PANTOPRAZOLE FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Fáanlegur frá:

TEVA CANADA LIMITED

ATC númer:

A02BC02

INN (Alþjóðlegt nafn):

PANTOPRAZOLE

Skammtar:

40MG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

15ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

PROTON-PUMP INHIBITORS

Vörulýsing:

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

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2018-04-30

Vara einkenni

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
______________________________________________________________________________
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
.................................