APOQUEL Comprimé

Țară: Canada

Limbă: franceză

Sursă: Health Canada

Ingredient activ:

OCLACITINIB (Acide d'oclacitinib malique)

Disponibil de la:

ZOETIS CANADA INC

Dozare:

16MG

Forma farmaceutică:

Comprimé

Compoziție:

OCLACITINIB (Acide d'oclacitinib malique) 16MG

Calea de administrare:

Orale

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Grupul Terapeutică:

Chiens

Rezumat produs:

Numéro de groupe d'ingrédients actifs (GIA) :0155910003

Statutul autorizaţiei:

APPROUVÉ

Data de autorizare:

2014-07-09

Prospect

Apoquel
Labelling
April 16, 2020
EXTENDED LABEL - 3.6 MG, 5.4 MG AND 16 MG TABLETS - 20 OR 100 COUNT
BOTTLES
Note that the net contents are interchangeable (there is one bottle
size only for all strengths and
count bottles).
3.6 MG STRENGTH
Apoquel
Labelling
April 16, 2020
5.4 MG STRENGTH
Apoquel
Labelling
April 16, 2020
16 MG STRENGTH
Apoquel
Labelling
April 16, 2020
PACKAGE INSERT (part of the extended label and applicable to all
strengths)
DIN 02427885
DIN 02427893
DIN 02427907
APOQUEL
TM
oclacitinib tablets
VETERINARY USE ONLY
JANUS KINASE INHIBITOR FOR DOGS
DESCRIPTION: APOQUEL
TM
(oclacitinib maleate) is a synthetic Janus Kinase inhibitor. The
chemical name of the active ingredient in
APOQUEL tablets is N-methyl[trans-4-(methyl-7H-
pyrrolo[2,3-d]pyrimidin-4-ylamino) cyclohexyl]methanesulfonamide
(2Z)-2-butenedioate.
The chemical structure of oclacitinib maleate is:
INDICATIONS: For the control of pruritus associated with allergic
dermatitis and for the control of
atopic dermatitis in dogs at least 12 months of age.
DOSAGE AND ADMINISTRATION: The dose of APOQUEL tablets is 0.4 mg/kg to
0.6 mg oclacitinib
/kg body weight, administered orally, twice daily for up to 14 days,
and then administered once
daily for maintenance therapy. APOQUEL tablets may be administered
with or without food.
DOSING CHART
DOG BODY WEIGHT
(KG)
3.6 MG TABLETS
5.4 MG TABLETS
16 MG TABLETS
3 – 4.4
0.5
4.5 – 5.9
0.5
6 – 8.9
1
9 – 13.4
1
13.5 – 19.9
0.5
20 – 26.9
2
27 – 39.9
1
40 – 54.9
1.5
55 – 80
2
Apoquel
Labelling
April 16, 2020
CONTRAINDICATIONS:
APOQUEL tablets should not be given to dogs with known or suspected
allergy or intolerance to
oclacitinib maleate or any other components of this product.
APOQUEL tablets are not for use in dogs less than 12 months of age
(see ANIMAL SAFETY).
APOQUEL tablets are not for use in dogs with serious infections,
evidence of immune
suppression or evidence of malignant neoplasia.
APOQUEL tablets are not for use in breeding dogs, pregnant or
lactating bitches.
CAUTIONS:
The safe us