ROPIBAM 1% Ropivacaine hydrochloride 100mg/10mL solution for injection ampoule

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

ropivacaine hydrochloride, Quantity: 10 mg/mL

Tilgængelig fra:

Boucher & Muir Pty Ltd

INN (International Name):

Ropivacaine hydrochloride

Lægemiddelform:

Injection, solution

Sammensætning:

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

Indgivelsesvej:

Epidural, Infiltration, Intracutaneous, Intradermal, Intramuscular, Intraneural, Intrathecal, Mucosal, Subcutaneous

Enheder i pakken:

10 mL ampoules in packs of 5

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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 2,500 g weight), infants and children up to and including 12 years,? continuous epidural infusion in infants (> 30 days and over 2,500 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 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 the use for up to 48 hours only).

Produkt oversigt:

Visual Identification: A clear, colourless solution; Container Type: Ampoule; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

2012-03-09

Indlægsseddel

ROPIBAM
_SOLUTION FOR INJECTION 0.2%, 0.75% AND 1%_
_Ropivacaine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given Ropibam.
This leaflet answers some common
questions about Ropibam. It does not
contain all the available information.
The most up-to-date Consumer
Medicine Information can be
downloaded from
www.ebs.tga.gov.au.
Reading this leaflet 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 Ropibam
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT ROPIBAM IS USED
FOR
Ropibam contains ropivacaine
hydrochloride which is a local
anaesthetic. It is injected into the
body where it makes the nerves
unable to pass messages to the brain.
Depending on the amount used,
Ropibam will either totally stop pain
or will cause a partial loss of feeling.
Ropibam is used as an anaesthetic to
stop the pain of surgery and/or to
make childbirth less painful. It is also
used after surgery to treat post-
operative pain. Your doctor will have
explained why you are being treated
with Ropibam and told you what
dose you will be given.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Ropibam is available only with a
doctor’s prescription.
Ropibam is not addictive.
BEFORE YOU ARE GIVEN
ROPIBAM
Ropibam is not suitable for everyone.
_WHEN YOU MUST NOT BE GIVEN_
_IT_
Ropibam must not be given if you:
•
are allergic to any medicine
containing ropivacaine, any other
local anaesthetics, or any of the
ingredients listed at the end of
this leaflet
•
have problems controlling your
low blood pressure
•
have inflammation and/or an
infection at the site of injection.
ROPIBAM MUST NOT BE USED AFTER
THE EXP

Produktets egenskaber

ROPIBAM
1
AUSTRALIAN PRODUCT INFORMATION
ROPIBAM 0.2%, 0.75% & 1%
ROPIVACAINE HYDROCHLORIDE
INJECTION SOLUTIONS FOR THE PRODUCTION OF LOCAL OR REGIONAL
ANAESTHESIA
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
1
NAME OF THE MEDICINE
ropivacaine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of the solution contains 2mg, 7.5mg or 10mg of Ropivacaine
hydrochloride.
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 Ropibam 0.2%
(2 mg/mL) is 284 mosmol/kg. The solution is preservative free.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ropibam solution for injection is a sterile, clear, colourless,
isotonic, isobaric, aqueous
solution of ropivacaine HCl in water for injections.
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)
ROPIBAM
2
•
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 2,500
g weight), infants
and children up to and including 12 years
•
continuous epidural infusion in infants (> 30 days and over 2,500 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