Maa: Kanada
Kieli: englanti
Lähde: Health Canada
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
APOTEX INC
C10AA05
ATORVASTATIN
40MG
TABLET
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 40MG
ORAL
90/100/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0133055003; AHFS:
APPROVED
2010-05-19
_APO-ATORVASTATIN (atorvastatin calcium) _ _ _ _ _ _ _ _ _ _Page 1 of 56 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-ATORVASTATIN Atorvastatin Calcium Tablets Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium propylene glycol solvate), Oral USP Lipid Metabolism Regulator APOTEX INC. 150 Signet Drive Toronto, Ontario Canada M9L 1T9 Date of Initial Authorization: MAY 19, 2010 Date of Revision: APR 19, 2022 Submission Control Number: 260660 _APO-ATORVASTATIN (atorvastatin calcium) _ _ _ _ _ _ _ _ _ _Page 2 of 56 _ _APO-ATORVASTATIN (atorvastatin calcium) _ _ _ _ _ _ _ _ _ _Page 3 of 56 _ RECENT MAJOR LABEL CHANGES 2 Contraindications 04/2022 7 Warnings and Precautions, Musculoskeletal 04/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .................................................................................... 3 TABLE OF CONTENTS ......................................................................................................... 3 PART I: HEALTH PROFESSIONAL INFORMATION.............................................................. 5 1 INDICATIONS ................................................................................................................. 5 1.1 Pediatrics ............................................................................................................... 5 1.2 Geriatrics ................................................................................................................ 6 2 CONTRAINDICATIONS .................................................................................................. 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 4.1 Dosing Considerations ............................................................................................ 6 4.2 Recommended Dose and Dosage Adjustment......................................................... 7 Lue koko asiakirja