CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CISATRACURIUM (CISATRACURIUM BESYLATE)

זמין מ:

OMEGA LABORATORIES LIMITED

קוד ATC:

M03AC11

INN (שם בינלאומי):

CISATRACURIUM

כמות:

2MG

טופס פרצבטיות:

SOLUTION

הרכב:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

10*5ML

סוג מרשם:

Prescription

איזור תרפויטי:

NEUROMUSCULAR BLOCKING AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2013-06-28

מאפייני מוצר

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