Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2816

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000950

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.

11-APR-24

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-APR-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. 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 11-Apr-2024, the animal owner contacted Elanco via phone to report a possible adverse event in a dog involving K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On 10-Apr-2024, a dog was administered 1 tube/pipette of K9 Advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) once, via the topical route, by the owner for flea/tick control. The product was used correctly. No concomitant products were administered.

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

Wheaten Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

18.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Loss of appetite

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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 11-Apr-2024, the 13 year(s) old, 18.2 kilograms, neutered male, Wheaten Terrier dog, in unknown condition, with no concomitant medical conditions, exhibited vomiting, not eating and lethargy approximately 12 hours following the application. The dog was not examined by a veterinarian. It is unknown if the canine was treated. The outcome of the dog is unknown.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here