Nouvelle déclaration d'incident
No de la demande: 2017-4041
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0014305
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: FLORIDA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556 122
Nom du produit: Advantage 100
Autre (préciser)
Spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Non
Propriétaire de l'animal
Dog / Chien
Unknown
1
Inconnu
Inconnu
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
Due to the sensitive nature of the communication, specific relevant details were not obtained nor will they be sought On an unknown date, in approximately 2011, a canine of unknown signalment and condition, with no known concomitant medical conditions, was administered an unknown amount of Advantage (dog-unspecified) (Imidacloprid) topically by the owner. This product is not labeled to be dosed in this manner. On an unknown date post application, in approximately 2011, the dog died due to an unknown cause. No necropsy was performed. The caller contacted Bayer Animal Health to inquire about using a different product on their pet and not to report this event. No more information is expected and the case is closed. Follow up Information 10th April 2017: On an unknown date, in approximately 2011, a canine of unknown signalment and condition, with no known concomitant medical conditions, was administered an unknown amount of Advantage 100 Topical Solution (Imidacloprid) topically by the owner. This was extra label use as the product is not intended to be applied as a partial dose.
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. No signs of allergic/anaphylactic reaction reported. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 6 years). Moreover, the information regarding the death of the dog was casually provided during an inquiry as the caller contacted Bayer Animal Health to inquire about using a different product on their pet and not to report death. Overall, even though low level of information is provided (animal details, medical history, time to onset and necropsy not available), considering the safety profile of the product and intent of the caller, a product relation is unlikely.