Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4882
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001048
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 1919 Minnesota Court, Suite 401
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L5N 0C9
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
06-JUN-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
09-MAY-23
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
Units: mL
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
On 06-Jun-2023, a pet owner contacted Elanco regarding a possible adverse reaction to K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. The dog takes 400mg of Potassium Bromide daily, 125mg of Zonisamide twice a day, Loratadine once daily, 5mg of Prednisone every other day, and Milk Thistle. On 15-Apr-2023 and 18-May-2023 the pet owner applied the K9 Advantix II to the dog.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Siberian Husky
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
26.8
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Nervous and Muscular Systems
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Fully Recovered / Complètement rétabli
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On 09-May-2023, the 5 year old, 26.8kg, neutered, female, Siberian Husky, with a history of epilepsy and an unspecified lung condition, had one seizure and then recovered. On 18-May-2023, 3 hours after application, the dog had one seizure. On 20-May-2023 the dog had one seizure. On 04-Jun-2023 the dog had one seizure. On 04-Jun-2023, an unknown time after onset, the dog recovered. At the time of the report the dog had not been seen by a veterinarian.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here