Nouvelle déclaration d'incident
No de la demande: 2016-0699
Numéro de référence du titulaire d'homologation: 2015KP334
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. Inconnu
Nom du produit: advantage spot-on unknown
Liquide
Oui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Autre
Dog / Chien
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date post administration, in 2010, the dog died. It is unknown if the dog 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 product use on her new cats and not to report the death of the patient. Follow up received: On an unknown date in 2010, a canine of unknown signalment and condition, with fleas, was administered 1 tube of Advantage (dog-unspecified) (Imidacloprid) topically by the owner.
Mort
Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold over dosage tolerated by dogs without showing any side effect. No connection in time reported between treatment and death. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (5 years). Further, the owner did not believe in product involvement either as reason for the initial call was to discuss product use on another cats and not to report the death of this dog. Considering these aspects, in spite of the limited information (animal details, time to onset, absence of necropsy results and medical history), a product relation is unlikely.