Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-7207

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002541

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.

26-OCT-23

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

25-OCT-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)

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PMRA Registration No. 27582      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • 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 26-Oct-2023, a clinic staff member contacted Elanco regarding a possible adverse reaction to Advantage II Large Dog (Imidacloprid, Pyriproxyfen) in a dog. On 23-Oct-2023 the pet owner applied the product to the dog (misuse overdose).

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred Cocker Spaniel/ Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.2

7. Weight (provide a range if necessary )

10.95

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Pain

• Respiratory System
  • Symptom - Panting

• General
  • Symptom - Vocalizing

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

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 25-Oct-2023, the 2.2 year old, 10.95 kg, neutered, male, crossbred Cocker Spaniel/ Poodle dog, was panting, crying (vocalizing), anorexic, and painful on his neck. On 26-Oct-2023 the dog was seen by the veterinarian who found the dog to have neck pain. A full blood panel was performed, and the results were all within normal limits. A SNAP 4DX was also performed and the result was negative. At the time of the report no treatments had been prescribed.

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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