Nouvelle déclaration d'incident
No de la demande: 2019-3158
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0025181 (Report 566943)
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: CALIFORNIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Cat (Flumethrin-Imidacloprid) Collar
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Turkish X Angora crossbred
1
Femme
7
4.536
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 17-May-2019 the cat exhibited lethargy, one episode of emesis that resolved approximately 5 minutes post onset, and vocalization. On 24-May-2019 the cat exhibited weight loss, hypersalivation, convulsions, and the cat died. No necropsy was performed. The cat was not evaluated by a veterinarian and no treatments were performed.
Mort
O - Unclassifiable/unassessable Reported vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Time to onset is long. Reported lethargy and vocalisation are also unspecific and may have numerous other causes. Signs may occur initially after collar administration. Time to onset is consistent for these signs. Lethargy in this case may be associated with vomiting. The product is not anticipated to cause serious neurological disorders such as convulsions 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 and also thereafter. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Hypersalivation may be associated with convulsions. Weight loss and death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Time to onset is long. Hence, other causes must be considered. Overall, considering all aspects, a product relation for the case remains unassessable.