国家: 加拿大
语言: 英文
来源: Health Canada
ATORVASTATIN (ATORVASTATIN CALCIUM)
PHARMASCIENCE INC
C10AA05
ATORVASTATIN
80MG
TABLET
ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG
ORAL
100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0133055004; AHFS:
APPROVED
2020-02-04
PRODUCT MONOGRAPH Pr pdp-ATORVASTATIN Atorvastatin Calcium Tablets 10 mg, 20 mg, 40 mg and 80 mg Lipid Metabolism Regulator PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com Date of Revision: February 3, 2020 Submission Control No: 235024 pdp-ATORVASTATIN Product Monograph Page 2 of 53 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................3 INDICATIONS AND CLINICAL USE .........................................................................3 CONTRAINDICATIONS .............................................................................................5 WARNINGS AND PRECAUTIONS .............................................................................5 ADVERSE REACTIONS............................................................................................ 11 DRUG INTERACTIONS ............................................................................................ 14 DOSAGE AND ADMINISTRATION ......................................................................... 20 OVERDOSAGE ......................................................................................................... 21 ACTION AND CLINICAL PHARMACOLOGY......................................................... 21 STORAGE AND STABILITY .................................................................................... 25 SPECIAL HANDLING INSTRUCTIONS ................................................................... 25 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 25 PART II: SCIENTIFIC INFORMATION .......................................................................... 27 PHARMACEUTICAL INFORMATION ..................................................................... 27 CLINICAL TRIALS ................................................................................................... 28 DETAILED 阅读完整的文件