Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4900

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001079

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.

08-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

05-JUN-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 08-Jun-2023, a clinic staff member contacted Elanco regarding a possible adverse reaction to K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On 28-Apr-2023 and on 05-Jun-2023 the pet owner applied the product to the dog. The pet owner reported that the dog has had this product in the past.

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 Poodle crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

5.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Abnormal behaviour
  • Specify - Rolling

• Skin
  • Symptom - Pruritus
  • Specify - Rubbing

• General
  • Symptom - Lethargy

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

On 05-Jun-2023, immediately after application, the 2 year old, 5.2kg, neutered, female, Shih Tzu/Poodle crossbred dog was rolling, rubbing, and was lethargic. The clinic recommended bathing the dog and applying Vitamin E to the application site. It is unknown if either was done. On 06-Jun-2023 the rolling and rubbing had resolved without treatment but the lethargy continued. On 07-Jun-2023 the lethargy resolved without treatment. The pet owner reported that the dog has reacted in the past, but the details of the previous reaction were not provided.

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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