Nouvelle déclaration d'incident
No de la demande: 2018-2737
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0033627 (Report 499700)
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: VIRGINIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: advantageII pipette size unknown
Autre (préciser)
Spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Unknown
1
Homme
Inconnu
Inconnu
Cutanée
<=15 min / <=15 min
<=30 min / <=30 min
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Immediately post-application, the cat started foaming at the mouth. The owner bathed the cat in an unspecified amount of an unknown shampoo. Approximately 10 minutes post-onset of the clinical sign, the cat stopped foaming at the mouth. On an unspecified date in approximately Jun-2016, the cat passed away. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained nor will they be sought. No further information is expected. This case is closed. Note: The intent of this call was not to report this event but to inquire about the use of Seresto on another animal.
Mort
N - Unlikely Foaming at the mouth after suspected ingestion of product. Sign is consistent with distaste reaction. Later reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. 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, adverse event would have been reported in close proximity and not long time after (2 years). Other causes are more probable. Further the owner does not believe in product involvement either as the intent of this call was not to report this event but to inquire about the use of product on another animal. Even though time to onset is consistent for initially reported foaming at mouth; it is too long for death. Finally, considering safety profile of the product and intent of the call, a product involvement is unlikely.