PMS-DIGOXIN SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DIGOXIN

Disponible depuis:

PHARMASCIENCE INC

Code ATC:

C01AA05

DCI (Dénomination commune internationale):

DIGOXIN

Dosage:

0.05MG

forme pharmaceutique:

SOLUTION

Composition:

DIGOXIN 0.05MG

Mode d'administration:

ORAL

Unités en paquet:

115ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CARDIOTONIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2010-11-10

Résumé des caractéristiques du produit

_ _
_pms-DIGOXIN (digoxin) _
_Page 1 of 51_
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:
NOV 23, 2022
Submission Control Number: 268869
_ _
_pms-DIGOXIN (digoxin) _
_Page 2 of 51_
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
..................................................................................................
4
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
..