Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0547

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2021_001273

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

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

Domestic Animal

4. Date registrant was first informed of the incident.

01-NOV-21

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

24-OCT-21

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)

---

PMRA Registration No. 29780      PMRA Submission No.       EPA Registration No. 11556-143

Product Name: K9 Advantix II Large Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

---

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 1-Nov-2021 Elanco was made aware of an adverse event with K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) involving a dog. On 24-Oct-2021, a dog in fair condition, with concomitant medical conditions of H of diabetes not well controlled who vocalizes and seems agitated when hypoglycemic, was administered 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner. On 24-Oct-2021 the canine/dog was also administered porcine insulin zinc injection via the injection route 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

Dog / Chien

3. Breed

Schnauzer - Miniature

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

12.7

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• General
  • Symptom - Hyperactivity
  • Symptom - Vocalizing

• Skin
  • Symptom - Erythema
  • Symptom - Other
  • Specify - Hot to touch
  • Symptom - Dermatitis
  • Symptom - Other
  • Specify - Eruption
  • Symptom - Other
  • Specify - Skin weeping
  • Symptom - Inflammation of the skin

• Blood
  • Symptom - Hypoglycemia

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Red skin

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

On 24-Oct-2021, 3 hours after application owner noticed the 11 year old, 12.7 kg, neutered, male, Schnauzer - Miniature crossbred canine/dog, become agitated, vocalized and the area of application looked like red and hot to the touch. The area worsened as the day progressed and the dog was taken to an emergency veterinarian. The veterinarian noted the area looked like a hot spot, having a skin eruption. The area was cleaned and dog was treated with a course of Apoquel. On 25-Oct-2021 the dog was re-examined at regular veterinary clinic as the dog was still agitated. The application site was weeping and inflamed measuring 10cm x 10 cm. Blood glucose levels were also very low. At 8:30 am dog was given 6 units of Caninsulin and a meal. Glucose = 3.8. Dog was given a bath with dish soap. Dog seemed to have calmed down. As of 5-Nov-2021 clinical signs continue.

---

To be determined by Registrant

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

Moderate

19. Provide supplemental information here