VPI-ETHACRYNATE SODIUM POWDER FOR SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ETHACRYNIC ACID (ETHACRYNATE SODIUM)

Beschikbaar vanaf:

VPI PHARMACEUTICALS INC

ATC-code:

C03CC01

INN (Algemene Internationale Benaming):

ETACRYNIC ACID

Dosering:

50MG

farmaceutische vorm:

POWDER FOR SOLUTION

Samenstelling:

ETHACRYNIC ACID (ETHACRYNATE SODIUM) 50MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

LOOP DIURETICS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2017-03-10

Productkenmerken

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
......................................................................