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Pr PREVACID® FasTab

PREVACI D , PREVACID FasTab Product Monograph Page 1 of 80 (lansoprazole delayed-release capsules, lansoprazole delayed-release tablets) PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr PREVACID lansoprazole Capsule (delayed-release), 15 mg and 30 mg, Nasogastric and Oral Pr PREVACID FasTab lansoprazole Tablet (delayed-release), 15 mg and 30 mg, Nasogastric and Oral Prescribed Proton-Pump Inhibitors PREVACID is a trademark of Takeda Pharmaceuticals , Inc. and used under license by BGP Pharma ULC. Takeda Pharmaceuticals America, Inc. 95 Hayden Avenue Lexington, MA 02421, Distributed by: BGP Pharma ULC 85 Advance Road Etobicoke, Ontario, M8Z 2S6 Date of Preparation: MAY 12, 1995 Date of Previous Revision: MAR 4, 2021 Date of Revision: SEP 15, 2021 Submission Control Number: 251460 PREVACI D , PREVACID FasTab Product Monograph Page 2 of 80 (lansoprazole delayed-release capsules, lansoprazole delayed-release tablets) RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Endocrine and Metabolism 03/2021 7 Warnings and Precautions, Gastrointestinal 07/2019 TABLE OF CONTENT

fetal development in monkeys, mice, rats and rabbits at doses that produced plasma levels 2 to 17 times the serum levels obtained in humans treated at the maximum recommended ... possible, an alternative therapy combination is recommended. Resistance to amoxicillin has not been demonstrated in clinical studies with PREVACID®

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