CISATRACURIUM BESYLATE INJECTION SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Commercializzato da:

MYLAN PHARMACEUTICALS ULC

Codice ATC:

M03AC11

INN (Nome Internazionale):

CISATRACURIUM

Dosaggio:

2MG

Forma farmaceutica:

SOLUTION

Composizione:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Via di somministrazione:

INTRAVENOUS

Confezione:

10ML

Tipo di ricetta:

Prescription

Area terapeutica:

NEUROMUSCULAR BLOCKING AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2018-06-15

Scheda tecnica

_ 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
...