Land: Canada
Sprog: engelsk
Kilde: Health Canada
NIFEDIPINE
PRO DOC LIMITEE
C08CA05
NIFEDIPINE
60MG
TABLET (EXTENDED-RELEASE)
NIFEDIPINE 60MG
ORAL
30/100
Prescription
DIHYDROPYRIDINES
Active ingredient group (AIG) number: 0115253005; AHFS:
APPROVED
2014-03-18
PRODUCT MONOGRAPH PR NIFEDIPINE ER Nifedipine Extended-Release Tablets, House Standard 20 mg, 30 mg and 60 mg Nifedipine Antianginal/Antihypertensive Agent PRO DOC LTÉE 2925, boul. Industriel Laval, Quebec H7L 3W9 Date of Revision: February 27, 2019 Submission Control No.: 224326 _ _ _NIFEDIPINE ER Product Monograph _ _Page 2 of 41_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................8 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................18 OVERDOSAGE ................................................................................................................19 ACTION AND CLINICAL PHARMACOLOGY ............................................................20 STORAGE AND STABILITY ..........................................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................23 PART II: SCIENTIFIC INFORMATION ...............................................................................24 PHARMACEUTICAL INFORMATION ..........................................................................24 CLINICAL TRIALS ..........................................................................................................25 DETAILED PHARMACOLOGY .................... Læs hele dokumentet