Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4971

2. Registrant Information.

Registrant Reference Number: 2018-CA-00144

Registrant Name (Full Legal Name no abbreviations): Virbac Animal Health

Address: 3200 Meacham Blvd.

City: Fort Worth

Prov / State: TX

Country: United States

Postal Code: 76137

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

Domestic Animal

4. Date registrant was first informed of the incident.

25-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

24-MAY-18

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. 32589      PMRA Submission No.       EPA Registration No.

Product Name: PREVENTIC Topical Solution

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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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 25 May 2018, sponsor was contacted to report an apparent adverse reaction to PREVENTIC (8.8 % imidacloprid, 44 % permethrin) Topical Solution Small Dog. According to the animal owner, the product was applied on 24 May 2018.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Hyperactivity

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Abnormal behaviour
  • Specify - agitated and jumping

• Nervous and Muscular Systems
  • Symptom - Agitation

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 25 May 2018, sponsor was contacted to report an apparent adverse reaction to PREVENTIC (8.8 % imidacloprid, 44 % permethrin) Topical Solution Small Dog. According to the animal owner, the product was applied on 24 May 2018 and upon application the dog appeared very restless, agitated, was jumping and was reported to be pruritic. The dog was bathed with an unspecified shampoo and the reported signs resolved. On 01 June 2018, a follow-up call was made and further confirmed that the dog was doing well. No additional information is expected.

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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

Sponsor notes that individual sensitivities can be noted with use of product.