VPI-ETHACRYNATE SODIUM POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ETHACRYNIC ACID (ETHACRYNATE SODIUM)

Disponibil de la:

VPI PHARMACEUTICALS INC

Codul ATC:

C03CC01

INN (nume internaţional):

ETACRYNIC ACID

Dozare:

50MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

ETHACRYNIC ACID (ETHACRYNATE SODIUM) 50MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

LOOP DIURETICS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-03-10

Caracteristicilor produsului

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