PRAVASTATIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PRAVASTATIN SODIUM

제공처:

SIVEM PHARMACEUTICALS ULC

ATC 코드:

C10AA03

INN (국제 이름):

PRAVASTATIN

복용량:

10MG

약제 형태:

TABLET

구성:

PRAVASTATIN SODIUM 10MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

HMG-COA REDUCTASE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0122563001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2022-09-21

제품 특성 요약

_PRAVASTATIN Product Monograph_
Page 1 of 40
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
pravastatin sodium tablets USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
SIVEM PHARMACEUTICALS ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
CONTROL NUMBER: 280722
DATE OF
PREPARATION:
JUL
23, 2012
DATE
OF
REVISION
NOV 27, 2023
_PRAVASTATIN Product Monograph_
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
........................................................................................................