Nouvelle déclaration d'incident
No de la demande: 2017-7470
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0064982 (Report 451008)
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: TENNESSEE
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-142
Nom du produit: K9 advantix II medium dog
Autre (préciser)
spot-onOui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Bichon Frise
1
Homme
16
6.804
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date, in Aug 2017, the dog was seen by the veterinarian and administered unspecified vaccinations. Approximately 8 hours post administration, the dog had a seizure. The dog was examined by the veterinarian; it was unspecified if any treatments were performed. Approximately 2 weeks post vaccination, in Sep 2017, the dog had another seizure and a behavior change. The caller contacted Bayer Animal Health to inquire about product use and not to report this event. On 2-Oct-2017 the dog died. It is unknown if a necropsy was performed. Follow up information received on 5th October 2017: Approximately 2 weeks post vaccination, in Sep 2017, the dog had another seizure and a behavior change. On 2-Oct-2017 the dog died. It is unknown if a necropsy was performed. No further information is expected; case is closed. The caller contacted Bayer Animal Health to inquire about product use and not to report this event.
Mort
N - Unlikely At recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after licking. Time to onset unknown, but seems long. Dog tolerated previous applications well, without neurological signs. Behavioural change is an unspecific sign and may have numerous other causes. Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Other causes are more probable. Time to onset too long. No signs of allergy or anaphylactic reaction reported. The caller contacted Bayer Animal Health to inquire about product use and not to report this event. Considering overall aspects, a product relation is deemed to be unlikely.