MYLAN-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
09-02-2018
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유효 성분:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
제공처:
MYLAN PHARMACEUTICALS ULC
ATC 코드:
A02BC05
INN (International Name):
ESOMEPRAZOLE
복용량:
20MG
약제 형태:
TABLET (DELAYED-RELEASE)
구성:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20MG
관리 경로:
ORAL
패키지 단위:
100
처방전 유형:
Prescription
치료 영역:
PROTON-PUMP INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0145162001; AHFS:
승인 상태:
CANCELLED POST MARKET
승인 날짜:
2020-06-16
제품 특성 요약
Page 1 of 58
PRODUCT MONOGRAPH
PR
MYLAN-ESOMEPRAZOLE
Esomeprazole Delayed Release Tablets
20 mg and 40 mg esomeprazole (as esomeprazole magnesium trihydrate)
H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Rd.
Etobicoke, Ontario Canada
M8Z 2S6
Control Number: 212758
Date of Revision: February 9, 2018
Page 2 of 58
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
....................................................................................................
9
DRUG
INTERACTIONS
..................................................................................................
17
DOSAGE
AND
ADMINISTRATION
................................................................................
20
OVERDOSAGE
..................................................................................................................
23
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................... 24
STORAGE
AND
STABILITY
..........................................................................................
28
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ................................................ 28
PART II: SCIENTIFIC INFORMATION .......................................................................
30
PHARMACEUTICAL
INFORMATION
.........................................................................
30
DETAILED
PHARMACOLOGY
.......................................................................................
38
TOXICOLOGY
.............................................
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