Bupivacaine spinal heavy BNM

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Bupivacaine hydrochloride monohydrate 5.28 mg/mL equivalent to bupivacaine hydrochloride 5mg/mL

Доступна с:

Boucher & Muir (New Zealand) Limited t/a BNM Group

дозировка:

0.5% w/v

Фармацевтическая форма:

Solution for injection

состав:

Active: Bupivacaine hydrochloride monohydrate 5.28 mg/mL equivalent to bupivacaine hydrochloride 5mg/mL Excipient: Glucose monohydrate Sodium hydroxide Water for injection

Тип рецепта:

Prescription

Терапевтические показания :

Bupivacaine spinal heavy BNM is indicated for · intrathecal (subarachnoid, spinal) anaesthesia for surgical and obstetrical procedures · lower abdominal surgery (including caesarean section), urological and lower limb, including hip surgery, lasting 1.5 to 3 hours.

Обзор продуктов:

Package - Contents - Shelf Life: Ampoule, glass, Clear Type I glass ampoule, 4mL deliverable volume - 10 dose units - 36 months from date of manufacture stored at or below 25°C

Дата Авторизация:

2019-02-21

тонкая брошюра

1
BUPIVACAINE SPINAL HEAVY BNM
Consumer Medicine Information
BUPIVACAINE SPINAL HEAVY BNM
Bupivacaine hydrochloride 20 mg/4 mL (0.5%)
Solution for intrathecal injection
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.medsafe.govt.nz.
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.
B

Характеристики продукта

1
BUPIVACAINE SPINAL HEAVY BNM
BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION 0.5% W/V
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
BUPIVACAINE SPINAL HEAVY BNM
0.5% w/v Injection, solution
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.
3
PHARMACEUTICAL FORM
Bupivacaine spinal heavy BNM is a clear and colourless solution for
injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bupivacaine spinal heavy BNM is indicated for
•
intrathecal
(subarachnoid,
spinal)
anaesthesia
for
surgical
and
obstetrical
procedures
•
lower abdominal surgery (including caesarean section), urological and
lower limb,
including hip surgery, lasting 1.5 to 3 hours.
4.2
DOSE AND METHOD OF ADMINISTRATION
The following dosage recommendations should be regarded as a guide for
use in the
average adult. The patient’s physical status and concomitant
medication should be
considered when deciding the dose, and the lowest dose required for
adequate anaesthesia
should be used. Duration varies with dose, while segmental spread may
be difficult to
predict.
2
BUPIVACAINE SPINAL HEAVY BNM
BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION 0.5% W/V
The dose should be reduced in the elderly and in patients in the late
stages of pregnancy.
DOSE
_SPINAL ANAESTHESIA FOR SURGERY _
The spread of anaesthesia obtained is dependent on several factors,
the most important
being volume of solution injected, position of patient and rate of
injection.
• 1.5 - 4 mL Bupivacaine spinal heavy BNM (7.5-20 mg bupivacaine
hydrochloride).
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