CISATRACURIUM SXP cisatracurium (as besilate) 20mg/10mL injection solution in vial

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

cisatracurium besilate

Verfügbar ab:

Southern Cross Pharma Pty Ltd

INN (Internationale Bezeichnung):

cisatracurium besilate

Berechtigungsstatus:

Registered

Gebrauchsinformation

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C: Products/Cisatracurium/CMI SXP oct12 14/10/12 Page
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CISATRACURIUM SXP INJECTION SOLUTION
_cisatracurium (as besylate) _
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
This leaflet answers some common
questions about CISATRACURIUM
SXP. 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 SXP ask your
doctor or pharmacist.
KEEP THIS INFORMATION.
You may want to read it again.
This leaflet provides information about
CISATRACURIUM SXP. 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
SXP is used for
CISATRACURIUM SXP is used to
relax the body's muscles.
CISATRACURIUM SXP will
normally be given to you when you are
in surgery, or during other medical
procedures. CISATRACURIUM SXP
is only used in conjunction with an
anaesthetic, so you will be asleep
during the procedure.
If you have any questions about why
CISATRACURIUM SXP is used ask
your doctor.
How does
CISATRACURIUM SXP
work?
Cisatracurium besylate (the active
ingredient in CISATRACURIUM
SXP) belongs to a group of medicines
called "neuromuscular blockers".
CISATRACURIUM SXP 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 SXP 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 it
CISAT

Fachinformation

AUSTRALIAN PRODUCT INFORMATION
CISATRACURIUM SXP (CISATRACURIUM AS BESILATE) INJECTION SOLUTION
_ _
1. NAME OF THE MEDICINE
Cisatracurium (as besilate).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cisatracurium SXP injection solution contains the active ingredient
cisatracurium (as besilate).
Cisatracurium SXP injection solution contains cisatracurium (as
besilate) 20 mg in 10 mL.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Cisatracurium AJS injection solution is a colourless to pale yellow or
yellowish-greenish solution.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Cisatracurium AJS injection solution 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 intensive
care unit.
4.2. DOSE AND METHOD OF ADMINISTRATION
Cisatracurium 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 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.
Table
1
summarises
mean
pharmacodynamic data when cisatracurium injection was administered at
doses of 0.1 to 0.4 mg/kg
bodyweight
to
healthy
adult
patients
during
opioid
(thiopentone/
fentanyl/
midazolam)
or
propofol
anaesthesia.
TABLE 1
Pharmacodynamic data in adults
INITIAL DOSE OF
CISATRACURIUM
INJECTION
ANAESTHETIC TYPE
TIME TO 90% T
1
*
SUPPRESSION
TIME TO
MAXIMUM T
1
*
SUPPRESSION
TIME TO
SPONTANEOUS
T
1
* RECOVERY
ADULTS
0.1 mg/kg
Opioid
3.4 minutes
4.8 minutes
45 minutes
0.15 mg/kg
Propofol
2.6 minutes
3.5 minutes
55 minutes
0.2 mg/kg
Opioid
2.4 minutes
2.9 minutes
65 minutes
0.4 mg/kg
Opioid
1.5 minutes
1.9 minutes
91