מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
ANGITA PHARMA INC.
A02BC02
PANTOPRAZOLE
40MG
TABLET (DELAYED-RELEASE)
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG
ORAL
30/100/500
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0133229001; AHFS:
APPROVED
2018-07-13
_Page 1 of 39_ PRODUCT MONOGRAPH PR AG-PANTOPRAZOLE Pantoprazole Sodium Delayed Release Tablets USP 20 and 40 mg pantoprazole (as pantoprazole sodium sesquihydrate) H + , K + -ATPase Inhibitor Control Number: 214737 Angita Pharma Inc. 1310 Nobel Street Boucherville, Quebec J4B 5H3 Date of Revision: July 13, 2018 _Page 2 of 39_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................ 3 SUMMARY PRODUCT INFORMATION ........................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................................ 3 CONTRAINDICATIONS ...................................................................................................... 4 WARNINGS AND PRECAUTIONS .................................................................................... 4 ADVERSE REACTIONS ...................................................................................................... 7 DRUG INTERACTIONS .................................................................................................... 11 DOSAGE AND ADMINISTRATION ................................................................................ 12 OVERDOSE ........................................................................................................................ 14 ACTION AND CLINICAL PHARMACOLOGY ............................................................... 14 STORAGE AND STABILITY ............................................................................................ 16 SPECIAL HANDLING INSTRUCTIONS .......................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 16 PART II: SCIENTIFIC INFORMATION ................................................................................... 17 PHARMACEUTICAL INFORMATION ............................................................................ 17 CLINICAL TRIA קרא את המסמך השלם