Nouvelle déclaration d'incident
No de la demande: 2014-6115
Numéro de référence du titulaire d'homologation: 2014CK412
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 77 Belfield Rd
Ville: Toronto
État: ON
Pays: Canada
Code postal /Zip: M9W 1G6
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. Inconnu
Nom du produit: Advantage uknown
Liquide
Oui
Inconnu
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
Unknown / Inconnu
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
At an unspecified time post application, the cat was hypersalivating.On an unspecified date post application, in approximately 2009, the cat died. 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 phone call was to discuss the expiration date of remaining product and not to report the death of this patient
Mort
Hypersalivation after suspected ingestion of product is consistent with distaste reaction, however, gastrointestinal sign if any would have occured short time after product application. Time to onset unknown in this case. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Reliability of data is questionable due to limited information (product and animal details, medical history, chronology, necropsy not available). Other etiologies are more probable. Though time to onset unknown, 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. Moreover, caller contacted Bayer Animal Health to inquire about using the remainder of the product on their new pet and not to report this event. Considering this, product involvement was unlikely.