ETHACRYNATE SODIUM FOR INJECTION POWDER FOR SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
30-07-2018
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Aktiv bestanddel:
ETHACRYNIC ACID (ETHACRYNATE SODIUM)
Tilgængelig fra:
ENDO PAR INNOVATION COMPANY, LLC
ATC-kode:
C03CC01
INN (International Name):
ETACRYNIC ACID
Dosering:
50MG
Lægemiddelform:
POWDER FOR SOLUTION
Sammensætning:
ETHACRYNIC ACID (ETHACRYNATE SODIUM) 50MG
Indgivelsesvej:
INTRAVENOUS
Enheder i pakken:
50ML
Recept type:
Prescription
Terapeutisk område:
LOOP DIURETICS
Produkt oversigt:
Active ingredient group (AIG) number: 0101703001; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2023-07-07
Produktets egenskaber
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ETHACRYNATE SODIUM FOR INJECTION
House Std.
_ _
Lyophilized powder for injection, 50 mg equivalent to ethacrynic
acid
Intravenous
Saluretic-Diuretic Agent
Endo Par Innovation Company, LLC
6 Ram Ridge Road, Chestnut Ridge,
New York 10977, USA
Imported/Distributed by:
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
Saint-Laurent, Quebec, Canada
H4M 2P2
Date of Preparation:
July 30, 2018
Version 1.0
Submission Control No: 209656
_Product Monograph_
_Page 2 of 20_
_Ethacrynate Sodium for Injection_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
......................................................................................................
5
WARNINGS AND PRECAUTIONS
....................................................................................
5
ADVERSE REACTIONS
......................................................................................................
7
DRUG INTERACTIONS
......................................................................................................
8
DOSAGE AND ADMINISTRATION
..................................................................................
9
OVERDOSAGE
...................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 10
STORAGE AND STABILITY
............................................................................................
11
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
11
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................ 11
PART
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