Država: Kanada
Jezik: angleščina
Source: Health Canada
ROSUVASTATIN (ROSUVASTATIN CALCIUM)
SANDOZ CANADA INCORPORATED
C10AA07
ROSUVASTATIN
40MG
TABLET
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 40MG
ORAL
30/100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0148963003; AHFS:
APPROVED
2012-03-15
_Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _ _Page 1 of 57_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SANDOZ ROSUVASTATIN Rosuvastatin Calcium Tablets Tablets, 5, 10, 20 and 40 mg rosuvastatin (as rosuvastatin calcium), Oral Manufacturer’s Standard Lipid Metabolism Regulator Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, (Québec), Canada J4B 1K6 Date of Initial Authorization: SEP 29, 2020 Date of Revision: December 13, 2023 Submission Control Number: 278851 _Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _ _Page 2 of 57_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 02/2023 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 12/2023 4.2 Recommended Dose and Dosage Adjustment 12/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .................................................................................................... 2 TABLE OF CONTENTS ...................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION.............................................................................. 4 1 INDICATIONS .......................................................................................................................... 4 1.1 Pediatrics .......................................................................................................................... 4 1.2 Geriatrics .......................................................................................................................... 4 2 CONTRAINDICATIONS ............................................................................................................. 5 4 DOSAGE AND ADMINISTRATION ............................................................................................. 5 4.1 Dosing Considerations .............................................................................. Preberite celoten dokument