País: Canadá
Língua: inglês
Origem: Health Canada
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
VANC PHARMACEUTICALS 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:
CANCELLED POST MARKET
2019-08-07
Page 1 of 39 PRODUCT MONOGRAPH PR VAN-PANTOPRAZOLE Pantoprazole Sodium Delayed-Release Tablets, Manufacturer’s Standard 40 mg pantoprazole (as pantoprazole sodium sesquihydrate) H + , K + - ATPase Inhibitor MANUFACTURER AND DISTRIBUTOR: Vanc Pharmaceuticals Inc. Date of Preparation: Building 152, 11782 River Road September 23, 2014 Richmond, BC V6X 1Z7 www.vancpharm.com Submission Control # 177608 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 ............................................................................................................................. 6 DRUG INTERACTIONS ........................................................................................................................... 10 DOSAGE AND ADMINISTRATION ....................................................................................................... 12 OVERDOSAGE .......................................................................................................................................... 13 ACTION AND CLINICAL PHARMACOLOGY ...................................................................................... 13 STORAGE AND STABILITY ................................................................................................................... 15 SPECIAL HANDLING INSTRUCTIONS ............................................................................... Leia o documento completo