VPI-ETHACRYNATE SODIUM POWDER FOR SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ETHACRYNIC ACID (ETHACRYNATE SODIUM)

MAH:

VPI PHARMACEUTICALS INC

ATC_code:

C03CC01

INN:

ETACRYNIC ACID

dosage:

50MG

pharmaceutical_form:

POWDER FOR SOLUTION

composition:

ETHACRYNIC ACID (ETHACRYNATE SODIUM) 50MG

administration_route:

INTRAVENOUS

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

LOOP DIURETICS

leaflet_short:

Active ingredient group (AIG) number: 0101703001; AHFS:

authorization_status:

APPROVED

authorization_date:

2017-03-10

SPC

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ETHACRYNATE SODIUM
(Ethacrynate sodium for injection, USP)
Lyophilized powder for injection, 50 mg equivalent to ethacrynic acid
STERILE
Saluretic-Diuretic
Agent
SteriMax Inc.
2770 Portland Drive,
Oakville, ON L6H 6R4.
Date of Preparation:
FEB 28, 2024
Submission Control No: 283328
_Product Monograph ETHACRYNATE SODIUM _
_Page 2 of 19_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
7
DOSAGE AND ADMINISTRATION
...............................................................................
8
OVERDOSAGE
.................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 9
STORAGE AND STABILITY
.........................................................................................
10
SPECIAL HANDLING INSTRUCTIONS
......................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 10
PART II: SCIENTIFIC INFORMATION
...............................................................................
11
PHARMACEUTICAL INFORMATION
......................................................................