PFIZER BUPIVACAINE 0.5% w/v WITH ADRENALINE (epinephrine) 1:200,000 injection solution vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bupivacaine hydrochloride monohydrate, Quantity: 5.27 mg/mL (Equivalent: bupivacaine hydrochloride, Qty 5 mg/mL); adrenaline (epinephrine) acid tartrate, Quantity: 9.1 microgram/mL (Equivalent: adrenaline (epinephrine), Qty 5 microgram/mL)

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; sodium metabisulfite; citric acid; sodium citrate

Administration route:

Subcutaneous, Epidural, Infiltration, Intramuscular

Units in package:

5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pfizer Bupivacaine with adrenaline 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 postoperative pain or labour pain,- Field block (minor nerve block and 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 or almost colourless solution, practically free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-10-19

Patient Information leaflet

PFIZER BUPIVACAINE WITH ADRENALINE INJECTION
1
PFIZER BUPIVACAINE
WITH ADRENALINE
_Bupivacaine hydrochloride monohydrate and adrenaline (epinephrine)
acid tartrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Pfizer Bupivacaine with adrenaline.
It does not contain all the information
that is known about Pfizer
Bupivacaine with adrenaline.
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 Pfizer
Bupivacaine with adrenaline 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 PFIZER
BUPIVACAINE WITH
ADRENALINE IS USED FOR
Pfizer Bupivacaine with adrenaline is
used to prevent or relieve pain, but it
will not put you to sleep.
Pfizer Bupivacaine with adrenaline is
also used after surgery to relieve
pain. It can also be used to make
childbirth less painful.
Pfizer Bupivacaine with adrenaline
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,
Pfizer Bupivacaine with adrenaline
will either totally stop pain or will
cause a partial loss of feeling.
Bupivacaine is combined with
adrenaline (epinephrine) to make it
last longer. Adrenaline (epinephrine)
makes the blood vessels at the site of
injection narrower, which keeps the
Bupivacaine where it is needed for a
longer time.
Your doctor will have explained why
you are being treated with Pfizer
Bupivacaine with adrenaline 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 doct

Summary of Product characteristics

Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION –
PFIZER BUPIVACAINE WITH ADRENALINE
(BUPIVACAINE HYDROCHLORIDE (AS
MONOHYDRATE) AND ADRENALINE
(EPINEPHRINE) ACID TARTRATE)
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
1.
NAME OF THE MEDICINE
bupivacaine hydrochloride
(as monohydrate)
adrenaline (epinephrine) acid tartrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pfizer Bupivacaine with Adrenaline, Bupivacaine 0.25% w/v with
adrenaline (epinephrine)
1:400,000 injection vial contains bupivacaine hydrochloride 2.5 mg/mL
with adrenaline
(epinephrine) 2.5 microgram/mL).
Pfizer Bupivacaine with Adrenaline, Bupivacaine 0.5% w/v with
adrenaline (epinephrine)
1:200,000
injection
vial
contains
bupivacaine
hydrochloride
5
mg/mL
with
adrenaline
(epinephrine) 5 microgram/mL).
Bupivacaine hydrochloride is a white or almost white, crystalline
powder or colourless crystal
that is soluble in water and freely soluble in ethanol (96%).
Bupivacaine has a pKa of 8.1 and
is more lipid soluble than lignocaine.
Adrenaline (epinephrine) acid tartrate appears as a white or
greyish-white, crystalline powder
that is freely soluble in water and slightly soluble in ethanol (96%).
Pfizer Bupivacaine with Adrenaline solution for injection is a
sterile, isotonic aqueous
solution of bupivacaine hydrochloride, adrenaline (epinephrine) and
sodium chloride in Water
for Injections BP. The pH of the solution is adjusted with citric acid
and sodium citrate to
remain between 3.3 - 5.0. Pfizer Bupivacaine with Adrenaline contain
sodium metabisulfite
as an antioxidant.
EXCIPIENT(S) WITH KNOWN EFFECT
Sodium metabisulfite
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Pfizer Bupivacaine with Adrenaline is a sterile solution for
injection. The solutions are
practically free from visible particles.
Page 2 of 19
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pfizer Bupivacaine with Adrenaline is indicated for the production of
local or regional
anaesthesia and analgesia in individuals as follows: