Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6268

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001863

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-AUG-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

18-MAY-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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Medium Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 24-Aug-2023, a clinic staff member contacted Elanco regarding a possible adverse reaction to K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 18-May-2023 the pet owner applied the product to the dog.

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

Dog / Chien

3. Breed

Schnauzer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.33

7. Weight (provide a range if necessary )

7.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting

• Skin
  • Symptom - Pruritus

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

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 18 May 2023, 2 hours post application, the 8.33-year-old, 7.8 kg, neutered female Schnauzer, in good condition, with no known concomitant medical conditions, began vomiting, had diarrhea, and had application site pruritus. On 18 May 2023, an unknown time after onset, the pet owner gave the dog maropitant 16mg as per the veterinarian's recommendation. The product had been prescribed for the dog previously. On 21 May 2023, the dog recovered.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here