Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0549

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2021_001306

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

08-NOV-21

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

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. 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 08-Nov-2021, a veterinarian reported a suspected adverse event to Elanco to Advantage II Large Cat (Imidacloprid, Pyriproxyfen) in a cat. On 20-Sept-2021, the pet owner administered 1 pipette of Advantage II Large Cat topically on the patient's shoulder blade area for flea treatment.

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

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

5.6

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 - Itchy skin
  • Symptom - Lesion

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

Less than 48 hours after application the 3 year old, male neutered, 5.6kg, cat of unknown breed, in good health, with no known concurrent medications or medical issues, developed generalized itchy skin and application site scab. Throughout the month, the patient developed other scabs on his face and neck. The patient was not seen by a veterinarian or treated, the itchy skin persisted throughout the month. On 20-Oct-2021, the pet owner administered 1 pipette of Advantage Large Cat (Imidacloprid, Pyriproxyfen) topically at the base of the neck. Less than 48 hours after application the patient's itchy skin continued and a second application site scab appeared. It is unknown if the patient was treated. The outcome 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