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)

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PMRA Registration No. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Medium Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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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
  • Symptom - Seizure

• General
  • Symptom - Death

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.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here