CISATRACURIUM PFIZER cisatracurium (as besilate) 10 mg/5 mL solution for injection ampoule

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

cisatracurium besilate

可用日期:

Pfizer Australia Pty Ltd

INN（国际名称）:

cisatracurium besilate

授权状态:

Registered

资料单张

CISATRACURIUM PFIZER
®
_Cisatracurium (as besylate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CISATRACURIUM
PFIZER. 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 PFIZER ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION.
You may want to read it again. This
leaflet provides information about
CISATRACURIUM PFIZER. 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
PFIZER IS USED FOR
CISATRACURIUM PFIZER is used
to relax the body's muscles.
CISATRACURIUM PFIZER will
normally be given to you when you
are in surgery, or during other
medical procedures. Cisatracurium
Pfizer is only used in conjunction
with an anaesthetic, so you will be
asleep during the procedure.
IF YOU HAVE ANY QUESTIONS ABOUT
WHY CISATRACURIUM PFIZER
IS USED ASK YOUR DOCTOR.
_HOW DOES CISATRACURIUM_
_PFIZER WORKS_
Cisatracurium besylate (the active
ingredient in CISATRACURIUM
PFIZER) belongs to a group of
medicines called "neuromuscular
blockers".
CISATRACURIUM PFIZER 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 PFIZER 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 YOU USE
CISATRACURIUM
PFIZER
CISATRACURIUM PFIZER IS
NOT SUITABLE FOR EVERYONE.
BEFORE CISATRACURIUM
PFIZER IS USED MAKE SURE THAT
YOUR

产品特点

Version: pfpcisai10713
Supersedes: pfpcisai10213
Page 1 of 16
PRODUCT INFORMATION
CISATRACURIUM PFIZER

CISATRACURIUM BESYLATE
NAME OF THE MEDICINE
The chemical name of cisatracurium besylate is
(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-
veratrylisoquinolinium) dibenzenesulfonate.
The molecular formula of cisatracurium besylate is C
65
H
82
N
2
O
18
S
2
and it has a molecular
weight of 1243.5. The structural formula is given below:
CAS NUMBER: 96946-42-8
DESCRIPTION
Cisatracurium besylate is a white to pale yellow powder.
CISATRACURIUM PFIZER is supplied in a concentration of 2.68 mg/mL
cisatracurium
besylate, equivalent to cisatracurium 2 mg/mL. CISATRACURIUM PFIZER
also contains
Water for Injections and benzenesulfonic acid.
CISATRACURIUM PFIZER does not contain any preservative and is for
single use in one
patient only. Discard any residue.
PHARMACOLOGY
PHARMACODYNAMICS
Cisatracurium besylate, a stereoisomer of atracurium, is an
intermediate duration, non-
depolarising benzylisoquinolinium skeletal muscle relaxant.
Cisatracurium besylate binds to
Version: pfpcisai10713
Supersedes: pfpcisai10213
Page 2 of 16
cholinergic receptors on the motor end-plate 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
besylate is estimated to be
0.05 mg/kg bodyweight during opioid anaesthesia (thiopentone,
fentanyl, midazolam). The
recommended intubation dose for cisatracurium besylate in adults is 3
× ED
95
, which has a
longer clinically effective duration than the recommended intubation
dose of atracurium (2 ×
ED
95
) (see DOSAGE AND ADMINISTRATION).
The ED
95
of cisatracurium besylate in children during halothane anaesthesia is
0.04 mg/kg
bodyweight.
Ci