Nouvelle déclaration d'incident
No de la demande: 2018-6448
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0065767 (Report 532063)
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: UTAH
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-152
Nom du produit: Advantage II Large Cat
Autre (préciser)
Spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Inconnu
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 12 hours post administration, the cat exhibited an application site rash. On an unknown date in approximately 2016, post administration and onset of clinical signs, the application site rash resolved with no medical intervention. On an unknown date in approximately 2016, post administration, the cat died due to unknown circumstances. It is unknown if a necropsy was performed. 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 the use of Advantage II in a new cat and not to report the death of the patient. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable Dermal reactions like reported transient rash at the application site in a particularly sensitive animal is expected. Time to onset is short. However, the information regarding the death of the cat was casually provided during an inquiry and intent of call was to discuss the use of product in a new cat and not to report the death of the patient. The level of information is extremely low (weight, age and state of health of the cat, necropsy details). Nevertheless death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic or anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. In case of suspected product involvement, death would have been reported in close proximity to the product application. Time to onset is unknown, however seems longer considering application site rash had already resolved. Considering overall aspect, a product relation is unassessable.