Nouvelle déclaration d'incident
No de la demande: 2019-5071
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0045848 (Report 588570)
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: TEXAS
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: advantageII pipette size unknown
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage Spot-on pipette size unknown
Autre (préciser)
spot onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
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
On an unspecified date post application, in 2018, the cat developed neoplasia. It was unknown if the cat was examined by a veterinarian or if any treatments were performed. An an unknown date in 2018, post application and post onset of the clinical sign, the cat died. It was not known if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will such be sought. The intent of the call was to inquire about product use in general and not to report this event. No further information is expected. This case is closed.
Mort
Advantage Plus Spot-on pipette size unknown O - Unclassifiable/unassessable Reported neoplasia and death are not expected with topical product application. They are not consistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Additionally, the intent of the call was to inquire about product use in general and not to report this event. Other causes must be considered. However, considering unknown time to onset, a product relation is unassessable. Advantage Spot-on pipette size unknown N - Unlikely Reported neoplasia and death are not expected with topical product application. They are not consistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Additionally, the intent of the call was to inquire about product use in general and not to report this event. Time to onset is too long (8 years). Other causes are likely. Overall, a product relation for the case is considered unlikely.