RAN-CARVEDILOL TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
06-10-2016
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Aktívna zložka:
CARVEDILOL
Dostupné z:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC kód:
C07AG02
INN (Medzinárodný Name):
CARVEDILOL
Dávkovanie:
6.25MG
Forma lieku:
TABLET
Zloženie:
CARVEDILOL 6.25MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
BETA-ADRENERGIC BLOCKING AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0122683004; AHFS:
Stav Autorizácia:
MARKETED
Dátum Autorizácia:
2005-07-22
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
RAN™-CARVEDILOL
Carvedilol Tablets, House Standard
3.125, 6.25, 12.5 and 25 mg
CONGESTIVE HEART FAILURE AGENT
Ranbaxy Pharmaceuticals Canada Inc. DATE OF REVISION:
126 East Drive SEPTEMBER 14, 2016
Brampton, Ontario
L4W 0A5
Submission Control No: 197425
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
_ _
_RAN-CARVEDILOL Product Monograph _
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_Page 2 of 38 _
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
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
.............................................................................................
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