Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
DASATINIB
APOTEX INC
L01EA02
DASATINIB
80MG
TABLET
DASATINIB 80MG
ORAL
30 BOTTLE / 30 BLISTER
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0152198005; AHFS:
APPROVED
2019-11-28
Page 1 of 61 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-DASATINIB Dasatinib Tablets 20 mg, 50 mg, 70 mg, 80 mg and 100 mg Protein Kinase Inhibitor APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Revision: May 10, 2021 Submission Control No: 247860 Page 2 of 61 RECENT MAJOR LABEL CHANGES Dosage and Administration, Dose reduction for concomitant use of strong CYP3A4 inhibitors 05/2021 Dosage and Administration, Dose Adjustment for Adverse Reactions 05/2021 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 ................................................................................................................ 13 DRUG INTERACTIONS................................................................................................................. 27 DOSAGE AND ADMINISTRATION ............................................................................................ 29 OVERDOSAGE ............................................................................................................................... 31 ACTION AND CLINICAL PHARMACOLOGY ........................................................................... 32 STORAGE AND STABILITY ........................................................................................................ 34 SPECIAL HANDLING INSTRUCTIONS ...................................................................................... 34 DOSAGE FORMS, COMPOSITION AN Կարդացեք ամբողջական փաստաթուղթը