CISATRACURIUM BESYLATE INJECTION SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Saadav alates:

MYLAN PHARMACEUTICALS ULC

ATC kood:

M03AC11

INN (Rahvusvaheline Nimetus):

CISATRACURIUM

Annus:

2MG

Ravimvorm:

SOLUTION

Koostis:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

10ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

NEUROMUSCULAR BLOCKING AGENTS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED PRE MARKET

Loa andmise kuupäev:

2018-06-15

Toote omadused

_ 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
...