Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2890

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2024_001219;

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.

29-APR-24

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-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. 27585      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Small Cat

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 29Apr2024, a pet owner contacted Elanco to report extra label use and an adverse reaction with Advantage II Small Cat (Imidacloprid, Pyriproxyfen). The following was reported: On 12Apr2024, the cat owner applied 1 tube of Advantage II Small Cat (Imidacloprid, Pyriproxyfen) to the cat. The product was not used correctly (Low dose). No concomitant products were administered.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair cat

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.25

7. Weight (provide a range if necessary )

4.1

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

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Pruritus
  • Symptom - Hair loss

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Hiding

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 14Apr2024, the approximately 1.25 year old, 4.1kg, neutered female, Domestic Shorthair cat developed generalized pruritus, was anorexic, lethargic, had application site hair loss, and was hiding. On 30Apr2024 the anorexia and lethargy improved and the cat was no longer hiding. The cat was not examined by a veterinarian. The cat was not treated. The outcome of this case is unknown.

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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