Nouvelle déclaration d'incident
No de la demande: 2018-2728
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0031846 (Report 498059)
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: NORTH CAROLINA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: advantageII pipette size unknown
Autre (préciser)
Spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Femme
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in approximately 2015, post administration, the dog died due to unknown circumstances. No 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 call was to discuss the use of K9 Advantix II in the owner's new dog and not to report the death of the patient. No further information is expected. This case is closed.
Mort
N - Unlikely Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. 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. No signs of allergic/anaphylactic reaction reported. Other etiologies are more probable. Moreover, the intent of the call was not to report this event, but to inquire about the product use in another pet. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (almost 3 years). Even though some information is not available (e.g. time to onset and necropsy report), considering unexpected fatal outcome and intent of the call, a product relation considered unlikely. N - Unlikely Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. 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. No signs of allergic/anaphylactic reaction reported. Other etiologies are more probable. Moreover, the intent of the call was not to report this event, but to inquire about the product use in another pet. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (almost 3 years). Even though some information is not available (e.g. time to onset and necropsy report), considering unexpected fatal outcome and intent of the call, a product relation considered unlikely.