Nouvelle déclaration d'incident
No de la demande: 2017-6926
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0057991 (Report 444108)
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: CALIFORNIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage Plus Spot-on pipette size unknown
Autre (préciser)
Spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Inconnu
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 approximately 01-Jan-2015, a canine of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On an unspecified date in 2015 the dog had halitosis. On an unspecifed date in 2015 the dog passed away. It is unknown if a 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 inquire about Seresto use with another pet and not to report the death or the halitosis in this event.
Mort
N - Unlikely Halitosis is an unspecific sign and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. 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. Moreover, the reason for the initial phone call call was to inquire about Seresto use with another pet and not to report the death or the halitosis in this event. In case of suspected product involvement case would have been reported in close proximity and not after long time (2 years). Even though some information is not available (e.g. animal details, time to onset, health status, medical history and necropsy report), considering known product profile a product relation is unlikely.