Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6721

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002173

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.

21-SEP-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-AUG-23

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)

---

PMRA Registration No. 27586      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large Cat

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

---

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 21-Sep-2023 a pet owner contacted Elanco to report a possible adverse event regarding Advantage II Large Cat (Imidacloprid, Pyriproxyfen) involving a cat. On approximately 17-Aug-2023, a cat was administered 1 tube of Advantage II Large Cat (Imidacloprid, Pyriproxyfen) topically by the owner. On approximately 14-Sep-2023 the pet owner applied a partial dose of Advantage II Large Cat (Imidacloprid, Pyriproxyfen) (misuse: underdose).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

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

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

4.7

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Other
  • Specify - Unspecified allergic reaction

• Skin
  • Symptom - Itchy skin
  • Symptom - Hair loss

• Nervous and Muscular Systems
  • Symptom - Agitation

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

On approximately 19-Aug-2023, the 5 year old, 4.7kg, neutered, female, Domestic Shorthair cat, in good condition, with no known concomitant medical conditions was itchy all over, agitated, and had a thinning hair coat (hair loss). On 25-Sep-2023, the cat was examined by a veterinarian who indicated the cat had an allergic reaction to the Advantage II affecting the whole body. The cat was administered an injection of Methyl Prednisolone 20 mg/ml. On 26-Sep-2023 the cat was no longer itchy or agitated but the hair loss continued.

---

To be determined by Registrant

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

Moderate

19. Provide supplemental information here