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ROPIVACAINE 7.5 MG/ML SOLUTION FOR INJECTION

Active substance(s): ROPIVACAINE HYDROCHLORIDE / ROPIVACAINE HYDROCHLORIDE MONOHYDRATE

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Package leaflet: Information for the user
Ropivacaine 2 mg/ml solution for injection
Ropivacaine 7.5 mg/ml solution for injection
Ropivacaine 10 mg/ml solution for injection
Ropivacaine hydrochloride

Read all of this leaflet carefully before you are given this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist, nurse or any other healthcare
professional.
If you get any side effects, talk to your doctor, pharmacist, nurse or any other healthcare
professional. This includes any possible side effects not listed in this leaflet. See section 4.
The full names of the medicines covered by this leaflet are:
Ropivacaine 2 mg/ml solution for injection
Ropivacaine 7.5 mg/ml solution for injection
Ropivacaine 10 mg/ml solution for injection
In this leaflet they are jointly referred to as Ropivacaine .
What is in this leaflet
1.
What Ropivacaine is and what it is used for
2.
What you need to know before you are given Ropivacaine
3.
How to use Ropivacaine
4.
Possible side effects
5.
How to store Ropivacaine
6.
Contents of the pack and other information

1.

What Ropivacaine is and what it is used for




Ropivacaine contains a medicine called ropivacaine hydrochloride.
It belongs to a group of medicines called local anaesthetics.

Ropivacaine 2 mg/ml solution for injection is used in adults and children of all ages for acute pain
management. It numbs (anaesthetises) parts of the body e.g. after surgery.
Ropivacaine 7.5 mg/ml and 10 mg/ml solution for injection is used in adults and children above 12
years 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.

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2.

What you need to know before you are given Ropivacaine

You must not be given Ropivacaine
If you are allergic (hypersensitive) to ropivacaine hydrochloride or any of the other ingredients
of this medicine (listed in section 6).
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
Ropivacaine.
Warnings and precautions
Children
Ropivacaine 2 mg/ml solution for injection
• In newborn children as they are more susceptible to Ropivacaine 2 mg/ml solution for
injection.
• In children < 12 years as some injections of Ropivacaine 2 mg/ml solution for injection in
order to numb parts of the body are not established in younger children.
Ropivacaine 7.5 mg/ml and 10 mg/ml solution for injection
In children up to and including 12 years. Other strengths (2 mg/ml, 5 mg/ml) may be more
appropriate.
Special care should be taken to avoid any injection of Ropivacaine directly into a blood vessel to
prevent any immediate toxic effects. Injection should not be performed in inflamed areas.
Talk to your doctor, pharmacist, nurse or to any other healthcare professional before Ropivacaine is
given to you
if you are in a poor general conditon due to your age or other factors.
if you have heart problems (partial or complete heart conduction block)
if you have advanced liver problems
if you have severe kidney problems.
Tell your doctor if you have any of these problems because your doctor may need to adjust the dose of
Ropivacaine.
Talk to your doctor, pharmacist, nurse or to any other healthcare professional before Ropivacaine is
given to you
if you suffer from acute porphyria (problems with building up red blood pigment, sometimes
resulting in neurological symptoms).
Tell your doctor if you or somebody in your family have porphyria because your doctor may need to
use another anaesthetic.
Other medicines and Ropivacaine
Tell your doctor, pharmacist or healthcare personnel if you are taking, have recently taken or might
take any other medicines. This is because Ropivacaine can affect the way some medicines work and
some medicines can have an effect on Ropivacaine.
In particular, tell your doctor if you are taking any of the following medicines:
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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
Ropivacaine 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 Ropivacaine if you are taking these medicines. If
you are taking either of these medicines, prolonged use of Ropivacaine should be avoided.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
It is not known if ropivacaine affects pregnancy or passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
Ropivacaine may make you feel sleepy and affect the speed of your reactions. After you have been
given Ropivacaine, you should not drive or use any tools or machines until the next day.
Ropivacaine contains sodium chloride
This medicinal product contains a maximum of 0.148 mmol (or 3.4 mg) sodium per ml. To be taken
into consideration by patients on a controlled sodium diet.

3.

How to use Ropivacaine

Ropivacaine 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.
Ropivacaine 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 Ropivacaine. Your doctor will give you Ropivacaine 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 Ropivacaine is given 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.
Dosage
The dose used will depend on what it is being used for and also on your health, age and weight. The
smallest dose that can produce effective numbing (anaesthesia) of the required area should be used.
The usual dose
for adults and adolescents older than 12 years of age is between 2 mg and 300 mg of
ropivacaine hydrochloride.
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-

in infants and children (0 up to and including 12 years of age) is 1-2 mg for each kilogram of
body weight.

Method of administration
Your doctor will administer Ropivacaine to you. It is administered by injection.
Duration of treatment
Administration of ropivacaine usually takes between 2 to 10 hours in case of anaesthesia prior to
certain surgeries and can take up to 72 hours in case of pain relief during or after surgery.
If you are given more Ropivacaine than you should be
Serious side effects from getting too much Ropivacaine need special treatment and the doctor treating
you is trained to deal with these situations. The first symptoms of being given too much Ropivacaine
are usually as follows:
hearing and sight,
numbness of lips, tongue and around the mouth,
dizziness or light-headedness,
tingling,
speech disorder characterised by poor articulation (dysarthria),
muscular stiffness, muscular twitching, fits (convulsions),
low blood pressure,
slow or irregular heart beat.
These symptoms may precede to cardiac arrest, breathing arrest or severe fits.
To reduce the risk of serious side effects, your doctor will stop giving you Ropivacaine as soon as
these signs appear. This means that if any of these happen to you, or you think you may have received
too much Ropivacaine, tell your doctor or healthcare personnel immediately.
More serious side effects from being given too much Ropivacaine include problems with your speech,
twitching of your muscles, tremors, trembling, fits (seizures), and loss of consciousness.
Tell your doctor or health care professional if you notice any of the symptoms above.

4.

Possible side effects

Like all medicines, this medicine can 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 in 10,000
people. 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 Ropivacaine is causing an allergic reaction, tell your doctor or healthcare
personnel immediately.
Other possible side effects:
Very common (may affect more than 1 in 10 people)

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

Feeling sick (nausea).
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Common (may affect up to 1 in 10 people)

Pins and needles (paraesthesia)

Feeling dizzy

Headache

Slow or fast heart beat (bradycardia, tachycardia)

High blood pressure (hypertension)

Being sick (vomiting)

Difficulty in passing urine (urinary retension)

High temperature (fever) or shivering (chills)

Stiffness (rigor)

Back pain
Uncommon (may affect up to 1 in 100 people)

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 Ropivacaine (see also section 3 “If you are given more Ropivacaine
than you should be” 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 (may affect up to 1 in 1,000 people)

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.

Involuntary muscle movements (dyskinesia).
Possible side effects seen with other local anaesthetics which might also be caused by
Ropivacaine include:

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

Damaged nerves. Rarely (affecting 1 to 10 people in 10,000), this may cause permanent
problems.

If too much Ropivacaine is given into the spinal fluid, the whole body may become numbed
(anaesthetised).
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).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. By reporting side effects you can help provide more information on the
safety of this medicine.
For UK - You can also report side effects directly via the Yellow Card Scheme at:
http://www.mhra.gov.uk/yellowcard www.mhra.gov.uk/yellowcard
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5.

How to store Ropivacaine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, ampoule or carton box.
The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Do not use this medicine if you notice any precipitation in the solution for injection.
Your doctor or the hospital will normally store Ropivacaine and they are responsible for the quality of
the product when it has been opened if it is not used immediately. They are also responsible for
disposing of any unused Ropivacaine correctly.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Ropivacaine contains
-

-

The active substance is ropivacaine 2 mg/ml/7.5 mg/ml/10 mg/ml. Each 10 ml polypropylene
ampoule contains 20 mg /75 mg /100 mg ropivacaine (as hydrochloride).
Each 20 ml polypropylene ampoule contains 40 mg/ 150 mg/ 200 mg ropivacaine, (as
hydrochloride).
The excipients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide
(for pH adjustment), and water for injections.

What Ropivacaine looks like and contents of the pack
Ropivacaine solution for injection is a clear, colourless solution for injection.
Ropivacaine 2 mg/ml/7.5 mg/ml/10 mg/ml solution for injection is available in 10 ml and 20 ml
transparent polypropylene ampoules.
Pack sizes:
1, 5, 10 ampoule(s) in blister pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park,
Runcorn, Cheshire WA7 1NT
United Kingdom
Manufacturer
Fresenius Kabi Norge AS
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NO-1753 Halden,
Norway
This medicinal product is authorised in the Member States of the EEA under the following
names:
Ropivacaine 2 mg/ml solution for injection
Name of the member
state

Name of the medicinal product

Netherlands

Ropivacaïne HCl Fresenius 2 mg/ml oplossing voor injectie

Bulgaria

Ropivacaïne HCl Fresenius 2 mg/ml oplossing voor injectie/solution
injectable/ Injektionslösung
Ropivacain 2 mg/ml, инжекционен разтвор

Cyprus

Ropivacaine 2 mg/ml, ενέσιμο διάλυμα

Germany

Ropivacainhydrochlorid 2 mg/ml Injektionslösung

Denmark

Ropivacain Fresenius injektionsvaeske, opløsning, 2 mg/ml

Greece

Ropivacaine 2 mg/ml, ενέσιμο διάλυμα

Spain

Ropivacaina 2 mg/ml solución inyectable

Finland

Ropivacain Fresenius 2 mg/ml injektioneste, liuos

France

Ropivacaïne 2 mg/ml, solution injectable

Ireland

Ropivacaine 2 mg/ml solution for injection

Italy

Ropivacaina 2mg/ml Soluzione iniettabile

Luxembourg

Ropivacainhydrochlorid 2 mg/ml Injektionslösung

Norway

Ropivacain Fresenius 2 mg/ml injeksjonsvæske, oppløsning

Portugal

Ropivacaína 2 mg/mL solução injectável

Romania

Ropivacaina 2 mg/ml soluţie injectabilă

Sweden

Ropivacain Fresenius 2 mg/ml, injektionsvätska, lösning

United Kingdom

Ropivacaine 2 mg/ml solution for injection

Belgium

Ropivacaine 7.5 mg/ml solution for injection
Name of the member
state

Name of the medicinal product

Netherlands

Ropivacaïne Fresenius 7,5 mg/ml oplossing voor injectie

Belgium
Bulgaria

Ropivacaïne Fresenius 7,5 mg/ml oplossing voor injectie/solution
injectable/ Injektionslösung
Ropivacain 7,5 mg/ml, инжекционен разтвор

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Name of the member
state

Name of the medicinal product

Cyprus

Ropivacaine 7,5 mg/ml, ενέσιμο διάλυμα

Germany

Ropivacainhydrochlorid 7,5 mg/ml Injektionslösung

Denmark

Ropivacaine Fresenius, injektionsvaeske, opløsning,7.5 mg/ml

Greece

Ropivacaine 7,5 mg/ml, ενέσιμο διάλυμα

Spain

Ropivacaina 7,5 mg/ml solución inyectable

Finland

Ropivacain Fresenius 7,5 mg/ml injektioneste, liuos

France

Ropivacaïne 7,5 mg/ml, solution injectable

Ireland

Ropivacaine 7.5 mg/ml solution for injection

Italy

Ropivacaina 7,5mg/ml Soluzione iniettabile

Luxembourg

Ropivacainhydrochlorid 7,5 mg/ml Injektionslösung

Norway

Ropivacain Fresenius 7,5 mg/ml injeksjonsvæske, oppløsning

Portugal

Ropivacaína 7,5 mg/mL solução injectável

Romania

Ropivacaina 7,5 mg/ml soluţie injectabilă

Slovenia

Ropivakainijev klorid 7,5 mg/ml raztopina za injiciranje

Sweden

Ropivacain Fresenius 7,5 mg/ml, injektionsvätska, lösning

United Kingdom

Ropivacaine 7.5 mg/ml solution for injection

Ropivacaine 10 mg/ml solution for injection
Name of the member
state

Name of the medicinal product

Netherlands

Ropivacaïne Fresenius 10 mg/ml oplossing voor injectie

Bulgaria

Ropivacaïne Fresenius 10 mg/ml oplossing voor injectie/solution
injectable/ Injektionslösung
Ropivacain 10 mg/ml, инжекционен разтвор

Cyprus

Ropivacaine 10 mg/ml, ενέσιμο διάλυμα

Germany

Ropivacainhydrochlorid 10 mg/ml Injektionslösung

Denmark

Ropivacaine Fresenius, injektionsvaeske, opløsning,10 mg/ml

Greece

Ropivacaine 10 mg/ml, ενέσιμο διάλυμα

Spain

Ropivacaina 10 mg/ml solución inyectable

Finland

Ropivacain Fresenius 10 mg/ml injektioneste, liuos

France

Ropivacaïne 10 mg/ml, solution injectable

Belgium

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Name of the member
state

Name of the medicinal product

Italy

Ropivacaina 10 mg/ml Soluzione iniettabile

Luxembourg

Ropivacainhydrochlorid 10 mg/ml Injektionslösung

Norway

Ropivacain Fresenius 10 mg/ml injeksjonsvæske, oppløsning

Portugal

Ropivacaína 10 mg/mL solução injectável

Romania

Ropivacaina 10 mg/ml soluţie injectabilă

Slovenia

Ropivakainijev klorid 10 mg/ml raztopina za injiciranje

Sweden

Ropivacain Fresenius 10 mg/ml, injektionsvätska, lösning

United Kingdom

Ropivacaine 10 mg/ml solution for injection

This leaflet was last revised in October 2017.

--------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Handling
Ropivacaine should only be used by, or under the supervision of, clinicians experienced in regional
anaesthesia (see section 3).
Shelf life
Shelf-life before opening
3 years
Shelf-life after 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 to 8 °C.
Ropivacaine products are preservative free and are intended for single use only. Discard any unused
solution.
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.
The intact container must not be re-autoclaved.
Posology
Ropivacaine 2 mg/ml solution for injection
Adults and children 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.

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Concentration
mg/ml

Volume
ml

Dose
mg

Onset
minutes

Duration
hours

Bolus

2.0

10-20

20-40

10-15

0.5-1.5

Intermittent injections (top-up) (e.g.
Labour pain management)

2.0

10-15
(minimum
interval 30
minutes)

20-30

Continuous
Labour pain

2.0

6-10 ml/h

12-20 mg/h

n/a

n/a

2.0

6-14 ml/h

12-28 mg/h

n/a

n/a

2.0

6-14 ml/h

12-28 mg/h

n/a

n/a

2.0

1-100

2.0-200

1-5

2-6

2.0

5-10 ml/h

10-20 mg/h

n/a

n/a

Lumbar Epidural Administration

infusion

e.g.

Postoperative pain management
Thoracic Epidural Administration
Continuous infusion
(postoperative pain management)
Field Block
(e.g. minor nerve blocks and
infiltration)
Peripheral nerve block
(Femoral or interscalene block)
Continuous infusion or intermittent
injections (e.g. postoperative pain
management)
n/a = not applicable

Method of administration
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 2% (lignocaine) with adrenaline
(epinephrine) 1:200.000 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.
In epidural block for surgery, single doses of up to 250 mg ropivacaine have been used and well
tolerated.
In brachial plexus block a single dose of 300 mg has been used in a limited number of patients and
was well tolerated.

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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 Ropivacaine 7.5 mg/ml is induced via an epidural
catheter. Analgesia is maintained with Ropivacaine 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.
In clinical studies an epidural infusion of ropivacaine 2 mg/ml alone or mixed with fentanyl 1-4 μg/ml
has been given for postoperative pain management for up to 72 hours. The combination of ropivacaine
and fentanyl provided improved pain relief but caused opioid side effects. The combination of
ropivacaine and fentanyl has been investigated only for ropivacaine 2 mg/ml.
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. In clinical studies, femoral nerve block was established with 300 mg ropivacaine
7.5 mg/ml and interscalene block with 225 mg ropivacaine 7.5 mg/ml, respectively, before surgery.
Analgesia was then maintained with ropivacaine 2 mg/ml. Infusion rates or intermittent injections of
10-20 mg per hour for 48 hours provided adequate analgesia and were well tolerated.
Concentrations above 7.5 mg/ml ropivacaine have not been documented for Caesarean section.
Renal impairment
Normally there is no need to modify the dose in patients with impaired renal function when used for
single dose or short-term treatment.
Hepatic impairment
Ropivacaine is metabolised in the liver and should therefore be used with caution in patients with
severe liver disease. Repeated doses may need to be reduced due to delayed elimination.

Paediatric patients from 0 up to and including 12 years of age
Concentration
mg/ml

Volume
ml/kg

Dose
mg/kg

2.0

1

2

Single Caudal Epidural Block
Blocks below T12, in children with
a body weight up to 25 kg
Continuous Epidural Infusion
In children with a body weight up
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to 25 kg
0 up to 6 months
Bolus dosea

2.0

0.5-1

1-2

Infusion up to 72 hours

2.0

0.1 ml/kg/h

0.2 mg/kg/h

Bolus dosea

2.0

0.5-1

1-2

Infusion up to 72 hours

2.0

0.2 ml/kg/h

0.4 mg/kg/h

Bolus doseb

2.0

1

2

Infusion up to 72 hours

2.0

0.2 ml/kg/h

0.4 mg/kg/h

6 up to12 months

1 to 12 years

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

Infants and children aged 1-12 years:
The proposed ropivacaine doses for peripheral block in infants and children provide guidelines for use
in children without severe disease. More conservative doses and close monitoring are recommended
for children with severe disease.
Single injections for peripheral nerve block (e.g. ilioinguinal nerve block, brachial plexus block)
should not exceed 2.5-3.0 mg/kg.
Continuous infusion for peripheral nerve block are recommended at 0.2-0.6 mg/kg/h (0.1-0.3 ml/kg/h)
up to 72 h.
The use of ropivacaine in premature children has not been documented.
Method of administration
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.
A single caudal epidural injection of ropivacaine 2 mg/ml produces adequate postoperative analgesia
below T12 in the majority of patients when a dose of 2 mg/kg is used in a volume of 1 ml/kg. The
volume of the caudal epidural injection may be adjusted to achieve a different distribution of sensory
block, as recommended in standard textbooks. In children above 4 years of age, doses up to 3 mg/kg
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of a concentration of ropivacaine 3 mg/ml have been studied. However, this concentration is
associated with a higher incidence of motor block.
Fractionation of the calculated local anaesthetic dose is recommended, whatever route of
administration.
In case infusion of ropivacaine is recommended, Ropivacaine solution for infusion can be used.

Ropivacaine 7.5 mg/ml and Ropivacaine 10 mg/ml solution for injection
Adults and children 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.
Concentration
mg/ml

Volume
ml

Dose
mg

Onset
minutes

Duration
hours

7.5

15-25

113-188

10-20

3-5

10.0

15-20

150-200

10-20

4-6

7.5

15-20

113-1501)

10-20

3-5

7.5

5-15
(dependent on
the level of
injection)

38-113

10-20

n/a2)

7.5

30-40

225-3003)

10-25

6-10

7.5

1-30

7.5-225

1-15

2-6

SURGICAL ANAESTHESIA
Lumbar Epidural Administration
Surgery

Caesarean section
Thoracic Epidural Administration
To establish block for post-operative
pain relief

Major Nerve Block*
Brachial plexus block
Field Block
(e.g. minor nerve blocks and
infiltration)

* With regard to major nerve block, only for brachial plexus block a dose recommendation can be given. 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 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.
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Method of administration
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 2% (lignocaine) with adrenaline
(epinephrine) 1:200.000 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.
In epidural block for surgery, single doses of up to 250 mg ropivacaine have been used and well
tolerated.
In brachial plexus block a single dose of 300 mg has been used in a limited number of patients and
was well tolerated.
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 Ropivacaine 7.5 mg/ml is induced via an epidural
catheter. Analgesia is maintained with Ropivacaine 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.
In clinical studies an epidural infusion of ropivacaine 2 mg/ml alone or mixed with fentanyl 1-4 μg/ml
has been given for postoperative pain management for up to 72 hours. The combination of ropivacaine
and fentanyl provided improved pain relief but caused opioid side effects. The combination of
ropivacaine and fentanyl has been investigated only for ropivacaine 2 mg/ml.
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. In clinical studies, femoral nerve block was established with 300 mg ropivacaine
7.5 mg/ml and interscalene block with 225 mg ropivacaine 7.5 mg/ml, respectively, before surgery.
Analgesia was then maintained with ropivacaine 2 mg/ml. Infusion rates or intermittent injections of
10-20 mg per hour for 48 hours provided adequate analgesia and were well tolerated.
Concentrations above 7.5 mg/ml ropivacaine have not been documented for Caesarean section.
Renal impairment
Normally there is no need to modify the dose in patients with impaired renal function when used for
single dose or short-term treatment.
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Hepatic impairment
Ropivacaine is metabolised in the liver and should therefore be used with caution in patients with
severe liver disease. Repeated doses may need to be reduced due to delayed elimination.
Paediatric population up to and including 12 years
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, 5 mg/ml) are more appropriate for administration to this
population.
In general, surgical anaesthesia (e.g. epidural administration) requires the use of the higher
concentrations and doses. The Ropivacaine 10 mg/ml formulation is recommended for epidural
anaesthesia in which a complete motor block is essential for the surgery. For analgesia (e.g. epidural
administration for acute pain management) the lower concentrations and doses are recommended.

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
In alkaline solutions precipitation may occur as ropivacaine shows poor solubility at pH > 6.0.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

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