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ROPIVACAINE 2 MG/ML SOLUTION FOR INFUSION

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

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01-59-18-008

Talk to your doctor, pharmacist, nurse or 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.

Package leaflet: Information for the user
Ropivacaine 2 mg/ml solution for infusion
Ropivacaine hydrochloride
Read all of this leaflet carefully before you start using this medicine.
- 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.

Talk to your doctor, pharmacist, nurse or 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.

What is in this leaflet:
1. What Ropivacaine is and what it is used for
2. What you need to know before you use Ropivacaine
3. How to use Ropivacaine
4. Possible side effects
5. How to store Ropivacaine
6. Contents of the pack and other information

Other medicines and Ropivacaine
Tell your doctor, pharmacist, or healthcare professional if you are taking, have recently
taken or might take any other medicines.
Caution should be exercised if you are receiving:
- Other local anaesthetics (e.g. lidocaine) or agents structurally related to amide-type
local anaesthetics, e.g. certain medicines used to treat an irregular heart beat
(arrhythmia), such as mexiletine or amiodarone
- General anaesthetics or opioids, such as morphine or codeine
- Medicines used to treat depression (e.g. fluvoxamine)
- Certain antibiotics (e.g. enoxacin)

1. What Ropivacaine is and what it is used for
Ropivacaine 2 mg/ml solution for infusion contains the
active substance ropivacaine hydrochloride which is a type of
medicine called local anaesthetic. These are chemical substances that
are used to numb an area of the body.

121

Ropivacaine 2 mg/ml solution for infusion is used in adults and children of all ages for
acute pain management. It numbs (anaesthetises) parts of the body e.g. after surgery.
2. What you need to know before you use Ropivacaine
You must not be given Ropivacaine
- if you are allergic to ropivacaine hydrochloride, other so called local
anaesthetics of the amide type or any of the other ingredients of this medicines (listed
in section 6),
- if you have a decrease in blood volume (hypovolaemia). This is measured by
healthcare personnel.
- for infusion into a blood vessel to numb a specific area of your body,
- for infusion into the neck of the womb to relieve pain during childbirth.

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 hydrochloride affects pregnancy or passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
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.

3. How to use Ropivacaine
Method of administration
Your doctor will administer Ropivacaine to you. It is administered by infusion.
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 200 mg
of ropivacaine hydrochloride.
- in infants and children (0 up to and including 12 years of age) is 1-2 mg for each
kilogram of body weight.
Duration of treatment
Administration of ropivacaine hydrochloride usually takes between 0.5 to 6 hours but
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
The first symptoms of being given too much ropivacaine hydrochloride are usually
problems with
- hearing and sight,
- numbness 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.
If you experience any of these symptoms or think you may have received too much
Ropivacaine, tell your doctor or healthcare professional immediately.
In case of acute toxicity, appropriate corrective actions will be taken immediately by the
healthcare professional.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist, nurse or any other healthcare professional.

Discuss with your doctor or pharmacist if you are unsure about anything.
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.

Warning and precautions
Children
- In newborn children as they are more susceptible to Ropivacaine 2 mg/ml solution for
infusion.
- In children < 12 years as some injections of Ropivacaine 2 mg/ml solution for infusion in
order to numb parts of the body are not established in younger children.
Special care should be taken to avoid any administration of Ropivacaine directly into a
blood vessel to prevent any immediate toxic effects. Administration should not be
performed in inflamed areas.
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
2 years
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. A bag wrapped in a foil overpouch should
be chosen when a sterile outside is required.
Posology

Adults and children above 12 years of age
The following table is a guide to dosage for the more commonly used blocks in adults. 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

2.0

10-20

20-40

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

2.0

10-15
(minimum
interval
30 minutes)

20-30

Continuous infusion e.g.
labour pain

2.0

6-10
ml/h

12-20
mg/h

n/a

n/a

Postoperative pain management

2.0

6-14
ml/h

12-28
mg/h

n/a

n/a

Thoracic Epidural Administration
Continuous infusion
(postoperative pain management)

2.0

6-14
ml/h

12-28
mg/h

n/a

n/a

1-5

2-6

n/a

n/a

Onset Duration
minutes
hours

Lumbar Epidural Administration
Bolus

Field Block
(e.g. minor nerve blocks and
infiltration)

2.0

1-100

2.0200

Peripheral nerve block
(Femoral or interscalene block)
Continuous infusion or intermittent
injections (e.g. postoperative pain
management)

2.0

5-10
ml/h

10-20
mg/h

10-15

0.5-1.5

Method of administration
Perineural and epidural administration by infusion.
Careful aspiration before and during administration is recommended to prevent
intravascular administration. When a large dose is to be injected, a test dose of 3-5
ml lidocaine (lignocaine) with adrenaline (epinephrine) 1:200.000 is recommended. An
inadvertent intravascular infusion 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 infusion 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
hydrochloride 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 hydrochloride 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 hydrochloride and fentanyl provided improved
pain relief but caused opioid side effects. The combination of ropivacaine hydrochloride
and fentanyl has been investigated only for ropivacaine hydorchloride 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 hydrochloride 7.5 mg/ml and interscalene block with
225 mg ropivacaine hydrochloride 7.5 mg/ml, respectively, before surgery. Analgesia was
then maintained with ropivacaine hydrochloride 2 mg/ml. Infusion rates or intermittent
injections of 10-20 mg per hour for 48 hours provided adequate analgesia and were well
tolerated.

Paediatric patients 0 up to and including 12 years of age
Concen-tration
mg/ml

Volume
ml/kg

Dose
mg/kg

2.0

1

2

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

Single Caudal Epidural Block
Blocks below T12, in children with
a body weight up to 25 kg 2.0 1 2
Continuous Epidural Infusion
In children with a body weight up
to 25 kg
0 up to 6 months

6 up to 12 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.

n/a = not applicable

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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, angioneurotic oedema
and urticaria) are rare. 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
• Low blood pressure (hypotension). This might make you feel dizzy or light-headed.
• Feeling sick (nausea)
Common
• Headache, pins and needles (paraesthesia), feeling dizzy
• Slow or fast heart beat (bradycardia, tachycardia)
• High blood pressure (hypertension)
• Being sick (vomiting)
• Difficulty in passing urine (urinary retention)
• Back pain, increased temperature, muscular stiffness (rigor)
Uncommon
• Anxiety
• Some symptoms can happen if the infusion 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 (convulsions, 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 (dysarthria), muscular twitching and trembling, reduced sense of touch
(hypoaesthesia)
• Fainting (syncope)
• Difficulty breathing (dyspnoea)
• Low body temperature
Rare
• Cardiac arrest, irregular heart beat (cardiac arrhythmias)
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, 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 less than 1 in 10 children) and
being sick which happens more often in children (affecting more than
1 in 10 children).
The evaluation of side effects is based on the following frequencies:
very common:

more than 1 user in 10

common:

1 to 10 users in 100

uncommon:

1 to 10 users in 1,000

rare:

1 to 10 users in 10,000

very rare:

less than 1 user in 10,000

not known:

frequency cannot be estimated from the available data

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.
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 bag. The expiry
date refers to the last day of that month.
Store below 30°C.
Do not refrigerate or freeze.
Do not use Ropivacaine if you notice any precipitation in the solution for infusion.
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 hydrochloride.
- Each 100 ml plastic bag contains 200 mg ropivacaine hydrochloride.
- Each 200 ml plastic bag contains 400 mg ropivacaine hydrochloride.
- The other 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 infusion is a clear, colourless solution.
Ropivacaine 2 mg/ml solution for infusion is available in 100 ml and 200 ml transparent
plastic bags.
Pack sizes:
1 bag in foil overpouch
5 bags in foil overpouches
10 bags in foil overpouches
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park,
Runcorn, Cheshire WA7 1NT
United Kingdom
Manufacturer
Fresenius Kabi Norge AS
NO-1753 Halden,
Norway
This medicinal product is authorised in the Member States of the EEA under the
following names:
The Netherlands
Belgium

Cyprus
Denmark
Finland
France
Germany
Greece
Italy
Luxemburg
Norway
Portugal
Spain
Sweden
Slovenia
UK

Ropivacaïne Fresenius Kabi 2 mg/ml oplossing voor infusie
Ropivacaïne Fresenius Kabi 2 mg/ml oplossing voor infusie / solution
pour perfusion / Infusionslösung
Ropivacaine Kabi 2 mg/ml, διάλυμα για έγχυση
Ropivacain Fresenius Kabi
Ropivacain Fresenius Kabi 2 mg/ml infuusioneste, liuos
Ropivacaïne Kabi 2 mg/ml, solution pour perfusion
Ropivacainhydrochlorid Kabi 2 mg/ml Infusionslösung
Ropivacaine Kabi 2 mg/ml, διάλυμα για έγχυση
Ropivacaina Kabi 2mg/ml soluzione per infusione
Ropivacainhydrochlorid Kabi 2 mg/ml Infusionslösung
Ropivacain Fresenius Kabi 2 mg/ml infusjonsvæske, oppløsning
Ropivacaína Kabi 2 mg/mL solução para perfusão
Ropivacaina Kabi 2 mg/ml solución para perfusión
Ropivacain Fresenius Kabi
Ropivakainijev klorid Kabi 2 mg/ml raztopina za infundiranje
Ropivacaine 2 mg/ml solution for infusion

This leaflet was last revised in July 2012.

Method of administration
Epidural administration by infusion.

Careful aspiration before and during application is recommended to prevent intravascular
application. The patient’s vital functions should be observed closely during the infusion. If
toxic symptoms occur, the infusion should be stopped immediately.
A single caudal epidural injection of ropivacaine hydrochloride 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 of a concentration of
ropivacaine hydrochloride 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 injection of ropivacaine hydrochloride is recommended, Ropivacaine solution for
injection can be used.
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 hydrochloride shows poor
solubility at pH > 6.0.
Ropivacaine solution for infusion in plastic infusion bags is chemically and physically
compatible with the following drugs:
Concentration of Ropivacaine 1-2 mg/ml
Additive

Concentration*

Fentanyl citrate

1.0 - 10.0 µg/ml

Sufentanil citrate

0.4 – 4.0 µg/ml

Morphine sulphate

20.0 – 100.0 µg/ml

Clonidine hydrochloride

5.0 – 50 µg/ml

* The concentration ranges stated in the table are wider than those used in clinical practice.
Epidural infusions of Ropivacaine/sufentanil citrate, Ropivacaine/morphine sulphate and
Ropivacaine/clonidine hydrochloride have not been evaluated in clinical studies.

The mixtures are chemically and physically stable for 30 days at 20 to 30°C. From a
microbiological point of view, the mixtures 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.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with
local requirements.
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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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