NAROPIN 2MG/ML SOLUTION FOR INFUSION

Active substance: ROPIVACAINE HYDROCHLORIDE

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8247807

PACKAGE LEAFLET: INFORMATION FOR THE USER

2

Naropin®

2 mg/ml, 7.5 mg/ml, 10 mg/ml solution for injection

Naropin®

2 mg/ml solution for infusion
Ropivacaine hydrochloride

Read all of this leaflet carefully before Naropin is
given to you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

1. What Naropin is and what it is used for
2. Before Naropin is given to you
3. How Naropin is given to you
4. Possible side effects
5. How to store Naropin
6. Further information

1

What Naropin is and what it is used for

The name of your medicine is “Naropin solution for injection” or
“Naropin solution for infusion”.
• It contains a medicine called ropivacaine hydrochloride.
• It belongs to a group of medicines called local anaesthetics
• It will be given to you either as an injection or as an infusion,
depending on what it is being used for.
Naropin 7.5 and 10 mg/ml is used in adults and children above
12 years of age to numb (anaesthetise) parts of the body. It is used to
stop pain happening or to provide pain relief. It can be used to:
• Numb parts of the body during surgery, including having a baby by
Caesarean section.
• Relieve pain during childbirth, after surgery, or after an accident.
Naropin 2 mg/ml is used in adults and children of all ages for acute
pain management. It numbs (anaesthetises) parts of the body e.g.
after surgery.

Before Naropin is given to you

You must not be given Naropin:

• If you are allergic (hypersensitive) to ropivacaine hydrochloride
or any of the other ingredients of Naropin (see Section 6: Further
information).
• If you are allergic to any other local anaesthetics of the same class
(such as lidocaine or bupivacaine).
• If you have been told that you have decreased volume of blood
(hypovolaemia).
• Into a blood vessel to numb a specific area of your body, or into the
neck of the womb to relieve pain during childbirth.
If you are not sure if any of the above apply to you, talk to your doctor
before you are given Naropin.

Take special care with Naropin:

• If you have heart, liver or kidney problems. Tell your doctor if you
have any of these problems because your doctor may need to
adjust the dose of Naropin.
• If you have ever been told that you have a rare disease of the blood
pigment called “porphyria” or if anyone in your family has it. Tell
your doctor if you or a family member has porphyria because your
doctor may need to give you a different anaesthetic medicine.
• Tell your doctor before treatment about any diseases or medical
conditions that you have.
• In newborn children as they are more susceptible to Naropin.
• In children up to and including 12 years as some injections to
numb parts of the body are not established in younger children.
• In children up to and including 12 years as the use of Naropin 7.5 mg
and 10 mg/ml injections to numb parts of the body is not established.
The strength of Naropin 2 mg/ml may be more appropriate.

Taking other medicines

Please tell your doctor if you are taking, or have recently taken, any
other medicines. This includes medicines that you buy without a
prescription and herbal medicines. This is because Naropin can affect
the way some medicines work and some medicines can have an
effect on Naropin.
In particular, tell your doctor if you are taking any of the following
medicines:
• Other local anaesthetics.
• Strong pain killers, such as morphine or codeine.
• Drugs used to treat an uneven heart beat (arrhythmia), such as
lidocaine and mexiletine.
Your doctor needs to know about these medicines to be able to work
out the correct dose of Naropin for you.

Also tell your doctor if you are taking any of the following medicines:
• Medicines for depression (such as fluvoxamine)
• Antibiotics to treat infections caused by bacteria (such as enoxacin).
This is because your body takes longer to get rid of Naropin if you are
taking these medicines. If you are taking either of these medicines,
prolonged use of Naropin should be avoided.

Pregnancy and breast-feeding

Before you are given Naropin, tell your doctor if you are pregnant,
planning to get pregnant, or if you are breast-feeding. It is not known if
ropivacaine hydrochloride affects pregnancy or passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine
if you are pregnant or breast-feeding.

Driving and using machines

Naropin may make you feel sleepy and affect the speed of your
reactions. After you have been given Naropin, you should not drive or
use tools or machines until the next day.

Important information about some of the ingredients
of Naropin

Naropin contains up to 3.7 milligrams (mg) of sodium in each
millilitre (ml) of solution. If you are on a sodium controlled diet you will
need to take this into account.

3

How Naropin is given to you

Naropin will be given to you by a doctor. The dose that your doctor
gives you will depend on the type of pain relief that you need. It will
also depend on your body size, age, and physical condition.
Naropin will be given to you as an injection or as an infusion. The part of
the body where it will be used will depend on why you are being given
Naropin. Your doctor will give you Naropin in one of the following places:
• The part of the body that needs to be numbed.
• Near to the part of the body that needs to be numbed.
• In an area away from the part of the body that needs to be
numbed. This is the case if you are given an epidural injection or
infusion (into the area around the spinal cord).
When Naropin is used in one of these ways, it stops the nerves from
being able to pass pain messages to the brain. It will stop you feeling
pain, heat or cold in where it is used however you may still have other
feelings like pressure or touch.
Your doctor will know the correct way to give you this medicine.
Please turn over

8247807

Medical Information Leaflet
The following information is intended for medical or healthcare
professionals only.
This leaflet is an abbreviated form of the Summary of Product
Characteristics. Information is strictly limited to that required at
the point of administration for correct preparation and handling
of the product, and is not adequate for the purposes of making
a prescribing decision. Please consult the SmPC for further
information.
1.
Product
Naropin® 2, 7.5 or 10 mg/ml solution for injection
Naropin® 2 mg/ml solution for infusion
2.
Preparation
In alkaline solutions precipitation may occur as ropivacaine shows
poor solubility at pH>6.
This medicinal product contains maximum 3.7 mg sodium per ml. To
be taken into consideration by patients on a controlled sodium diet.
Naropin 2 mg/ml solution for infusion in plastic infusion bags
(Polybag) is chemically and physically compatible with the following
drugs. Compatibilities with other solutions than those mentioned
below have not been investigated:
Concentration of Naropin: 1-2 mg/ml
Additive

Concentration*

Fentanyl citrate

1.0 - 10.0 microgram/ml

Sufentanil citrate

0.4 -

Morphine sulphate
Clonidine hydrochloride

4.0 microgram/ml

20.0 - 100.0 microgram/ml
5.0 - 50.0 microgram/ml

* The concentration ranges stated in the table are wider than those
used in clinical practice. Epidural infusions of Naropin/sufentanil
citrate, Naropin/morphine sulphate and Naropin/clonidine
hydrochloride have not been evaluated in clinical studies.
3.
Instructions for use, handling and disposal
Naropin should only be used by, or under the supervision of, clinicians
experienced in regional anaesthesia.
Naropin products are preservative free and are intended for single
use only. Discard any unused solution.
The intact container must not be re-autoclaved. A blistered container
should be chosen when a sterile outside is required.

Shelf life after first opening
From a microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2–8°C. The mixtures for
infusion are chemically and physically stable for 30 days at 20 to 30°C.
Posology - adults and adolescents above 12 years of age
The following table is a guide to dosage for the more commonly used
blocks. The smallest dose required to produce an effective block
should be used. The clinician’s experience and knowledge of the
patient’s physical status are of importance when deciding the dose.
Conc.
mg/ml
SURGICAL ANAESTHESIA
Lumbar Epidural
Administration
Surgery
7.5
10
Caesarean section
7.5
Thoracic Epidural
Administration
To establish block for 7.5
postoperative pain
relief
Major Nerve Block*
Brachial plexus block 7.5
Field Block
7.5
(e.g. minor nerve
blocks and infiltration)
ACUTE PAIN MANAGEMENT
Lumbar Epidural
Administration
Bolus
2
Intermittent injections 2
(top up)
(e.g. labour pain
management)
Continuous infusion e.g.
Labour pain
2
Postoperative pain
2
management

Volume
ml

15–25
15–20
15–20

30–40
1–30

10–20
10–15

Onset Duration
minutes hours

113–188 10–20 3–5
150–200 10–20 4–6
113–150(1) 10–20 3–5

5–15
38–113
(depending
on the level
of injection)

10–20 n/a(2)

225–300(3) 10–25 6–10
7.5–225
1–15 2–6

20–40
20–30

10–15 0.5–1.5

(minimum
interval
30 minutes)
6–10 ml/h 12–20 mg/h n/a(2)
6–14 ml/h 12–28 mg/h n/a(2)

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for artwork

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Dose
mg

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n/a(2)
n/a(2)

Thoracic Epidural
Administration
2
Continuous infusion
(postoperative pain
management)
Field Block
(e.g. minor nerve
2
blocks and infiltration)
Peripheral nerve block
(Femoral or
interscalene block)
Continuous infusion or 2
intermittent
injections
(e.g. postoperative pain
management)

6–14 ml/h 12–28 mg/h n/a(2)

n/a(2)

1–100

1–5

2–6

5–10 ml/h 10–20 mg/h n/a

n/a

2–200 

The doses in the table are those considered to be necessary to produce a successful
block and should be regarded as guidelines for use in adults. Individual variations
in onset and duration occur. The figures in the column ‘Dose’ reflect the expected
average dose range needed. Standard textbooks should be consulted for both factors
affecting specific block techniques and individual patient requirements.
* With regard to major nerve block, a dose recommendation can only be given for
brachial plexus block. For other major nerve blocks lower doses may be required.
However, there is presently no experience of specific dose recommendations for other
blocks.
(1) Incremental dosing should be applied, the starting dose of about 100 mg
(97.5 mg = 13 ml; 105 mg = 14 ml) to be given over 3–5 minutes. Two extra doses, in
total an additional 50mg, may be administered as needed.
(2) n/a = not applicable
(3) The dose for a major nerve block must be adjusted according to site of
administration and patient status. Interscalene and supraclavicular brachial plexus
blocks may be associated with a higher frequency of serious adverse reactions,
regardless of the local anaesthetic used, (see section 4.4. Special warnings and
special precautions for use).

In general, surgical anaesthesia (e.g. epidural administration) requires
the use of the higher concentrations and doses. The Naropin 10 mg/ml
formulation is recommended for epidural anaesthesia in which a
complete motor block is essential for surgery. For analgesia (e.g. epidural
administration for acute pain management) the lower concentrations and
doses are recommended.

If you have been given too much Naropin

Serious side effects from getting too much Naropin need special
treatment and the doctor treating you is trained to deal with these
situations. The first signs of being given too much Naropin are usually
as follows:
• Feeling dizzy or light-headed.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Problems with your sight (vision).
To reduce the risk of serious side effects, your doctor will stop giving
you Naropin as soon as these signs appear. This means that if any
of these happen to you, or you think you have received too much
Naropin, tell your doctor immediately.
More serious side effects from being given too much Naropin include
problems with your speech, twitching of your muscles, tremors,
trembling, fits (seizures), and loss of consciousness.

4

Possible side effects

Like all medicines, Naropin may cause side effects although not
everybody gets them.

Important side effects to look out for:

Sudden life-threatening allergic reactions (such as anaphylaxis) are
rare, affecting 1 to 10 users in 10,000. Possible symptoms include
sudden onset of rash, itching or lumpy rash (hives); swelling of the
face, lips, tongue or other parts of the body; and shortness of breath,
wheezing or difficulty breathing. If you think that Naropin is causing
an allergic reaction, tell your doctor immediately.

Other possible side effects:
Very common (affects more than 1 user in 10)

• Low blood pressure (hypotension). This might make you feel dizzy
or light-headed.
• Feeling sick (nausea).

Common (affects 1 to 10 users in 100)










Pins and needles.
Feeling dizzy.
Headache.
Slow or fast heart beat (bradycardia, tachycardia).
High blood pressure (hypertension).
Being sick (vomiting).
Difficulty in passing urine.
High temperature (fever) or stiffness (rigor).
Back pain.

Method of administration - adults and adolescents above
12 years of age
Careful aspiration before and during injection is recommended
to prevent intravascular injection. When a large dose is to be
injected, a test dose of 3–5 ml lidocaine (lignocaine) with adrenaline
(epinephrine) is recommended. An inadvertent intravascular injection
may be recognised by a temporary increase in heart rate and an
accidental intrathecal injection by signs of a spinal block.
Aspiration should be performed prior to and during administration
of the main dose, which should be injected slowly or in incremental
doses, at a rate of 25–50 mg/min, while closely observing the
patient’s vital functions and maintaining verbal contact. If toxic
symptoms occur, the injection should be stopped immediately.
When prolonged blocks are used, either through continuous infusion
or through repeated bolus administration, the risks of reaching a
toxic plasma concentration or inducing local neural injury must
be considered. Cumulative doses up to 675 mg ropivacaine for
surgery and postoperative analgesia administered over 24 hours
were well tolerated in adults, as were postoperative continuous
epidural infusions at rates up to 28 mg/hour for 72 hours. In a limited
number of patients, higher doses of up to 800 mg/day have been
administered with relatively few adverse reactions.
For treatment of postoperative pain, the following technique can be
recommended: Unless preoperatively instituted, an epidural block
with Naropin 7.5 mg/ml is induced via an epidural catheter. Analgesia
is maintained with Naropin 2 mg/ml infusion. Infusion rates of
6–14 ml (12–28 mg) per hour provide adequate analgesia with only
slight and non-progressive motor block in most cases of moderate
to severe postoperative pain. The maximum duration of epidural
block is 3 days. However, close monitoring of analgesic effect should
be performed in order to remove the catheter as soon as the pain
condition allows it. With this technique a significant reduction in the
need for opioids has been observed.
When prolonged peripheral nerve blocks are applied, either through
continuous infusion or through repeated injections, the risks of
reaching a toxic plasma concentration or inducing local neural injury
must be considered.
Concentrations above 7.5 mg/ml Naropin have not been documented
for Caesarean section.

Uncommon (affects 1 to 10 users in 1,000)







Anxiety.
Decreased sensitivity or feeling in the skin.
Fainting.
Difficulty breathing.
Low body temperature (hypothermia).
Some symptoms can happen if the injection was given into a blood
vessel by mistake, or if you have been given too much Naropin
(see also “If you have been given too much Naropin” above). These
include fits (seizures), feeling dizzy or light-headed, numbness of
the lips and around the mouth, numbness of the tongue, hearing
problems, problems with your sight (vision), problems with your
speech, stiff muscles, and trembling.

Rare (affects 1 to 10 users in 10,000)
• Heart attack (cardiac arrest).
• Uneven heart beat (arrhythmias).

Other possible side effects include:

• Numbness, due to nerve irritation caused by the needle or the
injection. This does not usually last for long.

Further information

What Naropin contains

The active ingredient is ropivacaine hydrochloride. Naropin comes
in the following strengths: 2 mg, 7.5 mg or 10 mg of ropivacaine
hydrochloride per ml of solution.
The other ingredients are sodium chloride, hydrochloric acid and/or
sodium hydroxide, and water for injections.

What Naropin looks like and contents of the pack

Naropin is a clear, colourless solution for injection or infusion.
Naropin solution for injection 2 mg/ml, 7.5 mg/ml and 10 mg/ml is
available as follows:
• 10 ml polypropylene ampoules (Polyamp) in packs of 5 or 10.
• 20 ml polypropylene ampoules (Polyamp) in packs of 5 or 10.
Naropin solution for infusion 2 mg/ml is available as follows:
• 100 ml polypropylene bags (Polybag) in packs of 5.
• 200 ml polypropylene bags (Polybag) in packs of 5.
Not all pack sizes may be marketed.

Possible side effects seen with other local anaesthetics
which might also be caused by Naropin include:

Marketing Authorisation Holder and Manufacturer

Children

This medicinal product is authorised in the Member
States of the EEA under the following names:

• Damaged nerves. Rarely (affecting 1 to 10 users in 10,000), this
may cause permanent problems.
• If too much Naropin is given into the spinal fluid, the whole body
may become numbed (anaesthetised).

In children, the side effects are the same as in adults except for
low blood pressure which happens less often in children (affecting
1 to 10 children in 100) and being sick which happens more often in
children (affecting more than 1 in 10 children).
If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.

5

How to store Naropin

• Keep out of the reach and sight of children.
• Do not use after the expiry date which is stated on the carton after
EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C. Do not freeze.
• Your doctor or the hospital will normally store Naropin and they are
responsible for the quality of the product when it has been opened if
it is not used immediately. The medicinal product should be visually
inspected prior to use. The solution should only be used if it is clear,
practically free from particles and if the container is undamaged.
• They are also responsible for disposing of any unused Naropin
correctly.

Paediatric population
Posology – Epidural block: Paediatric patients 0 (term neonates)
up to and including 12 years of age
Conc.
mg/ml

Volume
ml/kg

Dose
mg/kg

ACUTE PAIN MANAGEMENT
(per and postoperative)
Single Caudal Epidural Block
2
1
2
Blocks below T12, in children with a
body weight up to 25 kg
Continuous Epidural Infusion
In children with a body weight up
to 25 kg
0 up to 6 months
2
0.5–1
1–2
Bolus dosea
Infusion up to 72 hours
2
0.1 mL/kg/h 0.2 mg/kg/h
6 up to 12 months
2
0.5–1
1–2
Bolus dosea
2
Infusion up to 72 hours
0.2 mL/kg/h 0.4 mg/kg/h
1 to 12 years
2
1
2
Bolus doseb
Infusion up to 72 hours
2
0.2 mL/kg/h 0.4 mg/kg/h
The dose in the table should be regarded as guidelines for use in paediatrics.
Individual variations occur. In children with a high body weight, a gradual
reduction of the dosage is often necessary and should be based on the ideal
body weight. The volume for single caudal epidural block and the volume
for epidural bolus doses should not exceed 25 mL in any patient. Standard
textbooks should be consulted for factors affecting specific block techniques
and for individual patient requirements.
a. Doses in the low end of the dose interval are recommended for thoracic
epidural blocks while doses in the high end are recommended for lumbar or
caudal epidural blocks.
b. Recommended for lumbar epidural blocks. It is good practice to reduce
the bolus dose for thoracic epidural analgesia.

Peripheral nerve blocks: Infants and children aged 1‑12 years
Conc. Volume
mg/ml ml/kg

Dose
mg/kg

Single injections for peripheral 2.0
nerve block ( e.g. ilioinguinal
nerve block, brachial
plexus block, fascia iliaca
compartment block)

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The Marketing Authorisations for Naropin are held by AstraZeneca UK Ltd,
600 Capability Green, Luton, LU1 3LU, UK.
The manufacturer responsible for batch release is AstraZeneca AB,
S-151 85 Södertälje, Sweden and AstraZeneca UK Limited, Silk Road
Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom.

Austria, Belgium, Denmark, Germany, Greece, Ireland, Luxembourg,
Netherlands, Spain, United Kingdom: Naropin.
France, Portugal: Naropeine.
Italy: Naropina.
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name 
Naropin 2 mg/ml infusion & 2, 7.5, 10 mg/ml
injection
Reference number 17901/0149, 0150, 0151, 0152
This is a service provided by the Royal National Institute of Blind People
Leaflet updated: May 2013
© AstraZeneca 2013.
Naropin is a trade mark of the AstraZeneca group of companies.
PAI 12 0064b

Multiple blocks

2.0

0.5‑1.5 

Continuous infusion for
peripheral nerve block in
children 1 to 12 years.
Infusion up to 72 hours

2.0

0.1‑0.3 ml/kg/h 0.2‑0.6 mg/kg/h

1.0‑3.0

The dose in the table should be regarded as guidelines for use in paediatrics.
Individual variations occur. In children with a high body weight a gradual
reduction of the dosage is often necessary and should be based on the ideal
body weight. Standard textbooks should be consulted for factors affecting
specific block techniques and for individual patient requirements.

Method of Administration - paediatric patients 0 up to and
including 12 years of age:
Careful aspiration before and during injection is recommended to
prevent intravascular injection. The patient’s vital functions should
be observed closely during the injection. If toxic symptoms occur, the
injection should be stopped immediately.
Fractionation of the calculated local anaesthetic dose is recommended,
whatever the route of administration.
The use of ropivacaine 7.5 and 10 mg/ml may be associated with
systemic and central toxic events in children. Lower strengths
(2 mg/ml) are more appropriate for administration in this population.
The doses for peripheral block in infants and children provide guidance
for use in children without severe disease. More conservative doses
and close monitoring are recommended for children with severe
diseases.
Single injections for peripheral nerve block (e.g. ilioinguinal nerve
block, brachial plexus block) should not exceed 2.5‑3.0 mg/kg.
The use of ropivacaine in premature children has not been documented.
4.
Marketing Authorisation holder
AstraZeneca UK Ltd.,
600 Capability Green
Luton, LU1 3LU, UK.
Leaflet updated: May 2013
© AstraZeneca 2013

ACUTE PAIN MANAGEMENT
(per- and postoperative)

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6

0.5‑0.75 

1.0‑1.5 

Naropin is a trade mark of the AstraZeneca group of companies.
PAI 12 0064b

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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