PMS-DIGOXIN SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DIGOXIN

から入手可能:

PHARMASCIENCE INC

ATCコード:

C01AA05

INN（国際名）:

DIGOXIN

投薬量:

0.05MG

医薬品形態:

SOLUTION

構図:

DIGOXIN 0.05MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

CARDIOTONIC AGENTS

製品概要:

Active ingredient group (AIG) number: 0107281001; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2022-08-26

製品の特徴

_ _
_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