Land: Kanada
Språk: engelska
Källa: Health Canada
NIFEDIPINE
PHARMASCIENCE INC
C08CA05
NIFEDIPINE
30MG
TABLET (EXTENDED-RELEASE)
NIFEDIPINE 30MG
ORAL
30/100
Prescription
DIHYDROPYRIDINES
Active ingredient group (AIG) number: 0115253004; AHFS:
APPROVED
2014-01-08
PRODUCT MONOGRAPH PR PMS-NIFEDIPINE ER Nifedipine Extended-Release Tablets, House Standard 20 mg, 30 mg and 60 mg Nifedipine Antianginal/Antihypertensive Agent PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 www.pharmascience.com Date of Revision: December 14, 2016 Submission Control No: 200335 _ _ _pms-NIFEDIPINE ER Product Monograph _ _Page 2 of 43_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ....................................................................................................9 DRUG INTERACTIONS ..................................................................................................14 DOSAGE AND ADMINISTRATION ..............................................................................19 OVERDOSAGE ................................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY ............................................................21 STORAGE AND STABILITY ..........................................................................................23 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................24 PART II: SCIENTIFIC INFORMATION ...............................................................................25 PHARMACEUTICAL INFORMATION ..........................................................................25 CLINICAL TRIALS ........................................................................................................ Läs hela dokumentet