Страна: Канада
Език: английски
Източник: Health Canada
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
MYLAN PHARMACEUTICALS ULC
A02BC02
PANTOPRAZOLE
40MG
TABLET (DELAYED-RELEASE)
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG
ORAL
100/500
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0133229001; AHFS:
CANCELLED POST MARKET
2018-07-12
MYLAN-PANTOPRAZOLE (pantoprazole sodium) 1 of 37 PRODUCT MONOGRAPH PR MYLAN-PANTOPRAZOLE Pantoprazole sodium enteric-coated tablets 40 mg pantoprazole (as pantoprazole sodium sesquihydrate) H + , K + -ATPase Inhibitor Mylan Pharmaceuticals ULC 85 Advance Rd. Etobicoke, Ontario M8Z 2S6 Submission Control Number: 211159 Date of Revision: December 14, 2017 MYLAN-PANTOPRAZOLE (pantoprazole sodium) 2 of 37 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 .......................................................................................... 13 OVERDOSAGE .............................................................................................................................. 14 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 15 STORAGE AND STABILITY ...................................................................................................... 17 SPECIAL HANDLING INSTRUCTIONS ................................................................................... 17 DOSAGE FORMS, COMPOSITION AND PACKAGING ....................................................... 17 PART II: SCIENTIFIC INFORMATION .............. Прочетете целия документ