País: Canadà
Idioma: anglès
Font: Health Canada
ROCURONIUM BROMIDE
SANDOZ CANADA INCORPORATED
M03AC09
ROCURONIUM BROMIDE
10MG
SOLUTION
ROCURONIUM BROMIDE 10MG
INTRAVENOUS
10X5ML
Prescription
NEUROMUSCULAR BLOCKING AGENTS
Active ingredient group (AIG) number: 0126317001; AHFS:
APPROVED
2008-10-24
_Rocuronium Bromide Injection _ _Page 1 of 37 _ PRODUCT MONOGRAPH PR ROCURONIUM BROMIDE INJECTION Rocuronium Bromide 10 mg/mL Solution for Injection Sterile Non-depolarizing Skeletal Neuromuscular Blocking Agent Sandoz Canada Inc. 110 Rue de Lauzon Date of Revision: March 20, 2019 Boucherville, QC, Canada J4B 1E6 Submission Control No: 224236 _Rocuronium Bromide Injection _ _Page 2 of 37 _ 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 ..................................................................................... 27 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................... 27 PART II: SCIENTIFIC INFORMATION .... Llegiu el document complet