Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4929

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001109

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-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

04-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. 27586      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large 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.

.8

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 12-Jun-2023, an RVT contacted Elanco to report a possible adverse event regarding Advantage II Large Cat (Imidacloprid, Pyriproxyfen) concerning a cat. On 04-Jun-2023, a cat was administered 1 tube of Advantage II Large Cat (Imidacloprid, Pyriproxyfen) topically by the owner.

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

Cat / Chat

3. Breed

Maine Coon Cat

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.16

7. Weight (provide a range if necessary )

5.7

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
  • Symptom - Dry skin
  • Specify - Application site skin scaling
  • Symptom - Hair loss
  • Symptom - Lesion
  • Specify - Application site scab

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?

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

Immediately following the application of the Advantage II Large cat, the 1.16 year old, 5.7 kg, neutered, male, Maine Coon Cat, in good condition, with no known concomitant medical conditions, began to scratch at the application site. Approximately 3 hours later there was hair loss, scabs and scaling at the application site. On 05-Jun-2023, the cat was examined by a veterinarian. The cat was given an injection of Dexamethasone 5 mg/mL. Owner is applying Polymyxin B Sulfate 10,000 units/Gramicidin 0.25 mg/Lidocaine Hydrochloride 50mg Cream and Vit E at home. On 09-Jun-2023 the reaction continued. On 11-Jun-2023 the reaction continued. The outcome is unknown.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here