AMIODARONE SYRINGE SOLUTION

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

इसे खरीदें

सक्रिय संघटक:

AMIODARONE HYDROCHLORIDE

थमां उपलब्ध:

SANDOZ CANADA INCORPORATED

ए.टी.सी कोड:

C01BD01

INN (इंटरनेशनल नाम):

AMIODARONE

डोज़:

50MG

फार्मास्यूटिकल फॉर्म:

SOLUTION

रचना:

AMIODARONE HYDROCHLORIDE 50MG

प्रशासन का मार्ग:

INTRAVENOUS

पैकेज में यूनिट:

3ML

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

CLASS III ANTIARRYTHMICS

उत्पाद समीक्षा:

Active ingredient group (AIG) number: 0118593002; AHFS:

प्राधिकरण का दर्जा:

CANCELLED POST MARKET

प्राधिकरण की तारीख:

2020-04-30

उत्पाद विशेषताएं

                                _Amiodarone Hydrochloride for Injection/Amiodarone Syringe _
_Page 1 of 59 _
PRODUCT MONOGRAPH
PR
AMIODARONE HYDROCHLORIDE FOR INJECTION
Amiodarone hydrochloride for injection
Vials: 50 mg/mL
PR
AMIODARONE SYRINGE
Amiodarone hydrochloride for injection
Pre-filled syringes: 50 mg/mL
Antiarrhythmic Agent
Sandoz Canada Inc.
Date of Revision: December 6, 2016
145 Jules-Léger St.
Boucherville, QC, Canada
J4B 7K8
Control Number: 198348
_Amiodarone Hydrochloride for Injection/Amiodarone Syringe _
_Page 2 of 59 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
.............................................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
.......................................................................................................................
15
DRUG INTERACTIONS
.......................................................................................................................
18
DOSAGE AND ADMINISTRATION
...................................................................................................
22
OVERDOSAGE
.....................................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
27
STORAGE AND STABILITY
...............................................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
................................
                                
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