Nouvelle déclaration d'incident
No de la demande: 2018-2421
Numéro de référence du titulaire d'homologation: 2018EB038
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: CANADA
État: ONTARIO
ARLA No d'homologation 29778 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: K9advantixII medium dog
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Professionnel de la santé
Dog / Chien
Poodle
1
Homme
9
5.6
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
>1 mo and <= 2mos / >1 mois et < = 2mois
Oui
Oui
1
Day(s) / Jour(s)
Euthanised / Euthanasie
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Less than 12 hours later, the patient had some redness at the site of application and application site pruritus. The patient also developed diarrhea. The patient was seen at the clinic on May 3rd and was treated with an anti-inflammatory and an anti-histamine injection. on May 7 the dog was vomiting and was treated with injectable cerenia, oral metronidazole and fortiflora. the vomiting and diarrhea ended on May 10. On May 17 the dog was examined as he had been vomiting occasionally since May 14; Biochemistry and CBC blood work was normal. Dog was given a cerenia injection. on June 07 dog started to have stranguria and tenesmus. Abdominal Xrays and blood work were normal on June 7. dog was treated with Metacam,metronidazole and cerenia. on June 8, dog was seen at an emergency clinic for dysuria: physical exam was normal and dog was sent home; dog had more stranguria and bladder obstruction on June 14 and was admitted to a referral hospital and a urinary catheter was inserted to relieve the obstruction . On June 15 ,an ultra sound revealed possible prostatic neoplasia; dog was euthanized at the owner's request
Majeure
unlikely Redness and pruritus at the site of application site most likely reflect local dermal sensitivity to the product. Diarrhea is rather unspecific sign in dogs and may have multiple potential causes. Potential oral uptake was not reported. Later reported stranguria is not expected, however in this case it is likely a consequence of further diagnosed prostatic neoplasia. Further diagnosed enlarged and heterogeneous prostate with central mass of mineralization, diagnosed prostate neoplasia, chronic changes in the left kidney and need for euthanasia are not expected in dogs after product application, as inconsistent with pharmaco-toxicological product profile. However owner may have decided to euthanize the dog due to diagnosed prostate neoplasia. Other causes are more likely. Though time to onset is consistent for initial signs, prostate enlargement with subsequent stranguria 35 days after product application was likely pre-existing. In the end, a product connection is considered unlikely.