Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-2318

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_000432

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.

04-APR-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Large 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.

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 4-Apr-2022, a pet owner contacted Elanco regarding K9 Advantix II Large Dog. The pet owner applied the product monthly from approximately 04-May-2021 to approximately 04-Aug-2021.

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

Border Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

18.6

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

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Other
  • Specify - Inflammatory bowel disease

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non 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

An unknown time after each application, a 2.5 year old, 18.6kg, intact, male, Border Collie dog, in unknown condition, with concomitant medical condition of being an MDR1 carrier, developed pruritus, not specified if generalized or at the application site. The pruritus would last 2 weeks and the dog would recover without treatment. On 11-Aug-2021 the dog began vomiting. Approximately 1 1/2 weeks after the vomiting began the dog was seen by a veterinarian and prescribed Cerenia. On approximately 15-Sep-2021 the dog was diagnosed with Inflammatory bowel disease. The dog was prescribed a special diet (unspecified as to which diet). On approximately 31-Dec-2021 the vomiting resolved. The Inflammatory bowel disease is under control but not resolved.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here