Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2272

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000612

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.

11-MAR-24

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

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 11 Mar 2024, a veterinary clinic staff member contacted Elanco to report an adverse reaction with K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) involving a dog. On an unknown date in 2023 and on 07 Mar 2024, the pet owner applied K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) to a dog.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Shepherd Dog - Australian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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

• General
  • Symptom -
  • Specify - Unspecified adverse event

• 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

Unknown/Inconnu

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 an unknown date after the first application of K9 Advantix II, the female, neutered, Australian Shepherd dog of unknown age and weight, experienced an unspecified adverse event. On an unknown date the dog recovered. On 07 Mar 2024, one hour after application of K9 Advantix II, the now 1 year old, 19.63 kg, neutered female, Australian Shepherd Dog, exhibited application site pruritus. On 07 Mar 2024, the pet owner bathed the dog with an unspecified shampoo. The dog improved after the bath, but it is unknown if the dog recovered.

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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