Nouvelle déclaration d'incident
No de la demande: 2014-0692
Numéro de référence du titulaire d'homologation: 2013CK133
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 77 Belfield Rd
Ville: Toronto
État: ON
Pays: Canada
Code postal /Zip: M9W 1G6
Incident chez un animal domestique
Pays: CANADA
État: ONTARIO
ARLA No d'homologation 27660 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: k9 Advantix 55
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
unknown
1
Homme
4
70
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Inconnu
Inconnu
Unknown/Inconnu
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 11-Jun-2013, the patient was administered 1 tube of Advocate (non - US Registered Product) (Imidacloprid and Moxidectin) once topically by the owner. On 12-Jun-2013, the patient began vomiting. Approximately 12 hours later, the patient had red (erythema), irritated, blotchy (erythema) skin, and application site bleeding, which has continued.
Mineure
LDS Comment: Though dermal reactions at the application site are possible in animals that are particular sensitive, skin disorders on other sites than the application site of product are not expected. Application site bleeding development directly related to product is not expected. Vomiting rather unspecific in dogs and may have multiple potential causes. Time to onset for all signs inconsistent for Advantix (14 days) and occured after application of concomitant product. Considering all aspects, a product connection is deemed to be unlikely. GDS comment: Skin disorders on other than the application site are not typically seen, however considering the short onset time signs may represent a sensitive reaction to the product. They are usually transient. However, vomiting may have various other causes. Oral product uptake was not witnessed. Accidentally ingested product cannot be ruled out as onset time short .In individual cases, dermal reactions at the application site are possible in animals that are particular sensitive however described bleeding not expected and was likely a consequence of self-trauma. Overall, onset time short and thus a product involvement cannot be ruled out.