CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Saatavilla:

OMEGA LABORATORIES LIMITED

ATC-koodi:

M03AC11

INN (Kansainvälinen yleisnimi):

CISATRACURIUM

Annos:

2MG

Lääkemuoto:

SOLUTION

Koostumus:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

10*5ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NEUROMUSCULAR BLOCKING AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2013-06-28

Valmisteyhteenveto

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