Nouvelle déclaration d'incident
No de la demande: 2017-2236
Numéro de référence du titulaire d'homologation: 2017KP175
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: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar - Large Dog
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Standard Poodle
1
Homme
14
62
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 16-Mar-2017, the dog exhibited seizures and died. No necropsy was performed. The reason for the call was to discuss the use of Seresto on his current pets and not to report the death of the patient. No further information is expected. This case is closed. Follow up recieved on 16th Mar 2017: On approximately 16-Feb-2017, the dog exhibited seizures and died.
Mort
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. Merely gastrointestinal signs would be possible. 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. Further, death is 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. Dog involved in this case was geriatric and thus other unrelated causes must be considered. Death may be the consequence of seizure. The reason for the call was to discuss the use of product on his current pets and not to report the death of the patient. Time to onset short, though. Although product involvement is considered unlikely, due to limited information (e.g. no necropsy), a product relation is unassessable.