Country: Canada
Language: English
Source: Health Canada
REPAGLINIDE
SANDOZ CANADA INCORPORATED
A10BX02
REPAGLINIDE
1MG
TABLET
REPAGLINIDE 1MG
ORAL
100
Prescription
MEGLITINIDES
Active ingredient group (AIG) number: 0137035002; AHFS:
APPROVED
2010-09-27
_ _ _Sandoz Repaglinide _ _Page 1 of 43_ PRODUCT MONOGRAPH PR SANDOZ REPAGLINIDE (Repaglinide) 0.5 mg, 1 mg and 2 mg tablets Oral Antidiabetic Agent Manufacturer's Standard Sandoz Canada Inc. 110 de Lauzon Boucherville, QC J4B 1E6 Date of Revision: August 16, 2018 Submission Control No: 218326 _ _ _Sandoz Repaglinide _ _Page 2 of 43_ 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 ............................................................................. 16 OVERDOSAGE ............................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 18 STORAGE AND STABILITY ......................................................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 21 PART II: SCIENTIFIC INFORMATION .............................................................................. 22 PHARMACEUTICAL INFORMATION ......................................................................... 22 CLINICAL TRIALS ......................................................................................................... 23 DETAILED PHARMACOLOGY .................... Read the complete document