AMIODARONE HYDROCHLORIDE FOR INJECTION, USP SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

AMIODARONE HYDROCHLORIDE

থেকে পাওয়া:

FRESENIUS KABI CANADA LTD

এটিসি কোড:

C01BD01

INN (আন্তর্জাতিক নাম):

AMIODARONE

ডোজ:

50MG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

AMIODARONE HYDROCHLORIDE 50MG

প্রশাসন রুট:

INTRAVENOUS

প্যাকেজ ইউনিট:

3ML

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

CLASS III ANTIARRYTHMICS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2015-04-01

পণ্য বৈশিষ্ট্য

PRODUCT MONOGRAPH
PR
AMIODARONE HYDROCHLORIDE FOR INJECTION, USP
Amiodarone Hydrochloride Injection
Solution
for Injection
50 mg / mL
USP
Antiarrhythmic Agent
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision:
August 5, 2022
Submission
Control No: 259964
Amiodarone Hydrochloride for Injection, USP_ - _Product Monograph
Page 2 of 57_ _
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.........................................................
26
STORAGE AND STABILITY
....................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
................................................................... 30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 30
PART II: SCIENTIFIC INFORMATION
..........................................................................
31
PHARMACEUTICAL INFORMATION
.....................................................................
31
CLINICAL TRIALS
.......................................................................