CHIROCAINE levobupivacaine 50mg/10mL (as hydrochloride) injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levobupivacaine hydrochloride, Quantity: 5.633 mg/mL (Equivalent: levobupivacine, Qty 5 mg/mL)

Available from:

Abbvie Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Epidural, Intrathecal, Infiltration, Ophthalmic

Units in package:

10 x 10 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults Levobupivacaine is indicated in adults for: Surgical Anaesthesia: Major: Epidural (including for caesarean section), intrathecal, peripheral nerve block Minor: Local infiltration, oral, peribulbar block in ophthalmic surgery. Pain management: Continuous epidural infusion, single or multiple bolus administration for post-operative, labour or chronic pain. For continuous epidural analgesia, levobupivacaine may be administered in combination with epidural fentanyl, morphine or clonidine. Children Levobupivacaine is indicated in children greater than 6 months of age, for infiltration analgesia (ilioinguinal/iliohypogastric blocks). After careful consideration to alternative concentrations, the 7.5mg/mL concentration of levobupivacine may be considered for those procedures requiring a dense block with low volume. The 7.5mg/mL concentration should not be considered for paediatric use.

Product summary:

Visual Identification: Clear, colourless solution, practically free from particles; Container Type: Ampoule; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2001-05-07

Patient Information leaflet

CHIROCAINE
_SOLUTION FOR INJECTION & CONCENTRATED SOLUTION FOR INFUSION_
_levobupivacaine 25mg/10mL, 50mg/10mL, 75 mg/10mL, 62.5mg/100mL*,
125mg/100mL*, 250mg/_
_200mL_
CONSUMER MEDICINE INFORMATION
_PLEASE READ THIS INFORMATION CAREFULLY_
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about this medicine.
It does not contain all of the available
information. It does not take the
place of talking to your doctor.
All medicines have benefits and
risks. Your doctor has weighed the
risks associated with giving you
CHIROCAINE against the benefits
he/she expects it will have on you.
If you have any concerns about
taking this medicine, talk to your
doctor, pharmacist or nurse.
Keep this leaflet while you are being
given CHIROCAINE. You may need
to read it again.
WHAT CHIROCAINE IS
USED FOR
CHIROCAINE is used to
anaesthetise (numb) or make free
from pain, specific parts or areas of
the body before minor surgery
(including surgery to the eye and
mouth), and major surgery (including
having a baby by caesarean section).
CHIROCAINE is also used to help
relieve pain during labour and
childbirth and after an operation.
Your doctor, however, may have
prescribed CHIROCAINE for
another purpose. Ask your doctor if
you have any questions about why
CHIROCAINE has been prescribed
for you.
CHIROCAINE belongs to the group
of medicines called local
anaesthetics. These medicines work
by making an area of the body numb
or free from pain.
CHIROCAINE is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
CHIROCAINE
YOU SHOULD NOT BE GIVEN
CHIROCAINE IF:
You have ever had an allergic
reaction to CHIROCAINE or any
other anaesthetic. Some of the
symptoms of an allergic reaction
may include rash, itching or
hives, swelling of the face, lips,
tongue or other parts of the body,
shortness of breath, wheezing or
difficulty in breathing.
BEFORE YOU START TO TAKE OR ARE
GIVEN CHIROCAINE YOU MUST TELL
YOUR DOCTOR IF
1.
You are pregnant or plan to
become pregnant. Your doctor
will discuss the risks and benefits
of rec

Summary of Product characteristics

CHIROCAINE PI
Version 11
29 April
2019
Page 1 of 30
AUSTRALIAN PI – CHIROCAINE
®
LEVOBUPIVACAINE INJECTION
1
NAME OF THE MEDICINE
Levobupivacaine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levobupivacaine ampoules contain levobupivacaine hydrochloride
equivalent to 2.5 mg/mL, 5.0
mg/mL, and 7.5 mg/mL of levobupivacaine, and the levobupivacaine bags
for infusion contain
levobupivacaine hydrochloride equivalent to 0.625 mg/mL and 1.25 mg/mL
of levobupivacaine. Both
presentations contain sodium chloride for isotonicity, and Water for
Injections. Sodium hydroxide
and/or hydrochloric acid may have been added to adjust pH.
3
PHARMACEUTICAL FORM
Levobupivacaine is a sterile, non-pyrogenic, colourless solution (pH
4.0 - 6.5). Levobupivacaine is
preservative free and is available in 10 mL single dose injection
ampoules and 100 mL and 200 mL
injection bag.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AMPOULES
1. Adults
Levobupivacaine is indicated in adults for:
_SURGICAL ANAESTHESIA _
Major: Epidural (including for caesarean section), intrathecal,
peripheral nerve block.
Minor: Local infiltration, oral, peribulbar block in ophthalmic
surgery.
For
caesarean
section,
the
7.5
mg/mL
concentration
is
not
recommended,
see
4.3
CONTRAINDICATIONS and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE.
_ _
_ _
CHIROCAINE PI
Version 11
29 April
2019
Page 2 of 30
_PAIN MANAGEMENT _
Continuous epidural infusion, single or multiple bolus administration
for post-operative, labour or
chronic pain.
For continuous epidural analgesia, levobupivacaine may be administered
in combination with epidural
fentanyl, morphine or clonidine.
For labour analgesia, the 7.5 mg/mL concentration is not recommended,
see 4.3 CONTRAINDICATIONS
and 4.4 SPECIAL WARNINGS PRECAUTIONS FOR USE.
2. Children
Levobupivacaine is indicated in children greater than 6 months of age,
for infiltration analgesia
(ilioinguinal/iliohypogastric blocks) see 4.2 DOSE AND METHOD OF
ADMINISTRATION.
3.
After careful
consideration
to
alternative
concentrations, the
7.5 mg/mL
conce