ACID REDUCER TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

זמין מ:

LABORATOIRE RIVA INC.

קוד ATC:

A02BA02

INN (שם בינלאומי):

RANITIDINE

כמות:

75MG

טופס פרצבטיות:

TABLET

הרכב:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 75MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

6/10/12/20/24/30/36/40/42/50/54/60

סוג מרשם:

OTC

איזור תרפויטי:

HISTAMINE H2-ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0115150003; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2019-05-17

מאפייני מוצר

_ACID REDUCER - Product Monograph _
_Page 1 of 31 _
PRODUCT MONOGRAPH
ACID REDUCER
Ranitidine Tablets, USP
(As Ranitidine Hydrochloride)
75 mg
HISTAMINE H
2
-RECEPTOR ANTAGONIST
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Québec
J7C 3V4
www.labriva.com
Submission Control No.: 223956
Date of revision:
February 11, 2019
_ACID REDUCER - Product Monograph _
_Page 2 of 31 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
ADVERSE REACTIONS
...................................................................................................
5
DRUG INTERACTIONS
....................................................................................................
7
DOSAGE AND ADMINISTRATION
..............................................................................
10
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 16
PART II: SCIENTIFIC INFORMATION
................................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
...........................................................................................