Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
ATORVASTATIN (ATORVASTATIN CALCIUM)
DOMINION PHARMACAL
C10AA05
ATORVASTATIN
20MG
TABLET
ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG
ORAL
500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0133055002; AHFS:
CANCELLED POST MARKET
2019-07-31
_Dom-ATORVASTATIN _ _ _ _Page 1 of 49 _ _ _ PRODUCT MONOGRAPH PR DOM-ATORVASTATIN (Atorvastatin calcium tablets) 10 mg, 20 mg, 40 mg and 80 mg atorvastatin LIPID METABOLISM REGULATOR DOMINION PHARMACAL Date of Revision: July 26, 2016 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 Submission Control No: 196412 _Dom-ATORVASTATIN _ _ _ _Page 2 of 49 _ _ _ 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 ......................................................................................................... 10 DRUG INTERACTIONS ......................................................................................................... 13 DOSAGE AND ADMINISTRATION .................................................................................... 18 OVERDOSAGE ....................................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 19 STORAGE AND STABILITY ................................................................................................ 22 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 23 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 23 PART II: SCIENTIFIC INFORMATION ...............................................................................24 PHARMACEUTICAL INFORMATION ................... Διαβάστε το πλήρες έγγραφο