NAROPIN 0.2% ropivacaine hydrochloride 200mg/100mL injection bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ropivacaine hydrochloride, Quantity: 2 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Epidural

Units in package:

5 x 100mL, 1 x 100mL (export only)

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

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 (adult only). Analgesia (Children aged 0-12 years). Caudal epidural block in neonates (>37 weeks gestation and over 2500g weight), infants and children up to and including 12 years. Continuous epidural infusion in infants (>30 days and over 2500g 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).

Product summary:

Visual Identification: A clear, colourless solution.; Container Type: Bag; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1996-01-30

Patient Information leaflet

NAROPIN
®
1
NAROPIN
®
_Ropivacaine hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
NAROPIN
®
. It does not contain all
the information that is known about
NAROPIN.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you using
NAROPIN 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 NAROPIN IS FOR
NAROPIN 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,
NAROPIN will either totally stop
pain or will cause a partial loss of
feeling.
NAROPIN is used as an anaesthetic
to stop the pain of surgery and/or to
make childbirth less painful.
NAROPIN is also used after surgery
to treat post-operative pain.
Your doctor will have explained why
you are being treated with
NAROPIN 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.
NAROPIN is not addictive.
BEFORE YOU ARE GIVEN
NAROPIN
_WHEN YOU MUST NOT USE IT _
NAROPIN 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
•
problems with the clotting of your
blood
•
acidosis, or too much acid i

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
(INJECTION SOLUTIONS FOR THE PRODUCTION OF LOCAL OR REGIONAL
ANAESTHESIA)
1
NAME OF THE MEDICINE
Ropivacaine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in NAROPIN
®
is ropivacaine hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Injection, solution
A clear colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
2
There are no safety or efficacy data to support the use of NAROPIN 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).
4.2
D
OSE AND METHOD OF ADMINISTRATION
NAROPIN should only be used by or under the supervision of clinicians
experienced in regional
anae