Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0148

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0060247 (Report 678455)

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.

25-NOV-20

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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.       PMRA Submission No.       EPA Registration No. 11556-151

Product Name: advantageII small cat

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Other (specify)

spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 23-Oct-2020, an 18 month old, 2.2 pound, intact, male, Unknown Breed (Rabbit), in poor condition, with concomitant medical conditions of fleas, ear mites, anorexia and weight loss, was seen by the veterinarian and administered .2 ml of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically, an unknown dose of Baytril (enrofloxacin) Antibacterial Injectable Solution 2.27% For Dogs Only (Enrofloxacin) subcutaneously, fluids subcutaneously, .2 ml of ivermectin subcutaneously and an unknown dose of Capstar (nitenpyram) orally by the attending vet. These medications were administered off label.

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

Animal's Owner

2. Type of animal affected

Other / Autre

specify Rabbit

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

0.998

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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

An unspecified time later, in Oct 2020, the rabbit died. No necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable This is an off-label use of product (Unauthorized species). Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. No signs of allergy/anaphylactic reaction are reported. Additionally, this animal with poor health status had concomitant anorexia and weight loss. Other unrelated causes must be considered in this case. Considering the product profile, product involvement is deemed rather unlikely, however due to some information missing (no necropsy report) and time to onset is unknown. Product relation is considered as unassessable.