CISATRACURIUM BESYLATE INJECTION SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Disponible des:

MYLAN PHARMACEUTICALS ULC

Codi ATC:

M03AC11

Designació comuna internacional (DCI):

CISATRACURIUM

Dosis:

2MG

formulario farmacéutico:

SOLUTION

Composición:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

10ML

tipo de receta:

Prescription

Área terapéutica:

NEUROMUSCULAR BLOCKING AGENTS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED PRE MARKET

Data d'autorització:

2018-06-15

Fitxa tècnica

_ 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
...