Nouvelle déclaration d'incident
No de la demande: 2015-6154
Numéro de référence du titulaire d'homologation: 2015KP270
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Blvd. East
Ville: Mississauga
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. 11556-130
Nom du produit: Advantage II Extra Large dog
Liquide
Oui
Unités: mL
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
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application, in approximately 2014, the dog had a seizure. One day post seizure, the dog had another seizure and was examined by the veterinarian; no known treatments were provided. One week post exam, the dog had a cluster seizure. The dog was examined by the veterinarian and started on an unknown medication. The dog died approximately 4 hours post administration of the medication. No necropsy was performed. The reason for the initial call was to discuss the use of our product for an active flea infestation on another animal, and not to report the death of the patient. No further information is expected this case is closed.
Mort
Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. Death is inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Moreover death of the animal occurred after administration of the unknown medication. The dog involved in this case was geriatric. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. The reason for the initial call was to discuss the use of product for an active flea infestation on another animal, and not to report the death of the patient. Even though some information is not available (e.g. necropsy report and time to onset), sufficient information exists to ruled out product involvement. Finally, a product relation considered as unlikely.