Država: Kanada
Jezik: angleščina
Source: Health Canada
CARVEDILOL
TEVA CANADA LIMITED
C07AG02
CARVEDILOL
3.125MG
TABLET
CARVEDILOL 3.125MG
ORAL
100/500
Prescription
BETA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0122683003; AHFS:
CANCELLED PRE MARKET
2015-08-06
_ _ _Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 35_ _ _ _ _ _ _ _ _ PRODUCT MONOGRAPH Pr NTP-CARVEDILOL (carvedilol tablets) 3.125 mg, 6.25 mg, 12.5 mg, 25 mg Congestive Heart Failure Agent TEVA CANADA LIMITED 30 Novopharm Court Toronto, Canada M1B 2K9 Date of Preparation: July 12, 2013 Control #: 165863 _ _ _Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 35_ 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 ....................................................................................................9 DRUG INTERACTIONS ..................................................................................................16 DOSAGE AND ADMINISTRATION ..............................................................................17 OVERDOSAGE ................................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY ............................................................21 STORAGE AND STABILITY ..........................................................................................23 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................23 PART II: SCIENTIFIC INFORMATION ...............................................................................25 PHARMACEUTICAL INFORMATION ..........................................................................25 CLINICAL TRIALS ......................................................................................... Preberite celoten dokument