País: Canadà
Idioma: anglès
Font: Health Canada
VERAPAMIL HYDROCHLORIDE
TEVA CANADA LIMITED
C08DA01
VERAPAMIL
120MG
TABLET
VERAPAMIL HYDROCHLORIDE 120MG
ORAL
100/500/1000
Prescription
MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS
Active ingredient group (AIG) number: 0113846001; AHFS:
CANCELLED POST MARKET
2018-05-15
PRODUCT MONOGRAPH PR NOVO-VERAMIL (verapamil hydrochloride) 80 mg, 120 mg tablets Antiarrhythmic/Antianginal/Antihypertensive Agent PR NOVO-VERAMIL SR (verapamil hydrochloride) 240 mg sustained release tablets Antihypertensive Agent Teva Canada Limited Date of Preparation: 30 Novopharm Court May 28, 2013 Toronto, Ontario M1B 2K9 Submission Control No: 164741 2 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 ............................................................................................................. 12 DOSAGE AND ADMINISTRATION ......................................................................................... 18 OVERDOSAGE ........................................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 21 STORAGE AND STABILITY ..................................................................................................... 26 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................ 26 PART II: SCIENTIFIC INFORMATION ............................................................................... 28 PHARMACEUTICAL INFORMATION ................................................................................... Llegiu el document complet