II large dog
Autre (préciser)
spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
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 an unspecified date in approximately 2017, a canine, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application, in approximately 2017, the dog died. No known necropsy was performed. Limited information was obtained at the time of the communication. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about a product reimbursement and not to report the death of this animal. No more information is expected; this case is closed
Mort
N - Unlikely Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Moreover, the reason for the initial call to Bayer was to inquire about product reimbursement and not to report the death of this animal. No signs of allergy/anaphylactic reaction reported. Even though some information (e.g. health status, time to onset and necropsy results) is not available, considering the known safety profile of the product and serious outcome of the case, a product involvement is deemed to be unlikely.