RAN-CARVEDILOL TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CARVEDILOL

Mevcut itibaren:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC kodu:

C07AG02

INN (International Adı):

CARVEDILOL

Doz:

3.125MG

Farmasötik formu:

TABLET

Kompozisyon:

CARVEDILOL 3.125MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

BETA-ADRENERGIC BLOCKING AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0122683003; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2022-09-16

Ürün özellikleri

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