Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2017-2168

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2017KP112

Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc

Adresse: 2920 matheson BLVD

Ville: Mississaugua

État: ON

Pays: Canada

Code postal /Zip: L4W 5R6

3.Choisir le (les) sous-formulaire(s) correspondant à l'incident.

Incident chez un animal domestique

4. Date à laquelle le titulaire d'homologation a été informé pour la première fois de l'incident.

19-APR-17

5. Lieu de l'incident.

Pays: UNITED STATES

État: UNKNOWN

6. Date de la première observation de l'incident.

30-DEC-15

Description du produit

7. a) Donner le nom de la matière active et, si disponibles, le numéro d'homologation et le nom du produit (incluant tous les mélanges). Si le produit n'est pas homologué, donner le numéro de la demande d'homologation.

Matière(s) active(s)

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ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 11556-151

Nom du produit: advantage II small cat

• Matière active
  • IMIDACLOPRID
    • Garantie/concentration 9.1 %
  • PYRIPROXYFEN
    • Garantie/concentration .46 %

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7. b) Type de formulation.

Liquide

Renseignments sur l'application

8. Est-ce que le produit a été appliqué?

Oui

9. Dose d'application.

.4

Unités: mL

10. Site d'application (choisir tout ce qui s'applique).

Site: Animal / Usage sur un animal domestique

11. Donner tout renseignement additionnel concernant l'application (comment le produit a été appliqué, la quantité utilisée, la superficie de la zone traitée, etc.)

On 28-Dec-2015, an approximately 12.5 year old, 7.2 pound,neutered, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions,exhibited bleeding from her right ear. On 30-Dec-2015, the feline was examined by a veterinarian. A tumor was diagnosed in the right ear and the feline was started on a otic nystatin, neomycin, thiostrepton,triamcinolone ointment. On 13-Jan-2016, the feline was re-examined and the bleeding had resolved. On an unknown date in 2016, the owner accidentally instilled1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen)into the right ear by the owner. The product was wiped out ofthe ear and followed by administration of a ivermectin inglycol ear ointment.

À être déterminé par le titulaire

12. Selon vous, le produit a-t-il été utilisé en conformité avec le mode d'emploi de L'étiquette?

Oui

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Autre

2.Type d'animal touché

Cat / Chat

3. Race

Domestic Shorthair

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

6. Âge (fournir un ordre de grandeur si nécessaire)

12.5

7. Poids (fournir un ordre de grandeur si nécessaire)

7.2

lbs

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Temps écoulé entre l'exposition et l'apparition des symptômes

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Mort

• Systèmes nerveux et musculaire
  • Symptôme - Autre
  • Specify - Neurological disorder

• Oreille
  • Symptôme - Autre
  • Specify - Aural neoplasia

• Systèmes nerveux et musculaire
  • Symptôme - Ataxie

• Système gastro-intestinal
  • Symptôme - Anorexie

• General
  • Symptôme - Malaise

• Peau
  • Symptôme - Autre
  • Specify - Application site haemorrhage
  • Symptôme - Autre
  • Specify - Application site serous discharge

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Oui

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Non

14. b) Combien de temps l'animal était-il hospitalisé?

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Treatment / Traitement

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

On 11-Jun-2016, the feline was examined for unspecified neurological signs. No known treatments were performed. On 14-Jun-2016, the feline was examined by the veterinarian. The tumor in the right ear had increased in size, was glistening and had vast vascular network. A tumor was diagnosed in the left ear. No known treatments were performed. On 22-Jun-2016, the feline was re-examined by the veterinarian. No known treatments were performed. On 05-Jul-2016, the feline was examined, but no treatments were performed. On approximately 06-Jul-2016, the feline exhibited ataxia, circling, anorexia, and discomfort. On 13-Jul-2016, the feline was examined. The right ear tumor was bleeding, quiescent, with slight discharge. A nystatin, neomycin, thiostrepton, triamcinolone ointment was instilled in the ears by the attending vet. On an unknown date in Jul2016, the feline was examined by a veterinary neurologist. No known treatments were performed. On 21-Jul-2016, the feline died. No necropsy was performed. No further information is expected. This case is closed. Follow-up received on 15th March 2017: On 13-Jul-2016, the feline was examined. The right ear tumor had not changed in size but was bleeding and had a slight discharge.

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

Off label use of the product as product was administered in ear. Initially reported unspecified neurological signs are not anticipated with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs but no neurological signs would be expected. Worsening of pre-existing tumor and diagnosed tumor in another ear is not expected after product administration as not in line with pharmaco toxicological product profile. Later observed neurological signs, anorexia and discomfort likely associated with reported tumor in ears. Reported application site disorders are not expected after appropriate product administration, moreover in this case reported application site disorders associated with worsening of ear tumor. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. 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. Animal involved in this case was geriatric and had concomitant condition of tumor which may have further contributed to the death of the animal. Time to onset is unknown for initial reported signs but it is too long for later observed signs. In case of suspected product involvement adverse event would have been reported in close proximity not long time after (almost 7 months later). Even though some information is not available (animal health status and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product relation is consider as unlikely.