ROPIVACAINA 2 mg /Ml Infusion Solution

Зміст інструкції

1. Ropivacaina Kabi 2 mg/ml solution for infusion
   1. What is Ropivacaina Kabi and what is it used for
   2. What you need to know before you are given Ropivacaina Kabi
   3. How to take Ropivacaina Kabi
   4. Possible side effects
   5. How to store Ropivacaina Kabi
   6. Contents of the pack and other information
2. Ropivacaina Kabi 2 mg/ml injectable solution, 7.5 mg/ml injectable solution, 10 mg/ml injectable solution
   1. What is Ropivacaina Kabi and what is it used for
   2. What you need to know before you take Ropivacaina Kabi
   3. How to take Ropivacaina Kabi
   4. Possible side effects
   5. How to store Ropivacaina Kabi
   6. Contents of the pack and other information
3. Ropivacaina Kabi 5 mg/ml injectable solution
   1. What is Ropivacaina Kabi and what is it used for
   2. What you need to know before you are given Ropivacaina Kabi
   3. How to take Ropivacaina Kabi
   4. Possible side effects
   5. How to store Ropivacaina Kabi
   6. Contents of the pack and other information

Ropivacaina Kabi 2 mg/ml solution for infusion

Generic medicine

Read this leaflet carefully before using this medicine as it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, nurse or other healthcare professional.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist, nurse or other healthcare professional.

Contents of this leaflet:

• 1. What Ropivacaina Kabi is and what it is used for
• 2. What you need to know before you are given Ropivacaina Kabi
• 3. How Ropivacaina Kabi is administered
• 4. Possible side effects
• 5. How to store Ropivacaina Kabi
• 6. Contents of the pack and other information

1. What is Ropivacaina Kabi and what is it used for

Ropivacaina Kabi contains the active substance ropivacaine hydrochloride which is a type of medicine called a
local anesthetic. These are chemicals used to numb an area of the body.
Ropivacaina Kabi 2mg/ml solution for infusion is used in adults and children of all ages for the
treatment of acute pain. It makes parts of the body insensitive (anesthetizes) e.g. following a
surgical procedure.

2. What you need to know before you are given Ropivacaina Kabi

Ropivacaina Kabi must not be given to you

• if you are allergicto ropivacaine hydrochloride, other so-called local amide-type anesthetics or to any of the other ingredients of this medicine (listed in section 6),
• if you have a decrease in blood volume(hypovolemia). This is assessed by medical personnel,
• for infusion into a blood vesselto anesthetize a specific area of your body,
• for infusion into the cervixto relieve labor pain.

Warnings and precautions
Children

• In newborns as they are more sensitive to Ropivacaina Kabi 2mg/ml solution for infusion.
• In children under 12 years of age as some injections of Ropivacaina Kabi 2mg/ml solution for infusion for anesthetizing parts of the body have not been established in younger children.

Particular care must be taken to avoid any injectionof Ropivacaina Kabi

directly into the blood vesselto prevent any immediate toxic effect. Administration
must not be done in inflamed areas.
Contact your doctor, pharmacist, nurse or other healthcare professional before taking Ropivacaina
Kabi if:

• you are in a general state of poor healthdue to your age or other factors.
• if you have heart problems(partial or complete conduction block)
• if you have serious liver problems
• if you have serious kidney problems.

Tell your doctor if you have any of these problems because the doctor may need to adjust the
dose of Ropivacaina Kabi.
Contact your doctor, pharmacist, nurse or other healthcare professional before you are given
Ropivacaina Kabi:

• if you suffer from acute porphyria(problems with the production of red blood pigment, which sometimes leads to neurological symptoms). Tell your doctor if you or someone in your family suffers from porphyria because the doctor may need to use other anesthetics.

Other medicines and Ropivacaina Kabi
Tell your doctor, pharmacist or healthcare professional if you are taking, have recently taken or
may take any other medicine.
Caution should be exercised if you are taking:

• Other local anesthetics(e.g. lidocaine) or agents structurally related to amide local anesthetics, e.g. some drugs used to treat irregular heartbeat (arrhythmia), such as mexiletine or amiodarone
• General anestheticsor opioids, such as morphine or codeine
• Medicines used to treat depression(e.g. fluvoxamine)
• Some antibiotics(e.g. enoxacin)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether ropivacaine hydrochloride has effects on pregnancy or passes into breast milk.

Driving and using machines
Ropivacaina Kabi can make you feel sleepy and have consequences on your reaction speed. After
administration of Ropivacaina Kabi, do not drive vehicles or use machines until the next day.
Ask your doctor or pharmacist if you have any doubts.

Ropivacaina Kabi contains sodium chloride.
This medicinal product contains 0.148 mmol (or 3.4 mg) of sodium per ml. This should be taken into
consideration by patients on a sodium-controlled diet.

3. How to take Ropivacaina Kabi

Dosage
The dose used will depend on the reason why it is being used and also on your health, age and weight.
The minimum dose that can induce an anesthetic (anesthesia) effect in the area of
interest should be used.
The usual dose

• For adultsand adolescents over 12 years of ageis between 2 mg and 200mgof ropivacaine hydrochloride.
• In newborns and children (from 0 to 12 years inclusive) it is 1-2mg per kilogramof body weight.

Method of administration
The doctor will administer Ropivacaina Kabi to you. It is administered by infusion.

Duration of treatment
The administration of ropivacaine hydrochloride generally requires from 0.5 to 6 hoursbut may
require up to 72 hoursin case of pain reliefduring or after surgery.

If you are given more Ropivacaina Kabi than you should
The first symptoms that occur from receiving an excessive amount of ropivacaine hydrochloride are
generally problems with

• hearing and vision,
• numbness around the mouth,
• dizziness or lightheadedness,
• tingling,
• speech disorder characterized by poor articulation (dysarthria),
• muscle stiffness, muscle spasm, seizures,
• low blood pressure,
• slow or irregular heartbeat. These symptoms may precede cardiac arrest, respiratory arrest or severe crises. If you have experienced any of these symptoms or think you have received an excessive amount of Ropivacaina Kabi,inform your doctor or healthcare professional immediately.

In case of acute toxicity, appropriate corrective actions will be taken immediately by healthcare
personnel.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist, nurse or other
healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Serious side effects to consider:
Sudden life-threatening allergic reactions(such as anaphylaxis, angioedema and
urticaria) are rare. Possible symptoms include:

• sudden onset of skin rash,
• itching or nodular rash (urticaria),
• swelling of the face, lips, tongue or other parts of the body
• shortness of breath, wheezing or difficulty breathing.

If you think Ropivacaina Kabi is causing you an allergic reaction, tell your doctor or
healthcare professional immediately.
Other possible side effects:
Very common (may affect more than 1 in 10 people)

• low blood pressure (hypotension). This may make you feel dizzy or lightheaded.
• feeling sick (nausea)

Common (may affect up to 1 in 10 people)

• Headache, tingling (paresthesia), feeling of dizziness
• Slow or fast heartbeat (bradycardia, tachycardia)
• High blood pressure (hypertension)
• Feeling sick (vomiting)
• Difficulty urinating (urinary retention)
• Back pain, high body temperature, muscle stiffness (rigor)

Uncommon (may affect up to 1 in 100 people)

• Anxiety
• Some symptoms may occur if the infusion is given into a blood vessel by mistake, or if you have been given too much Ropivacaina Kabi (see also section 3 “If you use more Ropivacaina Kabi than you should” above). These include seizures (convulsions, fits), feeling dizzy or lightheaded, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems (vision), speech problems (dysarthria), muscle spasm and tremor, reduced sense of touch (hypoesthesia)
• Fainting (syncope)
• Difficulty breathing (dyspnea)
• Low body temperature

Rare (may affect up to 1 in 1000 people)

• Cardiac arrest, irregular heartbeat (cardiac arrhythmias)

Possible side effects observed with other local anesthetics that may also be caused by
Ropivacaina Kabi include:

• Numbness, due to irritation of the nerve caused by the needle or injection. This usually does not last long.
• Nerve damage. Rarely, this can cause permanent problems.
• If too much Ropivacaina Kabi is given into the spinal fluid, the whole body may become numb (anesthetized).

Children
In children, the side effects are the same as those in adults except for low blood pressure
which occurs less frequently in children (affecting less than 1 in 10 children) and nausea which
occurs more frequently in children (affecting more than 1 in 10 children).
If any side effects occur, even those not listed in this leaflet, please tell your
doctor, pharmacist, nurse or other healthcare professional.

5. How to store Ropivacaina Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bag. The expiry date refers
to the last day of the month.
Store at a temperature below 30°C.
Do not refrigerate or freeze.
Do not use this medicine if you notice any precipitate in the infusion solution.
The doctor or hospital will normally store Ropivacaina Kabi and are responsible for the quality of the
product when it has been opened if not used immediately. They are also responsible for the
correct disposal of unused Ropivacaina Kabi.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ropivacaine Kabi contains

• The active substance is ropivacaine hydrochloride 2 mg/ml. Each 100 ml plastic bag contains 200 mg of ropivacaine (as hydrochloride). Each 200 ml plastic bag contains 400 mg of ropivacaine (as hydrochloride).
• The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

Description of the appearance of Ropivacaine Kabi and contents of the pack
Ropivacaine Kabi solution for infusion is a clear and colourless solution.
Ropivacaine Kabi 2 mg/ml solution for infusion is available in transparent plastic bags of 100 ml and
200 ml.
Packs:
1 bag with overpack
5 bags with overpack
10 bags with overpack
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona
Manufacturer:
Fresenius Kabi Norge AS
Svinesundsveien 80,NO-1788 Halden, Norway
This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Ropivacaine Kabi 2mg/ml solution for infusion

Date of revision.
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The following information is intended for healthcare professionals only:
Handling
Ropivacaine Kabi must only be used by or under the supervision of clinicians experienced in local anaesthesia
(see section 3).
Shelf life
2 years
Shelf life after opening:
From a microbiological point of view, the product must be used immediately. If this
does not happen, the storage conditions and times before use are the responsibility of the
user, but in any event, they must not exceed 24 hours at a temperature
between 2 and 8°C.
Ropivacaine Kabi products are without preservatives and are intended for single use only.
Discard any unused solution.
The medicinal product must be visually inspected before use. The solution must be
used only if it is clear, practically free from particles, and if the container is undamaged.
The intact container must not be autoclaved. A bag enclosed in an overpack must
be chosen when external sterility is required.
Dosage

Adults and children over 12 years of age

The following table is a guide to the recommended doses for the most common types of block. The minimum dose required to achieve an effective block should be used. The clinician’s experience and knowledge of the patient’s physical condition are important in deciding the dose.

Onset
ConcentrationVolumeDoseDuration of
action
mg/mlmlmghours
minutes
Lumbar epidural administration
Bolus 2.0 10-20 20-40 10-15 0.5-1.5
10-15
Intermittent injections (top-up) (interval
(e.g. labour and delivery analgesia)
2.0 20-30
minimum
30 min.)
Continuous infusion e.g.:

• labour and delivery analgesia 2.0 6-10 ml/h 12-20 mg/h n/a n/a
• postoperative pain control 2.0 6-14 ml/h 12-28 mg/h n/a n/a Thoracic epidural administrationContinuous infusion (postoperative pain control) 2.0 6-14 ml/h 12-28 mg/h n/a n/a Regional block(e.g. minor nerve blocks and infiltration )2.0 1-100 2.0-200 1-5 2-6 Peripheral nerve block(femoral or interscalene block) Continuous infusion or intermittent injections (e.g. postoperative pain treatment) 2.0 5-10 ml/h 10-20 mg/h n/a n/a

Method of administration
Perineural and epidural administration for infusion.
Careful aspiration is recommended before and during administration to prevent
intravascular administration.
When a larger dose is to be injected, a test dose of 3-5 ml of lidocaine
with adrenaline (epinephrine) 1:200,000 is recommended. Accidental intravascular infusion may
be recognised by a temporary increase in heart rate and accidental intrathecal injection by symptoms of spinal block.
Aspiration should be performed before and during the administration of the main dose, which should be
injected slowly or in increasing doses, at a rate of 25-50 mg/min, while carefully observing
the patient's vital functions and maintaining verbal contact. If symptoms of toxicity occur, the
infusion must be stopped immediately.
When performing prolonged blocks, either by continuous infusion or by repeated bolus
administration, the possible risk of reaching toxic plasma concentrations or of
inducing local neuronal damage must be considered. Cumulative doses of up to 675 mg of ropivacaine hydrochloride
administered over 24 hours for surgical anaesthesia and postoperative analgesia have been
well tolerated in adults, as have continuous epidural infusions of up to 28 mg/h for 72 hours in the postoperative period. In a limited number of patients, higher doses of up to 800 mg/day have been administered
with a relatively low number of adverse reactions.
For postoperative pain treatment, the following technique is recommended: unless already
induced before the operation, an epidural block is performed with Ropivacaine Kabi 7.5 mg/ml
administered via an epidural catheter. Analgesia is then maintained with an infusion of
Ropivacaine Kabi 2 mg/ml. In most cases of moderate to severe postoperative pain, an infusion rate of 6 - 14 ml (12 - 28 mg) per hour maintains adequate analgesia, with only mild and non-progressive motor block. The maximum duration of the epidural block is 3 days. In any case,
careful monitoring of the analgesic effect must be carried out in order to remove the catheter as soon as the intensity of the pain allows. 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 has been administered for a maximum period of 72 hours, alone or mixed with fentanyl 1-4 μg/ml, for the control of postoperative pain. The combination of ropivacaine hydrochloride with fentanyl may provide additional pain control, but may cause side effects due to the administration of the opioid. The combination
of ropivacaine hydrochloride and fentanyl has only been studied with ropivacaine hydrochloride 2 mg/ml.
When performing prolonged peripheral nerve blocks, either through continuous infusion or through
repeated injections, the risks of reaching a toxic plasma concentration or of
causing local neuronal damage must be assessed. In clinical studies performed, the femoral nerve block was
obtained with 300 mg of ropivacaine hydrochloride 7.5 mg/ml and the interscalene block with 225 mg of
ropivacaine hydrochloride 7.5 mg/ml, respectively, before the surgical operation. 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.

Renal impairment
Normally there is no need to adjust the dose in patients with impaired renal
function when used in 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 hepatic impairment. Repeated doses should be reduced due to delayed elimination.

Paediatric patients aged 0 to 12 years inclusive
Dose
mg/kg
Single lumbar caudal epidural block
Blocks below level T12,
in children with body weight up
to 25 kg

ConcentrationVolume
mg/mlml/kg
2.0 1 2

Continuous epidural infusion
in children with body weight up to 25 kg

From 0 to 6 months
Bolus dose 2.0 0.5-1 1-2
Infusion up to 72 hours 2.0
0.1
ml/kg/h
0.2 mg/kg/h

From 6 to 12 months
Bolus dose 2.0 0.5-1 1-2
Infusion up to 72 hours 2.0 0.2 0.4 mg/kg/h
ml/kg/h

From 1 to 12 years
Bolus dose 2.0 1 2
Infusion up to 72 hours 2.0
0.2
ml/kg/h
0.4 mg/kg/h

Infants and children from 1 to 12 years of age:
The doses of ropivacaine proposed for peripheral block in infants and children are a guide for use
in children without serious illnesses. More cautious doses and careful monitoring are recommended for
children with serious illnesses.
Single injections for peripheral nerve block should not exceed 2.5-3.0 mg/kg (e.g. ilioinguinal nerve block, brachial plexus block).
Continuous infusion is recommended for peripheral nerve block at 0.2-0.6 mg/kg/h (0.1-0.3 ml/kg/h)
for up to 72 hours.
The use of ropivacaine in premature infants has not been documented.
Method of administration
Epidural administration for infusion.
To avoid intravascular administration, careful aspiration is recommended before and during
infusion. The patient's vital parameters must be closely monitored during
infusion. If signs of toxicity occur, administration must be stopped immediately.
In the majority of patients, a single caudal epidural injection of ropivacaine hydrochloride 2 mg/ml at
below level T12 produces adequate postoperative analgesia when a dose of 2
mg/kg in a volume of 1 ml/kg is used. The volume of the caudal epidural injection can be adjusted to
achieve a different distribution of sensory block, as indicated in reference texts. In
children over 4 years of age, doses of up to 3 mg/kg at a concentration of
ropivacaine hydrochloride of 3 mg/ml have been evaluated. As a result, a high
incidence of motor block has been associated with this concentration.
Gradual administration of the calculated dose of local anaesthetic is recommended, regardless of
the route of administration.
In cases where the injection of ropivacaine hydrochloride is recommended, Ropivacaine Kabi injectable solution
can be used.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other
medicinal products.
Precipitation may occur in alkaline solutions as ropivacaine hydrochloride has poor solubility at
pH > 6.0.
Ropivacaine solution for infusion in plastic infusion bags is chemically and physically
compatible with the following drugs:

Ropivacaine Kabi concentration: 1-2 mg/ml
AdditivesConcentration*
Fentanyl citrate 1.0 – 10.0 µg/ml
Sufentanil citrate 0.4 – 4.0 µg/ml
Morphine sulfate 20.0 – 100.0 µg/ml
Clonidine hydrochloride 5.0 – 50 µg/ml
The mixtures are chemically and physically stable for 30 days between 20° and 30°C. From a microbiological point of view, the mixtures must be used immediately. If not used immediately, the storage conditions and times before use are the responsibility of the user and normally must not exceed
24 hours between 2 and 8°C.
Disposal
Unused medicinal product and waste derived from such medicinal product must be disposed of in
accordance with local regulations.

Ropivacaina Kabi 2 mg/ml injectable solution, 7.5 mg/ml injectable solution, 10 mg/ml injectable solution

Generic medicine

Read this leaflet carefully before you use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, nurse or other healthcare professional.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist, nurse or other healthcare professional.

Contents of this leaflet:

• 7. What is Ropivacaina Kabi and what it is used for
• 8. What you need to know before you are given Ropivacaina Kabi
• 9. How to administer Ropivacaina Kabi
• 10. Possible side effects
• 11. How to store Ropivacaina Kabi
• 12. Contents of the pack and other information

2. What is Ropivacaina Kabi and what is it used for

Ropivacaina Kabi contains the active ingredient ropivacaine hydrochloride which is a type of medicine called
a local anesthetic. These are the chemicals used to numb an area of the body.
Ropivacaina Kabi 2 mg/ml injectable solution is used:
In adults and children of all ages for the treatment of acute pain. It makes parts of the body insensitive (anesthetizes)
e.g. following a surgical intervention.
Ropivacaina Kabi 7.5 mg/ml and 10 mg/ml injectable solution is used:
In adults and children over 12 years of age to make specific parts of the
body insensitive (anesthetize). It is used to block pain as it occurs or to relieve pain. It can be used for:

• numbing parts of the body during a surgical intervention, including cesarean section
• relieving pain during labor, following a surgical intervention or after an accident

4. What you need to know before you take Ropivacaina Kabi

Do not receive Ropivacaina Kabi

• if you are allergicto ropivacaine hydrochloride, other so-called local amide-type anesthetics or to any of the other ingredients of this medicine (listed in section 6),
• if you have a decrease in blood volume(hypovolemia). This is assessed by medical personnel,
• for infusion into a blood vesselto anesthetize a specific area of your body,
• for injecting it into the cervixto relieve labor pain.

Warnings and precautions
Children
Ropivacaina Kabi 2 mg/ml injectable solution

• In newborn babies as they are more sensitive to Ropivacaina Kabi 2 mg/ml injectable solution.
• In children under 12 years of age as some injections of Ropivacaina Kabi 2 mg/ml injectable solution for anesthetizing parts of the body have not been tested in younger children.

Ropivacaina Kabi 7.5 mg/ml and 10 mg/ml injectable solution
In children up to and including 12 years of age. Other dosages (2 mg/ml, 5 mg/ml) may be more appropriate.
Particular attention must be paid to avoid any injectionof Ropivacaina Kabi directly
into the blood vesselto prevent any immediate toxic effect. Administration must not be
done in inflamed areas.
Consult your doctor, pharmacist, nurse or other healthcare professional before taking Ropivacaina
Kabi if:- you are in a generally poor state of healthdue to your age or other factors,

• if you have heart problems(partial or complete block of cardiac conduction),
• if you have severe liver problems,
• if you have severe kidney problems.

Inform your doctor if you have any of these problems because your doctor may need to adjust
the dose of Ropivacaina Kabi.
Consult your doctor, pharmacist, nurse or other healthcare professional before taking Ropivacaina
Kabi:

• if you suffer from acute porphyria(problems with the production of red blood pigment, which sometimes leads to neurological symptoms).

Inform your doctor if you or someone in your family suffers from porphyria because the doctor may need to use other anesthetics.

Other medicines and Ropivacaina Kabi
Tell your doctor, pharmacist or healthcare professional if you are taking, have recently taken or
may take any other medicines.
Caution should be exercised if you are taking:

• Other local anesthetics(e.g. lidocaine) or agents structurally related to amide local anesthetics, e.g. some drugs used to treat irregular heartbeat (arrhythmia), such as mexiletine or amiodarone
• General anestheticsor opioids, such as morphine or codeine
• Medicines used to treat depression(e.g. fluvoxamine)
• Some antibiotics(e.g. enoxacin)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether ropivacaine hydrochloride has effects on pregnancy or passes into breast milk.

Driving and using machines
Ropivacaina Kabi can make you feel sleepy and have consequences on your reaction speed. After
administration of Ropivacaina Kabi, do not drive vehicles or use machines until the next day.
Ask your doctor or pharmacist if you have any doubts.

Ropivacaina Kabi contains sodium chloride
This medicinal product contains a maximum of 0.148 mmol (or 3.4 mg) of sodium per ml. This must be
taken into consideration by patients on a sodium-controlled diet.

5. How to take Ropivacaina Kabi

Dosage
The dose used will depend on the reason why it is being used and also on your health, age and weight.
The minimum dose that can induce an anesthetic (anesthesia) effect in the area of
interest should be used.
The usual dose

• for adultsand adolescents over 12 years of ageis between 2 mg and 300 mgof ropivacaine hydrochloride,
• in newborns and children (from 0 to 12 years inclusive) is 1-2mgper kilogram of body weight.

Method of administration
The doctor will administer Ropivacaina Kabi to you. It is administered by injection.

Duration of treatment
The administration of ropivacaine hydrochloride generally requires from 2 to 10 hoursin case of

anesthesiabefore some operations and may require up to 72 hoursin case of pain reliefduring or
after surgery.

If you are given more Ropivacaina Kabi than you should
The first symptoms of having received an excessive amount of ropivacaine hydrochloride are generally
problems with

• hearing and vision,
• numbness around the mouth,
• dizziness or lightheadedness,
• tingling,
• speech disorder characterized by poor pronunciation (dysarthria),
• muscle stiffness, muscle spasm, seizures,
• low blood pressure,
• slow or irregular heartbeat. These symptoms may precede cardiac arrest, respiratory arrest or severe crises. If you have experienced any of these symptoms or think you have received an excessive amount of Ropivacaina Kabi,inform your doctor and healthcare professionals immediately.

In case of acute toxicity, corrective actions will be taken immediately by healthcare professionals.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist, nurse or other
healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Serious side effects that require medical attention:
Sudden life-threatening allergic reactions(such as anaphylaxis, angioedema and
urticaria) are rare. Possible symptoms include:

• sudden onset of skin 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 Ropivacaina Kabi is causing you an allergic reaction, tell your doctor or
healthcare professional immediately.
Other possible side effects:
Very common (may affect more than 1 in 10 people)

• Low blood pressure (hypotension). This may make you feel dizzy or lightheaded
• Feeling sick (nausea)

Common (may affect up to 1 in 10 people)

• Headache, tingling (paresthesia), feeling of dizziness
• Slow or fast heartbeat (bradycardia, tachycardia)
• High blood pressure (hypertension)
• Feeling sick (vomiting)
• Difficulty urinating (urinary retention)
• Back pain, high temperature, muscle stiffness (rigor)

Uncommon (may affect up to 1 in 100 people)

• Anxiety
• Some symptoms may occur if the injection is given into a blood vessel by mistake, or if you have been given too much Ropivacaina Kabi (see also paragraph 3 “If you use more Ropivacaina Kabi than you should” above). These include convulsions (seizures, fits), feeling dizzy or lightheaded, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems (vision), speech problems (dysarthria), muscle spasm and tremor, reduced sense of touch (hypoesthesia)
• Fainting (syncope)
• Difficulty breathing (dyspnea)
• Low body temperature

Rare (may affect up to 1 in 1000 people)

• Cardiac arrest, irregular heartbeat (cardiac arrhythmias)

Possible side effects observed with other local anesthetics that may also be caused by
Ropivacaina Kabiinclude:

• Numbness, due to irritation of the nerve caused by the needle or the injection. This usually does not last long.
• Nerve damage. Rarely, this can cause permanent problems.
• If too much Ropivacaina Kabi is given into the spinal fluid, the whole body may become numb (anesthetized).

Children
In children, the side effects are the same as those in adults except that low blood pressure
occurs less often in children (affecting less than 1 in 10 children) and nausea
occurs more often in children (affecting more than 1 in 10 children).
If any side effects occur, even those not listed in this leaflet, please tell your
doctor, pharmacist, nurse or other healthcare professional.

5. How to store Ropivacaina Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, vial or carton. The expiry date refers to the last day of the month.
Do not refrigerate or freeze.
Do not use this medicine if you notice any precipitate in the injectable solution.
The doctor or hospital will normally store Ropivacaina Kabi and are responsible for the quality of the
product when it has been opened if not used immediately. They are also responsible for the
correct disposal of unused Ropivacaina Kabi.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ropivacaine Kabi contains

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

Description of the appearance of Ropivacaine Kabi and contents of the pack
Ropivacaine Kabi injectable solution is a clear and colourless solution.
Ropivacaine Kabi 2 mg/ml, 7.5 mg/ml, 10 mg/ml injectable solution is available in transparent polypropylene
vials of 10 ml and 20 ml.
Packs:
1, 5, 10 vial(s) in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona
Manufacturer:
Fresenius Kabi Norge AS
Address: Svinesundsveien 80, NO 1788 Halden, Norway
This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Ropivacaine Kabi 2 mg/ml injectable solution

Ropivacaine Kabi 7.5 mg/ml injectable solution

Ropivacaine Kabi 10 mg/ml injectable solution

----------------------------------------------------------------------------------------------------------------------------- ------
The following information is intended for healthcare professionals only:
Handling
Ropivacaine Kabi must only be used by or under the supervision of clinicians experienced in local anaesthesia
(see section 3).
Shelf life
Shelf life before opening
3 years
Shelf life after opening
From a microbiological point of view, the product must be used immediately. If not used immediately, the
storage times and conditions before use are the responsibility of the person administering the product and
should normally not exceed 24 hours at 2 to 8°C.
Ropivacaine Kabi products are without preservatives and for single use only. Discard any unused solution
remaining.
The medicinal product must be visually inspected before use. The solution must only be used if it is clear,
practically free from particles and if the container is not damaged.
The intact container must not be autoclaved.
Dosage

Ropivacaine 2 mg/ml injectable solution
Adults and children over 12 years of age
The following table is a guide to the recommended doses for the most common types of block. The minimum dose
required to achieve an effective block should be used. The clinician’s experience and knowledge of the
patient’s physical state are important in deciding the dose.

ConcentrationVolumeDoseOnsetDuration
mg/mlinin hours
minutes
mlmg
Epidural
Lumbar
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 of 30
20-30
minutes)
Continuous infusion (e.g.
labour pain)
2.0 6-10 ml/hour 12-20
mg/hour
n/a n/a
2.0 6-14 ml/hour 12-28
mg/hour
Postoperative pain n/a n/a
control

Epidural
Thoracic
Continuous infusion
(postoperative pain
management)
2.0 6-14 ml/hour 12-28
mg/hour
n/a n/a

Regional block
(e.g. minor nerve block and
infiltration)
2.0 1-100 2.0-200 1-5 2-6

Peripheral nerve block
(Femoral or
interscalene block)
2.0 5-10 ml/hour 10-20
mg/hour
Continuous infusion or intermittent injections n/a n/a
(e.g. postoperative pain
management)
n/a= not applicable
Route of administration
Perineural and epidural administration by injection.
Careful aspiration before and during administration is recommended to prevent intravascular
administration.
When a larger dose is to be injected, a test dose of 3-5 ml of lidocaine 2% with adrenaline (epinephrine) 1:200,000 is recommended. Intravascular injection may be recognised by a temporary increase in heart rate and accidental intrathecal injection by symptoms of spinal block.
Aspiration should be performed before and during the administration of the main dose, which should be
injected slowly or in increasing doses, at a rate of 25-50 mg/min, while carefully monitoring the patient’s
vital functions and maintaining verbal contact. If symptoms of toxicity occur, the injection should be stopped
immediately.
In epidural block for surgical intervention, single doses of up to 250 mg of ropivacaine hydrochloride 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 has been well tolerated.
When performing prolonged blocks, either by continuous epidural infusion or by repeated bolus injections, the
possible risk of reaching toxic plasma concentrations or of inducing local neuronal damage must be considered. Cumulative doses of up to 675 mg of
ropivacaine hydrochloride administered over 24 hours for surgical anaesthesia and postoperative analgesia have been well tolerated in adults, as have continuous epidural infusions of up to 28 mg/h
for 72 hours in the postoperative period. In a limited number of patients, higher doses of up to 800 mg/day have been administered with a relatively low number of adverse reactions.
For the treatment of postoperative pain, the following technique is recommended: unless already induced before surgery, an epidural block is performed with Ropivacaine Kabi 7.5 mg/ml
administered via an epidural catheter. Analgesia is then maintained with an infusion of
Ropivacaine Kabi 2 mg/ml. In most cases of moderate to severe postoperative pain, an infusion at a rate of 6-14 ml (12-28 mg) per hour maintains adequate analgesia, with only mild and non-progressive motor block. The maximum duration of the epidural block is 3 days. In any case,
careful monitoring of the analgesic effect must be carried out to remove the catheter as soon as the intensity of the pain allows. 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 has been administered for a maximum period of 72 hours, alone or mixed with fentanyl 1-4 μg/ml, for the control of postoperative pain. The combination of ropivacaine hydrochloride with fentanyl may provide additional pain relief, but may cause side effects due to the administration of the opioid. The combination
of ropivacaine hydrochloride and fentanyl has only been studied for ropivacaine hydrochloride 2 mg/ml.
When performing prolonged blocks of peripheral nerves, either through continuous infusion or through
repeated injections, the risks of reaching a toxic plasma concentration or of
causing local neuronal damage must be assessed. In clinical studies conducted, the femoral nerve block was
obtained with 300 mg of ropivacaine hydrochloride 7.5 mg/ml and the interscalene block with 225 mg of
ropivacaine hydrochloride 7.5 mg/ml, respectively, before surgical intervention. Analgesia was then
maintained with ropivacaine hydrochloride 2 mg/ml. Infusion rates or intermittent injections of 10-
20 mg every hour for 48 hours provided adequate analgesia and were well tolerated.
In caesarean section, the use of ropivacaine hydrochloride at concentrations higher than 7.5
mg/ml is not documented.

Renal impairment
It is not normally necessary to modify the dose in patients with renal impairment when used for a single or short-term treatment.

Hepatic impairment
Ropivacaine hydrochloride is metabolised in the liver and should therefore be used with caution in
patients with severe hepatic impairment. Repeated doses may need to be reduced due to
delayed elimination.

Pediatric patients from 0 up to and including 12 years of age

The dose indicated in the table should be considered as a guide for use in pediatrics. Individual variations may be necessary. In pediatric patients with high body weight, a gradual reduction of the dosage is often necessary, which should be based on ideal weight. The volume per single caudal epidural block and the volume for epidural bolus doses should not exceed 25 ml per patient. Reference texts should be consulted both regarding aspects that affect specific blocking techniques and regarding individual patient needs.
Within the dose range reported, lower doses are recommended for thoracic epidural blocks, while higher doses are recommended for lumbar or caudal epidural blocks.
Recommended for lumbar epidural blocks. It is good practice to reduce the bolus dose for thoracic epidural analgesia.

Infants and children from 1 to 12 years of age
The doses of ropivacaine proposed for peripheral block in infants and children are a guide for use in children without serious pathologies. Lower doses and careful monitoring are recommended for children with serious pathologies.
Single injections for peripheral nerve block should not exceed 2.5-3.0 mg/kg (e.g., ilioinguinal nerve block, brachial plexus block).
Continuous infusion is recommended for peripheral nerve block at 0.2-0.6 mg/kg/h (0.1-0.3 ml/kg/h) for up to 72 hours.
The use of ropivacaine in premature infants has not been documented.
Method of administration
Epidural administration by injection.
To avoid intravascular injection, careful aspiration is recommended before and during the injection. The patient's vital parameters must be kept under close observation during the injection. If signs of toxicity appear, administration must be immediately stopped.
In the majority of patients, a single caudal epidural injection of ropivacaine 2 mg/ml below the T12 level produces adequate postoperative analgesia when a dose of 2 mg/kg is used in a volume of 1 ml/kg. The volume of the caudal epidural injection can be adjusted to achieve a

different distribution of sensory block, as indicated in reference texts. In children over 4 years of age, doses up to 3 mg/kg have been evaluated for a ropivacaine hydrochloride concentration of 3 mg/ml. As a consequence, a high incidence of motor block was associated with this concentration.
Gradual administration of the calculated dose of local anesthetic is recommended, regardless of the route of administration.
In cases where the infusion of ropivacaine hydrochloride Ropivacaina Kabi infusion solution is recommended, it can be used.

Ropivacaina Kabi 7.5 mg/ml and Ropivacaina Kabi 10 mg/ml injectable solution
Adults and children over 12 years of age
The following table is a guide to the recommended dosages in the most common types of block. The dose to be used should be the lowest required to achieve an effective block. The dose to be administered should also be chosen based on the physician's experience and knowledge of the patient's clinical condition.

Concentration

mg/ml

Volume ml

DoseOnsetDuration

hours

SURGICAL ANESTHESIA
Lumbar epidural administration

mgminutes
7.5 15-25
113-
188
10-20 3-5
Surgery
10.0 15-20
150-
200
10-20 4-6
Cesarean section 7.5 15-20
113-
150
10-20 3-5

Thoracic epidural administration
To determine the block for
postoperative pain control
5-15
(dependent on
injection level)
38-
113
7.5 10-20 n/a

Major nerve block*
Brachial plexus block 7.5 30-40
225-
300
10-25 6-10

Regional block(e.g.: minor nerve
block and infiltration)
7.5 1-30
7.5-
225
1-15 2-6
* With reference to major nerve block, a dose is only recommended for brachial plexus block. For other types of major nerve block, lower doses may be required. However, at present, there is no experience of specific recommended doses for other types of block.
increasing doses can be administered starting from a dose of about 100 mg (97.5 mg = 13 ml; 105 mg = 14 ml) over 3-5 minutes. If necessary, two further doses up to a maximum of 50 mg can be used.
n/a = not applicable.
The dose for major nerve block should be adjusted according to the site of administration and the patient's conditions.
Interscalene and supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used.
Method of administration
Perineural and epidural administration by injection.
Careful aspiration is recommended before and during administration to prevent intravascular administration.
When a larger dose is to be injected, a test dose of 3-5 ml of lidocaine 2% with epinephrine 1:200,000 is recommended. Unintentional intravascular injection can be recognized by a temporary increase in heart rate and unintentional intrathecal injection by symptoms of spinal block.
Aspiration should be performed before and during the administration of the main dose, which should be injected slowly or in increasing doses, at a rate of 25-50 mg/min, while carefully observing the patient's vital functions and maintaining verbal contact. If symptoms of toxicity appear, the injection must be stopped immediately.
In epidural block for surgical intervention, single doses of up to 250 mg of ropivacaine hydrochloride 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 has been well tolerated.
When performing prolonged blocks, either by continuous epidural infusion or by repeated bolus administration, the possible risk of reaching toxic plasma concentrations or inducing local neuronal damage must be considered. Cumulative doses of up to 675 mg of ropivacaine hydrochloride administered over 24 hours for surgical anesthesia and postoperative analgesia have been well tolerated in adults, as have continuous epidural infusions of up to 28 mg/h for 72 hours in the postoperative period. In a limited number of patients, higher doses of up to 800 mg/day have been administered with a relatively low number of adverse reactions.
For the treatment of postoperative pain, the following technique is recommended: unless already induced before the intervention, an epidural block is performed with Ropivacaina Kabi 7.5 mg/ml administered via an epidural catheter. Analgesia is then maintained with an infusion of Ropivacaina Kabi 2 mg/ml. In most cases of moderate to severe postoperative pain, infusion at a rate of 6-14 ml (12-28 mg) per hour maintains adequate analgesia, with only mild and non-progressive motor block. The maximum duration of the epidural block is 3 days. In any case, careful monitoring of the analgesic effect must be carried out in order to remove the catheter as soon as the intensity of the pain allows. With this technique, a significant reduction in the need to use 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 administered for a maximum period of 72 hours for postoperative pain control. The association of ropivacaine hydrochloride with fentanyl may provide additional pain control, but may cause side effects due to the administration of the opioid. The association of ropivacaine hydrochloride and fentanyl has only been studied for ropivacaine hydrochloride 2 mg/ml.
When performing prolonged peripheral nerve blocks, either through continuous infusion or through repeated injections, the risks of reaching a toxic plasma concentration or causing local neuronal damage must be assessed. In clinical studies conducted, femoral nerve block was obtained with 300 mg of ropivacaine hydrochloride 7.5 mg/ml and interscalene block with 225 mg of ropivacaine hydrochloride 7.5 mg/ml, respectively, before surgical intervention. Analgesia was then maintained with ropivacaine hydrochloride 2 mg/ml. Infusion rates or intermittent injections of 10-20 mg every hour for 48 hours provided adequate analgesia and were well tolerated.
In cesarean section, the use of ropivacaine hydrochloride at concentrations higher than 7.5 mg/ml has not been documented.

Renal insufficiency
It is normally not necessary to modify the dose in patients with renal insufficiency when used for a single or short-term treatment.

Hepatic insufficiency
Ropivacaine hydrochloride is metabolized in the liver and should therefore be used with caution in patients with severe hepatic impairment. Repeated doses may need to be reduced due to delayed elimination.

Pediatric population up to and including 12 years of age
The use of Ropivacaina Kabi 7.5 and 10 mg/ml in children may be associated with systemic and central toxic events. Lower dosages (2 mg/ml, 5 mg/ml) are more appropriate for administration in this population of patients.
In general, surgical anesthesia (e.g. for epidural administration) requires the use of higher concentrations and dosages. The use of Ropivacaina Kabi 10 mg/ml is recommended for epidural anesthesias in surgical interventions where complete motor block is required. Lower concentrations and dosages are recommended for analgesia (e.g. for epidural administration for the treatment of acute pain).
Incompatibilities
In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
Precipitation may occur in alkaline solutions as ropivacaine has poor solubility at pH > 6.0.
Disposal
Unused medicinal product and waste derived from such medicinal product must be disposed of in accordance with local regulations.

Ropivacaina Kabi 5 mg/ml injectable solution

Generic medicine

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, nurse or other healthcare professional.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, nurse or other healthcare professional.

Contents of this leaflet:

• 13. What is Ropivacaina Kabi and what it is used for
• 14. What you need to know before you are given Ropivacaina Kabi
• 15. How to use Ropivacaina Kabi
• 16. Possible side effects
• 17. How to store Ropivacaina Kabi
• 18. Contents of the pack and other information

1. What is Ropivacaina Kabi and what is it used for

Ropivacaina Kabi contains the active ingredient ropivacaine hydrochloride which is a type of medicine called a
local anesthetic. These are the chemicals used to anesthetize an area of the body.
Ropivacaina Kabi is used to numb(anesthetize) specific parts of the bodyand to block pain during surgical operations.

2. What you need to know before you are given Ropivacaina Kabi

You must not be given Ropivacaina Kabi

• if you are allergicto ropivacaine hydrochloride, other anesthetics so-called locals of the amide type or to any of the other ingredients of this medicine (listed in section 6),
• if you have a decrease in blood volume(hypovolemia). This is assessed by medical personnel,
• to inject it into a blood vesselto anesthetize a specific area of your body,
• to inject it into the cervixto relieve the pain of childbirth.

Warnings and precautions
Particular attention must be paid to avoiding any injectionof Ropivacaina Kabi directly into the blood vesselto prevent any immediate toxic effect. The injection should not be
performed in inflamed areas.
Consult your doctor, pharmacist, nurse or other healthcare professional before taking Ropivacaina
Kabi if:

• you are in a generally poor state of healthdue to your age or other factors,
• you have heart problems(partial or complete blockage of cardiac conduction),
• you have severe liver problems,
• you have severe kidney problems.

Inform your doctor if you have any of these problems because the doctor may need to adjust the
dose of Ropivacaina Kabi.
An injection into the lower spinecan lead to low blood pressureor to

reduced heart rate. If necessary, the doctor will take appropriate measures.
Consult your doctor, pharmacist, nurse or other healthcare professional before taking Ropivacaina
Kabi:

• if you suffer from acute porphyria(problems with the production of red blood pigment, which sometimes leads to neurological symptoms). Inform your doctor if you or someone in your family suffers from porphyria because the doctor may need to use other anesthetics.

Other medicines and Ropivacaina Kabi
Tell your doctor, pharmacist or healthcare professional if you are taking, have recently taken or
may take any other medicines.
Caution should be taken if you are taking:

• other local anesthetics(e.g. lidocaine) or agents structurally related to amide local anesthetics, e.g. some drugs used to treat irregular heartbeat (arrhythmia), such as mexiletine or amiodarone
• general anestheticsor opioids, such as morphine or codeine
• medicines used to treat depression(e.g. fluvoxamine)
• some antibiotics(e.g. enoxacin)

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether ropivacaine hydrochloride has effects on pregnancy or passes into breast milk.

Paediatric patients
There is no experience regarding injection into the lower spine (intrathecal administration), neither in newborns, nor in children of 12 years or younger.

Driving and using machines
Ropivacaina Kabi can make you feel sleepy and affect your reaction time. After
administration of Ropivacaina Kabi, do not drive vehicles or use machinery until the next day.
Ask your doctor or pharmacist if you have any doubts.

Ropivacaina Kabi contains sodium chloride
This medicinal product contains 0.138 mmol (or 3.17 mg) of sodium per ml. This should be taken into
consideration by patients on a sodium-controlled diet.

3. How to take Ropivacaina Kabi

Dosage
The dose used will depend on the reason why it is being used and also on your health, age and weight.
The minimum dose that can induce the anesthetic (anesthesia) effect in the area of
interest must be used.
The usual dose

• for adults and adolescents over 12 years of ageis between 15 mg and 25 mg of ropivacaine hydrochloride.

Method of administration
The doctor will administer Ropivacaina Kabi to you. It is administered by injection.

Duration of treatment
The administration of ropivacaine hydrochloride generally takes from 2 to 6 hoursin case of
anesthesia before some surgical procedures.
It is administered by injection into the lower part of the spine (intrathecal administration).

If you are given more Ropivacaina Kabi than you should
The first symptoms of having received an excessive amount of ropivacaine hydrochloride are generally
problems with

• hearing and vision,
• numbness around the mouth,
• dizziness or lightheadedness,
• tingling,
• speech disorder characterized by poor pronunciation (dysarthria),
• muscle stiffness, muscle spasm, seizures,
• low blood pressure,
• slow or irregular heartbeat. These symptoms may precede cardiac arrest, respiratory arrest or severe crises. If you have experienced any of these symptoms or think you have received an excessive amount of Ropivacaina Kabi,inform your doctor or healthcare professional immediately.

In case of acute toxicity, appropriate corrective actions will be taken immediately by healthcare
personnel.
Due to the low dose administered during injection into the lower part of the spine
(intrathecal administration), undesirable effects affecting the whole body should generally not occur.
If you have any other questions about the use of this medicinal product, ask your doctor, pharmacist,
nurse or other healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects requiring attention:
Sudden allergic reactions that are life-threatening(such as anaphylaxis, angioedema and
urticaria) are rare. Possible symptoms include:

• sudden onset of skin rash,
• itching or lumpy rash (urticaria),
• swelling of the face, lips, tongue or other parts of the body
• shortness of breath, wheezing or difficulty breathing.

If you think Ropivacaina Kabi is causing an allergic reaction, tell your doctor or
healthcare professional immediately.
Other possible side effects:
Very common (may affect more than 1 in 10 people)

• Low blood pressure (hypotension). This may make you feel dizzy or lightheaded.
• Feeling sick (nausea)

Common (may affect up to 1 in 10 people)

• Headache, tingling (paraesthesia), feeling of dizziness
• Slow or fast heartbeat (bradycardia, tachycardia)
• High blood pressure (hypertension)
• Feeling sick (vomiting)
• Difficulty urinating (urinary retention)
• Back pain, high temperature, muscle stiffness (rigor)

Uncommon (may affect up to 1 in 100 people)

• Anxiety
• Some symptoms may occur if the injection is given into a blood vessel by mistake, or if you have been given too much Ropivacaina Kabi (see also “If you use more Ropivacaina Kabi than you should” above). These include convulsions (fits, seizures), feeling dizzy or lightheaded, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems (vision), speech problems (dysarthria), muscle spasm and tremor, reduced sense of touch (hypoaesthesia)
• Fainting (syncope)
• Difficulty breathing (dyspnoea)
• Low body temperature

Rare (may affect up to 1 in 1,000 people)

• Cardiac arrest, irregular heartbeat (cardiac arrhythmias)

Possible side effects observed with other local anaesthetics which may also be caused by
Ropivacaina Kabiinclude:

• Numbness, due to irritation of the nerve caused by the needle or injection. This usually does not last long.
• Nerve damage. Rarely, this can cause permanent problems.
• If too much Ropivacaina Kabi is given into the spinal fluid, your whole body may become numb (anaesthetized).

Adolescents
In adolescents, the side effects are the same as in adults except that low blood pressure occurs less often in adolescents (affects less than 1 in 10) and nausea occurs
more often in adolescents (affects more than 1 in 10). Ropivacaina Kabi should not
be used for an injection into the lower back in newborns and children under the
age of 12 years.
If any side effects occur, including those not listed in this leaflet, tell your
doctor, pharmacist, nurse or other healthcare professional.

5. How to store Ropivacaina Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial, blister or carton. The expiry date refers to the last day of the month.
Do not refrigerate or freeze.
Do not use this medicine if you notice any precipitate in the injectable solution.
The doctor or hospital will normally store Ropivacaina Kabi and are responsible for the quality of the
product when opened, if not used immediately. They are also responsible for the
correct disposal of unused Ropivacaina Kabi.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ropivacaina Kabi contains

• The active substance is ropivacaine hydrochloride 5 mg/ml. Each 10 ml polypropylene vial contains 50 mg of ropivacaine (as hydrochloride).
• The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Ropivacaina Kabi and contents of the pack
Ropivacaina Kabi injectable solution is a clear and colourless solution.
Ropivacaina Kabi 5 mg/ml injectable solution is available in transparent 10 ml polypropylene vials.
Packs:
1, 5, 10 vials in blisters
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona
Manufacturer:
Fresenius Kabi Norge AS
Svinesundsveien 80, NO 1788 Halden, Norway
This medicinal product is authorised in the Member States of the European Economic Area with the following denominations:
-----------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
Handling
Ropivacaina Kabi must be used only by or under the supervision of physicians experienced in local anaesthesia
(see section 3).
Shelf life
Shelf life before opening
3 years
Shelf life after opening
From a microbiological point of view, the product must be used immediately. If not used immediately, the time and conditions of storage before use are the responsibility of the person using the product and should normally not exceed 24 hours at 2 to 8°C.
Ropivacaina Kabi products are preservative-free and are intended for single use only.
Discard any unused solution.
This medicinal product must be visually inspected before use. The solution must
be used only if it is clear, practically free from particles and if the container is undamaged.
The intact container must not be autoclaved.
Dosage

Adults and adolescents (> 12 years of age)
The following table is a guide to doses for intrathecal block in adults. The lowest dose required to achieve an effective block should be used. The clinician’s experience and knowledge of the patient’s physical condition are important for establishing the dose.

The doses in the table are those considered necessary to produce an effective block and should be

considered as a guideline for use in adults. Individual variations may occur in

the onset of anaesthetic effect and duration. The numbers in the “Dose” column represent the

average dose range required. Reference texts should be consulted for both factors

relating to specific block techniques and individual patient needs.
Route of administration
Intrathecal administration for injection only.
Careful aspiration before and during injection is recommended to prevent intravascular injection.
An accidental intravascular injection can be recognised by a temporary increase in heart rate.
Aspiration should be performed before and during the administration of the main dose, which should be
injected slowly, at a rate of 25-50 mg/min, while carefully monitoring the
patient’s vital functions and maintaining verbal contact. If symptoms of toxicity occur, the injection should be stopped immediately.
Intrathecal injection should be performed after the subarachnoid space has been identified and cerebrospinal fluid is seen to emerge from the spinal needle or is aspirated.
Incompatibilities
In the absence of compatibility studies, this medicinal product should not be mixed with other
medicines.
Precipitation may occur in alkaline solutions as ropivacaine hydrochloride has poor solubility
at pH > 6.0.
Disposal
Unused medicinal product and waste materials derived from such medicinal product should be disposed of
in accordance with local regulations.