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ROPIVACAINE 2 MG/ML SOLUTION FOR INJECTION

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

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01-59-18-XXX

- 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.

Package leaflet: Information for the user

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).

Ropivacaine 2 mg/ml, 7.5 mg/ml and 10 mg/ml solution for injection
Ropivacaine hydrochloride
Read all of this leaflet carefully before you start using 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.
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

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 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 any other healthcare professorial before
Ropivacaine is given to you:
- if you suffer from acute porphyria (problems with building up red blood pigment, some
times 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.

1. What Ropivacaine is and what it is used for
Ropivacaine solution for injection 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.
Ropivacaine 2 mg/ml solution for injection is used in adults and children of all116
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.
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 medicine (listed in
section 6).
- if you have a decrease in blood volume (hypovolaemia). This is measured by healthcare
personnel.
- for injection into a blood vessel to numb a specific area of your body,
- for injection into the neck of the womb to relieve pain during childbirth.

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

Warnings and precautions
Children
Ropivacaine 2mg/ml solution for injection
- In newborn children as they are more susceptible to Ropivacaine 2 mg/ml solution for
injection.
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.

Important information about some of the ingredients of Ropivacaine
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.

Method of administration
Perineural and epidural administration by injection.
Careful aspiration before and during administration 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 250mg ropivacaine hydrochloride have
been used and well tolerated.
In brachial plexus block a single dose of 300mg has been used in a limited number of
patients and was well tolerated.

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.
Concentration
mg/ml

Volume
ml

Dose
mg

Onset Duration
minutes hours

Lumbar Epidural Administration
Bolus

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

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

2.0

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

2.0

n/a = not applicable

15918XXX_UK.indd 1

1-100

2.0-200

5-10 ml/h 10-20 mg/h

10-15

0.5-1.5

1-5

2-6

n/a

n/a

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

3. How to use Ropivacaine
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.
- 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 hydrochloride 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
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 personnel immediately.
In case of acute toxicity, appropriate corrective actions will be taken immediately by the
healthcare personnel.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist, nurse or any other healthcare professional.
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.

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 hydrochloride 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
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

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
to 25 kg
0 up to 6 months

6 up to 12 months

1 to 12 years
Bolus doseb

2.0

1

2

Infusion up to 72 hours

2.0

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

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.

2013-10-02 14:29:02

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)
Common (may affect up to 1 in 10 people)
• 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)

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.

Uncommon (may affect up to 1 in 100 people)
• Anxiety
• 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 (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 (may affect up to 1 in 1000 people)
• 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).
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.

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 waste water or household waster. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Ropivacaine solution for injection contains
- The active substance is ropivacaine hydrochloride.
- For Ropivacaine 2 mg/ml solution for injection:
Each 10 ml polypropylene ampoule contains 20 mg ropivacaine hydrochloride.
Each 20 ml polypropylene ampoule contains 40 mg ropivacaine hydrochloride.
- For Ropivacaine 7.5 mg/ml solution for injection:
Each 10 ml polypropylene ampoule contains 75 mg ropivacaine hydrochloride.
Each 20 ml polypropylene ampoule contains 150 mg ropivacaine hydrochloride.
- For Ropivacaine 10 mg/ml solution for injection:
Each 10 ml polypropylene ampoule contains 100 mg ropivacaine hydrochloride.
Each 20ml polypropylene ampoule contains 200 mg ropivacaine hydrochloride.
- The other ingredients 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.
Ropivacaine 2 mg/ml, 7.5 mg/ml and 10 mg/ml solution for injection are 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.

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:
HYPERLINK http://www.mhra.gov.uk/yellowcard www.mhra.gov.uk/yellowcard

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

Method of administration
Epidural administration by injection.

* 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.

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 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 infusion of ropivacaine hydrochloride is recommended, Ropivacaine solution for
infusion can be used.

Ropivacaine Kabi 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

SURGICAL ANAESTHESIA

Caesarean section

7.5

15-25

113-188

10-20

3-5

10.0

15-20

150-200

10-20

4-6

7.5

15-20

113-150

10-20

3-5

1)

Thoracic Epidural Administration
To establish block for
postoperative pain
relief

5-15
(dependent on
the level
of injection)

38-113

7.5

30-40

2253003)

10-25

6-10

7.5

1-30

7.5-225

1-15

2-6

7.5

10-20

n/a2)

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

15918XXX_UK.indd 2

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.

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 hydrochloride 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.
Concentrations above 7.5 mg/ml ropivacaine hydrochloride 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.

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.

Hepatic impairment
Ropivacaine hydrochloride 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.

In epidural block for surgery, single doses of up to 250 mg ropivacaine hydrochloride
have been used and well tolerated.

Paediatric population up to and including 12 years
The use of Ropivacaine 7,5 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 brachial plexus block a single dose of 300 mg has been used in a limited number of
patients and was well tolerated.

Lumbar Epidural Administration
Surgery

Method of administration
Perineural and epidural administration by injection.

This medicinal product is authorised in the Member States of the EEA under the
following names:
The Netherlands Ropivacaïne HCl Fresenius Kabi 2 mg/ml oplossing voor injectie
Ropivacaïne HCl Fresenius Kabi 7,5 mg/ml oplossing voor injectie
Ropivacaïne HCl Fresenius Kabi 10 mg/ml oplossing voor injectie
Belgium
Ropivacaïne Fresenius Kabi 2 mg/ml oplossing voor injectie /
solution injectable / Injektionslösung
Ropivacaïne Fresenius Kabi 7,5 mg/ml oplossing voor injectie /
solution injectable / Injektionslösung
Ropivacaïne Fresenius Kabi 10 mg/ml oplossing voor injectie /
solution injectable / Injektionslösung
Bulgaria
Ropivacain Kabi 2 mg/ml, инжекционен разтвор
Ropivacain Kabi 7,5 mg/ml, инжекционен разтвор
Ropivacain Kabi 10 mg/ml, инжекционен разтвор
Cyprus
Ropivacaine Kabi 2 mg/ml, eνέsιµο dιάλυµa
Ropivacaine Kabi 7,5 mg/ml, eνέsιµο dιάλυµa
Ropivacaine Kabi 10 mg/ml, eνέsιµο dιάλυµa
Germany
Ropivacainhydrochlorid Kabi 2 mg/ml Injektionslösung
Ropivacainhydrochlorid Kabi 7,5 mg/ml Injektionslösung
Ropivacainhydrochlorid Kabi 10 mg/ml Injektionslösung
Denmark
Ropivacain Fresenius Kabi injektionsvæske, opløsning, 2 mg/ml
Ropivacaine Fresenius Kabi, injektionsvæske, opløsning,7.5 mg/ml
Ropivacaine Fresenius Kabi, injektionsvæske, opløsning,10 mg/ml
Greece
Ropivacaine Kabi 2 mg/ml, eνέsιµο dιάλυµa
Ropivacaine Kabi 7,5 mg/ml, eνέsιµο dιάλυµa
Ropivacaine Kabi 10 mg/ml, eνέsιµο dιάλυµa
Spain
Ropivacaina Kabi 2 mg/ml solución inyectable
Ropivacaina Kabi 7,5 mg/ml solución inyectable
Ropivacaina Kabi 10 mg/ml solución inyectable
Finland
Ropivacain Fresenius Kabi 2 mg/ml injektioneste, liuos
Ropivacain Fresenius Kabi 7,5 mg/ml injektioneste, liuos
Ropivacain Fresenius Kabi 10 mg/ml injektioneste, liuos
France
Ropivacaïne Kabi 2 mg/ml, solution injectable
Ropivacaïne Kabi 7,5 mg/ml, solution injectable
Ropivacaïne Kabi 10 mg/ml, solution injectable
Ireland
Ropivacaine 2 mg/ml solution for injection
Ropivacaine 7.5 mg/ml solution for injection
Italy
Ropivacaina Kabi 2mg/ml Soluzione iniettabile
Ropivacaina Kabi 7,5mg/ml soluzione iniettabile
Ropivacaina Kabi 10 mg/ml soluzione iniettabile
Luxemburg
Ropivacainhydrochlorid Kabi 2 mg/ml Injektionslösung
Ropivacainhydrochlorid Kabi 7,5 mg/ml Injektionslösung
Ropivacainhydrochlorid Kabi 10 mg/ml Injektionslösung
Norway
Ropivacain Fresenius Kabi 2 mg/ml injeksjonsvæske, oppløsning
Ropivacain Fresenius Kabi 7,5 mg/ml injeksjonsvæske, oppløsning
Ropivacain Fresenius Kabi 10 mg/ml injeksjonsvæske, oppløsning
Portugal
Ropivacaína Kabi 2 mg/mL solução injectável
Ropivacaína Kabi 7,5 mg/mL solução injectável
Ropivacaína Kabi 10 mg/mL solução injectável
Romania
Ropivacaina Kabi 2 mg/ml solutie injectabila
Ropivacaina Kabi 7,5 mg/ml solutie injectabila
Ropivacaina Kabi 10 mg/ml solutie injectabila
Sweden
Ropivacain Fresenius Kabi 2 mg/ml, injektionsvätska, lösning
Ropivacain Fresenius Kabi 7,5 mg/ml, injektionsvätska, lösning
Ropivacain Fresenius Kabi 10 mg/ml, injektionsvätska, lösning
Slovenia
Ropivakainijev klorid Kabi 7,5 mg/ml raztopina za injiciranje
Ropivakainijev klorid Kabi 10 mg/ml raztopina za injiciranje
UK
Ropivacaine 2 mg/ml solution for injection
Ropivacaine 7.5 mg/ml solution for injection
Ropivacaine 10 mg/ml solution for injection
The leaflet was last revised in September 2013

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 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 hydrochloride shows poor
solubility at pH > 6.0.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

V004/UK
01-59-18-xxx

2013-10-02 14:29:02

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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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