ROPIVACAINE PFIZER ropivacaine hydrochloride solution for injection 400 mg/200 mL bag

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

ropivacaine hydrochloride

Dostopno od:

Pfizer Australia Pty Ltd

INN (mednarodno ime):

Ropivacaine hydrochloride

Status dovoljenje:

Registered

Navodilo za uporabo

ROPIVACAINE PFIZER
®
_Ropivacaine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ROPIVACAINE
PFIZER.
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 using Ropivacaine
Pfizer against the benefits it is
expected to 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
PFIZER IS USED FOR
ROPIVACAINE PFIZER is a local
anaesthetic (an-a-set-ik). It is injected
into the body where it makes the
nerves unable to pass messages to the
brain. Depending on the amount
used, ROPIVACAINE PFIZER will
either totally stop pain or will cause a
partial loss of feeling.
ROPIVACAINE PFIZER is used as
an anaesthetic to stop the pain of
surgery and/or to make childbirth
less painful.
ROPIVACAINE PFIZER is also
used after surgery to treat post-
operative pain.
Your doctor will have explained why
you are being treated with
ROPIVACAINE PFIZER 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 PFIZER is not
addictive.
BEFORE YOU ARE GIVEN
ROPIVACAINE PFIZER
_WHEN YOU MUST NOT USE IT_
ROPIVACAINE PFIZER 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.
YOU HAVE ANY ALLERGIES TO OTHER
SUBSTANCES
2.
YOU HAVE ANY OF THESE MEDICAL
CONDITIONS
•
problems with your blood
pressure or circulation
•
blood poisoning
•
prob

Lastnosti izdelka

Version: pfpropvi10514
Supersedes: pfpropii10913
Page 1 of 22
PRODUCT INFORMATION
ROPIVACAINE PFIZER

ROPIVACAINE HYDROCHLORIDE
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
NAME OF THE MEDICINE
The active ingredient in ROPIVACAINE PFIZER
®
is ropivacaine hydrochloride. The CAS
number for the free base is 84057-95-4.
The molecular formula of Ropivacaine hydrochloride is C
17
H
26
N
2
O·HCl.
The chemical name for ropivacaine hydrochloride is
(_S_)-(-)-propyl-piperidine-2-carboxylic
acid (2,6-dimethyl-phenyl)-amide hydrochloride.
The chemical structure of ropivacaine hydrochloride is:
DESCRIPTION
Ropivacaine hydrochloride monohydrate 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 PFIZER solution for injection is a sterile, isotonic,
isobaric, aqueous
solution of ropivacaine HCl 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 PFIZER 0.2% (2
mg/mL) is 288
mosmol/kg. The solution is preservative free.
Version: pfpropvi10514
Supersedes: pfpropii10913
Page 2 of 22
Product is for single use in one patient only. Any solution remaining
from an opened
container should be discarded.
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 nerve fibres by preventi