CISATRACURIUM BESYLATE INJECTION SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CISATRACURIUM (CISATRACURIUM BESYLATE)

متاح من:

MYLAN PHARMACEUTICALS ULC

ATC رمز:

M03AC11

INN (الاسم الدولي):

CISATRACURIUM

جرعة:

2MG

الشكل الصيدلاني:

SOLUTION

تركيب:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

10ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

NEUROMUSCULAR BLOCKING AGENTS

ملخص المنتج:

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

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2018-06-15

خصائص المنتج

_ 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
...