CISATRACURIUM OMEGA MULTIDOSE SOLUTION

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Disponibbli minn:

OMEGA LABORATORIES LIMITED

Kodiċi ATC:

M03AC11

INN (Isem Internazzjonali):

CISATRACURIUM

Dożaġġ:

2MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

10*10ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

NEUROMUSCULAR BLOCKING AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2013-06-28

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
PR
C
ISATRACURIUM
O
MEGA
S
INGLE
D
OSE
Cisatracurium Besylate Injection
2 mg/mL cisatracurium
(5 mL single dose vial)
PR
C
ISATRACURIUM
O
MEGA
M
ULTI
-D
OSE
Cisatracurium Besylate Injection
2 mg/mL cisatracurium
(10 mL multiple dose vial)
NON-DEPOLARIZING SKELETAL NEUROMUSCULAR BLOCKING AGENT
Sterile solution
THIS DRUG SHOULD BE ADMINISTERED ONLY BY ADEQUATELY TRAINED
PROFESSIONALS FAMILIAR
WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
Omega Laboratories Limited
11 177, Hamon
Montreal, Canada
H3M 3E4
DATE OF PREPARATION
:
June 27, 2013
SUBMISSION CONTROL NO: 138615
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
.............................................................................................
10
DRUG INTERACTIONS
.............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
13
OVERDOSAGE
............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 20
STORAGE AND STABILITY
.....................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
................................................................... 28
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 28
PART II: SCIENTIFIC INFORMATION
...................................