ROPIVACAINE KABI ropivacaine hydrochloride 150 mg/20 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

ropivacaine hydrochloride, Quantity: 150 mg

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Ropivacaine hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Epidural, Intrathecal

Units in package:

5 x 20 mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. Analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). Analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. For peri- and postoperative pain man

Product summary:

Visual Identification: Clear solution; Container Type: Ampoule; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2013-06-13

Patient Information leaflet

CMI for Ropivacaine Kabi
Feb, 2016
Page 1 of 3
ROPIVACAINE KABI
Ropivacaine hydrochloride Solution for Injection
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
about
Ropivacaine
Kabi.
It
does
not
contain
all
the
available
information.
It does not take the place of talking
to your doctor or pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the risks of you taking Ropivacaine
Kabi
against
the
benefits
they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ROPIVACAINE KABI
IS USED FOR
Ropivacaine
Kabi
is
a
local
anaesthetic
(an-es-thet-ic).
It
is
injected
into
the
body
where
it
makes the nerves unable to pass
messages to the brain. Depending
on the amount used, ropivacaine
will either totally stop pain or will
cause a partial loss of feeling.
Ropivacaine
Kabi
is
used
as
an
anaesthetic
to
stop
the
pain
of
surgery and/or to make childbirth
less
painful.
Ropivacaine
Kabi
is
also
used
after
surgery
to
treat
post-operative pain.
Your
doctor
will
have
explained
why
you
are
being
treated
with
Ropivacaine
Kabi
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 another use. Ask your
doctor
if
you
want
more
information.
Ropivacaine Kabi is not addictive.
BEFORE YOU ARE GIVEN
ROPIVACAINE KABI
_WHEN YOU MUST NOT TAKE IT _
Ropivacaine Kabi must not be used
if:
1. YOU HAVE ANY ALLERGIES TO

any ingredient listed at the end
of this leaflet

any other local anaesthetics
2. YOU HAVE PROBLEMS CONTROLLING
YOUR LOW BLOOD PRESSURE
3. YOU HAVE INFLAMMATION AND/OR
AN
INFECTION
AT
THE
SITE
OF
INJECTION
_BEFORE YOU START TO TAKE IT _
You must tell your doctor if
1.
YOU
HAVE
ANY
ALLERGIES
TO
OTHER SUBSTANCES
2.
YOU
HAVE
ANY
OF
THESE
MEDICAL CONDITIONS

problems
with
your
blood
pr

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Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION- ROPIVACAINE
KABI (ROPIVACAINE HYDROCHLORIDE)
1 NAME OF THE MEDICINE
Ropivacaine hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION/ 3
PHARMACEUTICAL FORM
Ropivacaine Kabi solution for injection is a sterile, isotonic,
isobaric, aqueous solution of
ropivacaine hydrochloride in Water for Injections BP. The pH of the
solution is adjusted with
sodium hydroxide or hydrochloric acid to remain between 4.0 - 6.0
during the approved
shelf-life. The nominal osmolality of Ropivacaine Kabi 0.2% (2 mg/mL)
is 288 mosmol/kg.
The solution is preservative free.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Surgical anaesthesia (adults and children over 12 years of age)
•
epidural block for surgery including caesarean section
•
intrathecal anaesthesia
•
field block (minor nerve block and infiltration)
•
major nerve block
Analgesia (adults and children over 12 years of age)
•
continuous epidural infusion or intermittent bolus epidural
administration for analgesia in
postoperative pain or labour pain
•
field block (minor nerve block and infiltration)
•
continuous peripheral nerve block infusion or intermittent injections
for post operative pain
management
•
continuous wound infusion for postoperative pain management (adults
only)
Analgesia (children aged 0 - 12 years)
•
caudal epidural block in neonates (> 37 weeks gestation and over 2500
g weight), infants
and children up to and including 12 years
•
continuous epidural infusion in infants (> 30 days and over 2500 g
weight) and children up
to and including 12 years
•
peripheral nerve block in children aged 1 up to and including 12 years
For peri- and postoperative pain management.
There are no safety or efficacy data to support the use of ropivacaine
hydrochloride for
analgesia for longer than 72 hours. (Data for peripheral nerve block
administered as a
continuous peripheral infusion or intermittent injections and for
continuous wound infusion
support

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