Nouvelle déclaration d'incident
No de la demande: 2017-4019
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0022032
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
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Unknown
1
Femme
5
Inconnu
Cutanée
>3 days <=1 wk / >3 jours <=1 sem
>3 days <=1 wk / >3 jours <=1 sem
Système
>8 hrs <=24 hrs / > 8 h < = 24 h
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 02-May-2017, a 5 year old, of unknown weight, female, dog, in unknown condition, with no known concomitant medical conditions, was administered 1 collar of Seresto Large Dog (Flumethrin-Imidacloprid) via the topical route by the animal owner. On 02-May-2017 the dog was also administered an unknown dose of milbemycin Oxime/lufenuron and unspecified vaccines. On 06 May 2017 the dog refused to eat or drink. On 07 May 2017, the clinical signs continued. The owner consulted with a veterinarian via telephone and the dog was given aspirin. The dog died later that night. No necropsy was performed. Follow-up received on 08th May 2017: No necropsy was performed. No more information is expected and the case is closed.
Mort
N - Unlikely Reported not eating and drinking are unspecific and may have numerous other causes. Signs may occur initially after collar administration but not several days after collar application. 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. An overdose of 5 collars around the neck was investigated in 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 without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Overall time to onset is long. Other products were given concurrently. Some information is not available (e.g. state of health and necropsy details). But overall, other unrelated causes were deemed more likely as time to onset long and a product involvement is deemed to be unlikely.