Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5702

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001479

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.

20-JUL-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

10-JUL-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 20 Jul 2023, a veterinary technician contacted Elanco to report an adverse reaction in a dog that had been treated with K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 20 (Imidacloprid, Moxidectin). This dog had previously been treated with both products during the summer of 2022 with no issues. On approximately 1 Jun 2023, the patient was treated topically with Advantage Multi 20. On approximately 10 Jun 2023, the patient was treated topically with K9 advantix II Medium Dog. On approximately 1 Jul 2023, the patient was dosed again with Advantage Multi 20. On 10 Jul 2023, the patient was dosed with K9 advantix II Medium 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

crossbred Shih Tzu X Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12.58

7. Weight (provide a range if necessary )

7.5

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

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Loss of appetite
  • Symptom - Vomiting
  • Symptom - Diarrhea

• Skin
  • Symptom - Pruritus

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 10 Jul 2023, 3 to 4 hours after application, the 12.58 year old, 7.5 kg, neutered female, Shih Tzu X Chihuahua dog, vomited 10 times, had diarrhea with mucous, and application site pruritus. On 12 Jul 2023, the patient vomited once, continued to have diarrhea and had a decreased appetite. On 13 Jul 2023, the vomiting resolved. On15 Jul 2023, the diarrhea resolved. The other signs were ongoing.

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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