Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4937

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001136

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.

14-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Large 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.

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 14 Jun 2023, the pet owner contacted Elanco regarding an adverse reaction involving a dog administered K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). Further information was obtained from the veterinary staff member. On an unknown date in May 2023, the owner administered the dog's first dose of K9 Advantix ll.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Sheepdog X Poodle crossbreed dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

19.5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Foaming at mouth

• Nervous and Muscular Systems
  • Symptom - Recumbent
  • Symptom - Other
  • Specify - Paddling legs

• Respiratory System
  • Symptom - Laboured breathing

• Eye
  • Symptom - Decreased vision

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 day after administration of K9 Advantix II, the 3 year old, 19.5 kg, neutered female Sheepdog X Poodle crossbreed dog was foaming at the mouth, on her side, paddling her legs, with laboured breathing for between 30-50 seconds. After this the dog recovered slowly during which time it appeared to not see very well. An examination was sought with the regular veterinarian and a veterinary neurologist who confirmed the signs were due to a seizure. The dog experienced several more seizures until 2 Jun 2023, at which time it recovered with no further signs at the time of case reporting. No treatment was reported.

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To be determined by Registrant

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

Major

19. Provide supplemental information here