Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2276

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000665

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.

16-MAR-24

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-MAR-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. 27586      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large Cat

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 16Mar2024, a pet owner contacted Elanco to report an adverse reaction with Advantage II Large Cat (Imidacloprid, Pyriproxyfen). The following was reported: On an unknown date in Aug 2023 and on 14 Mar 2024, the pet owner applied 1 tube of Advantage II Large Cat (Imidacloprid, Pyriproxyfen) to a cat. The product was used according to label.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

5.45

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Abnormal behaviour
  • Specify - Ran away
  • Symptom - Lethargy
  • Symptom - Licking

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

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 14Mar2024, an unknown time after application, the approximately 1.5 year old, 5.45 kilogram, neutered male, domestic shorthair cat, in unknown condition and no concomitant medical conditions, ran away, was lethargic, and was licking at the application site. On 16Mar2024 the cat developed diarrhea and had a decreased appetite but the cat did come out to play with the pet owner. The cat was not examined by a veterinarian.

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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