CISATRACURIUM BESYLATE INJECTION SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Dostopno od:

MYLAN PHARMACEUTICALS ULC

Koda artikla:

M03AC11

INN (mednarodno ime):

CISATRACURIUM

Odmerek:

2MG

Farmacevtska oblika:

SOLUTION

Sestava:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

10ML

Tip zastaranja:

Prescription

Terapevtsko območje:

NEUROMUSCULAR BLOCKING AGENTS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED PRE MARKET

Datum dovoljenje:

2018-06-15

Lastnosti izdelka

_ 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
...