Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4978

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001193

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.

20-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-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 20 Jun 2023, the veterinary technician contacted Elanco to report an adverse reaction in a dog that had been treated topically with K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 55 (Imidacloprid, Moxidectin). Dates of application on the form were different than the dates verbally reported by the veterinary technician therefore the verbal report dates have been used for reporting purposes. On 16 Jun 2023, the patient was treated topically with K9 advantix II for the first time. On 19 Jun 2023, the patient was treated topically with Advantage Multi

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

Havanese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

10.48

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Skin
  • Symptom - Red skin
  • Symptom - Irritated skin

• General
  • Symptom - Abnormal behaviour
  • Specify - Rolling

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

12. How long did the symptoms last?

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

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 19 Jun 2023, an unknown time after administration of Advantage Multi, the 6 year old, 10.48 kg, neutered female, Havanese dog, in good condition with no concomitant medication or prior medical history, developed red irritated skin at the application site, rolling on the ground, vomited once and became lethargic. On 20 Jun 2023, a phone conversation between the veterinary technician and the pet owner indicated that he patient had recovered from all signs. No veterinary exam or treatment had been done.

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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