CISATRACURIUM BESYLATE INJECTION SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CISATRACURIUM (CISATRACURIUM BESYLATE)

זמין מ:

MYLAN PHARMACEUTICALS ULC

קוד ATC:

M03AC11

INN (שם בינלאומי):

CISATRACURIUM

כמות:

2MG

טופס פרצבטיות:

SOLUTION

הרכב:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

10ML

סוג מרשם:

Prescription

איזור תרפויטי:

NEUROMUSCULAR BLOCKING AGENTS

leaflet_short:

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

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2018-06-15

מאפייני מוצר

_ 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
...