DBL CISATRACURIUM INJECTION CONCENTRATE cisatracurium (as besilate) 5 mg/2.5 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cisatracurium besilate

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

cisatracurium besilate

Authorization status:

Registered

Patient Information leaflet

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DBL™ Cisatracurium Injection Concentrate
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DBL™ CISATRACURIUM INJECTION CONCENTRATE
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_Cisatracurium besilate (sis-at-rah-CURE-e-um BESS-ee-late) _
CONSUMER MEDICINE INFORMATION
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WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL™
Cisatracurium Injection Concentrate
(cisatracurium besilate).
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DBL™
CISATRACURIUM
INJECTION CONCENTRATE
IS USED FOR
This medicine is used to relax the
body’s muscles during surgery or
other medical procedures.
The medicine contains cisatracurium
besilate, which belongs to a family of
medicines called neuromuscular
blockers.
The medicine works by blocking the
effects of one of the body’s chemical
messengers called acetylcholine.
Acetycholine is involved in muscle
contraction.
By relaxing your body’s muscles
cisatracurium besilate makes it easier
for you to be kept asleep (under
anaesthesia) or sedation.
Cisatracurium besilate is only used in
conjunction with an anaesthetic, so
you will be asleep during the
procedure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is only available with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
DBL™ CISATRACURIUM
INJECTION CONCENTRATE
_WHEN YOU MUST NOT BE GIVEN _
_IT _

Summary of Product characteristics

Product Information - Australia
Version 2.0
- 1 -
DBL
TM CISATRACURIUM INJECTION CONCENTRATE
NAME OF MEDICINE
Cisatracurium besilate
DESCRIPTION
The active ingredient, Cisatracurium besilate, is a white to off-white
or yellowish powder.
DBL
TM
Cisatracurium Injection Concentrate is presented as a clear,
colourless or faint
yellow solution containing cisatracurium besilate, benzenesulfonic
acid and water for
injections, pH is 3.0 – 3.7. It contains no antimicrobial
preservative.
DBL
TM
Cisatracurium Injection Concentrate is available in the following
presentations:
Cisatracurium (as besilate salt), 5 mg per 2.5 mL
Cisatracurium (as besilate salt), 10 mg per 5 mL
Chemical name: (1R,1’R,2R,2’R)-2,2’- (3,11-dioxo-4,
10-dioxatridecamethylene)-_bis_-
(1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratry-lisoquinolinium)
dibenzenesulfonate.
Molecular formula: C
65
H
82
N
2
O
18
S
2
Molecular weight: 1,243.5
CAS number: 96946-42-8
Product Information - Australia
Version 2.0
- 2 -
The structural formula of cisatracurium besilate is shown below:-
ACTIONS
Cisatracurium
besilate,
a
stereoisomer
of
atracurium,
is
an
intermediate
duration,
nondepolarising benzylisoquinolinium skeletal muscle relaxant.
PHARMACOLOGY
PHARMACODYNAMICS
Cisatracurium
besilate
binds
to
cholinergic
receptions
on
the
motor
endplate
to
antagonise the action of acetylcholine, resulting in a competitive
block of neuromuscular
transmission. This action is readily reversed by anticholinesterase
agents such as
neostigmine.
The ED
95
(dose required to produce 95% depression of the twitch response of the
adductor pollicis muscle to stimulation of the ulnar nerve) of
cisatracurium besilate is
estimated to be 0.05 mg/kg bodyweight during opioid anaesthesia
(thiopentone, fentanyl,
midazolam). The recommended intubation dose for cisatracurium besilate
in adults is
three
times
the
ED
95
,
which
has
a
longer
clinically
effective
duration
than
the
recommended intubation dose of atracurium (two times the ED
95
) (SEE DOSAGE AND
ADMINISTRATION).
The
ED
95
of
cis