PRZ-ROSUVASTATIN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
23-09-2020
이 제품에 대한 일부 문서는 현재 사용할 수 없습니다. 고객 서비스에 요청을 보내면 가능한 빨리 알려 드리겠습니다.
요청을 보내십시오.
요청을 보내십시오.
유효 성분:
ROSUVASTATIN (ROSUVASTATIN CALCIUM)
제공처:
PHARMARIS CANADA INC
ATC 코드:
C10AA07
INN (International Name):
ROSUVASTATIN
복용량:
40MG
약제 형태:
TABLET
구성:
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 40MG
관리 경로:
ORAL
패키지 단위:
15G/50G
처방전 유형:
Prescription
치료 영역:
HMG-COA REDUCTASE INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0148963003; AHFS:
승인 상태:
APPROVED
승인 날짜:
2020-09-25
제품 특성 요약
Page 1 of 43
PRODUCT MONOGRAPH
PR
PRZ-ROSUVASTATIN
Rosuvastatin Calcium Tablets, USP
Tablets: 5 mg, 10 mg, 20 mg and 40 mg of rosuvastatin (as rosuvastatin
calcium)
Lipid Metabolism Regulator
Pharmaris Canada Inc.
8310-130 Street, Suite 102,
Surrey, British Columbia
Canada V3W 8J9
DATE OF PREPARATION: September 23,
2020
CONTROL NO: 234091
Page 2 of 43
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................. 3
INDICATIONS AND CLINICAL
USE.......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
5
ADVERSE REACTIONS
..........................................................................................
10
DRUG INTERACTIONS
...........................................................................................
14
DOSAGE AND ADMINISTRATION
.......................................................................
21
OVERDOSAGE
.........................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 23
STORAGE AND STABILITY
..................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 26
PART II: SCIENTIFIC INFORMATION
.............................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................. 27
CLINICAL
TRIALS...................................................................................................
28
DETAILED PHARMACOLOGY
..............................................................................
31
TOXICO
전체 문서 읽기
