Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2875

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_001173

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.

24-APR-24

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

10-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. 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 24Apr2024, a veterinary clinic staff member contacted Elanco to report an adverse reaction involving Advantage II Large Cat (Imidacloprid, Pyriproxyfen). The following was reported: From 10Nov2023 to 10Apr2024, the pet owner applied 1 tube of Advantage II Large Cat (Imidacloprid, Pyriproxyfen) to the cat monthly. 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.5

7. Weight (provide a range if necessary )

4.38

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

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Head shaking

12. How long did the symptoms last?

>30 min <=2 hrs / >30 min <=2 h

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

Fully Recovered / Complètement 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

On 10Apr2024, 6 hours after the most recent application, the 7.5 year old, 4.38kg, neutered female, Domestic Shorthair cat was twitching it's head like something was bothering her ears (Head Shaking). 2 hours after onset the cat recovered without treatment. 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