CISATRACURIUM BESYLATE INJECTION SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Beszerezhető a:

MYLAN PHARMACEUTICALS ULC

ATC-kód:

M03AC11

INN (nemzetközi neve):

CISATRACURIUM

Adagolás:

2MG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

10ML

Recept típusa:

Prescription

Terápiás terület:

NEUROMUSCULAR BLOCKING AGENTS

Termék összefoglaló:

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

Engedélyezési státusz:

CANCELLED PRE MARKET

Engedély dátuma:

2018-06-15

Termékjellemzők

_ 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
...