PMS-DIGOXIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DIGOXIN

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

C01AA05

INN (Nama Antarabangsa):

DIGOXIN

Dos:

0.0625MG

Borang farmaseutikal:

TABLET

Komposisi:

DIGOXIN 0.0625MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CARDIOTONIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0107281004; AHFS:

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2022-08-26

Ciri produk

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_pms-DIGOXIN (digoxin) _
_Page 1 of 54_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-DIGOXIN
Digoxin Tablets
Tablets 0.0625 mg, 0.125 mg and 0.25 mg, Oral
C.S.D.
Digoxin Oral Solution
Solution 0.05 mg/mL, Oral
C.S.D.
Cardiotonic Glycoside
Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montréal, QC, Canada
H4P 2T4
Date of Initial Authorization:
July 30, 2021
Submission Control Number: 252985
_ _
_ _
_pms-DIGOXIN (digoxin) _
_Page 2 of 54_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
........................................................................................................
10
4.5
Missed Dose
............................................................................................................
10
5
OVERDOSAGE