NIMBEX cisatracurium (as besilate) 150mg/30mL injection vial

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

cisatracurium besilate, Quantity: 6.7 mg/mL (Equivalent: cisatracurium, Qty 5 mg/mL)

Boleh didapati daripada:

Aspen Pharmacare Australia Pty Ltd

Borang farmaseutikal:

Injection, solution

Komposisi:

Excipient Ingredients: benzenesulfonic acid; water for injections

Laluan pentadbiran:

Intravenous

Unit dalam pakej:

1 X 30mL

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Nimbex 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.

Ringkasan produk:

Visual Identification: Colourless to pale yellow or greenish yellow solution, practically free from visible particulate matter; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

1996-09-13

Risalah maklumat

1
NIMBEX
® INJECTION
_CISATRACURIUM BESILATE_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about NIMBEX. 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
NIMBEX ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION.
You may want to read it again.
This
leaflet
provides
information
about
NIMBEX. 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 NIMBEX IS USED FOR
NIMBEX is used to relax the body’s muscles.
NIMBEX will normally be given to you when you
are
in
surgery,
or
during
other
medical
procedures.
NIMBEX
is
only
used
in
conjunction with an anaesthetic, so you will be
asleep during the procedure.
IF YOU HAVE ANY QUESTIONS ABOUT WHY NIMBEX
IS USED ASK YOUR DOCTOR.
_HOW DOES NIMBEX WORK?_
Cisatracurium besilate (the active ingredient in
NIMBEX) belongs to a group of medicines called
“neuromuscular blockers”.
NIMBEX 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 NIMBEX 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 NIMBEX
NIMBEX IS NOT SUITABLE FOR EVERYONE.
BEFORE NIMBEX IS USED MAKE SURE THAT YOUR
DOCTOR KNOWS IF:
1. YOU ARE ALLERGIC TO:
•
cisatracurium
besilate,
atracurium
or
benzenesulfonic acid.
•
any other muscle relaxants.
2. YOU ARE PREGNANT OR BREASTFEEDING.
3. YOU SUFFER FROM MYASTHENIA GRAV

Ciri produk

1
AUSTRALIAN PRODUCT INFORMATION
NIMBEX (CISATRACURIUM BESILATE)
INJECTION
1
NAME OF THE MEDICINE
Cisatracurium besilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nimbex injection is supplied in two strengths, either 2 mg or 5 mg of
cisatracurium besilate
per mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Nimbex injection is a colourless to pale yellow or greenish solution,
practically free from
visible particulate matter.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Nimbex 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
Nimbex 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 Nimbex
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, Table
1, summarises mean pharmacodynamic data when Nimbex 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.
2
TABLE 1
INITIAL NIMBEX
INJECTION DOSE
(MG/KG
BODYWEIGHT)
ANAESTHETIC
BACKGROUND
TIME TO 90%
T
1
®
SUPPRESSION
(MIN)
TIME TO
MAXIMUM T
1
®
SUPPRESSION
(MIN)
TIME TO
SPONTANEOUS
T
1
®
RECOVERY
(MIN)
0.1
Opioid
3.4
4.8
45
0.15
Propofol
2.6
3.5
55
0.2
Opioid
2.4
2.9
65
0.4
Opioid
1.5
1.9
91
®
Single twitch response as well as the first component of the
Train-of-Four response of
the adductor pollicis muscle following the supramaximal electrical
stimulation of the ulnar
nerve
Enflurane or isoflurane anaesthesia may