Nouvelle déclaration d'incident
No de la demande: 2015-3780
Numéro de référence du titulaire d'homologation: 2015CK261
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
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 1556-155
Nom du produit: Seresto Collar - cat
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
dsh
1
Femme
3
6
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>6 mos / > 6 mois
Système
>24 hrs <=3 days / >24 h <=3 jours
Non
Oui
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 01-Jun-2015, the cat started twitching and having seizures. The cat was examined by the attending veterinarian, had a leukemia test performed which is unknown what the results were, and was given an unknown dose of diazepam to stop the seizures. The vet clinic was able to stop the cat's seizure activity and was sent home.On 02-Jun-2015, the cat started having seizures again. The cat was again examined by the attending veterinarian, had bloodwork performed which is unknown what the results were, was bathed in an unknown shampoo, and was given an unknown dose of diazepam to stop the seizures. The veterinary clinic staff removed the collar from the cat's neck. The cat this time was hospitalized at the veterinary clinic.On 03-Jun-2015, the cat died at the veterinary clinic. A necropsy examination was not performed.Note: Previous exposure is well tolerated by animal.
Mort
N - Unlikely. The product is not anticipated to cause serious neurological disorders such as seizures and twitching 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. Other causes are more likely (e.g. idiopathic epilepsy, tumor). Any action or treatment may trigger seizures in an animal with a respective disposition. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile either. Moreover death is reported after collar removal. Overall, time to onset is exceptionally long. Further, previous application was well tolerated by animal. The collar was worn for 8 months without any adverse signs and had reached the end of its claimed efficacy which means that remaining active ingredient in the collar was low. Considering the known product profile and time to onset, sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out.