Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-5518
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001305
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.
04-JUL-23
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
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)
PMRA Registration No. 29778
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
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 4 Jul 2023, the veterinary technician contacted Elanco to adverse event that had been treated with Advantage Multi 20 (Imidacloprid, Moxidectin) and K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). From an unknown date in approximately Jan 2023 to Jul 2023, the patient was treated monthly and topically with Advantage Multi. From an unknown date in approximately Jan 2023 to Jul 2023, the patient was treated monthly and topically with K9 advantix II.
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
Miniature Schnauzer
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
6
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>6 mos <=1 yr / > 6 mois < = 1 an
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
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
Not recovered / Non 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
Immediately after each K9 Advantix II application from Jan 2023 to Jul 2023, the 1 year old, 6 kg, neutered female, Miniature Schnauzer, in good condition, with no prior medical history and no other concomitant product, had application site pruritus, lethargy and anorexia. Each time, the lethargy and anorexia resolved after 2 days while the pruritus resolved after 2 weeks. On 4 Jun 2023, the patient was examined and no treatment was done.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here