Država: Kanada
Jezik: angleščina
Source: Health Canada
RANITIDINE (RANITIDINE HYDROCHLORIDE)
NU-PHARM INC
A02BA02
RANITIDINE
150MG
TABLET
RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG
ORAL
100/500
Prescription
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0115150002; AHFS:
CANCELLED POST MARKET
2012-09-04
Page 1 of 25 PRODUCT MONOGRAPH PR NU-RANIT RANITIDINE TABLETS USP 150 MG AND 300 MG RANITIDINE (AS RANITIDINE HYDROCHLORIDE) HISTAMINE H 2 - RECEPTOR ANTAGONIST NU-PHARM INC. DATE OF PREPARATION: 50 Mural Street, Units 1 & 2 JANUARY 27, 2009 Richmond Hill, Ontario L4B 1E4 _ _ Control # 127275 Page 2 of 25 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION....................................................... 3 SUMMARY PRODUCT INFORMATION.............................................................................. 3 INDICATIONS AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS......................................................................................................... 3 WARNINGS AND PRECAUTIONS ....................................................................................... 4 ADVERSE REACTIONS ......................................................................................................... 5 DRUG INTERACTIONS.......................................................................................................... 6 DOSAGE AND ADMINISTRATION ..................................................................................... 7 OVERDOSAGE........................................................................................................................ 8 ACTION AND CLINICAL PHARMACOLOGY.................................................................... 9 STORAGE AND STABILITY ............................................................................................... 11 DOSAGE FORMS, COMPOSITION AND PACKAGING................................................... 11 PART II: SCIENTIFIC INFORMATION ............................................................................. 12 PHARMACEUTICAL INFORMATION ............................................................................... 12 CLINICAL TRIALS............................................................................................................ Preberite celoten dokument