Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-6146
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2022_001779
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 1919 Minnesota Court, Suite 401
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L5N 0C9
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
19-SEP-22
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
01-SEP-22
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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
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 19 Sep 2022, the clinic's staff contacted Elanco regarding an adverse event in a dog following administration of Interceptor Plus 23/228 mg (milbemycin oxime, praziquantel) and K9 Advantix II Extra Large dog (Permethrin, Imidacloprid, Pyriproxyfen). On 1 Jun 2022, the patient was started on monthly application of K9 Advantix II. No issues were reported. On 1 Aug 2022, the patient was started on monthly oral administration of Interceptor Plus. No issues were observed following the first administration. On 1 Sep 2022, the second dose of Interceptor Plus was given.
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
Siberian Husky dog
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.8
7. Weight (provide a range if necessary )
28.5
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
12. How long did the symptoms last?
Unknown / Inconnu
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 1 Sep 2022, within 20 minutes of the Interceptor Plus administration, the 10 month old, 28.5 kg, intact male, Siberian Husky dog, with no known concomitant medical conditions, presented one episode of emesis. The dog recovered the same day without treatment.
Redosing of the patient was planned in the next days.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here