TARO-DASATINIB TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
19-03-2021
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Aktiva substanser:
DASATINIB
Tillgänglig från:
TARO PHARMACEUTICALS INC
ATC-kod:
L01EA02
INN (International namn):
DASATINIB
Dos:
70MG
Läkemedelsform:
TABLET
Sammansättning:
DASATINIB 70MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
ANTINEOPLASTIC AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0152198003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2020-05-21
Produktens egenskaper
Page 1 of 65
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-DASATINIB
Dasatinib Tablets
20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg dasatinib
Protein-tyrosine kinase inhibitor
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario
Canada L6T 1C1
Date of Revision:
March 19, 2021
Submission Control No: 245318
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
.............................................................................................
14
DRUG INTERACTIONS
.............................................................................................
28
DOSAGE AND ADMINISTRATION
..........................................................................
30
OVERDOSAGE
...........................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 33
STORAGE AND STABILITY
.....................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
................................................................... 35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 35
PART II: SCIENTIFIC INFORMATION
..........................................................................
37
PHARMACEUTICAL INFORMATION
......................................................................
37
CLINICAL TRIALS
.........................................................................................
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