Nouvelle déclaration d'incident
No de la demande: 2017-4477
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0029125
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: OHIO
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage II pipette size unknown
Autre (préciser)
Spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Unknown/Inconnu
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in 2016, a feline, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unknown date post application, in 2016, the feline died. It is unknown if the feline was euthanized or if a necropsy was performed. No further information is expected. This case is closed. 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 on her dog and was 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. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Other etiologies are more probable. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Moreover, the reason for the initial call to Bayer Animal Health was to discuss the use of K9 Advantix II on her dog and not to report the death of the patient. Though some information is missing in this cat (e.g. exact time to onset, weight, state of health, pipette size and necropsy detail) death is inconsistent with the pharmacological product profile. Also, previous applications were well tolerated. In the end, considering all aspects, a product involvement was ruled out for serious outcome and classified as unlikely.