Nouvelle déclaration d'incident
No de la demande: 2017-7495
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0069368 (Report 455025)
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: PENNSYLVANIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Cat Collar
Autre (préciser)
COLLAROui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Shorthair
1
Femme
8
6.35
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Persisted until death
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 20-Oct-2017, blood was observed on the face of the feline; no active bleeding or the origin could be determined. On 21-Oct-2017, the feline had two seizures lasting approximately 1 minute. On 22-Oct-2017, the feline had another seizure and the collar was removed. Immediately post collar removal, the head of the feline began twitching. Approximately 6 hours post collar removal, the feline was examined by a veterinarian, administered an unknown dose of diazepam via intravenous catheter, and died. No necropsy was performed.
Mort
O - Unclassifiable/unassessable Bleeding is not expected with appropriate 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. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Other causes are more likely. Head twitching is not typically seen with appropriate topical product administration. It may be associated with the seizures in this case. Further death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Time to onset is long. Other causes are must be considered. Considering all aspects, a product involvement is unassessable.