ETHACRYNATE SODIUM FOR INJECTION POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ETHACRYNIC ACID (ETHACRYNATE SODIUM)

Διαθέσιμο από:

ENDO PAR INNOVATION COMPANY, LLC

Φαρμακολογική κατηγορία (ATC):

C03CC01

INN (Διεθνής Όνομα):

ETACRYNIC ACID

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

ETHACRYNIC ACID (ETHACRYNATE SODIUM) 50MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

50ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

LOOP DIURETICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2023-07-07

Αρχείο Π.Χ.Π.

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