DIGOXIN INJECTION C.S.D. LIQUID

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DIGOXIN

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

C01AA05

INN (Nama Internasional):

DIGOXIN

Dosis:

0.5MG

Bentuk farmasi:

LIQUID

Komposisi:

DIGOXIN 0.5MG

Rute administrasi :

INTRAMUSCULAR

Unit dalam paket:

10X2ML

Jenis Resep:

Prescription

Area terapi:

CARDIOTONIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0107281002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2005-10-05

Karakteristik produk

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D
IGOXIN INJECTION
C.S.D.
>
Page 1 of 42
Product Monograph
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DIGOXIN INJECTION C.S.D.
Digoxin Injection
Liquid, 0.5 mg / 2 mL, Intramuscular, Intravenous
Manufacturer’s Standard
Cardiotonic Glycoside
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Initial Authorization:
DEC 31, 1994
Date of Revision:
SEP 14, 2022
Submission Control Number: 262879
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Page 2 of 42
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics (<10 years of age)
................................................................................
4
1.2
Geriatrics (>70 years of age)
................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................... 5
4.4
Administration
...................................................................................................
10
4.5
Missed Dose
..........................................................................................