CHIROCAINE levobupivacaine hydrochloride 62.5mg/100mL solution for injection bag

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

levobupivacaine hydrochloride, Quantity: 0.718 mg; levobupivacine, Quantity: 0.625 mg

Tilgjengelig fra:

Abbvie Pty Ltd

Legemiddelform:

Injection, solution

Sammensetning:

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

Administreringsrute:

Epidural

Enheter i pakken:

5 x 100mL bags, 24 x 100mL bags, 60 x 100mL bags, 1 x 100 mL bag

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Adults - Pain management. Continuous epidural infusion, for post operative and labour analgesia.

Produkt oppsummering:

Visual Identification: Clear, colourless solution, practically free from visible particulates.; Container Type: Bag; Container Material: Plastic; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2003-09-09

Preparatomtale

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