Nouvelle déclaration d'incident
No de la demande: 2018-2271
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0022248 (Report 486891)
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: KANSAS
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Cat
Autre (préciser)
COLLAROui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Shorthair
1
Homme
1
Inconnu
Cutanée
Unknown / Inconnu
<=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
Approximately 5 minutes post application, the cat exhibited abnormal behavior of staring at a fixed object out the window. Approximately 6 minutes post application, the cat exhibited a seizure-like episode that resolved approximately 1 minute post onset then the cat ran into a wall and died. No known necropsy was performed. The reason for the initial phone call was to discuss use of another product with another animal and not to report the death in this event.
Mort
O - Unclassifiable/unassessable Reported staring behaviour is unspecific and may have numerous other causes. Unclear if it may be a behavioural response to the collar application as started shortly after product application. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of adult cats for an 8 months period and in 10 week old kittens for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Also, seizures not confirmed by a veterinarian. Thus, misinterpretation of clinical condition cannot be ruled out. Other causes must be considered as well. Later reported running into a wall is not expected and may be associated with the seizure like episode. Serious sign like death is not expected either, following appropriate topical product application as inconsistent with product's pharmacological profile. Death not directly related to the collar application but likely to the cats running into a wall. Moreover, the reason for the initial phone call was to discuss use of another product with another animal and not to report the death in this event. Time to onst short, though. In the end, a product relation is deemed to be unassessable.