Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
CISATRACURIUM (CISATRACURIUM BESYLATE)
PFIZER CANADA ULC
M03AC11
CISATRACURIUM
2MG
SOLUTION
CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG
INTRAVENOUS
10ML
Prescription
NEUROMUSCULAR BLOCKING AGENTS
Active ingredient group (AIG) number: 0133260001; AHFS:
CANCELLED POST MARKET
2019-03-28
PRODUCT MONOGRAPH PR CISATRACURIUM BESYLATE INJECTION Solution for Injection 20 mg/10 mL (2 mg/mL) Cisatracurium Non-depolarizing Skeletal Neuromuscular Blocking Agent THIS DRUG SHOULD BE ADMINISTERED ONLY BY ADEQUATELY TRAINED PROFESSIONALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS. Pfizer Canada Inc. 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Submission Control No.: 210419 Date of Revision: November 07, 2017 _Product Monograph -_ _Pr_ _Cisatracurium besylate Injection_ _Page 2 of 32_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS....................................................................................................9 DRUG INTERACTIONS ..................................................................................................10 DOSAGE AND ADMINISTRATION..............................................................................12 OVERDOSAGE ................................................................................................................17 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 STORAGE AND STABILITY..........................................................................................24 SPECIAL HANDLING INSTRUCTIONS .......................................................................25 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................25 PART II: SCIENTIFIC INFORMATION ............................................................................ Baca dokumen lengkap