Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4848
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001001
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.
31-MAY-23
5. Location of incident.
Country: CANADA
Prov / State: ALBERTA
6. Date incident was first observed.
16-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. 29780
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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 31-May-2023, a veterinary clinic staff member contacted Elanco regarding a possible adverse event to K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On 15-May-2023, the dog was administered 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the veterinarian (misuse type: under dose). The dog was also prescribed 1 dose of oclacitinib maleate orally by the owner once daily.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Siberian Husky
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7.4
7. Weight (provide a range if necessary )
26.7
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
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
Unknown/Inconnu
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 16-May-2023, the 7.4 year old, 26.7 kg, neutered, male, Siberian Husky dog, in fair condition, with concomitant medical conditions of lice, had a seizure and became tachypneic and lethargic. It was examined at another veterinary clinic where bloodwork was done that was within all normal limits. On 22-May-2023 the dog had another seizure. On 24-May-2023 the dog was examined by the attending veterinarian who did radiographs with no significant findings. On 31-May-2023 the dog had a Snap 4DX test, which was negative.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here