CISATRACURIUM BESYLATE INJECTION (PRESERVATIVE-FREE) SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Saatavilla:

MYLAN PHARMACEUTICALS ULC

ATC-koodi:

M03AC11

INN (Kansainvälinen yleisnimi):

CISATRACURIUM

Annos:

2MG

Lääkemuoto:

SOLUTION

Koostumus:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

5ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NEUROMUSCULAR BLOCKING AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2018-06-15

Valmisteyhteenveto

_ _
_Page 1 of 30 _
_ _
PRODUCT MONOGRAPH
PR
CISATRACURIUM BESYLATE INJECTION (PRESERVATIVE-FREE)
SOLUTION FOR INJECTION
2 MG/ML CISATRACURIUM (AS CISATRACURIUM BESYLATE)
5 ML SINGLE 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 30 _
_ _
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
............................................................................................................
8
DRUG INTERACTIONS
............................................................................................................
9
DOSAGE AND ADMINISTRATION
......................................................................................
10
OVERDOSAGE
.........................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
16
STORAGE AND STABILITY
..................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................