APO-OMEPRAZOLE CAPSULE (DELAYED RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

OMEPRAZOLE

Dostopno od:

APOTEX INC

Koda artikla:

A02BC01

INN (mednarodno ime):

OMEPRAZOLE

Odmerek:

20MG

Farmacevtska oblika:

CAPSULE (DELAYED RELEASE)

Sestava:

OMEPRAZOLE 20MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

PROTON-PUMP INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2004-01-27

Lastnosti izdelka

_APO-OMEPRAZOLE (Omeprazole delayed-release capsules) _
_Page 1 of 49 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-OMEPRAZOLE
Omeprazole Delayed-Release Capsules
Capsules (delayed release), 20 mg, Oral
Apotex Standard
Proton Pump Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
January 27, 2004
Date of Revision:
August 31, 2023
Submission Control Number: 273446
_APO-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
....................................