New incident report
Incident Report Number: 2018-5804
Registrant Reference Number: 2018EB220
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: CANADA
Prov / State: QUEBEC
PMRA Registration No. 27582 PMRA Submission No. EPA Registration No.
Product Name: advantageII large dog
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Medical Professional
Dog / Chien
Poodle
1
Female
13
24
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
Persisted until death
No
No
Euthanised / Euthanasie
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On August 29th at 11 pm the patient had a seizure, the patient had 2 other seizures on August 30th at 2 am and 7 am. The patient was seen in clinic on August 30th and was euthanized. This patient did not have a previous history of seizures.
Major
N - Unlikely Serious nervous system disorder such as seizure is not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But seizures are not expected. Other causes are more likely in this geriatric dog. Further, need for euthanasia is not expected following appropriate topical product application. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Election has been elected due to underlying condition of seizures. Time to onset is long. Even though no necropsy was performed, overall, a product involvement is considered to be unlikely.