DOM-LANSOPRAZOLE CAPSULE (DELAYED RELEASE)
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
22-06-2017
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유효 성분:
LANSOPRAZOLE
제공처:
DOMINION PHARMACAL
ATC 코드:
A02BC03
INN (국제 이름):
LANSOPRAZOLE
복용량:
15MG
약제 형태:
CAPSULE (DELAYED RELEASE)
구성:
LANSOPRAZOLE 15MG
관리 경로:
ORAL
패키지 단위:
100
처방전 유형:
Prescription
치료 영역:
PROTON-PUMP INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0127666002; AHFS:
승인 상태:
APPROVED
승인 날짜:
2013-11-05
제품 특성 요약
PRODUCT MONOGRAPH
PR
DOM-LANSOPRAZOLE
Lansoprazole delayed-release capsules
15 mg and 30 mg
USP
H+, K+-ATPase Inhibitor
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Quebec
H4P 2T4
Date of Revision:
June 14, 2017
Submission Control No.: 205386
_ _
_Dom-LANSOPRAZOLE Product Monograph _
_Page 2 of 89_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
.........................................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 35
PART II: SCIENTIFIC INFORMATION
..............................................................................
36
PHARMACEUTICAL INFORMATION
.........................................................................
36
CLINICAL TRIALS
.........................................................................................................
37
DETAILED PHARMACOLOGY
.....................................
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