Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1819
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000436
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.
27-FEB-24
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
23-FEB-24
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. 29778
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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 27 Feb 2024, an attending veterinary dermatologist contacted Elanco regarding a possible adverse effect Atopica 50 mg (cyclosporine) in a dog, and noted the dog was also receiving K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). For the last 2 years, the dog was administered K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) monthly for parasite control, oral oclacitinib daily, and lokivetmab injections once monthly (with the most recent dose on 5 Feb 2024). On 15 Feb 2024 the dog was administered Atopica 50 mg (cyclosporine), 1 capsule daily, in addition to the previously listed medications.
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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Terrier - Boston
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5.5
7. Weight (provide a range if necessary )
10.4
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 yr / > 1 an
10. Time between exposure and onset of symptoms
>6 mos / > 6 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
Died
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 23 Feb 2024, the 5.5 year old, 10.4 kg, neutered male Boston Terrier, with a 2 year history of atopic dermatitis, began having seizures. On 24 Feb 2024 the dog was found dead. No necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here