Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2819

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_000968

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.

12-APR-24

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-APR-24

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 12Apr2024, a clinic staff member contacted Elanco regarding a possible adverse reaction K9 advantix II Large Dog on their pet and reported the following: On 09Apr2024, the dog was applied with 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen), topically for flea/tick control. No concomitant products were administered.

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

Samoyed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

20.1

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Agitation

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 09Apr2024, immediately post application, the 4-year-old, 20.1 kilogram, neutered female, Samoyed dog in a good condition with no concomitant medical conditions, developed pruritus (unknown if at application site), drooling, and was agitation. Update from the clinic on 17Apr2024: On 10Apr2024, the drooling resolved without treatment. On 12Apr2024, the pruritus and agitation resolved without treatment.

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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