CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Beszerezhető a:

OMEGA LABORATORIES LIMITED

ATC-kód:

M03AC11

INN (nemzetközi neve):

CISATRACURIUM

Adagolás:

2MG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

10*5ML

Recept típusa:

Prescription

Terápiás terület:

NEUROMUSCULAR BLOCKING AGENTS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2013-06-28

Termékjellemzők

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