Nouvelle déclaration d'incident
No de la demande: 2017-3239
Numéro de référence du titulaire d'homologation: US-BAYERBAH-2017-406619
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: WASHINGTON
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: advantage II pipette size unknown
Autre (préciser)
Spot-on solutionOui
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
Other / Autre
préciser Unknown
(p.ex. description des symptômes tels que la fréquence et la gravité
2016-08-25 13:47:24 by (name) : Call Notes: Caller was difficult to follow. She reported that three of her cats died that previously used the medication but was not calling to report a fatality. She was wondering if the product had an expiration date. She also was confused and that we were also 1-800 Pet Meds and was trying to ask about ordering. Reason for use of drug: Adverse Reaction-Other Reproductive status: Unknown Place of purchase: Other Animal to animal exposure?: Unknown Misuse: NA/Unknown Case status: Closed No more information is expected. The case is closed. No known necropsy was performed. Call Review: Both large and small cat products were found in a drawer from previous pets. She did not clarify which of the products were used on each of the cats that had died.
Mort
N - Unlikely Death is not expected as inconsistent with pharmacotoxicological product profile and experience. 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. No signs of allergic/anaphylactic reaction reported. Moreover, the information regarding the death of the cat was casually provided during an inquiry, which too was possibly intended for another organisation (Pet meds). Finally, even though some information (e.g. time to onset, necropsy results, particular of the animal, pipette size) was missing, considering known product profile and intent of caller, a product involvement is deemed to be unlikely.