PRO-RABEPRAZOLE TABLET (ENTERIC-COATED)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

RABEPRAZOLE SODIUM

Mevcut itibaren:

PRO DOC LIMITEE

ATC kodu:

A02BC04

INN (International Adı):

RABEPRAZOLE

Doz:

10MG

Farmasötik formu:

TABLET (ENTERIC-COATED)

Kompozisyon:

RABEPRAZOLE SODIUM 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

10/100/500

Reçete türü:

Prescription

Terapötik alanı:

PROTON-PUMP INHIBITORS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2023-07-10

Ürün özellikleri

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