PANTOPRAZOLE FOR INJECTION POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

から入手可能:

TEVA CANADA LIMITED

ATCコード:

A02BC02

INN（国際名）:

PANTOPRAZOLE

投薬量:

40MG

医薬品形態:

POWDER FOR SOLUTION

構図:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

15ML

処方タイプ:

Prescription

治療領域:

PROTON-PUMP INHIBITORS

製品概要:

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

認証ステータス:

CANCELLED POST MARKET

承認日:

2018-04-30

製品の特徴

PRODUCT MONOGRAPH
PR
PANTOPRAZOLE FOR INJECTION
Pantoprazole sodium sesquihydrate for injection
40 mg pantoprazole per vial
Intravenous Use Only
Sterile Lyophilized Powder
H
+
, K
+
-ATPASE INHIBITOR
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control Number: 211084
Date of Revision:
November 30, 2017
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Page 2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
8
DOSAGE AND ADMINISTRATION
..............................................................................
10
OVERDOSAGE
.................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 13
STORAGE AND STABILITY
..........................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
........................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 15
PART II: SCIENTIFIC INFORMATION
................................................................................
16
PHARMACEUTICAL INFORMATION
.................................