Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-6130

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001543

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.

16-AUG-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-AUG-22

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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Small 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.

.4

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 16 Aug 2022 the veterinary technician contacted Elanco regarding a possible adverse effect of Advantage Multi 10 (Imidacloprid, Moxidectin) and K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen). This dog had received monthly seasonal (summer) doses of both products since 2014 with no previous adverse effects. On approximately 30 Jul 2022 the owner administered a dose of K9 Advantix ll small dog. On approximately 1 Aug 2022 the owner applied a dose of Advantage Multi.

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

4

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure

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

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

The owner reported that 7 days after the Advantage Multi was applied, on approximately 08Aug2022, the 8 year old, 4 kg, neutered male Shih tzu dog, had a seizure like episode then recovered with no treatment. At the time of the call there had been no further episodes. No veterinary examination or diagnostics were done.

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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