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Sécurité des produits de consommation

Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2018-0471

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0078493 (Report 464603)

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.

20-DEC-17

5. Lieu de l'incident.

Pays: UNITED STATES

État: VIRGINIA

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

Inconnu

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)

ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. Inconnu

Nom du produit: Advantage II (cat-unspecified)

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

ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 11556-155

Nom du produit: Seresto Cat

  • Matière active
    • FLUMETHRIN
    • IMIDACLOPRID
      • Garantie/concentration 10 %

7. b) Type de formulation.

Autre (préciser)

COLLAR

Renseignments sur l'application

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

Oui

9. Dose d'application.

1

Autres unités: Collar

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 an unknown date in approximately Jul 2017, an 11 year old, 18 pound, neutered, male, Maine Coon Cat feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date in approximately Sep2017 the cat was pruritic and had fleas. The owner applied 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically to the cat. On an unspecified date in approximately Oct 2017 the cat continued to have fleas and the pruritus increased. The owner applied 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically to the cat. On an unspecified date in Nov2017 the cat had 1 Seresto cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unspecified date in approximately Nov2017 the owner applied 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically to the cat.

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?

Inconnu

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Cat / Chat

3. Race

Maine Coon

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

Femme

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

11

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

8.165

kg

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

Unknown / Inconnu

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

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

  • General
    • Symptôme - Mort
  • Peau
    • Symptôme -
  • Système gastro-intestinal
    • Symptôme - Vomit
    • Symptôme - Diarrhée

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.

Non

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 an unspecified date in late Nov2017 the cat exhibited vomiting and diarrhea. On an unspecified date in Dec2017 the pruritus worsened, fleas continued to be found and vomiting and diarrhea continued. On 19 Dec2017 the cat died. It was unknown if the cat was treated by a veterinarian for the signs. No necropsy was performed. No further information is expected. This case is closed. The intent of the call was to discuss product use in other pets and not to report the death of the cat.


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 (cat-unspecified) N - Unlikely SLEE/fleas. Reported pruritus is not expected with appropriate topical product use. If any, skin reaction would be located at the application site. Skin disorder in this case rather associated with current flea infestation. However, presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Animal received regular treatments. However, a break in treatment probably induced the rebuilding of the flea population in the environment. The new treatment does not cover the flea cycle since the break. As existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, a re-infestation from the environment is likely. Therefore a lack of efficacy cannot be considered. Reported digestive disorders are unspecific and may have multiple other causes. Oral ingestion of product was not observed. Further, death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Other unrelated causes are more probable in this geriatric cat. Moreover, the intent of the call was to discuss product use in other pets and not to report the death of the cat. Finally, considering long time to onset and fatal outcome, a product involvement is unlikely. Seresto Cat N - Unlikely SLEE/fleas. Reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure reported. Reported pruritus is not expected with appropriate topical product use. If any, skin reaction would be located at the application site of the collar. Skin disorder in this case rather associated with current flea infestation. However, presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Unknown if re-infestation from infested environment (e.g. by means of other untreated animals, wildlife) occurred. Reported death is not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. Other unrelated causes are more probable in this geriatric cat. Moreover, the intent of the call was to discuss product use in other pets and not to report the death of the cat. Even though time to onset is unknown, considering products known safety profile and fatal outcome, a product involvement is unlikely.