CISATRACURIUM ACCORD cisatracurium (as besilate) 50 mg / 25 mL solution for injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
cisatracurium besilate, Quantity: 67 mg (Equivalent: cisatracurium, Qty 50 mg)
Available from:
Accord Healthcare Pty Ltd
INN (International Name):
cisatracurium besilate
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: benzenesulfonic acid; water for injections
Administration route:
Intravenous
Units in package:
1 vial
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit
Product summary:
Visual Identification: A clear colourless to slightly yellow or greenish yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2015-03-19
Patient Information leaflet
Version 2.0
Page 1 of 2
CISATRACURIUM ACCORD
_Cisatracurium Besilate Solution for Injection 2 mg/mL and 50 mg/mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cisatracurium Accord. It
does not contain all of the available
information.
Reading this leaflet does not take the
place of talking to your doctor or
pharmacist.
Taking any medicine involves some risk.
It is possible that all risks associated with
this medicine might not have been
detected, despite proper testing. Only
your doctor or pharmacist is able to
weigh up all of the relevant facts, and you
should consult them if you have any
queries.
IF YOU HAVE ANY CONCERNS ABOUT THE USE
OF CISATRACURIUM ACCORD ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
This leaflet provides information about
Cisatracurium Accord. The statements
that are made in this leaflet cannot be
applied to any other medicine, even those
that are similar or appear to contain the
same ingredients.
WHAT CISATRACURIUM
ACCORD IS USED FOR
Cisatracurium Accord is used to relax the
body’s muscles. Cisatracurium Accord
will normally be given to you when you
are in surgery, or during other medical
procedures. Cisatracurium Accord is only
used in conjunction with an anaesthetic,
so you will be asleep during the
procedure.
IF YOU HAVE ANY QUESTIONS ABOUT WHY
CISATRACURIUM ACCORD IS USED ASK YOUR
DOCTOR.
_HOW DOES CISATRACURIUM _
_ACCORD WORK? _
Cisatracurium besilate (the active
ingredient in Cisatracurium Accord)
belongs to a group of medicines called
“neuromuscular blockers”.
Cisatracurium Accord works by blocking
the effects of one of the body’s chemical
messengers called acetylcholine.
Acetylcholine is involved in muscle
contraction.
By relaxing your body’s muscles
Cisatracurium Accord makes it easier for
you to be kept asleep (under anaesthesia)
or sedation.
Your doctor will be able to provide you
with more information.
BEFORE RECEIVING
CISATRACURIUM ACCORD
CISATRACURIUM ACCORD IS NOT SUITABLE
Read the complete document
Summary of Product characteristics
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
CISATRACURIUM
ACCORD
(CISATRACURIUM
BESILATE)
SOLUTION
FOR INJECTION
1
NAME OF THE MEDICINE
Cisatracurium besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 2 mg cisatracurium (as besilate)
1 vial of 2.5 mL solution for injection contains 5 mg cisatracurium
(as besilate)
1 vial of 5 mL solution for injection contains 10 mg cisatracurium (as
besilate)
1 vial of 10 mL solution for injection contains 20 mg cisatracurium
(as besilate)
1 vial of 25 mL solution for injection contains 50 mg cisatracurium
(as besilate)
or
1 mL contains 5 mg cisatracurium (as besilate)
1 vial of 30 mL solution for injection contains 150 mg cisatracurium
(as besilate)
Cisatracurium besilate is a white to pale yellow powder.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Cisatracurium Accord Injection is a colourless to pale yellow or
greenish solution.
Cisatracurium Accord Injection is intended for single patient use
only.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Cisatracurium Accord Injection is indicated for use during surgical
and other procedures and in intensive
care to relax skeletal muscles, and to facilitate tracheal intubation
and mechanical ventilation. It is used
as an adjunct to general anaesthesia, or sedation in the intensive
care unit.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Cisatracurium Accord Injection contains no antimicrobial preservative
and is intended for single patient
use.
USE BY INTRAVENOUS BOLUS INJECTION
DOSAGE IN ADULTS
_Tracheal intubation._
The recommended intubation dose of Cisatracurium Accord Injection for
adults is
0.15 mg/kg bodyweight. This dose produces good to excellent conditions
for tracheal intubation 120
seconds following injection.
Higher doses will shorten the time to onset of neuromuscular block.
The following table summarises
mean pharmacodynamic data when cisatracurium besilate was administered
at doses of 0.1 to 0.4 mg/kg
bodyweight to healthy adult patients during opioid
(thiope
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