CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Inapatikana kutoka:

OMEGA LABORATORIES LIMITED

ATC kanuni:

M03AC11

INN (Jina la Kimataifa):

CISATRACURIUM

Kipimo:

2MG

Dawa fomu:

SOLUTION

Tungo:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

10*5ML

Dawa ya aina:

Prescription

Eneo la matibabu:

NEUROMUSCULAR BLOCKING AGENTS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2013-06-28

Tabia za bidhaa

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