APO-PRAVASTATIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PRAVASTATIN SODIUM

제공처:

APOTEX INC

ATC 코드:

C10AA03

INN (International Name):

PRAVASTATIN

복용량:

20MG

약제 형태:

TABLET

구성:

PRAVASTATIN SODIUM 20MG

관리 경로:

ORAL

패키지 단위:

30/100/500

처방전 유형:

Prescription

치료 영역:

HMG-COA REDUCTASE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0122563002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2001-02-27

제품 특성 요약

Page 1 of 40
PRODUCT MONOGRAPH
Pr
APO-PRAVASTATIN
PRAVASTATIN SODIUM TABLETS USP
10 MG, 20 MG AND 40 MG
LIPID METABOLISM REGULATOR
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JULY 17, 2020
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 240816
Page 2 of 40
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
........................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................
5
ADVERSE REACTIONS
.......................................................................................................11
DRUG INTERACTIONS
.......................................................................................................16
DOSAGE AND ADMINISTRATION
......................................................................................18
OVERDOSAGE
....................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
......................................................................19
STORAGE AND STABILITY
................................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................22
PART II: SCIENTIFIC INFORMATION .................................................................................23
PHARMACEUTICAL INFORMATION
..................................................................................23
CLINICAL TRIALS
..............................................................................................................24
DETAILED PHARMACOLOGY
......