Pfizer (Australia) BUPIVACAINE HYDROCHLORIDE 0.5% (100mg/20mL) injection BP vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bupivacaine hydrochloride monohydrate, Quantity: 105.4 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid

Administration route:

Epidural, Infiltration

Units in package:

20mL x 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bupivacaine Injection is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: Surgical anaesthesia - Epidural block for surgery - Field block (minor and major nerve blocks and infiltration). Analgesia - Continuous epidural infusion or intermittent bolus epidural administration for analgesia in post operative pain or labour pain. - Field block (minor nerve block amd infiltration). The choice of 2 strengths, 0.25% and 0.5%, makes it possible to vary the degree of motor blockade.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

MARCAIN
®
AND MARCAIN WITH ADRENALINE INJECTION
1
MARCAIN
®
AND
MARCAIN WITH
ADRENALINE INJECTION
_Bupivacaine hydrochloride _
_Bupivacaine hydrochloride and adrenaline (epinephrine) (as acid
tartrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
MARCAIN. It does not contain all
the information that is known about
MARCAIN.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you using
MARCAIN against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MARCAIN IS FOR
MARCAIN is used to prevent or
relieve pain, but it will not put you to
sleep.
MARCAIN is also used after surgery
to relieve pain. It can also be used to
make childbirth less painful.
MARCAIN belongs to a group of
medicines called local anaesthetics.
When injected, it makes the nerves
nearby unable to pass messages to
the brain and will therefore prevent
or relieve pain.
Depending on the amount used,
MARCAIN will either totally stop
pain or will cause a partial loss of
feeling.
MARCAIN is sometimes combined
with adrenaline to make it last
longer. Adrenaline makes the blood
vessels at the site of injection
narrower, which keeps the
MARCAIN where it is needed for a
longer time.
Your doctor will have explained why
you are being treated with
MARCAIN 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.
Your doctor may prescribe this
medicine for uses other than those
listed above. Ask your doctor if you
want more information.
MARCAIN is not addictive
BEFORE YOU ARE GIVEN
MARCAIN
_WHEN YOU MUST NOT BE GIVEN _
_IT _
ASK YOUR DOCTOR ABOUT THE RISKS
AND BENEFITS OF BEING GIVEN
MARCAIN WHILE YOU ARE PREGNANT
OR BREASTFEEDING.
We

Patient Information leaflet

BUPIVACAINE
INJECTION
_Bupivacaine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Bupivacaine
Injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Bupivacaine
Injection against the benefits this
medicine is expected to have for you.
This medicine is likely to be used
while you are at the clinic or in
hospital. If possible, please read this
leaflet carefully before this medicine
is given to you. In some cases this
leaflet may be given to you after the
medicine has been used.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BUPIVACAINE
INJECTION IS USED FOR
Bupivacaine is used to prevent or
relieve pain, but it will not put you to
sleep. Bupivacaine Injection is used
during or after surgery to relieve
pain. It can also be used to make
childbirth less painful.
Bupivacaine Injection belongs to a
group of medicines known as local
anaesthetics. It is injected into the
body where it will either totally stop
pain or will cause partial loss of
feeling (numbness), depending on the
amount used.
Your doctor will have explained why
you are being treated with
Bupivacaine and what dose you will
be given.
FOLLOW ALL THE DIRECTIONS AND ADVICE
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 THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This product is available only on a
doctor's prescription.
BEFORE YOU ARE GIVEN
BUPIVACAINE INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT:_
DO NOT USE BUPIVACAINE INJECTION IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
bupivacaine or other local
anaesthetics e.g. lignocaine
•
any of the ingredients listed at the
e

Summary of Product characteristics

MARCAIN AND MARCAIN WITH ADRENALINE Product Information
1(21)
AUSTRALIAN PRODUCT INFORMATION
Bupivacaine Hydrochloride
Bupivacaine Hydrochloride and Adrenaline (Epinephrine) (as Acid
Tartrate)
(MARCAIN
® AND MARCAIN
® WITH ADRENALINE)
(Injection solutions for the production of local or regional
anaesthesia)
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
1.
NAME OF THE MEDICINE
Bupivacaine hydrochloride with or without adrenaline (epinephrine)
acid tartrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MARCAIN solutions are available with or without adrenaline.
MARCAIN 0.125% EPIDURAL INFUSION
bupivacaine hydrochloride 1.25 mg/mL
MARCAIN 0.25%
bupivacaine hydrochloride 2.5 mg/mL
MARCAIN 0.25% WITH ADRENALINE 1:400,000
bupivacaine hydrochloride 2.5 mg/mL with adrenaline (epinephrine) 2.5
(as acid
tartrate) microgram/mL
MARCAIN 0.375%
bupivacaine hydrochloride 3.75 mg/mL
MARCAIN 0.5%
bupivacaine hydrochloride 5 mg/mL
MARCAIN 0.5% WITH ADRENALINE 1:200,000
bupivacaine hydrochloride 5 mg/mL with adrenaline (epinephrine) 5 (as
acid
tartrate) microgram/mL
MARCAIN solutions for injection are sterile, isotonic aqueous
solutions of
bupivacaine hydrochloride in Water for Injections BP. The pH of the
solution is
adjusted with sodium hydroxide or hydrochloric acid to remain between
4.0 - 6.5
during the approved shelf-life.
MARCAIN with adrenaline solutions for injection are sterile, isotonic
aqueous
solutions of bupivacaine hydrochloride in Water for Injections BP. The
pH of the
solution is adjusted with sodium hydroxide or hydrochloric acid to
remain between
3.3 - 5.0.
MARCAIN AND MARCAIN WITH ADRENALINE Product Information
2(21)
MARCAIN with adrenaline also contains sodium metabisulfite as an
antioxidant.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Clear, colourless solution for injection or infusion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MARCAIN solutions are indicated for the production of local or
regional
anaesthesia and analgesia in individuals as

Summary of Product characteristics

Version: pfpbupii10512
Supersedes: pfpbupiv10511
Page 1 of 13
PRODUCT INFORMATION
BUPIVACAINE INJECTION BP
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
NAME OF THE MEDICINE
Bupivacaine hydrochloride (anhydrous) BP
Chemical name:
(2RS)-1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide
hydrochloride
monohydrate.
It appears as a white, crystalline powder or colourless crystals. It
is soluble in water, freely soluble in
ethanol (96%), slightly soluble in chloroform and in ether.
Bupivacaine has a pKa of 8.1 and is more
lipid soluble than lignocaine.
The structural formula is represented below.
O
NH
C
4
H
9
H
C
N
H
3
C
H
3
C
,HCl, H
2
O
Molecular Formula:
C
18
H
29
ClN
2
O.H
2
O
Molecular Weight:
342.9
CAS Number:
14252-80-3
DESCRIPTION
Bupivacaine is classed as a membrane stabilising agent and is a local
anaesthetic of the amide type.
Bupivacaine Injection BP is a sterile, isotonic, preservative-free
solution containing bupivacaine
hydrochloride BP (anhydrous) 0.25% or 0.5% and sodium chloride in
water for injections.
Bupivacaine solutions contain no antimicrobial agent and should be
used only once and any residue
discarded.
PHARMACOLOGY
Bupivacaine, like other local anaesthetics, causes a reversible
blockade of impulse propagation along
nerve fibres by preventing the inward movement of sodium ions through
the nerve membrane. Local
anaesthetics of the amide type are thought to act within the sodium
channels of the nerve membrane.
Version: pfpbupii10512
Supersedes: pfpbupiv10511
Page 2 of 13
Local
anaesthetic
drugs
may
have
similar
effects
on
excitable
membranes
in
the
brain
and
myocardium. If excessive amounts of drug reach the systemic
circulation rapidly, symptoms and
signs
of
toxicity
will
appear,
emanating
mainly
from
the
central
nervous
system
and
the
cardiovascular system.
Central nervous system toxicity usually precedes the cardiovascular
effects as it occurs at lower
plasma concentrations. Direct effects of local anaesthetics on the
heart include slow conduction,
negative inotropism and eve