Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-3999

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_000993

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.

30-MAY-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-MAY-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. 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 30 May 2023, a hospital manager contacted Elanco to report a possible adverse event regarding K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On approximately 15 May 2022, 15 Jun 2022, 15 Jul 2022, 15 Aug 2022, 15 Sep 2022, 15 Oct 2022 and 15 Nov 2022, a dog was administered 1 tube of K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner along the dorsal midline.

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

Terrier - Yorkshire Crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

8.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Other
  • Specify - Appetite disorder

• General
  • Symptom - Pica

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.

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 approximately 15 May 2022, approximately 8 hours following the application, the 13-year-old, 8.8 kg, neutered, female, Yorkshire Terrier crossbred dog, in good condition, with no known concomitant medical conditions, went off food and ate grass. On approximately 18 May 2022, the dog recovered. The same signs occurred 8 hours after each monthly application, then resolved 3 days after each application.

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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