Nouvelle déclaration d'incident
No de la demande: 2017-3251
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2015-US0051342
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: WASHINGTON
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage II dog unspecified size
Autre (préciser)
Spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Dachshund
1
Femme
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
>6 mos / > 6 mois
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will be sought. The reason for the initial call was to discuss product expectations and not to report the death of this dog. On an unknown date in approximately 2014, a female, Dachshund canine, of an unknown age, weight, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unknown date post application, in Jul2015, the dog died. It is unknown if a necropsy was performed. No further information expected. Case closed. Follow up received on 01 October 2015: On an unknown date post application, in Jul2015, the dog died.
Mort
N - Unlikely Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW and a 20-fold overdosage is tolerated by dogs without showing any side effect. Time to onset, though not exactly known, is evidently exceptionally long (more than 6 months). Moreover, in this case, the reason for the initial call was to discuss product expectations and not to report the death of this dog. Considering all these aspects, even though level of information was low (regarding animal and product details, necropsy), a product relation was deemed to be unlikely.