CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Tillgänglig från:

OMEGA LABORATORIES LIMITED

ATC-kod:

M03AC11

INN (International namn):

CISATRACURIUM

Dos:

2MG

Läkemedelsform:

SOLUTION

Sammansättning:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

10*5ML

Receptbelagda typ:

Prescription

Terapiområde:

NEUROMUSCULAR BLOCKING AGENTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2013-06-28

Produktens egenskaper

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
...................................