Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-6149

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001796

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court, Suite 401

City: Mississauga

Prov / State: Ontario

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.

21-SEP-22

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

24-AUG-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. 31517      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Kitten

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.23

Other 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 21-Sep-2022, a clinic staff member contacted Elanco regarding a possible adverse reaction to Advantage II Kitten (Imidacloprid, Pyriproxyfen). On 24-Aug-2022 the pet owner applied half a tube of the product to the cat (misuse underdose).

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

18.75

7. Weight (provide a range if necessary )

5

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

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Recumbent

• General
  • Symptom - Fever

• Blood
  • Symptom - Hyperglycemia

• Nervous and Muscular Systems
  • Symptom - Muscle spasm

• Eye
  • Symptom - Other
  • Specify - Abnormal menace response
  • Symptom - Blindness (permanent)

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

2

Day(s) / Jour(s)

15. Outcome of the incident

Euthanised / Euthanasie

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 24-Aug-2022, an unknown time after application, the 18.75 year old, approximately 5kg, neutered, female, Domestic Shorthair cat, in unknown condition, with concomitant medical conditions of diabetes, which has been treated with 2 unit(s) of protamine zinc recombinant human insulin subcutaneously twice a day since an unknown date, began to seizure and continued to seizure throughout the night. On 25-Aug-2022 the cat was seen by a veterinarian. The cat was in lateral recumbency, had a fever, was hyperglycemic, was having severe spasms, intermittent seizures, had a negative menace, and was blind. The cat was put on IV fluids and was slowly improving throughout the day. On 26-Aug-2022 the seizures had resolved, the spasms had improved but not resolved, body temperature and blood glucose level were both within normal limits, the cat was still in lateral recumbency, and still had a negative menace, and was still blind. On 27-Aug-2022 the cat was discharged from the hospital but symptoms had not resolved. On 30-Aug-2022 the cat was euthanized.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Major

19. Provide supplemental information here