PRO-RABEPRAZOLE TABLET (ENTERIC-COATED)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

RABEPRAZOLE SODIUM

Prieinama:

PRO DOC LIMITEE

ATC kodas:

A02BC04

INN (Tarptautinis Pavadinimas):

RABEPRAZOLE

Dozė:

10MG

Vaisto forma:

TABLET (ENTERIC-COATED)

Sudėtis:

RABEPRAZOLE SODIUM 10MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

10/100/500

Recepto tipas:

Prescription

Gydymo sritis:

PROTON-PUMP INHIBITORS

Produkto santrauka:

Active ingredient group (AIG) number: 0143681001; AHFS:

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2023-07-10

Prekės savybės

PRODUCT MONOGRAPH
PR
PRO-RABEPRAZOLE
Rabeprazole Sodium Enteric-Coated Tablets
10 mg and 20 mg
H
+
,
K
+
-ATPASE INHIBITOR
DATE OF REVISION:
September 5, 2019
PRO DOC LTÉE
2925, boul. Industriel,
Laval, Quebec
H7L 3W9
_Control #: 230299_
Rabeprazole pm en
Pg. 1
_PRO-RABEPRAZOLE Product Monograph _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
................................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
CLINICAL TRIALS
..........................................................................................................24
DETAILED PHARMACOLOGY
.......................................