AVA-PRAVASTATIN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
30-03-2011
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유효 성분:
PRAVASTATIN SODIUM
제공처:
AVANSTRA INC
ATC 코드:
C10AA03
INN (국제 이름):
PRAVASTATIN
복용량:
20MG
약제 형태:
TABLET
구성:
PRAVASTATIN SODIUM 20MG
관리 경로:
ORAL
패키지 단위:
100
처방전 유형:
Prescription
치료 영역:
HMG-COA REDUCTASE INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0122563002; AHFS:
승인 상태:
CANCELLED POST MARKET
승인 날짜:
2011-12-12
제품 특성 요약
Page 1 of 42
PRODUCT MONOGRAPH
Pr
AVA-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
AVANSTRA INC. DATE OF PREPARATION:
10761 – 25TH NE, SUITE 110, BUILDING “B” FEBRUARY 21, 2011
CALGARY, ALBERTA
T2C 3C2
CONTROL NO.: 145177
Page 2 of 42
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.......................................................................................................
10
DRUG INTERACTIONS
.......................................................................................................
15
DOSAGE AND ADMINISTRATION
...................................................................................
17
OVERDOSAGE......................................................................................................................
18
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
19
STORAGE AND
STABILITY...............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 21
PART II: SCIENTIFIC INFORMATION
.............................................................................
22
PHARMACEUTICAL
INFORMATION...............................................................................
22
CLINICAL TRIALS
...............................................................................................................
23
DETAILED PHARMACOLOGY
.......
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