Nouvelle déclaration d'incident
No de la demande: 2018-5637
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0051327 (Report 517345)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: NEW YORK
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Non
Propriétaire de l'animal
Dog / Chien
Retriever - Golden/Poodle (Unspecified) crossbred
3
Homme
Femme
0.0013
Inconnu
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
<=30 min / <=30 min
Non
Non
Mort
Other / Autre
préciser Puppies were exposure to bitch wearing the collar
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 12 hours after being born on 28-Aug-2018, three of the puppies had perianal burns (anal irritation) and died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss whether the remaining puppies should continue nursing. No further information is expected. This case is closed.
Mort
O - Unclassifiable/unassessable Reported perianal burns is unspecific and may have numerous other causes. 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. 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 oral exposure reported in this case. Further, Laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not produced any effects on fertility or reproduction and showed no teratogenic, or foetotoxic effects. However, the safety of the veterinary medicinal product has not been established in target animals during pregnancy and lactation and in the absence of available data. Moreover, the reason for the initial call was to discuss whether the remaining puppies should continue nursing. Considering short time to onset and limited information about product exposure in puppies, a product involvement is unassessable.