PANTOPRAZOLE FOR INJECTION POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

A02BC02

INN (International Nazwa):

PANTOPRAZOLE

Dawkowanie:

40MG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

15ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PROTON-PUMP INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2018-04-30

Charakterystyka produktu

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