APO-PRAVASTATIN TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

PRAVASTATIN SODIUM

มีจำหน่ายจาก:

APOTEX INC

รหัส ATC:

C10AA03

INN (ชื่อสากล):

PRAVASTATIN

ปริมาณ:

40MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

PRAVASTATIN SODIUM 40MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

30/100

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

HMG-COA REDUCTASE INHIBITORS

สรุปสินค้า:

Active ingredient group (AIG) number: 0122563003; AHFS:

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2001-02-27

สรุปลักษณะสินค้า

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
......