LOSEC CAPSULE (DELAYED RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

OMEPRAZOLE

Dostopno od:

CHEPLAPHARM ARZNEIMITTEL GMBH

Koda artikla:

A02BC01

INN (mednarodno ime):

OMEPRAZOLE

Odmerek:

20MG

Farmacevtska oblika:

CAPSULE (DELAYED RELEASE)

Sestava:

OMEPRAZOLE 20MG

Pot uporabe:

ORAL

Enote v paketu:

28

Tip zastaranja:

Prescription

Terapevtsko območje:

PROTON-PUMP INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-11-02

Lastnosti izdelka

_Product Monograph _
_Date: September 2023 _
_LOSEC (omeprazole delayed release capsules) _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
LOSEC®
Omeprazole delayed release capsules
Capsules (delayed release), 20 mg omeprazole, oral
Proton Pump Inhibitor
MANUFACTURER:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
IMPORTER / DISTRIBUTOR:
Xediton Pharmaceuticals Inc.
2020 Winston Park Drive, Suite 402
Oakville, Ontario L6H 6X7
Tel: 1-888-XEDITON (933-4866)
DATE OF INITIAL AUTHORIZATION:
JAN 13, 1989
DATE OF REVISION:
OCT 17, 2023
Submission Control Number: 275360
LOSEC
®
is a registered trademark.
_Product Monograph _
_Date: September 2023 _
_LOSEC (omeprazole delayed release capsules) _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
10/2023
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 Conside