TARO-SUNITINIB CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SUNITINIB (SUNITINIB MALATE)

Διαθέσιμο από:

TARO PHARMACEUTICALS INC

Φαρμακολογική κατηγορία (ATC):

L01EX01

INN (Διεθνής Όνομα):

SUNITINIB

Δοσολογία:

37.5MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

SUNITINIB (SUNITINIB MALATE) 37.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0151642004; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2022-01-07

Αρχείο Π.Χ.Π.

_Pr_
_TARO-SUNITINIB Product Monograph _
_ Page 1 of 65_
PRODUCT MONOGRAPH
PR
TARO-SUNITINIB
Sunitinib
Capsules
12.5 mg, 25 mg, 37.5 mg, 50 mg sunitinib
per capsule (as sunitinib
malate)
Tyrosine Kinase Inhibitor, Anti-Tumour Agent
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, ON
L6T 1C1
Date of Preparation:
January 5, 2022
Submission
Control No.: 235867
_Pr_
_TARO-SUNITINIB Product Monograph _
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_Page 2 of 65 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND
PRECAUTIONS....................................................................................
4
ADVERSE
REACTIONS....................................................................................................15
DRUG INTERACTIONS
....................................................................................................30
DOSAGE AND ADMINISTRATION
.................................................................................31
OVERDOSAGE
..................................................................................................................32
ACTION AND CLINICAL
PHARMACOLOGY...............................................................32
STORAGE AND STABILITY
............................................................................................36
SPECIAL HANDLING
INSTRUCTIONS..........................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................36
PART II: SCIENTIFIC INFORMATION
.............................................................................37
PHARMACEUTICAL INFORMATION
.............