Ropivacaine Kabi

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Ropivacaine hydrochloride 2 mg/mL equivalent to ropivacaine 1.77 mg/mL;  

Disponible depuis:

Fresenius Kabi New Zealand Limited

DCI (Dénomination commune internationale):

Ropivacaine hydrochloride 2 mg/mL (= ropivacaine 1.77 mg/mL)

Dosage:

2 mg/mL

forme pharmaceutique:

Solution for injection

Composition:

Active: Ropivacaine hydrochloride 2 mg/mL equivalent to ropivacaine 1.77 mg/mL   Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Type d'ordonnance:

Prescription

Fabriqué par:

Excella GmbH & Co KG

indications thérapeutiques:

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 postoperative pain management · Continuous wound infusion for postoperative pain management (adults only) Analgesia (children aged 0-12 years of age) · 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

Descriptif du produit:

Package - Contents - Shelf Life: Ampoule, plastic, polypropylene 20 ml in Al/PC blister with PE fibre non-woven lid in printed carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Ampoule, plastic, polypropylene 10 ml in Al/PC blister with PE fibre non-woven lid in printed carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, olifine, 200 ml capacity in overpouch packed in printed carton - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Bag, plastic, olifine, 100 ml capacity in overpouch packed in printed carton - 5 dose units - 24 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

2013-07-17

Notice patient

CMI for Ropivacaine Kabi
September 2021
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
pre

Résumé des caractéristiques du produit

Page 1 of 26
DATA SHEET
Ropivacaine Kabi
1.
NAME OF THE MEDICINAL PRODUCT
Ropivacaine Kabi 0.2% (2.0 mg/mL)
Ropivacaine Kabi 0.5% (5.0 mg/mL)
Ropivacaine Kabi 0.75% (7.5 mg/mL)
Ropivacaine Kabi 1% (10. mg/mL)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution is filled into 100 mL or 250 mL (filling volume 100 mL
and 200 mL respectively)
polyolefine bags (freeflex
®
) or into 10 mL or 20 mL polypropylene ampoules (Ovalia) in the
following concentrations of ropivacaine hydrochloride:
Ropivacaine Kabi 0.2% (2.0 mg/mL)
10 mL, 20 mL polypropylene ampoules (5’s).
100 mL, 200 mL freeflex
®
infusion bags (5’s)
Ropivacaine Kabi 0.5% (5.0 mg/mL)
10 mL polypropylene ampoules (5’s)
Ropivacaine Kabi 0.75% (7.5 mg/mL)
10 mL, 20 mL polypropylene ampoules (5’s)
Ropivacaine Kabi 1% (10.mg/mL)
10L, 20 mL polypropylene ampoules (5’s)
3.
PHARMACEUTICAL FORM
The active ingredient is ropivacaine hydrochloride. The CAS number for
the free base is 84057-95-
4. The chemical formula of ropivacaine hydrochloride is C
17
H
26
N
2
O.HCl.H
2
O.
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
Page 2 of 26
The chemical structure of ropivacaine hydrochloride is:
The chemical name for ropivacaine hydrochloride is
(S)-(-)-propyl-piperidine-2-carboxylic acid
(2,6-dimethyl-phenyl)-amide hydrochloride monohydrate. It is a white
crystalline powder and has
a water solubility of about 50 mg/mL. Ropivacaine hydrochloride was
developed as the pure S-(-)-
isomer and has an enantiomeric purity of > 99%. It has a pKa of 8.1
(at 25°C) and a molecular
weight of 328.89. The pH of a saturated solution of ropivacaine
hydrochloride is 4.5 and that of a
1% (w/v) aqueous solution is 5.0.
Ropivacaine
Kabi
solution
for
injection
is
a
sterile,
isotonic,
isobaric,
aqueous
solution
ofropivacaine 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
mosm