Nouvelle déclaration d'incident
No de la demande: 2017-4040
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0014181
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: UNKNOWN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-125
Nom du produit: advantage II medium dog
Autre (préciser)
Spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Miniature Schnauzer
1
Homme
16
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 approximately 2017, a 16 year old, male, Schnauzer (Miniature) canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Medium Dog (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date in 2017, the dog passed away. It is unknown if the dog was examined by a veterinarian and any treatments were performed. No necropsy was performed. No further information is expected. Case is closed. Note: Previous exposure of product was well tolerated by animal. 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 the use of the product and not to report the death of the patient.
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. Previous exposure of product was well tolerated by animal. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of this geriatric patient. Even though some information is not available (health status, medical history, time to onset and necropsy result), sufficient information exists to rule out product relation completely. Overall, a product relation is deemed to be unlikely.