Țară: Canada
Limbă: engleză
Sursă: Health Canada
LANSOPRAZOLE
SIVEM PHARMACEUTICALS ULC
A02BC03
LANSOPRAZOLE
15MG
CAPSULE (DELAYED RELEASE)
LANSOPRAZOLE 15MG
ORAL
100
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0127666002; AHFS:
APPROVED
2014-12-08
PRODUCT MONOGRAPH PR LANSOPRAZOLE Lansoprazole Delayed-Release Capsules, USP 15 mg H + , K + – ATPase Inhibitor Sivem Pharmaceuticals ULC 4705 Dobrin Street Saint-Laurent, Quebec, Canada H4R 2P7 www.sivem.ca Submission Control No: 260412 Date of Initial Authorization: June 8, 2012 Date of Revision: January 27, 2022 _ _ _LANSOPRAZOLE Product Monograph _ _Page 2 of 83_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................................ 3 SUMMARY PRODUCT INFORMATION .............................................................................................................. 3 INDICATIONS AND CLINICAL USE .................................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................................ 5 WARNINGS AND PRECAUTIONS ....................................................................................................................... 5 ADVERSE REACTIONS ....................................................................................................................................... 12 DRUG INTERACTIONS ....................................................................................................................................... 22 DOSAGE AND ADMINISTRATION.................................................................................................................... 24 OVERDOSAGE ..................................................................................................................................................... 27 ACTION AND CLINICAL PHARMACOLOGY .................................................................................................. 27 STORAGE AND STABILITY ............................................................................................................................... 32 DOSAGE FORMS, COMPOSITI Citiți documentul complet