Land: Kanada
Sprache: Englisch
Quelle: Health Canada
OMEPRAZOLE
CHEPLAPHARM ARZNEIMITTEL GMBH
A02BC01
OMEPRAZOLE
20MG
CAPSULE (DELAYED RELEASE)
OMEPRAZOLE 20MG
ORAL
28
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0121643001; AHFS:
APPROVED
2020-11-02
_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 Lesen Sie das vollständige Dokument