CISATRACURIUM BESYLATE INJECTION (PRESERVATIVE-FREE) SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Preparatomtale Preparatomtale (SPC)
20-08-2014

Aktiv ingrediens:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

M03AC11

INN (International Name):

CISATRACURIUM

Dosering :

2MG

Legemiddelform:

SOLUTION

Sammensetning:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

5ML

Resept typen:

Prescription

Terapeutisk område:

NEUROMUSCULAR BLOCKING AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0133260001; AHFS:

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2018-06-15

Preparatomtale

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_Page 1 of 30 _
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PRODUCT MONOGRAPH
PR
CISATRACURIUM BESYLATE INJECTION (PRESERVATIVE-FREE)
SOLUTION FOR INJECTION
2 MG/ML CISATRACURIUM (AS CISATRACURIUM BESYLATE)
5 ML SINGLE DOSE VIAL
NON-DEPOLARIZING SKELETAL NEUROMUSCULAR BLOCKING AGENT
THIS DRUG SHOULD BE ADMINISTERED ONLY BY ADEQUATELY TRAINED
PROFESSIONALS FAMILIAR
WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation: August 18, 2014
Control No.: 176645
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_Page 2 of 30 _
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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
............................................................................................................
8
DRUG INTERACTIONS
............................................................................................................
9
DOSAGE AND ADMINISTRATION
......................................................................................
10
OVERDOSAGE
.........................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
16
STORAGE AND STABILITY
..................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................
                                
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