MINT-SPIRONOLACTONE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

SPIRONOLACTONE

Tilgængelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

C03DA01

INN (International Name):

SPIRONOLACTONE

Dosering:

100MG

Lægemiddelform:

TABLET

Sammensætning:

SPIRONOLACTONE 100MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

MINERALOCORTICOID (ALDOSTERONE) RECEPTOR ANTAGONISTS

Produkt oversigt:

Active ingredient group (AIG) number: 0106462002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2019-05-03

Produktets egenskaber

_ _
_MINT-SPIRONALACTONE (spironolactone) _
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-SPIRONOLACTONE
Spironolactone Tablets
Tablets, 25 mg and 100 mg , Oral
USP
Aldosterone Antagonist
ATC Code: C03DA01
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
MAY, 02, 2019
Date of Revision:
AUGUST 01, 2023
Submission Control Number: 272402
_ _
_MINT-SPIRONALACTONE (spironolactone) _
_Page 2 of 35_
RECENT MAJOR LABEL CHANGES
n/a
n/a
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics (< 18 years of age):
..................................................................................
5
1.2
Geriatrics: .
...............................................................................................................
5
2
CONTRAINDICATIONS
................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.5
Missed Dose
.............................................................................................................
7
5
OVERDOSAGE
.....................................................................................................