Pfizer (Australia) BUPIVACAINE HYDROCHLORIDE 0.5% (50mg/10mL) injection BP ampoule

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

bupivacaine hydrochloride monohydrate, Quantity: 52.7 mg

Tilgængelig fra:

Pfizer Australia Pty Ltd

Lægemiddelform:

Injection, solution

Sammensætning:

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

Indgivelsesvej:

Epidural, Infiltration

Enheder i pakken:

10mL x 50

Klasse:

Medicine Registered

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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.

Produkt oversigt:

Visual Identification: Clear, colourless solution, free from visible particles; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

1991-08-13

Indlægsseddel

BUPIVACAINE
INJECTION BP
_Bupivacaine hydrochloride monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Bupivacaine
Injection BP.
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 BP 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 BP IS USED
FOR
Bupivacaine is used to prevent or
relieve pain, but it will not put you to
sleep. Bupivacaine Injection BP is
used during or after surgery to relieve
pain. It can also be used to make
childbirth less painful.
Bupivacaine Injection BP 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 Injection BP 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
BP
_WHEN YOU MUST NOT BE GIVEN_
_IT:_
DO NOT USE BUPIVACAINE INJECTION
BP IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
bupivacaine or other local
anaesthetics e.g. lido

Produktets egenskaber

Version: pfpbupii11120
Supersedes: pfpbupii10720
Page 1 of 15
AUSTRALIAN
PRODUCT
INFORMATION
–
BUPIVACAINE
INJECTION
BP
(BUPIVACAINE
HYDROCHLORIDE MONOHYDRATE)
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
1.
NAME OF THE MEDICINE
Bupivacaine hydrochloride monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Bupivacaine Injection contains bupivacaine hydrochloride
(as monohydrate) 50
mg or 100 mg.
Each ampoule of Bupivacaine Injection contains bupivacaine
hydrochloride (as monohydrate)
50 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Bupivacaine Injection BP is a sterile, isotonic, preservative-free
solution.
4.
CLINICAL PARTICULARS
4.1 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
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.
Version: pfpbupii11120
Supersedes: pfpbupii10720
Page 2 of 15
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
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.
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. The volume of the drug used will affect the extent of
spread of anaesthesia.
The presentations of B