国家: 加拿大
语言: 英文
来源: Health Canada
ROCURONIUM BROMIDE
SANDOZ CANADA INCORPORATED
M03AC09
ROCURONIUM BROMIDE
10MG
SOLUTION
ROCURONIUM BROMIDE 10MG
INTRAVENOUS
2.5/5/10ML
Prescription
NEUROMUSCULAR BLOCKING AGENTS
Active ingredient group (AIG) number: 0126317001; AHFS:
CANCELLED PRE MARKET
2018-08-01
_Rocuronium Bromide Injection & Rocuronium Bromide Injection SDZ _ _Page 1 of 39 _ PRODUCT MONOGRAPH PR ROCURONIUM BROMIDE INJECTION Rocuronium Bromide 10 mg/mL Solution for Injection PR ROCURONIUM BROMIDE INJECTION SDZ Rocuronium Bromide 10 mg/mL Solution for Injection Sterile Non-depolarizing Skeletal Neuromuscular Blocking Agent Sandoz Canada Inc. 145 Jules-Léger Date of Revision : April 1, 2015 Boucherville, QC, Canada J4B 7K8 Submission Control No: 183292 _Rocuronium Bromide Injection_ & _Rocuronium Bromide Injection SDZ _ _Page 2 of 39 _ 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 ........................................................................................................ 27 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 阅读完整的文件