MYLAN-RABEPRAZOLE TABLET (DELAYED-RELEASE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

RABEPRAZOLE SODIUM

Pieejams no:

MYLAN PHARMACEUTICALS ULC

ATĶ kods:

A02BC04

SNN (starptautisko nepatentēto nosaukumu):

RABEPRAZOLE

Deva:

20MG

Zāļu forma:

TABLET (DELAYED-RELEASE)

Kompozīcija:

RABEPRAZOLE SODIUM 20MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

PROTON-PUMP INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0143681002; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2017-08-02

Produkta apraksts

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Mylan-Rabeprazole Page 1 of 48
PRODUCT MONOGRAPH
PR
MYLAN-RABEPRAZOLE
rabeprazole sodium
10 and 20 mg Enteric-Coated Tablets
H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
June 05, 2017
Submission Control No: 204817
__________________________________________________________________________________
Mylan-Rabeprazole 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
....................................................................................
5
ADVERSE REACTIONS
......................................................................................................
8
DRUG INTERACTIONS
.....................................................................................................
11
DOSAGE AND ADMINISTRATION
.................................................................................
13
OVERDOSAGE
...................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 14
STORAGE AND STABILITY
............................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 19
PART II: SCIENTIFIC INFORMATION
...........................................................................
21
PHARMACEUTICAL INFORMATION
..................................................................