NAROPIN 2MG/ML SOLUTION FOR INJECTION

Active substance: ROPIVACAINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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”.
• It contains a medicine called ropivacaine hydrochloride.
• It belongs to a group of medicines called local anaesthetics
• It will be given to you as an injection.
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.

PS00951

2. 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.

379612-A03
05-06-13
PS00951

Black

AZL026A
8020
Naropin 2mg/ml, 7.5mg/ml,
10mg/ml Leaflet: Combined UK-IE
RR
Body text size

Smallest text size

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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. 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
(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.
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.

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

2. Preparation
This medicinal product contains maximum 3.7 mg sodium per ml. To be taken into consideration by
patients on a controlled sodium diet.
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.
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
Caesarean section
Thoracic Epidural Administration
To establish block for postoperative
pain relief
Major Nerve Block*
Brachial plexus block
Field Block
(e.g. minor nerve blocks and
infiltration)

Volume
ml

7.5
10
7.5

15–25
15–20
15–20

7.5

7.5
7.5

Dose
mg

113–188
150–200
113–150(1)

Onset Duration
minutes
hours

10–20
10–20
10–20

3–5
4–6
3–5

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

10–20

n/a(2)

30–40
1–30

10–25
1–15

225–300(3)
7.5–225

6–10
2–6

ACUTE PAIN MANAGEMENT
Lumbar Epidural Administration
Bolus
Intermittent injections (top up)
(e.g. labour pain management)

2
2

10–20
20–40
10–15
10–15
20–30
(minimum interval
30 minutes)
6–14 ml/h
12–28 mg/h n/a(2)

0.5–1.5

Postoperative pain management
2
n/a(2)
Field Block
(e.g. minor nerve blocks and infiltration) 2
1–100
2–200 
1–5
2–6
Peripheral nerve block
(Femoral or interscalene block)
Intermittent injections
2
5–10 ml/h
10–20 mg/h n/a
n/a
(e.g. postoperative pain management)
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.
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, 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. In a limited number of patients, higher doses of up to 800 mg/day have been
administered with relatively few adverse reactions.

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.

When prolonged peripheral nerve blocks are applied, through repeated injections, the risks of
reaching a toxic plasma concentration or inducing local neural injury must be considered.

Single injections for peripheral nerve block (e.g. ilioinguinal nerve block, brachial plexus block)
should not exceed 2.5‑3.0 mg/kg.

Concentrations above 7.5 mg/ml Naropin have not been documented for Caesarean section.

The use of ropivacaine in premature children has not been documented.

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

4. Marketing Authorisation holder
AstraZeneca UK Ltd.,
600 Capability Green
Luton, LU1 3LU, UK.

mg/ml

ml/kg

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
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 should
not exceed 25 mL in any patient. Standard textbooks should be consulted for factors affecting
specific block techniques and for individual patient requirements.
Peripheral nerve blocks: Infants and children aged 1‑12 years
Conc.
mg/ml
ACUTE PAIN MANAGEMENT
(per- and postoperative)
Single injections for peripheral nerve block ( e.g. ilioinguinal nerve
block, brachial plexus block, fascia iliaca compartment block)
Multiple blocks

Volume
ml/kg

Dose
mg/kg

2.0

0.5‑0.75 

1.0‑1.5 

2.0

0.5‑1.5 

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 doses for peripheral block in infants and children provide guidance for use in children without
severe disease. More conservative doses and closer monitoring are recommended for children with
severe disease.

Leaflet updated: May 2013
© AstraZeneca 2013
Naropin is a trade mark of the AstraZeneca group of companies.
PAI 12 0063b

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.
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.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Naropin are held by
AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, UK.

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

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.

Children
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.
6. 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.

PS00951

Black

AZL026A
8020
Naropin 2mg/ml, 7.5mg/ml,
10mg/ml Leaflet: Combined UK-IE
RR
Body text size

Smallest text size

9.0 pt

6.0 pt

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, 7.5, 10 mg/ml injection
Reference number
17901/0150, 0151, 0152
This is a service provided by
the Royal National Institute of
Blind People

The other ingredients are sodium chloride, hydrochloric acid and/
or sodium hydroxide, and water for injections.

Leaflet updated: May 2013

What Naropin looks like and contents of the pack
Naropin is a clear, colourless solution for injection.

Naropin is a trade mark of the AstraZeneca group of companies.

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.
Not all pack sizes may be marketed.

379612-A03
05-06-13

This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria, Belgium, Denmark, Germany, Greece, Ireland,
Luxembourg, Netherlands, Spain, United Kingdom: Naropin.
France, Portugal: Naropeine.
Italy: Naropina.

© AstraZeneca 2013.
PAI 12 0063b

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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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