Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2017-7483

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0067345 (Report 453563)

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

Adresse: 2920 Matheson BLVD

Ville: Mississaugua

État: ON

Pays: Canada

Code postal /Zip: L5W5R6

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.

13-OCT-17

5. Lieu de l'incident.

Pays: UNITED STATES

État: DELAWARE

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

12-OCT-17

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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ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 11556-143

Nom du produit: K9 Advantix II Large Dog

• Matière active
  • IMIDACLOPRID
    • Garantie/concentration 8.8 %
  • PERMETHRIN
    • Garantie/concentration 44 %
  • PYRIPROXYFEN
    • Garantie/concentration .44 %

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7. b) Type de formulation.

Autre (préciser)

Spot-on

Renseignments sur l'application

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

Oui

9. Dose d'application.

2.5

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.)

A 3 year old, 7 pound, neutered, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 12-Oct-2017, the feline was accidentally administered a partial tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was extra label use of product as it is not labeled for use in cats.

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?

Non

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

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)

3

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

3.18

kg

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

>8 hrs <= 24 hrs / >8 h <= 24 h

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

<=30 min / <=30 min

11. Énumérer tous les symptômes

Système

• Systèmes nerveux et musculaire
  • Symptôme - Agitation
  • Symptôme - Allongé
  • Symptôme - Crise
  • Symptôme - Réveil difficile
  • Symptôme - Contraction musculaire

• Sang
  • Symptôme - Hypoglycémie

• General
  • Symptôme - Hypothermie
  • Symptôme - Comportement anormal
  • Specify - Behavioural disorder NOS (animal ran off outside)
  • Symptôme - Mort

12. Quelle a été la durée des symptômes?

>8 hrs <=24 hrs / > 8 h < = 24 h

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?

Inconnu

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 an unspecified date in approximately 2017, a 3 year old, 7 pound, neutered, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 12-Oct-2017, the feline was accidentally administered a partial tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was extra label use of product as it is not labeled for use in cats. The Advantage II Small Cat box contained 1 tube of K9 Advantix II Large Dog within the box. Immediately post application, the cat exhibited agitation and ran off outside (behavioral disorder NOS). On 13-Oct-2017, approximately 12 hours post application, the cat returned home, behavioral disorder NOS resolved, and then exhibited recumbency, seizures and was unable to rise. The cat was examined by a veterinarian, on presentation, the cat continued to exhibit seizures, and hypothermia. The cat was administered 2 unspecified doses of midazolam followed by 1 unspecified dose of Propofol then was administered intravenous fluids; the seizure resolved and the cat began to exhibit twitching. The cat was then bathed with an unspecified hand soap and bloodwork was performed; the blood glucose was 22 (hypoglycemia), the patient was then warmed and the clinical signs continued. Follow up received on 24th Oct 2017: On an unspecified date in approximately 2017, a 3 year old, 7 pound, neutered, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 12-Oct-2017, the feline was accidentally administered a full tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was extra label use of product as it is not labeled for use in cats. The Advantage II Small Cat box contained 1 tube of K9 Advantix II Large Dog within the box. Immediately post application, the cat exhibited agitation and ran off outside (behavioral disorder NOS). On 13-Oct-2017, approximately 12 hours post application, the cat returned home then exhibited recumbency, seizures and was unable to rise. The cat was examined by a veterinarian and exhibited seizures, and hypothermia. The cat was administered 2 unspecified doses of midazolam followed by 1 unspecified dose of propofol then intravenous fluids; the seizure resolved and the cat began to exhibit twitching. The cat was then bathed with an unspecified hand soap and bloodwork was performed; the blood glucose was 22 (hypoglycemia), the patient was then warmed. Approximately 4 hours post onset, the feline died. No necropsy conducted.

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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

Advantage II Small Cat N - Unlikely Agitation and running off are unspecific signs and may have multiple potential other causes in an animal. Serious nervous system disorder such as seizure is not anticipated with topical administration of product. No direct relation in time reported for this product. The use of Advantix containing the active ingredient permethrin which is toxic for cats has to be considered first in that case. Twitching, recumbency, hypothermia and unable to rise are not anticipated after product application, signs are likely a consequence of seizures. Hypoglycemia is likely inter related to seizure. Death is not expected either, as it is inconsistent with pharmaco-toxicological product profile. Cat may have died due to underlying medical condition or application of permethrin containing product. Though time to onset is unknown, overall, a product connection is deemed to be unlikely. K9 Advantix II Large Dog B - Possible Off-label Use (unauthorized species). Reported agitation, seizures and twitching are consistent with permethrin toxicity following direct product use on a cat. Running off might be associated with agitation. Recumbency and unable to rise are likely linked to reported seizures. Hypothermia might be a consequence of therapy. Hypoglycemia is not expected after product exposure, however, might be associated with other reported signs. However, even though permethrin is toxic for cats and may have a fatal outcome, generally cats have a good chance to recover if adequate treatment is applied in time. Considering consistent time to onset and typical signs of permethrin toxicity in cats, a product connection is deemed to be possible.