PANTOPRAZOLE FOR INJECTION POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Disponibbli minn:

TEVA CANADA LIMITED

Kodiċi ATC:

A02BC02

INN (Isem Internazzjonali):

PANTOPRAZOLE

Dożaġġ:

40MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

15ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

PROTON-PUMP INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2018-04-30

Karatteristiċi tal-prodott

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