NAT-APIXABAN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

APIXABAN

제공처:

NATCO PHARMA (CANADA) INC

ATC 코드:

B01AF02

INN (국제 이름):

APIXABAN

복용량:

5MG

약제 형태:

TABLET

구성:

APIXABAN 5MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

제품 요약:

Active ingredient group (AIG) number: 0153051002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2022-09-20

제품 특성 요약

IMPORTANT: PLEASE READ
_Pr_
_NAT-APIXABAN (apixaban) Product Monograph_
_Page 1 of 80 _
_ _
PRODUCT MONOGRAPH
PR
NAT-APIXABAN
Apixaban Tablets
2.5 mg and 5 mg
Anticoagulant
Natco Pharma (Canada) Inc.
Date of Revision:
2000 Argentia Road, Plaza 1, Suite 200
June 18, 2022
Mississauga ON L5N 1P7
Submission
Control No: 260519
_Pr_
_NAT-APIXABAN Product Monograph_
_Page 2 of 80 _
_ _
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
................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
20
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
............................................................33
SPECIAL HANDLING INSTRUCTIONS
......................................................................
38
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 38
PART II: SCIENTIFIC INFORMATION
..............................................................................
39
PHARMACEUTICAL INFORMATION
........................................................................
39
CLINICAL TRIALS
.........................................................................................................
40
DETAILED PH