RAN-CARVEDILOL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CARVEDILOL

Tersedia dari:

RANBAXY PHARMACEUTICALS CANADA INC.

Kode ATC:

C07AG02

INN (Nama Internasional):

CARVEDILOL

Dosis:

6.25MG

Bentuk farmasi:

TABLET

Komposisi:

CARVEDILOL 6.25MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

BETA-ADRENERGIC BLOCKING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0122683004; AHFS:

Status otorisasi:

MARKETED

Tanggal Otorisasi:

2005-07-22

Karakteristik produk

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.
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_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
.............................................................................................