Nouvelle déclaration d'incident
No de la demande: 2015-6297
Numéro de référence du titulaire d'homologation: 2015KP303
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Boulevard
Ville: Missisaugua
État: ON
Pays: Canada
Code postal /Zip: L4W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar - Cat
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Maine Coon
1
Femme
2.5
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Two days post application on an unknown date, the cat was lethargic. Five days post application on an unknown date, the cat was inappetent and adipsic, so the collar was removed. One week post application on an unknown date, the cat presented to the attending vet with worsening clinical signs and had bloodwork performed with unknown results. The veterinarian administered intravenous fluids and steroid injections to the cat. Thirteen days post application on an unknown date, the cat was improving, but could not walk more than a couple feet at a time (weakness). Two weeks post application, the cat began vocalizing, had seizures, and died. It is not known if a necropsy was performed. Limited information was provided by the reporting party in the initial bazaarvoice communication. Attempts to obtain more specific details have been unsuccessful to date.
Mort
Reported non serious systemic disorders two days after collar application are unspecific and may have various causes. Worsening of clinical signs some days later is not expected and is reported after collar removal hence likely related to other cause. Weakness may be consequence of other clinical signs. After the non serious signs improved following collar removal, serious signs seizures and death were reported to start one week after collar was already removed. 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 and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period did not cause serious signs either. Even with oral product exposure, seizures are not expected. Merely gastrointestinal signs would be possible. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset for seizure and death is too long. Hence, other causes are more probable (e.g. idiopathic epilepsy). Overall, considering unexpected serious outcome and long time to onset, sufficient information exists to rule out product involvement.