País: Canadá
Idioma: inglés
Fuente: Health Canada
ROSUVASTATIN (ROSUVASTATIN CALCIUM)
PHARMARIS CANADA INC
C10AA07
ROSUVASTATIN
40MG
TABLET
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 40MG
ORAL
15G/50G
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0148963003; AHFS:
APPROVED
2020-09-25
Page 1 of 43 PRODUCT MONOGRAPH PR PRZ-ROSUVASTATIN Rosuvastatin Calcium Tablets, USP Tablets: 5 mg, 10 mg, 20 mg and 40 mg of rosuvastatin (as rosuvastatin calcium) Lipid Metabolism Regulator Pharmaris Canada Inc. 8310-130 Street, Suite 102, Surrey, British Columbia Canada V3W 8J9 DATE OF PREPARATION: September 23, 2020 CONTROL NO: 234091 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 .......................................................................... 5 ADVERSE REACTIONS .......................................................................................... 10 DRUG INTERACTIONS ........................................................................................... 14 DOSAGE AND ADMINISTRATION ....................................................................... 21 OVERDOSAGE ......................................................................................................... 23 ACTION AND CLINICAL PHARMACOLOGY ..................................................... 23 STORAGE AND STABILITY .................................................................................. 25 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................... 26 PART II: SCIENTIFIC INFORMATION ............................................................................. 27 PHARMACEUTICAL INFORMATION .................................................................. 27 CLINICAL TRIALS................................................................................................... 28 DETAILED PHARMACOLOGY .............................................................................. 31 TOXICO Leer el documento completo