APO-DASATINIB TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DASATINIB

제공처:

APOTEX INC

ATC 코드:

L01EA02

INN (국제 이름):

DASATINIB

복용량:

80MG

약제 형태:

TABLET

구성:

DASATINIB 80MG

관리 경로:

ORAL

패키지 단위:

30 BOTTLE / 30 BLISTER

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0152198005; AHFS:

승인 상태:

APPROVED

승인 날짜:

2019-11-28

제품 특성 요약

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