PRO-VERAPAMIL SR TABLET (EXTENDED-RELEASE)
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
18-01-2017
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Aktívna zložka:
VERAPAMIL HYDROCHLORIDE
Dostupné z:
PRO DOC LIMITEE
ATC kód:
C08DA01
INN (Medzinárodný Name):
VERAPAMIL
Dávkovanie:
240MG
Forma lieku:
TABLET (EXTENDED-RELEASE)
Zloženie:
VERAPAMIL HYDROCHLORIDE 240MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0113846003; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2018-07-26
Súhrn charakteristických
_ _
_PRO-VERAPAMIL SR Product Monograph _
_Page 1 of 40_
PRODUCT MONOGRAPH
PR
PRO-VERAPAMIL SR
Verapamil hydrochloride Sustained-Release Tablets, USP
240 mg
Antihypertensive Agent
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
January 17, 2017
Submission Control No.: 201003
_ _
_PRO-VERAPAMIL SR Product Monograph _
_Page 2 of 40_
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
................................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
..........................................................................................................28
DETAILED PHARMA
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