BUPIVACAINE SPINAL HEAVY BNM bupivacaine hydrochloride 20 mg/4 mL solution for injection ampoule

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

bupivacaine hydrochloride monohydrate, Quantity: 5.28 mg/mL (Equivalent: bupivacaine hydrochloride, Qty 5 mg/mL)

Boleh didapati daripada:

Boucher & Muir Pty Ltd

Borang farmaseutikal:

Injection, solution

Komposisi:

Excipient Ingredients: glucose; water for injections; sodium hydroxide

Laluan pentadbiran:

Intrathecal

Unit dalam pakej:

10 x 4 mL

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Bupivacaine spinal heavy BNM is indicated for the production of spinal anaesthesia.,Bupivacaine spinal heavy BNM is suitable for abdominal surgery lasting 45 - 60 minutes and urological and lower limb surgery lasting 2 - 3 hours.

Ringkasan produk:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status kebenaran:

Registered

Tarikh kebenaran:

2019-05-20

Risalah maklumat

BUPIVACAINE SPINAL
HEAVY BNM
_SOLUTION FOR INTRATHECAL INJECTION_
_Bupivacaine hydrochloride 20 mg/4 mL (0.5%)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given Bupivacaine
spinal heavy BNM.
This leaflet answers some common
questions about Bupivacaine spinal
heavy BNM. It does not contain all
the available information. The most
up-to-date Consumer Medicine
Information can be downloaded from
www.ebs.tga.gov.au.
Reading this leaflet does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks associated with giving you
Bupivacaine spinal heavy BNM
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST OR NURSE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT BUPIVACAINE
SPINAL HEAVY BNM IS
USED FOR
Bupivacaine spinal heavy BNM
contains bupivacaine hydrochloride
monohydrate.
Bupivacaine spinal heavy BNM is
used to prevent or relieve pain before
surgery of the lower abdomen and
lower limbs. They will not put you to
sleep.
Bupivacaine spinal heavy BNM can
also be used to make childbirth less
painful.
Bupivacaine spinal heavy BNM
belongs to a group of medicines
called spinal local anaesthetics. They
are injected into the spinal fluid
where they make the nerves unable to
pass messages to the brain.
Depending on the amount used,
Bupivacaine spinal heavy BNM will
either totally stop pain or will cause a
partial loss of feeling.
Your doctor will have explained why
you are being treated with
Bupivacaine spinal heavy BNM and
told you what dose you will be given.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Bupivacaine spinal heavy BNM is
only available with a doctor's
prescription.
Bupivacaine spinal heavy BNM

Ciri produk

BUPIVACAINE SPINAL HEAVY BNM
1
AUSTRALIAN PRODUCT INFORMATION
BUPIVACAINE SPINAL HEAVY BNM
BUPIVACAINE HYDROCHLORIDE MONOHYDRATE
(Injection solution for the production of spinal anaesthesia)
NOT FOR INTRAVENOUS ADMINISTRATION
UNDER ANY CIRCUMSTANCES
1
NAME OF THE MEDICINE
Bupivacaine hydrochloride monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bupivacaine spinal heavy BNM solution for injection is a sterile,
hyperbaric, isotonic
aqueous
solution
containing
bupivacaine
hydrochloride
monohydrate
equivalent
to
bupivacaine hydrochloride 5 mg/mL (0.5%w/v) in water for injections.
It also contains glucose monohydrate equivalent to glucose 80 mg per
mL of solution
(8% w/v). It has a specific gravity of 1.03 g/mL at 20°C. The pH of
the solution is adjusted
with sodium hydroxide to remain between 4.0 and 6.0 during the
approved shelf-life.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Clear and colourless solution for injection.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bupivacaine spinal heavy BNM is indicated for the production of spinal
anaesthesia.
Bupivacaine spinal heavy BNM is suitable for abdominal surgery lasting
45 - 60 minutes
and urological and lower limb surgery lasting 2 - 3 hours.
4.2 DOSE AND METHOD OF ADMINISTRATION
As with all local anaesthetics, the dosage varies and depends upon the
area to be
anaesthetised, the vascularity of the tissues, the number of neuronal
segments to be blocked,
the depth of anaesthesia and degree of muscle relaxation required,
individual tolerance, the
technique of anaesthesia, and the physical condition of the patient.
BUPIVACAINE SPINAL HEAVY BNM
2
The lowest dosage that results in effective anaesthesia should be
used. In general, surgical
anaesthesia requires the use of higher concentrations and doses than
those required for
analgesia.
Bupivacaine spinal heavy BNM is for use in one patient on one occasion
only. Any solution
remaining from an opened container should be discarded.
The following dosage recommendatio