Nouvelle déclaration d'incident
No de la demande: 2017-0672
Numéro de référence du titulaire d'homologation: 2017KP028
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: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-151
Nom du produit: advantage II small cat
Liquide
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Unknown
1
Homme
22
4
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 28-Oct-2016, the cat died due to unknown causes. No known 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 on her current pet and not to report the death of the patient. No further information is expected. This case is closed. Follow-up received on 1st Dec 2016: On an unknown date in 2016, a 22 year old, 4 pound, neutered, male, Unknown Breed feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid- Pyriproxyfen) topically by the owner.
Mort
Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported in close proximity of product application. 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. The information regarding the death of the cat was casually provided during an inquiry as the reporting party did not contact Bayer Animal Health to report the death of the animal but to discuss the use of Advantage II on her current pet. The cat in this case was geriatric and likely have died of old age. Finally, even though some information (e.g. time to onset, health status and necropsy results) is not available, considering known product safety profile a product relation is unlikely.