PANTOPRAZOLE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Available from:

TEVA CANADA LIMITED

ATC code:

A02BC02

INN (International Name):

PANTOPRAZOLE

Dosage:

40MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Administration route:

INTRAVENOUS

Units in package:

15ML

Prescription type:

Prescription

Therapeutic area:

PROTON-PUMP INHIBITORS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-04-30

Summary of Product characteristics

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
.................................