ABBOTT-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

זמין מ:

ABBOTT LABORATORIES, LIMITED

קוד ATC:

A02BC02

INN (שם בינלאומי):

PANTOPRAZOLE

כמות:

40MG

טופס פרצבטיות:

TABLET (DELAYED-RELEASE)

הרכב:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100/500

סוג מרשם:

Prescription

איזור תרפויטי:

PROTON-PUMP INHIBITORS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2015-12-31

מאפייני מוצר

_ _
_Abbott-Pantoprazole Product Monograph _
_Page 1 of 39 _
PRODUCT MONOGRAPH
PR
ABBOTT-PANTOPRAZOLE
Pantoprazole Sodium Delayed Release Tablets USP
20 and 40 mg pantoprazole (as pantoprazole sodium sesquihydrate)
H
+
, K
+
-ATPase Inhibitor
Abbott Laboratories, Limited
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Preparation:
September 18, 2013
Date of Revision:
June 3, 2015
Submission Control No.: 184223
_ _
_Abbott-Pantoprazole Product Monograph _
_Page 2 of 39 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTIC