Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-1107

2. Registrant Information.

Registrant Reference Number: CA201500260

Registrant Name (Full Legal Name no abbreviations): Novartis Animal Health Canada Inc.

Address: 2000 Argentia Road, Suite 400 Plaza 3

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L5N 1V9

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

25-FEB-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

25-FEB-15

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. 28297      PMRA Submission No.       EPA Registration No.

Product Name: Agita Fly Bait 1 kg

• Active Ingredient(s)
  • (Z)-9-TRICOSENE
  • THIAMETHOXAM

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7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Shepherd cross

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

36.4

kg

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Respiratory System
  • Symptom - Dyspnea
  • Symptom - Cyanosis

• Gastrointestinal System
  • Symptom - Salivating excessively

• Nervous and Muscular Systems
  • Symptom - Confusion

• Respiratory System
  • Symptom - Difficulty Breathing

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Impaired conciousness

• Respiratory System
  • Symptom - Respiratory distress

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.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

15. Outcome of the incident

Euthanised / Euthanasie

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 25 Feb 2015, the clinic's staff contacted the company call center regarding dyspnea, impaired consciousness and drooling in a dog following accidental ingestion of an unknown quantity of thiamethoxam (worst case scenario dose: 1.1 mg/kg). A verbal history was obtained. The dog was not a regular patient at the clinic where it was presented. On 22 Feb 2015, the owner had found the dog eating thiamethoxam fly bait in the room where the product was stored with other farm products which may have also included warfarin. 72 hours post ingestion, the patient started to present breathing difficulty. The sign worsened overnight and the owner took the dog to the clinic where it was hospitalized and treated with intravenous fluids (IV fluids) and an injection of dexamethasone. A radiograph of the chest was unremarkable. The signs improved for a period of time but worsened again. The dog was having more and more difficulty to breathe (coded as respiratory distress) and became cyanotic. It was euthanized for humane reason. UPDATE 11 Mar 2015 The clinic staff confirmed that the owner declined necropsy. The clinic was also informed that per the safety data for this product, the dose ingested by the patient was very unlikely to cause the reported signs.

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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

Assessment: Timing possible. Not fitting pharmacodynamics but fitting for signs reported in the literature with this class of pesticide (neonicotinoid) at toxic levels. Not fitting pharmacodynamics in this dog considering the estimated maximum dose ingested and known safety data in dogs and LD50 in rats. Health status of patient prior to incident is unknown. Possible ingestion of other pesticide is confounding. Without necropsy, this case is unassessable. (O)