CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Saadav alates:

OMEGA LABORATORIES LIMITED

ATC kood:

M03AC11

INN (Rahvusvaheline Nimetus):

CISATRACURIUM

Annus:

2MG

Ravimvorm:

SOLUTION

Koostis:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

10*5ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

NEUROMUSCULAR BLOCKING AGENTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2013-06-28

Toote omadused

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