Nouvelle déclaration d'incident
No de la demande: 2017-6937
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0059970 (Report 445858)
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: UNKNOWN
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
English Springer Spaniel
1
Homme
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
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 2016, a male, Spaniel - Springer (Unspecified) dog, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On an unspecified date in approximately 2016, post application, the dog 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 inquire about product expiration date and not to report the death in this event. No further information is expected.; the case is closed Note: Previous exposure was well tolerated by animal.
Mort
N - Unlikely Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergy/anaphylactic reaction reported. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Moreover, the reason the initial phone call was to inquire about product expiration date and not to report the death of the dog. Previous exposure was well tolerated by animal. Even though, some information( time to onset, no necropsy report) available, considering safety profile of the product, a product relation is unlikely.