País: Canadá
Língua: inglês
Origem: Health Canada
ETHACRYNIC ACID (ETHACRYNATE SODIUM)
ENDO PAR INNOVATION COMPANY, LLC
C03CC01
ETACRYNIC ACID
50MG
POWDER FOR SOLUTION
ETHACRYNIC ACID (ETHACRYNATE SODIUM) 50MG
INTRAVENOUS
50ML
Prescription
LOOP DIURETICS
Active ingredient group (AIG) number: 0101703001; AHFS:
CANCELLED PRE MARKET
2023-07-07
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 Leia o documento completo