Nouvelle déclaration d'incident
No de la demande: 2017-0568
Numéro de référence du titulaire d'homologation: 2017KP071
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 - Cat
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Cat / Chat
Maine Coon
1
Homme
12
7
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 06-Oct-2016, the feline devloped seizures. The feline was taken into a veterinary clinic for evaluation. The feline had a complete blood count, chemistry, Vetscan, FIV test, and blood pressure taken but the results were not provided. The feline was given Prednisone. On approximately 09-Oct-2016, the feline was doing better. On 10-Oct-2016, the feline died. It is not known if a necropsy was conducted. No additional information expected. Case closed. Follow-up received on 14th Oct 2016: On 14-Sep-2016, a 12 year old, 7 pound, neutered, male, Maine Coon Cat feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat collar(Flumethrin-Imidacloprid) applied by the owner. On 07-Oct-2016, the feline developed seizures. The feline was examined by the veterinarian. A complete blood count, blood chemistry, unspecified blood gas, a feline immunodeficiency virus test, and blood pressure were performed; the results are unknown. The feline was administered an unspecified dose of prednisone. On approximately 09-Oct-2016, the clinical signs continued but improved. On 10-Oct-2016, the feline died. No necropsy was performed. No additional information expected. Case closed.
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. Death is not expected either as inconsistent with pharmacotoxicological product profile. 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, serious signs are not expected. Merely gastrointestinal signs would be possible. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Time to onset is not suggestive of product involvement. Other causes are more probable in this advanced aged cat. Although unknown if necropsy was performed, considering the known product profile sufficient information exists to conclude that the product did not cause the serious event and hence product involvement is unlikely.