MYLAN-ESOMEPRAZOLE CAPSULE (DELAYED RELEASE)
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
28-01-2017
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유효 성분:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)
제공처:
MYLAN PHARMACEUTICALS ULC
ATC 코드:
A02BC05
INN (International Name):
ESOMEPRAZOLE
복용량:
20MG
약제 형태:
CAPSULE (DELAYED RELEASE)
구성:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 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 PRE MARKET
승인 날짜:
2017-01-11
제품 특성 요약
1
PRODUCT MONOGRAPH
PR
MYLAN-ESOMEPRAZOLE
esomeprazole delayed release capsules
20 and 40 mg esomeprazole (as esomeprazole magnesium)
H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Rd.
Etobicoke, Ontario
M8Z 2S6
Control Number: 194955
Submission Control No.
Date of Revision:
June 03, 2016
2
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
......................................................................................................
8
DRUG INTERACTIONS
....................................................................................................
14
DOSAGE AND ADMINISTRATION
................................................................................
17
OVERDOSAGE
..................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 19
STORAGE AND STABILITY
............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 22
PART II: SCIENTIFIC INFORMATION
............................................................................
24
PHARMACEUTICAL INFORMATION
........................................................................
24
CLINICAL TRIALS
............................................................................................................
25
DETAILED PHARMACOLOGY
................
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