ROCURONIUM BROMIDE INJECTION SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

ROCURONIUM BROMIDE

থেকে পাওয়া:

AURO PHARMA INC

এটিসি কোড:

M03AC09

INN (আন্তর্জাতিক নাম):

ROCURONIUM BROMIDE

ডোজ:

10MG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

ROCURONIUM BROMIDE 10MG

প্রশাসন রুট:

INTRAVENOUS

প্যাকেজ ইউনিট:

15G/50G

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

NEUROMUSCULAR BLOCKING AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0126317001; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2020-05-07

পণ্য বৈশিষ্ট্য

Page 1 of 35
PRODUCT MONOGRAPH
PR ROCURONIUM BROMIDE INJECTION
10 mg/mL Solution for Injection
(50 mg/5 mL and 100 mg/10 mL)
Sterile Solution
Non-depolarizing
Skeletal Neuromuscular Blocking Agent
AURO PHARMA INC. Date of Preparation:
3700 Steeles Avenue West, Suite # 402 May 5, 2020
Woodbridge, Ontario, L4L 8K8,
Canada
Submission
Control No:
213553
Page 2 of 35
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
...........................................................................................................
8
DRUG
INTERACTIONS..........................................................................................................
11
DOSAGE AND ADMINISTRATION
.......................................................................................
12
OVERDOSAGE
.......................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
18
STORAGE AND STABILITY
..................................................................................................
25
SPECIAL HANDLING
INSTRUCTIONS.................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 26
PART II: SCIENTIFIC
INFORMATION.................................................................................
27
PHARMACEUTICAL
INFO