RIVA-ESOMEPRAZOLE DR CAPSULE (DELAYED RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

זמין מ:

LABORATOIRE RIVA INC.

קוד ATC:

A02BC05

INN (שם בינלאומי):

ESOMEPRAZOLE

כמות:

40MG

טופס פרצבטיות:

CAPSULE (DELAYED RELEASE)

הרכב:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 40MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30/90

סוג מרשם:

Prescription

איזור תרפויטי:

PROTON-PUMP INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0145162002; AHFS:

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2016-05-31

מאפייני מוצר

PRODUCT MONOGRAPH
PR
RIVA-ESOMEPRAZOLE DR
ESOMEPRAZOLE (AS ESOMEPRAZOLE MAGNESIUM DIHYDRATE)
20 MG AND 40 MG DELAYED-RELEASE CAPSULES
H
+
, K
+
-ATPASE INHIBITOR
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville Québec
J7C 3V4
DATE OF PREPARATION:
May 16, 2012
SUBMISSION CONTROL NO: 154931
_ _
_Riva-ESOMEPRAZOLE DR Product Monograph _
_Page 2 of 48_
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........................................................................................................14
DOSAGE
AND
ADMINISTRATION....................................................................................16
OVERDOSAGE......................................................................................................................18
ACTION
AND CLINICAL PHARMACOLOGY
..................................................................19
STORAGE
AND
STABILITY................................................................................................22
DOSAGE
FORMS, COMPOSITION AND PACKAGING
...................................................22
PART II: SCIENTIFIC INFORMATION
.............................................................................24
PHARMACEUTICAL
INFORMATION...............................................................................24
CLINICAL
TRIALS..........................................................................