Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
PANTOPRAZOLE (PANTOPRAZOLE SODIUM)
ABBOTT LABORATORIES, LIMITED
A02BC02
PANTOPRAZOLE
20MG
TABLET (DELAYED-RELEASE)
PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 20MG
ORAL
100
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0133229002; AHFS:
CANCELLED PRE MARKET
2015-12-31
_ _ _Abbott-Pantoprazole Product Monograph _ _Page 1 of 39 _ PRODUCT MONOGRAPH PR ABBOTT-PANTOPRAZOLE Pantoprazole Sodium Delayed Release Tablets USP 20 and 40 mg pantoprazole (as pantoprazole sodium sesquihydrate) H + , K + -ATPase Inhibitor Abbott Laboratories, Limited 8401 Trans-Canada Highway Saint-Laurent, Quebec H4S 1Z1 Date of Preparation: September 18, 2013 Date of Revision: June 3, 2015 Submission Control No.: 184223 _ _ _Abbott-Pantoprazole Product Monograph _ _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 OVERDOSAGE ................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY ............................................................14 STORAGE AND STABILITY ..........................................................................................16 SPECIAL HANDLING INSTRUCTIONS .......................................................................16 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................16 PART II: SCIENTIFIC INFORMATION ...............................................................................18 PHARMACEUTIC Izlasiet visu dokumentu