CISATRACURIUM BESYLATE INJECTION SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Fáanlegur frá:

MYLAN PHARMACEUTICALS ULC

ATC númer:

M03AC11

INN (Alþjóðlegt nafn):

CISATRACURIUM

Skammtar:

2MG

Lyfjaform:

SOLUTION

Samsetning:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

10ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

NEUROMUSCULAR BLOCKING AGENTS

Vörulýsing:

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

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2018-06-15

Vara einkenni

_ Page 1 of 31 _
PRODUCT MONOGRAPH
PR
CISATRACURIUM BESYLATE INJECTION
SOLUTION FOR INJECTION
2 MG/ML CISATRACURIUM (AS CISATRACURIUM BESYLATE)
10 ML MULTIPLE DOSE VIAL
NON-DEPOLARIZING SKELETAL NEUROMUSCULAR BLOCKING AGENT
THIS DRUG SHOULD BE ADMINISTERED ONLY BY ADEQUATELY TRAINED
PROFESSIONALS FAMILIAR
WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation: August 18, 2014
Control No.: 176645
_ Page 2 of 31 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
............................................................................................................
3
WARNINGS AND PRECAUTIONS
..........................................................................................
4
ADVERSE REACTIONS
............................................................................................................
9
DRUG INTERACTIONS
..........................................................................................................
10
DOSAGE AND ADMINISTRATION
......................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
16
STORAGE AND STABILITY
..................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 24
PART II: SCIENTIFIC INFORMATION
................................................................................
25
PHARMACEUTICAL INFORMATION
...