Nouvelle déclaration d'incident
No de la demande: 2018-5549
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0057770 (Report 524062)
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: OHIO
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-152
Nom du produit: Advantage II Large Cat
Autre (préciser)
spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic (Unspecified
1
Homme
2
5.897
kg
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>2 hrs <=8 hrs / > 2 h < = 8 h
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 3 hours post application, the cat developed shaking. Approximately 4 hours post application, the cat developed a seizure, hypersalivaton, and eyes rolling back. Approximately 1 minute after onset of clinical signs, the seizure, hypersalivation, and rolling back eyes stopped, and the saking continued. Approximately 12 hours post application, the cat died. The cat was not examined by the veterinarian. It is unkown if a necropsy has been performed.
Mort
O - Unclassifiable/unassessable Reported shaking is not expected and may have multiple potential other causes in an animal. In this case sign likely associated with onset of later reported seizure. Serious nervous system disorders such as seizure is not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizure in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But seizure is not expected. 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. Other causes must be considered. Hypersalivation and eyes rolling back are likely secondary to seizure. Further reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile and likely consequence of seizure. a lot of Information not available (e.g. necropsy and animal details), thus considering all aspects and short time to onset , a product relation is unassessable.