ROPIVACAINE READYFUSOR ropivacaine hydrochloride 0.2% solution for injection, bottle in dispenser device

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

ropivacaine hydrochloride monohydrate, Quantity: 2.116 mg/mL (Equivalent: ropivacaine hydrochloride, Qty 2 mg/mL)

Dostopno od:

BioQ Pharma Pty Ltd

INN (mednarodno ime):

Ropivacaine hydrochloride monohydrate

Farmacevtska oblika:

Injection, solution

Sestava:

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

Pot uporabe:

Infiltration

Enote v paketu:

One unit

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Ropivacaine ReadyFusOR (0.2% ropivacaine solution for injection) is indicated for: ? Continuous peripheral nerve block infiltration for postoperative pain management in adults ? Continuous wound infiltration for postoperative pain management in adults,(Data for peripheral nerve block administered as a continuous peripheral infusion and for continuous wound infusion support the use for up to 48 hours only).

Povzetek izdelek:

Visual Identification: 250 mL drug reservoir compressible bottle in a dispenser with an indicator window in the dispenser to show drug level; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Registered

Datum dovoljenje:

2017-03-10

Navodilo za uporabo

Ropivacaine ReadyfusOR
_Version 04 29 August 2017_
Page 1 of 3
ROPIVACAINE READYFUSOR
0.2% ROPIVACAINE HYDROCHLORIDE
SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some of the
common questions people ask about
the Ropivacaine ReadyfusOR, and the
medicine inside the dispenser.
All medicines have risks and benefits.
Your doctor will have weighed the
risks of you using the Ropivacaine
ReadyfusOR against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THE MEDICINE IN THIS PRODUCT,
ASK YOUR DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ROPIVACAINE
READYFUSOR IS USED
FOR
Ropivacaine ReadyfusOR contains a
local anaesthetic (anas-thet-ik) called
ropivacaine hydrochloride, which is
already inside the dispenser. The local
anaesthetic is injected into the body
where it makes the nerves unable to
pass messages to the brain.
Depending on the amount used, it will
either totally stop pain or will cause a
partial loss of feeling.
THE ROPIVACAINE READYFUSOR IS
USED IN ADULTS AFTER SURGERY TO TREAT
POST-OPERATIVE PAIN.
Your doctor will have explained why
you are being treated with ropivacaine
hydrochloride and will have told you
about the length of time you will be
treated and the 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 hydrochloride, the
medicine in Ropivacaine
ReadyfusOR, is not addictive.
BEFORE YOU USE
ROPIVACAINE
READYFUSOR
_ _
_WHEN YOU MUST NOT USE IT _
Ropivacaine ReadyfusOR 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 USE IT _
• You must tell your doctor if:
1

Lastnosti izdelka

PRODUCT INFORMATION –
_Ropivacaine ReadyfusOR_
_ _
_Version 06 - 29 August 2017_
Page 1 of 24
NAME OF THE MEDICINE
The active ingredient in Ropivacaine ReadyfusOR is ropivacaine
hydrochloride.
The CAS number for ropivacaine hydrochloride is 98717-15-8.
The chemical formula of ropivacaine hydrochloride is C
17
H
26
N
2
O.HCl.
Chemical structure:
DESCRIPTION
T h e
c h e m i c a l
n a m e
f o r
r o p i v a c a i n e
h yd r o c h l o r i d e
i s
(-)-(2
_S_
)-
_N_
-(2,6-dimethylphenyl)-1-
propylpiperidine-2-carboxamide
hydrochloride.
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 310.86. 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 ReadyfusOR 0.2% solution for injection is a sterile,
isotonic, isobaric, aqueous
solution of ropivacaine HCl in Water for Injections BP with sodium
chloride as an excipient.
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
ReadyfusOR 0.2% solution for injection is 288 mOsm/kg. The solution is
preservative free.
The presentation of the Ropivacaine ReadyfusOR 0.2% solution for
injection is intended for
single use only. The Dispenser should be discarded after single use.
PRODUCT INFORMATION –
_Ropivacaine ReadyfusOR_
_ _
_Version 06 - 29 August 2017_
Page 2 of 24
PHARMACOLOGY
Ropivacaine has both anaesthetic and analgesic effects. At higher
doses it produces surgical
anaesthesia
with
motor
block,
while
at
lower
doses
it
produces
a sensory
block
including
analgesia with little motor block. The duration and intensity of
ropivacaine sensory block is
not improved by the addition of adrenaline. Ropivacaine, like other
local anaesthetics, causes
reversible
blockade
of
impulse propagation
along