Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5473

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0051654 (Report 669156)

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.

05-OCT-20

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

02-OCT-20

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. 11556-150

Product Name: advantage II kitten

• 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.

.23

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 02-Oct-2020, a 5 pound, 9 week old, male, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Kitten (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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.18

7. Weight (provide a range if necessary )

2.268

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Weakness

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Limp

• General
  • Symptom - Death
  • Symptom - Hypothermia

• Nervous and Muscular Systems
  • Symptom - Recumbent

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

Approximately 4 hours post application, the feline exhibited vomiting. On 03-Oct-2020, the feline was limp, weak, and unable to move. The feline was examined by a veterinarian, had a temperature of 92.0 degrees, and was hospitalized. On 04-Oct-2020, the feline died. No necropsy was performed. No further information is expected. This case is closed.

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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 Vomiting may have many potential causes. Sign is not expected after topical product use and oral product intake was not witnessed. However, short time to onset and thus a reaction to accidentally ingested product cannot be excluded. Waekness is likely associated with vomiting. Further limping, unable to rise, hypothermia and death are not expected with use of product as inconsistent with the pharmaco-toxicological product profile. No signs of allergy/anaphylactic reaction. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. No necropsy was performed. Considering the product profile, product involvement is deemed rather unlikely, however due to limited information and short time to onset, case was considered to be unassessable.