Kraj: Kanada
Język: angielski
Źródło: Health Canada
MIDODRINE HYDROCHLORIDE
MARCAN PHARMACEUTICALS INC
C01CA17
MIDODRINE
5MG
TABLET
MIDODRINE HYDROCHLORIDE 5MG
ORAL
100
Prescription
ALPHA-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0123066002; AHFS:
APPROVED
2018-03-19
Page 1 of 23 PRODUCT MONOGRAPH Pr MAR-MIDODRINE MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG AND 5 MG MANUFACTURER’S STANDARD VASOPRESSOR Marcan Pharmaceuticals Inc. Date of Preparation: 2 Gurdwara Road, Suite #112, June 16, 2020 Ottawa, ON, K2E 1A2 Submission Control No: 239625 Page 2 of 23 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 ............................................................................................................... 12 DOSAGE AND ADMINISTRATION ........................................................................................... 12 OVERDOSAGE ............................................................................................................................. 13 ACTION AND CLINICAL PHARMACOLOGY ......................................................................... 14 STORAGE AND STABILITY ...................................................................................................... 15 PART II: SCIENTIFIC INFORMATION ........................................................................................ 12 PHARMACEUTICAL INFORMATION ...................................................................................... 12 CLINICAL TRIALS ................................................................................................................... Przeczytaj cały dokument