OMEPRAZOLE CAPSULE (DELAYED RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

OMEPRAZOLE

Dostępny od:

SANIS HEALTH INC

Kod ATC:

A02BC01

INN (International Nazwa):

OMEPRAZOLE

Dawkowanie:

20MG

Forma farmaceutyczna:

CAPSULE (DELAYED RELEASE)

Skład:

OMEPRAZOLE 20MG

Droga podania:

ORAL

Sztuk w opakowaniu:

500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PROTON-PUMP INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0121643001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2010-06-07

Charakterystyka produktu

_OMEPRAZOLE (Omeprazole delayed-release capsules) _
_Page 1 of 49 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OMEPRAZOLE
Omeprazole Delayed-Release Capsules
Capsules (delayed release), 20 mg, Oral
Manufacturer’s Standard
Proton Pump Inhibitor
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
December 13, 2016
Date of Revision:
October 06, 2023
Submission Control Number: 279325
_OMEPRAZOLE (Omeprazole delayed-release capsules) _
_Page 2 of 49 _
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.4
Administration
.........................................................................................................
7
4.5
Missed Dose
.....................