Nouvelle déclaration d'incident
No de la demande: 2017-6942
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0060956 (Report 447010)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: NEW YORK
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-151
Nom du produit: Advantage II Small Cat
Autre (préciser)
Spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Non
Propriétaire de l'animal
Cat / Chat
Birman (Sacred Birman)
1
Homme
16
4.536
kg
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Unknown / Inconnu
Inconnu
Oui
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 22-Aug-2017, a 16 year old, approximately 10 pound, neutered, male, Birman (Sacred Birman) cat, in unknown condition, with a concomitant medical condition of fleas, was administered a partial tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. This product is not labeled for partial tube application, nor is it labeled for application on cats weighing more than 9 pounds. On 23-Aug-2017, the cat exhibited multiple seizure episodes. The cat was examined by a veterinarian who hospitalized the cat for continued observation and the cat died. No necropsy was performed. No further information is expected; the case is closed. On Aug 2017 the cat was also administered unknown of via the unknown route by the animal owner.
Mort
O - Unclassifiable/unassessable Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. No oral product exposure is reported. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/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 this case, a tool low dose of product was applied which makes product involvement even more unlikely. Involved animal was geriatric, thus other underlying conditions must be considered. Time to onset is short, though. Finally, a product involvement is considered as unassessable.