MAR-MIDODRINE TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
16-06-2020
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유효 성분:
MIDODRINE HYDROCHLORIDE
제공처:
MARCAN PHARMACEUTICALS INC
ATC 코드:
C01CA17
INN (국제 이름):
MIDODRINE
복용량:
5MG
약제 형태:
TABLET
구성:
MIDODRINE HYDROCHLORIDE 5MG
관리 경로:
ORAL
패키지 단위:
100
처방전 유형:
Prescription
치료 영역:
ALPHA-ADRENERGIC AGONISTS
제품 요약:
Active ingredient group (AIG) number: 0123066002; AHFS:
승인 상태:
APPROVED
승인 날짜:
2018-03-19
제품 특성 요약
Page 1 of 23
PRODUCT MONOGRAPH
Pr
MAR-MIDODRINE
MIDODRINE HYDROCHLORIDE TABLETS
2.5 MG AND 5 MG
MANUFACTURER’S STANDARD
VASOPRESSOR
Marcan Pharmaceuticals Inc.
Date of Preparation:
2 Gurdwara Road, Suite #112,
June 16, 2020
Ottawa, ON, K2E 1A2
Submission Control No:
239625
Page 2 of 23
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION
.................................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
................................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................................
4
ADVERSE REACTIONS
................................................................................................................
6
DRUG INTERACTIONS
...............................................................................................................
12
DOSAGE AND ADMINISTRATION
...........................................................................................
12
OVERDOSAGE
.............................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
14
STORAGE AND STABILITY
......................................................................................................
15
PART II: SCIENTIFIC INFORMATION
........................................................................................
12
PHARMACEUTICAL INFORMATION
......................................................................................
12
CLINICAL TRIALS
...................................................................................................................
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