Nouvelle déclaration d'incident
No de la demande: 2017-4951
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0046888
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. 11556-117
Nom du produit: Advantage 10 Topical Solution
Autre (préciser)
Spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Inconnu
Inconnu
2.268
kg
Cutanée
Unknown / Inconnu
>2 hrs <=8 hrs / > 2 h < = 8 h
Système
Unknown / Inconnu
Non
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 6 hours post administration, the canine developed halitosis that smelled like product. The canine recovered the next day with no medical treatment. On an unknown date in 2003 post application the canine died. No necropsy was performed.
Mort
The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. This case is closed. N-Unlikely:The product is not expected to cause halitosis in the treated dog. As oral ingestion of product was not reported, other causes (e.g. diet, tartar) have to be considered in this case. Apart from that, the smell of any agent is subjective to the individual concerned. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. No signs of allergy/anaphylactic reaction reported. Further, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Finally, even though some information is missing (medical history, time to onset for serious sign and necropsy result) considering known product profile and unexpected fatal outcome, a product involvement is deemed to be unlikely.