PANTOPRAZOLE TABLET (DELAYED-RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

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17-01-2014

有效成分:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

可用日期:

MELIAPHARM INC

ATC代码:

A02BC02

INN(国际名称):

PANTOPRAZOLE

剂量:

40MG

药物剂型:

TABLET (DELAYED-RELEASE)

组成:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

给药途径:

ORAL

每包单位数:

100/500

处方类型:

Prescription

治疗领域:

PROTON-PUMP INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0133229001; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2014-06-25

产品特点

                                PRODUCT MONOGRAPH
PR
PANTOPRAZOLE
Pantoprazole Sodium Delayed-Release Tablets, House Standard
(as pantoprazole 20 mg, 40 mg)
H
+
, K
+
-ATPase Inhibitor
MELIAPHARM INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
January 17, 2014
Submission Control No: 170312
_ _
_PANTOPRAZOLE Product Monograph _
_Page 2 of 39_
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
................................................................................17
PHARMACEUTICAL INFORMATION
..........................................................................17
CLINICAL TRIALS
...................................
                                
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