Package leaflet: Information for the user

Ropivacaine Kabi 2 mg/ml infusion solution

Equivalent medicinal product
Please 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:

What Ropivacaine Kabi is and what it is used for
What you need to know before using Ropivacaine Kabi
How to use Ropivacaine Kabi
Possible side effects
How to store Ropivacaine Kabi
Contents of the pack and other information

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

Ropivacaina Kabi contains the active substance ropivacaine hydrochloride, which is a type of medicine called a local anaesthetic. These are chemicals used to numb an area of the body. Ropivacaina Kabi 2 mg/ml solution for infusion is used in adults and children of all ages for the treatment of acute pain. It numbs (anaesthetizes) parts of the body, for example following surgical procedures.

2. What you need to know before taking Ropivacaine Kabi

Do not administer Ropivacaine Kabi to you if:

you are allergic to ropivacaine hydrochloride, to other so-called local anesthetics of the amide type, or to any of the other ingredients of this medicine (listed in section 6),
you have reduced blood volume (hypovolemia). This will be assessed by medical personnel,
for infusion into a blood vessel to anesthetize a specific area of your body,
for infusion into the cervix to relieve labor pain.

Warnings and precautions
Children

In newborns, because they are more sensitive to Ropivacaine Kabi 2 mg/ml solution for infusion.
In children under 12 years of age, because certain injections of Ropivacaine Kabi 2 mg/ml solution for infusion for regional anesthesia have not been established in younger children.

Special care must be taken to avoid any injection of Ropivacaine Kabi
directly into a blood vessel to prevent any immediate toxic effects. Administration
must not be performed in inflamed areas.
Talk to your doctor, pharmacist, nurse, or other healthcare professional before taking
Ropivacaine Kabi if:

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

Inform your doctor if you have any of these conditions, as the doctor may need to adjust the
dose of Ropivacaine Kabi.
Talk to your doctor, pharmacist, nurse, or other healthcare professional before being administered
Ropivacaine Kabi:

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

Other medicines and Ropivacaine Kabi
Inform your doctor, pharmacist, or healthcare professional if you are taking, have recently taken, or
might take any other medicine.
Use caution if you are taking:

Other local anesthetics (e.g., lidocaine) or structurally related agents to amide-type local anesthetics, e.g., certain medicines used to treat irregular heartbeat (arrhythmia), such as mexiletine or amiodarone,
General anesthetics or opioids, such as morphine or codeine,
Medicines used to treat depression (e.g., fluvoxamine),
Certain antibiotics (e.g., enoxacin).

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

Driving and using machines
Ropivacaine Kabi may cause drowsiness and affect your reaction speed. After receiving
Ropivacaine Kabi, you must not drive or operate machinery until the following day.
Consult your doctor or pharmacist if you have any doubts.

Ropivacaine 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 Ropivacaine Kabi

Dosage
The dose used will depend on the reason for its use, as well as your health, age, and weight.
The minimum dose required to achieve the desired anesthetic effect (anesthesia) in the target area should be used.
The usual dose is:

For adults and adolescents over 12 years of age, between 2 mg and 200 mg of ropivacaine hydrochloride.
For neonates and children (from 0 to 12 years inclusive), 1–2 mg per kilogram of body weight.

Method of administration
Your doctor will administer Ropivacaine Kabi. It is given by infusion.
Duration of treatment
Administration of ropivacaine hydrochloride generally lasts from 0.5 to 6 hours, but may last up to 72 hours when used for pain relief during or after surgical procedures.

If you are given more Ropivacaine Kabi than you should
The first symptoms of an overdose of ropivacaine hydrochloride are usually:

Hearing and vision disturbances,
Numbness around the mouth,
Dizziness or lightheadedness,
Tingling sensations (paresthesia),
Speech disturbances characterized by poor articulation (dysarthria),
Muscle stiffness, muscle spasms, seizures (convulsions),
Low blood pressure,
Slow or irregular heartbeat.
These symptoms may precede cardiac arrest, respiratory arrest, or severe seizures. If you experience any of these symptoms or think you have been given too much Ropivacaine Kabi, inform your doctor or healthcare professional immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Serious side effects to be aware of:
Sudden, life-threatening allergic reactions (such as anaphylaxis, angioneurotic edema, 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,
difficulty breathing, breathlessness or trouble breathing.

If you think Ropivacaine Kabi is causing you an allergic reaction, inform 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), dizziness
slow or fast heartbeat (bradycardia, tachycardia)
high blood pressure (hypertension)
feeling sick (vomiting)
difficulty passing urine (urinary retention)
back pain, increased body temperature, muscle stiffness (rigor)

Uncommon (may affect up to 1 in 100 people)

anxiety
certain symptoms may occur if the infusion is accidentally administered into a blood vessel, or if you have been given an excessive dose of Ropivacaine Kabi (see also section 3 “If you take more Ropivacaine Kabi than you should” above). These include seizures (convulsions, fits), dizziness or lightheadedness, numbness of the lips and around the mouth, numbness of the tongue, hearing disturbances, vision problems, speech difficulties (dysarthria), muscle twitching and tremor, reduced sense of touch (hypoesthesia)
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 that may also be caused by Ropivacaine Kabi include:

numbness, due to nerve irritation caused by the needle or injection. This is usually temporary.
nerve damage. Rarely, this may lead to permanent problems.
if an excessive amount of Ropivacaine Kabi is administered into the spinal fluid, numbness (anaesthesia) may spread to the entire body.

Children
In children, the side effects are the same as in adults, except that low blood pressure occurs less frequently in children (affects fewer than 1 in 10 children), while nausea occurs more frequently in children (affects more than 1 in 10 children).
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, nurse, or other healthcare professional.

5. How to store Ropivacaine 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 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 Ropivacaine Kabi and is responsible for the quality of the product once it has been opened if not used immediately. They are also responsible for the proper disposal of unused Ropivacaine Kabi.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components 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 the contents of the pack
Ropivacaine Kabi infusion solution is a clear, colourless solution.
Ropivacaine Kabi 2 mg/ml infusion solution is available in transparent plastic bags of 100 ml and 200 ml.
Pack sizes:
1 bag with overpouch
5 bags with overpouch
10 bags with overpouch
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, Italy

Manufacturer:
Fresenius Kabi Norge AS
Svinesundsveien 80, NO-1788 Halden, Norway

This medicinal product is authorised in the European Economic Area Member States under the following name:
Ropivacaine Kabi 2 mg/ml infusion solution

Member State	Medicinal product name
Netherlands	Ropivacaine HCl Fresenius Kabi 2 mg/ml solution for infusion
Belgium	Ropivacaine Fresenius Kabi 2 mg/ml solution for infusion
Member State	Medicinal product name
Cyprus	Ropivacaine/Kabi 2mg solution for injection
Germany	Ropivacaine hydrochloride Kabi 2 mg/ml injection solution
Denmark	Ropivacaine Fresenius Kabi, infusion solution, solution, 2 mg/ml
Greece	Ropivacaine/Kabi 2mg solution for injection
Spain	Ropivacaine Kabi 2 mg/ml solution for perfusion
Finland	Ropivacaine Fresenius Kabi 2 mg/ml infusion solution, solution
France	Ropivacaine Kabi 2 mg/ml solution for perfusion in bag
Italy	Ropivacaine Kabi 2 mg/ml solution for infusion
Luxembourg	Ropivacaine hydrochloride Kabi 2 mg/ml infusion solution
Norway	Ropivacaine Fresenius Kabi 2 mg/ml, infusion solution, solution
Portugal	Ropivacaine Kabi 2 mg/mL solution for perfusion
Slovenia	Ropivacaine chloride Kabi 2 mg/ml solution for infusion
Sweden	Ropivacaine Fresenius Kabi 2 mg/ml, infusion fluid, solution
United Kingdom	Ropivacaine 2 mg/ml solution for infusion

Date of determination.

The following information is intended exclusively for healthcare professionals:

Handling
Ropivacaine Kabi must be used only 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 standpoint, the product should be used immediately. If not, the conditions and duration of storage prior to use are the responsibility of the user; however, storage must not exceed 24 hours at a temperature between 2 and 8°C.

Ropivacaine Kabi products are preservative-free and are intended for single use only. Any unused solution should be discarded.

The medicinal product must be visually inspected before use. The solution should only be used if it is clear, practically free of particles, and if the container is undamaged.

The intact container must not be re-sterilized in an autoclave. A bag enclosed in an overpouch should be selected when an externally sterile condition is required.

Dosage
Adults and children over 12 years of age

The following table provides a guide to recommended doses for the most common types of block. The lowest effective dose required to achieve adequate block should always be used. Clinical experience and knowledge of the patient's physical condition are important in determining the appropriate dose.

| Onset | Concentration | Volume | Dose | Duration | Activity |
|-----------|-------------------|----------|--------|------------|-------------|
| minutes | mg/ml | ml | mg | hours | |

Lumbar epidural administration

Bolus
2.0 10–20 20–40 10–15 0.5–1.5
Intermittent injections (top-up) (minimum interval 30 min)
2.0 20–30

e.g., labour and delivery analgesia
Continuous infusion, e.g.:
- Labour and delivery analgesia: 2.0 6–10 ml/h n/a n/a mg/h 12–28
- Postoperative pain management: 2.0 6–14 ml/h n/a n/a mg/h

Thoracic epidural administration

Continuous infusion (postoperative pain management): 2.0 6–14 ml/h n/a n/a mg/h 12–28

Regional block

(e.g., minor nerve blocks and infiltration): 2.0 1–100 2.0–200 1–5 2–6

Peripheral nerve block (e.g., femoral or interscalene block)

Continuous infusion or intermittent injections (e.g., postoperative pain treatment): 2.0 5–10 ml/h n/a n/a mg/h 10–20

Method of administration
Perineural and epidural administration via infusion.

Careful aspiration before and during administration is recommended to avoid intravascular injection.

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 recognized by a transient increase in heart rate, while accidental intrathecal injection may be indicated by signs of spinal block.

Aspiration should be performed before and during administration of the main dose, which should be injected slowly or in incremental doses at a rate of 25–50 mg/min, with close monitoring of vital functions and maintenance of verbal contact with the patient. If signs of toxicity occur, the infusion must be immediately discontinued.

When performing prolonged blocks, either via continuous infusion or repeated bolus injections, the potential risk of achieving toxic plasma concentrations or causing local neurotoxicity should be considered. Cumulative doses of up to 675 mg of ropivacaine hydrochloride administered within 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 up to 800 mg/day have been administered with a relatively low incidence of adverse reactions.

For postoperative pain management, the following technique is recommended: unless already established before surgery, an epidural block is induced 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 provides adequate analgesia, with only mild and non-progressive motor block. The maximum duration of epidural block is 3 days. In any case, careful monitoring of the analgesic effect is required, and the catheter should be removed as soon as pain intensity permits. This technique has been associated with a significant reduction in opioid requirements.

In clinical studies, a continuous epidural infusion of ropivacaine hydrochloride 2 mg/ml, alone or mixed with fentanyl 1–4 μg/ml, has been administered for up to 72 hours for postoperative pain control. The combination of ropivacaine hydrochloride with fentanyl may provide additional pain control but may also cause opioid-related side effects. The combination of ropivacaine hydrochloride and fentanyl has only been studied with ropivacaine hydrochloride 2 mg/ml.

When performing prolonged peripheral nerve blocks, either via continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or causing local neurotoxicity must be evaluated. In clinical studies, femoral nerve block was achieved with 300 mg of ropivacaine hydrochloride 7.5 mg/ml and interscalene block with 225 mg of ropivacaine hydrochloride 7.5 mg/ml, respectively, prior to 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.

Renal impairment
Dose adjustment is normally not required in patients with impaired renal function when used as a single dose or for short-term treatment.

Hepatic impairment
Ropivacaine hydrochloride is metabolized 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 from 0 to 12 years of age inclusive

| Concentration | Volume | Dose |
|-------------------|----------|--------|
| mg/ml | ml/kg | mg/kg |

Single caudal epidural block

Blocks below the T12 level in children weighing up to 25 kg:
2.0 1 2

Continuous epidural infusion in children weighing 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 ml/kg/h 0.4 mg/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 aged 1 to 12 years:
The ropivacaine doses proposed for peripheral blocks in infants and children serve as a guide for use in children without severe pathology. More cautious dosing and careful monitoring are recommended for children with severe underlying conditions.

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

Continuous infusion for peripheral nerve block is recommended 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 via infusion.

To avoid intravascular administration, careful aspiration before and during infusion is recommended. The patient's vital signs must be closely monitored during infusion. If signs of toxicity occur, administration must be immediately discontinued.

In most patients, a single caudal epidural injection of ropivacaine hydrochloride 2 mg/ml below the T12 level provides adequate postoperative analgesia when a dose of 2 mg/kg in a volume of 1 ml/kg is used. The volume of caudal epidural injection can be adjusted to achieve different extents of sensory block, as described in standard reference texts. In children over 4 years of age, doses up to 3 mg/kg using a ropivacaine hydrochloride concentration of 3 mg/ml have been evaluated. However, this concentration has been associated with a higher incidence of motor block.

Gradual administration of the calculated dose of local anaesthetic is recommended regardless of the route of administration.

Where injection of ropivacaine hydrochloride is indicated, Ropivacaine Kabi injectable solution may 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 infusion solution in plastic infusion bags is chemically and physically compatible with the following drugs:

| Ropivacaine Kabi concentration: 1–2 mg/ml |
|---------------------------------------------|
| Additives | Concentration* |
| Fentanyl citrate | 1.0 – 10.0 µg/ml |
| Sufentanil citrate | 0.4 – 4.0 µg/ml |
| Morphine sulphate | 20.0 – 100.0 µg/ml |
| Clonidine hydrochloride | 5.0 – 50 µg/ml |

The mixtures are chemically and physically stable for 30 days at temperatures between 20°C and 30°C. From a microbiological standpoint, the mixtures should be used immediately. If not used immediately, storage conditions and duration prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C.

Disposal
Unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.

Package leaflet: information for the user

Ropivacaine Kabi 2 mg/ml solution for injection, 7.5 mg/ml solution for injection, 10 mg/ml solution for injection

Equivalent medicine
Please 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:

What Ropivacaine Kabi is and what it is used for
What you need to know before using Ropivacaine Kabi
How to use Ropivacaine Kabi
Possible side effects
How to store Ropivacaine Kabi
Contents of the pack and other information

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

Ropivacaine Kabi contains the active substance ropivacaine hydrochloride, which is a type of medicine called a local anaesthetic. These are chemical substances used to numb an area of the body.
Ropivacaine Kabi 2 mg/ml solution for injection is used:
In adults and children of all ages for the treatment of acute pain. It numbs (anaesthetizes) parts of the body, e.g. following surgery.
Ropivacaine Kabi 7.5 mg/ml and 10 mg/ml solution for injection is used:
In adults and children over 12 years of age to numb (anaesthetize) specific parts of the body. It is used to block pain or to relieve pain. It may be used for:

anaesthetizing parts of the body during surgery, including caesarean section
relieving pain during labour, after surgery, or following an accident

4. What you should know before taking Ropivacaine Kabi

Do not receive Ropivacaine Kabi

if you are allergic to ropivacaine hydrochloride, to other so-called amide-type local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6),
if you have reduced blood volume (hypovolaemia). This will be assessed by medical personnel,
for infusion into a blood vessel to anaesthetize a specific area of your body,
for injection into the cervix to relieve labour pain.

Warnings and precautions
Children
Ropivacaine Kabi 2 mg/ml solution for injection

In newborn children, as they are more sensitive to Ropivacaine Kabi 2 mg/ml solution for injection.
In children under 12 years of age, as certain injections of Ropivacaine Kabi 2 mg/ml solution for injection for anaesthetizing parts of the body have not been studied in younger children.

Ropivacaine Kabi 7.5 mg/ml and 10 mg/ml solution for injection
In children up to and including 12 years of age. Other strengths (2 mg/ml, 5 mg/ml) may be more appropriate.
Particular care must be taken to avoid any injection of Ropivacaine Kabi directly into a blood vessel
to prevent any immediate toxic effects. Administration must not be performed in inflamed areas.
Talk to your doctor, pharmacist, nurse, or other healthcare professional before receiving Ropivacaine Kabi if:

you are in a general state of poor health due to your age or other factors,
you have heart problems (partial or complete heart conduction block),
you have severe liver problems,
you have severe kidney problems.

Inform your doctor if you have any of these conditions, as your doctor may need to adjust the dose of Ropivacaine Kabi.
Talk to your doctor, pharmacist, nurse, or other healthcare professional before receiving Ropivacaine Kabi:

if you suffer from acute porphyria (a disorder affecting the production of the red pigment in blood, which sometimes causes neurological symptoms).

Inform your doctor if you or someone in your family suffers from porphyria, as your doctor may need to use alternative anaesthetics.
Other medicines and Ropivacaine Kabi
Inform your doctor, pharmacist, or healthcare professional if you are taking, have recently taken, or might take any other medicines.
Caution is required if you are taking:

Other local anaesthetics (e.g. lidocaine) or structurally related agents to amide-type local anaesthetics, e.g. certain medicines used to treat irregular heartbeat (arrhythmia), such as mexiletine or amiodarone,
General anaesthetics or 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.
Driving and using machines
Ropivacaine Kabi may cause drowsiness and affect your reaction speed. After receiving Ropivacaine Kabi, you must not drive or operate machinery until the following day.
Ask your doctor or pharmacist if you have any doubts.
Ropivacaine Kabi contains sodium chloride
This medicinal product contains up to 0.148 mmol (or 3.4 mg) of sodium per ml. This should be taken into consideration by patients on a sodium-controlled diet.

5. How to take Ropivacaine Kabi

Dosage
The dose used will depend on the reason for which it is being administered, as well as on your health, age, and weight.
The lowest effective dose required to achieve anaesthesia in the target area should be used.
The usual dose is:

for adults and adolescents over 12 years of age, between 2 mg and 300 mg of ropivacaine hydrochloride,
for neonates and children (0 to 12 years inclusive), 1–2 mg per kilogram of body weight.

Method of administration
Ropivacaine Kabi will be administered to you by a doctor. It is given by injection.
Duration of treatment
Administration of ropivacaine hydrochloride generally lasts from 2 to 10 hours when used for anaesthesia prior to certain procedures, and may last up to 72 hours when used for pain relief during or after surgery.
If you are given more Ropivacaine Kabi than you should
The first symptoms of receiving an excessive amount of ropivacaine hydrochloride are usually:

hearing and vision disturbances,
numbness around the mouth,
dizziness or lightheadedness,
tingling sensations,
speech disturbances characterized by difficulty in articulation (dysarthria),
muscle stiffness, muscle spasms, seizures (convulsions),
low blood pressure,
slow or irregular heartbeat.
These symptoms may precede cardiac arrest, respiratory arrest, or severe seizures. If you experience any of these symptoms or think you have been given too much Ropivacaine Kabi, inform your doctor or healthcare provider immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects that require 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 (urticaria),
swelling of the face, lips, tongue or other parts of the body,
and shortness of breath, breathlessness or difficulty breathing.

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

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

Common (may affect up to 1 in 10 patients)

Headache, tingling (paraesthesia), dizziness
Slow or fast heartbeat (bradycardia, tachycardia)
High blood pressure (hypertension)
Feeling sick (vomiting)
Difficulty passing urine (urinary retention)
Back pain, raised body temperature, muscle stiffness (rigor)

Uncommon (may affect up to 1 in 100 patients)

Anxiety
Some symptoms may occur if the injection is accidentally administered into a blood vessel, or if you have been given too much Ropivacaine Kabi (see also section 3 “If you take more Ropivacaine Kabi than you should” above). These include seizures (convulsions, fits), dizziness or lightheadedness, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, speech problems (dysarthria), muscle spasms and tremor, reduced sense of touch (hypoesthesia)
Fainting (syncope)
Difficulty breathing (dyspnoea)
Low body temperature

Rare (may affect up to 1 in 1000 patients)

Cardiac arrest, irregular heartbeat (cardiac arrhythmias)

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

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

Children
In children, the side effects are the same as in adults, except that low blood pressure occurs less frequently in children (affects fewer than 1 in 10 children), and nausea occurs more frequently in children (affects more than 1 in 10 children).
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, nurse or other healthcare professional.

5. How to store Ropivacaine 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 Ropivacaine Kabi and are responsible for maintaining the product quality once it has been opened if not used immediately. They are also responsible for the proper disposal of unused Ropivacaine Kabi.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 components 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 package contents
Ropivacaine Kabi injectable solution is a clear, 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.
Pack sizes:
1, 5, 10 vial(s) in blister packs.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona, Italy
Manufacturer:
Fresenius Kabi Norge AS
Address: Svinesundsveien 80, NO 1788 Halden, Norway

This medicinal product is authorised in the European Economic Area Member States under the following names:
Ropivacaine Kabi 2 mg/ml solution for injection

Member State Name	Medicinal Product Name
Netherlands	Ropivacaïne HCl Fresenius Kabi 2 mg/ml solution for injection
Belgium	Ropivacaïne HCl Fresenius Kabi 2 mg/ml solution for injection/injectable solution/Injektionslösung
Bulgaria	Ropivacain Kabi 2 mg/ml, injektsionen raztvor
Cyprus	Ropivacaine Kabi 2 mg/ml, enesimo diavasma
Germany	Ropivacainhydrochlorid Kabi 2 mg/ml Injektionslösung
Denmark	Ropivacain Fresenius Kabi injektionsvaeske, opløsning, 2 mg/ml
Greece	Ropivacaine Kabi 2 mg/ml, enesimo diavasma
Spain	Ropivacaina Kabi 2 mg/ml solución inyectable
Finland	Ropivacain Fresenius Kabi 2 mg/ml injektioneste, liuos
France	Ropivacaïne Kabi 2 mg/ml, solution injectable
Ireland	Ropivacaine 2 mg/ml solution for injection
Italy	Ropivacaina Kabi 2 mg/ml Soluzione iniettabile
Luxembourg	Ropivacainhydrochlorid Kabi 2 mg/ml Injektionslösung
Norway	Ropivacain Fresenius Kabi 2 mg/ml injeksjonsvæske, oppløsning
Portugal	Ropivacaína Kabi 2 mg/mL solução injectável
Romania	Ropivacaina Kabi 2 mg/ml soluţie injectabilă
Sweden	Ropivacain Fresenius Kabi 2 mg/ml, injektionsvätska, lösning
United Kingdom	Ropivacaine 2 mg/ml solution for injection

Ropivacaine Kabi 7.5 mg/ml solution for injection

Member State Name	Medicinal Product Name
Netherlands	Ropivacaine Fresenius Kabi 7.5 mg/ml solution for injection
Belgium	Ropivacaine Fresenius Kabi 7.5 mg/ml solution for injection/injection solution/Injektionslösung
Bulgaria	Ropivacain Kabi 7.5 mg/ml, injectable solution
Cyprus	Ropivacaine Kabi 7.5 mg/ml, injectable solution
Germany	Ropivacaine hydrochloride Kabi 7.5 mg/ml injection solution
Denmark	Ropivacaine Fresenius Kabi, concentrate for solution for injection, 7.5 mg/ml
Greece	Ropivacaine Kabi 7.5 mg/ml, injectable solution
Spain	Ropivacaine Kabi 7.5 mg/ml injectable solution
Finland	Ropivacaine Fresenius Kabi 7.5 mg/ml, concentrate for injection, solution
France	Ropivacaine Kabi 7.5 mg/ml, solution for injection
Ireland	Ropivacaine 7.5 mg/ml solution for injection
Italy	Ropivacaine Kabi 7.5 mg/ml Injectable Solution
Luxembourg	Ropivacaine hydrochloride Kabi 7.5 mg/ml injection solution
Norway	Ropivacaine Fresenius Kabi 7.5 mg/ml, injection solution, solution
Portugal	Ropivacaine Kabi 7.5 mg/mL injectable solution
Romania	Ropivacaine Kabi 7.5 mg/ml injectable solution
Slovenia	Ropivacaine chloride Kabi 7.5 mg/ml solution for injection
Sweden	Ropivacaine Fresenius Kabi 7.5 mg/ml, injection solution, solution
United Kingdom	Ropivacaine 7.5 mg/ml solution for injection

Ropivacaine Kabi 10 mg/ml solution for injection

Member State Name	Medicinal Product Name
Netherlands	Ropivacaine Fresenius Kabi 10 mg/ml solution for injection
Belgium	Ropivacaine Fresenius Kabi 10 mg/ml solution for injection/injection solution/Injektionslösung
Bulgaria	Ropivacain Kabi 10 mg/ml, injektsionen razvor
Cyprus	Ropivacaine Kabi 10 mg/ml, ενέσιμο διάλυμα
Germany	Ropivacaine hydrochloride Kabi 10 mg/ml injection solution
Denmark	Ropivacaine Fresenius Kabi, injection solution, solution, 10 mg/ml
Greece	Ropivacaine Kabi 10 mg/ml, ενέσιμο διάλυμα
Spain	Ropivacaine Kabi 10 mg/ml injectable solution
Finland	Ropivacaine Fresenius Kabi 10 mg/ml injection solution, solution
France	Ropivacaine Kabi 10 mg/ml, solution for injection
Italy	Ropivacaine Kabi 10 mg/ml Injectable Solution
Luxembourg	Ropivacaine hydrochloride Kabi 10 mg/ml injection solution
Norway	Ropivacaine Fresenius Kabi 10 mg/ml, injection solution, solution
Portugal	Ropivacaine Kabi 10 mg/ml solution for injection
Romania	Ropivacaine Kabi 10 mg/ml injectable solution
Slovenia	Ropivakainijev klorid Kabi 10 mg/ml raztopina za injiciranje
Sweden	Ropivacaine Fresenius Kabi 10 mg/ml, injection solution, solution
United Kingdom	Ropivacaine 10 mg/ml solution for injection

This patient information leaflet was last updated on a determined date.

The following information is intended for healthcare professionals only:

Handling
Ropivacaine Kabi must be used only by or under the supervision of clinical experts in local anesthesia (see section 3).

Shelf Life
Shelf life before opening:
3 years

Shelf life after opening:
From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours between 2 and 8°C.

Ropivacaine Kabi products are preservative-free and for single use only. Any unused solution must be discarded.

The medicinal product must be visually inspected before use. The solution should only be used if it is clear, practically free of particles, and if the container is undamaged.

The intact container must not be re-sterilized in an autoclave.

Dosage
Ropivacaine 2 mg/ml injectable solution
Adults and children over 12 years of age

The following table provides guidance on recommended doses for the most common types of block. The lowest effective dose required to achieve adequate block should always be used. The clinician's experience and knowledge of the patient's physical condition are important in determining the appropriate dose.

| Concentration | Volume | Dose | Onset | Duration |
|-------------------|----------|--------|---------|------------|
| mg/ml | ml | mg | in minutes | in hours |
| Epidural administration | | | | |
| Lumbar | | | | |
| Bolus | 2.0 | 10–20 | 20–40 | 10–15 | 0.5–1.5 |
| Intermittent injections (top-up) | 2.0 | 10–15 | 20–30 | (minimum interval of 30 minutes) | |
| Continuous infusion (e.g. labor pain) | 2.0 | 6–10 ml/hour | 12–20 mg/hour | n/a | n/a |
| Postoperative pain control | 2.0 | 6–14 ml/hour | 12–28 mg/hour | n/a | n/a |
| Thoracic epidural administration | | | | |
| Continuous infusion (postoperative pain control) | 2.0 | 6–14 ml/hour | 12–28 mg/hour | 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 (e.g. femoral or interscalene block) | | | | |
| Continuous infusion or intermittent injections (e.g. postoperative pain treatment) | 2.0 | 5–10 ml/hour | 10–20 mg/hour | n/a | n/a |

n/a = not applicable

Method of Administration
Perineural and epidural administration by injection.

Careful aspiration before and during administration is recommended to avoid intravascular injection.

When a larger dose is to be administered, it is recommended to first administer a test dose of 3–5 ml of 2% lidocaine with adrenaline (epinephrine) 1:200,000. Accidental intravascular injection may be recognized by a transient increase in heart rate, and accidental intrathecal injection by signs of spinal block.

Aspiration must be performed before 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 monitoring the patient's vital functions and maintaining verbal contact. If signs of toxicity occur, the injection must be immediately stopped.

In surgical epidural block, single doses 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 was well tolerated.

When performing prolonged blocks, either via continuous epidural infusion or repeated bolus administration, the potential risk of achieving toxic plasma concentrations or causing local neurotoxicity must be considered. Cumulative doses up to 675 mg of ropivacaine hydrochloride administered within 24 hours for surgical anesthesia and postoperative analgesia have been well tolerated in adults, as have continuous epidural infusions of up to 28 mg/hour for 72 hours in the postoperative period. In a limited number of patients, higher doses up to 800 mg/day have been administered with a relatively low incidence of adverse reactions.

For postoperative pain treatment, the following technique is recommended: unless already established before surgery, an epidural block is performed using Ropivacaine Kabi 7.5 mg/ml administered via an epidural catheter. Analgesia is then maintained with 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 epidural block is 3 days. In any case, careful monitoring of analgesic effect should be performed so that the catheter can be removed as soon as pain intensity allows. This technique has been associated with a significant reduction in the need for opioid use.

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 up to 72 hours for postoperative pain control. Combining ropivacaine hydrochloride with fentanyl may provide additional pain control but may also cause opioid-related side effects. The combination of ropivacaine hydrochloride and fentanyl has only been studied with ropivacaine hydrochloride 2 mg/ml.

When performing prolonged peripheral nerve blocks, either via continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or causing local neurotoxicity must be evaluated. In clinical studies conducted, femoral nerve block was achieved with 300 mg of ropivacaine hydrochloride 7.5 mg/ml and interscalene block with 225 mg of ropivacaine hydrochloride 7.5 mg/ml, respectively, prior to 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.

For cesarean section, use of ropivacaine hydrochloride at concentrations higher than 7.5 mg/ml has not been documented.

Renal impairment
Dose adjustment is generally not required in patients with renal impairment when used for single-dose or short-term treatment.

Pediatric patients from 0 to 12 years of age, inclusive

	Concentration	Volume	Dose
	mg/ml	ml/kg	mg/kg
Single caudal epidural block
Block below T12 in children with body weight up to 25 kg	2.0	1	2
Continuous epidural infusion
In children with body weight up to 25 kg
From 0 to 6 months
Bolus dosea	2.0	0.5–1	1–2
Infusion up to 72 hours	2.0	0.1 ml/kg/h	0.2 mg/kg/h
From 6 to 12 months
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
From 1 to 12 yearsb
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 indicated in the table should be considered as a guide for use in paediatrics. Individual adjustments may be necessary. In paediatric patients with high body weight, a gradual dose reduction based on ideal body weight is often required. The volume for a single caudal epidural block and the volume for epidural bolus doses must not exceed 25 ml per patient. Reference texts should be consulted regarding factors affecting specific block techniques and individual patient requirements.

Within the dose range indicated, 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 aged 1 to 12 years

The ropivacaine doses proposed for peripheral nerve block in infants and children are intended as a guide for use in children without severe pathology. More conservative dosing and careful monitoring are recommended for children with severe comorbidities.

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

Continuous infusion for peripheral nerve block is recommended at 0.2–0.6 mg/kg/h (0.1–0.3 ml/kg/h), 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 injection. The patient's vital signs must be closely monitored during injection. If signs of toxicity occur, administration must be immediately discontinued.

In most patients, a single caudal epidural injection of ropivacaine 2 mg/ml below the T12 level provides adequate postoperative analgesia when a dose of 2 mg/kg is administered in a volume of 1 ml/kg. The volume of caudal epidural injection may be adjusted to achieve a different sensory block distribution, as indicated in reference texts. In children above 4 years of age, doses up to 3 mg/kg have been evaluated using a ropivacaine hydrochloride concentration of 3 mg/ml. Consequently, this concentration has been associated with a high incidence of motor block.

Gradual administration of the calculated local anaesthetic dose is recommended, regardless of the route of administration.

In cases where ropivacaine hydrochloride infusion is indicated, Ropivacaine Kabi solution for infusion may be used.

Ropivacaine Kabi 7.5 mg/ml and Ropivacaine Kabi 10 mg/ml injectable solution

Adults and children above 12 years of age

The following table provides guidance on recommended dosages for the most common types of block. The dose used should be the lowest required to achieve effective block. The dose to be administered should also be selected based on the physician's experience and knowledge of the patient's clinical condition.

Concentration Dose Onset Duration
mg/ml mg minutes hours Volume ml
SURGICAL ANAESTHESIA
Lumbar epidural administration
7.5 113–150 10–20 3–5 15–25
Surgery
10.0 150–225 10–20 4–6 15–20
7.5 113–150 10–20 3–5 15–20
Caesarean section
Thoracic epidural administration
For postoperative pain control 7.5 38–113 (depending on injection level) 10–20 n/a 5–15
Major nerve blocks*
Brachial plexus block 7.5 225–300 10–25 6–10 30–40
Regional block (e.g. minor nerve blocks and infiltration) 7.5 7.5–225 1–15 2–6 1–30
* Regarding major nerve blocks, a recommended dose is available only for brachial plexus block. For other types of major nerve blocks, lower doses may be required. However, specific recommended doses for other types of major nerve blocks are currently not available.

Incremental doses may be administered, starting with a dose of approximately 100 mg (97.5 mg = 13 ml; 105 mg = 14 ml) over 3–5 minutes. If necessary, up to two additional doses may be administered, up to a maximum of 50 mg.

n/a = not applicable.

The dose for major nerve blocks must be adjusted according to the site of administration and the patient's condition.

Interscalene and supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used.

Method of administration

Perineural and epidural administration by injection.

Careful aspiration before and during administration is recommended to prevent intravascular injection.

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. Accidental intravascular injection may be recognized by a transient increase in heart rate, and accidental intrathecal injection by symptoms of spinal block.

Aspiration must be performed before 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 monitoring the patient's vital functions and maintaining verbal contact. If symptoms of toxicity occur, injection must be immediately discontinued.

In surgical epidural block, single doses 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 was well tolerated.

When performing prolonged blocks, either via continuous epidural infusion or repeated bolus administration, the potential risk of achieving toxic plasma concentrations or inducing local neurotoxicity must be considered. Cumulative doses 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 up to 28 mg/h for 72 hours in the postoperative period. In a limited number of patients, higher doses up to 800 mg/day have been administered with a relatively low incidence of adverse reactions.

For postoperative pain management, the following technique is recommended: unless already established before surgery, an epidural block is performed with Ropivacaine Kabi 7.5 mg/ml administered via an epidural catheter. Analgesia is then maintained with infusion of Ropivacaine 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 epidural block is 3 days. However, careful monitoring of analgesic effect should be performed, and the catheter should be removed as soon as pain intensity permits. With this technique, a significant reduction in opioid requirements 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 up to 72 hours for postoperative pain control. The addition of fentanyl to ropivacaine hydrochloride may provide additional pain control but may also cause opioid-related side effects. The combination of ropivacaine hydrochloride and fentanyl has been studied only with ropivacaine hydrochloride 2 mg/ml.

When performing prolonged peripheral nerve blocks, either via continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or causing local neurotoxicity must be evaluated. In clinical studies, femoral nerve block was achieved 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 surgery. 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.

The use of ropivacaine hydrochloride at concentrations above 7.5 mg/ml in caesarean section has not been documented.

Renal impairment

Dose adjustment is normally not required in patients with renal impairment when used for single-dose or short-term treatment.

Hepatic impairment

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

Paediatric population up to and including 12 years of age

The use of Ropivacaine Kabi 7.5 and 10 mg/ml in children may be associated with systemic and central toxic events. Lower concentrations (2 mg/ml, 5 mg/ml) are more appropriate for administration in this patient population.

In general, surgical anaesthesia (e.g. for epidural administration) requires higher concentrations and doses. Ropivacaine Kabi 10 mg/ml is recommended for epidural anaesthesia in surgical procedures requiring complete motor block. Lower concentrations and doses are recommended for analgesia (e.g. for epidural administration in the treatment of acute pain).

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 has poor solubility at pH > 6.0.

Disposal

Unused medicinal product or waste material must be disposed of in accordance with local regulations.

Package leaflet: Information for the user

Ropivacaine Kabi 5 mg/ml solution for injection

Generic medicine
Please 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, consult your doctor, pharmacist, nurse, or other healthcare professional.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, nurse, or other healthcare professional.

Contents of this leaflet:

What Ropivacaine Kabi is and what it is used for
What you need to know before using Ropivacaine Kabi
How to use Ropivacaine Kabi
Possible side effects
How to store Ropivacaine Kabi
Contents of the pack and other information

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

Ropivacaine Kabi contains the active substance ropivacaine hydrochloride, which is a type of medicine called a local anaesthetic. These are chemicals used to numb an area of the body.
Ropivacaine Kabi is used to numb (anaesthetise) specific parts of the body and to block pain during surgical procedures.

2. What you need to know before taking Ropivacaina Kabi

Do not take Ropivacaina Kabi if

you are allergic to ropivacaine hydrochloride, to other so-called local anesthetics of the amide type, or to any of the other ingredients of this medicine (listed in section 6),
you have reduced blood volume (hypovolemia). This will be assessed by medical personnel,
you intend to inject it into a blood vessel to anesthetize a specific area of your body,
you intend to inject it into the cervix to relieve labor pain.

Warnings and precautions
Particular care must be taken to avoid any injection of Ropivacaina Kabi directly into a blood vessel to prevent any immediate toxic effects. The injection must not be administered into inflamed areas.
Talk to your doctor, pharmacist, nurse, or other healthcare professional before taking Ropivacaina Kabi if:

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

Inform your doctor if you have any of these conditions, as your doctor may need to adjust the dose of Ropivacaina Kabi.
An injection into the lower part of the spine may lead to low blood pressure or slowed heart rate. If necessary, your doctor will take appropriate measures.
Talk to your doctor, pharmacist, nurse, or other healthcare professional before taking Ropivacaina Kabi:

if you suffer from acute porphyria (a disorder affecting the production of the red pigment in blood, which may sometimes cause neurological symptoms). Inform your doctor if you or a family member has porphyria, as your doctor may need to use alternative anesthetics.

Other medicines and Ropivacaina Kabi
Inform your doctor, pharmacist, or healthcare professional if you are taking, have recently taken, or might take any other medicines.
Caution is required if you are taking:

other local anesthetics (e.g., lidocaine) or structurally related agents to amide-type local anesthetics, such as certain medicines used to treat irregular heartbeat (arrhythmia), like mexiletine or amiodarone,
general anesthetics or 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, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.

Pediatric patients
There is no experience with administration into the lower spine (intrathecal administration) in newborns or in children aged 12 years or younger.

Driving and using machines
Ropivacaina Kabi may cause drowsiness and affect your reaction speed. After receiving Ropivacaina Kabi, you must not drive or operate machinery until the following 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 Ropivacaine Kabi

for adults and adolescents over 12 years of age is between 15 mg and 25 mg of ropivacaine hydrochloride.

Method of administration
Your doctor will administer Ropivacaine Kabi. It is given by injection.
Duration of treatment
Administration of ropivacaine hydrochloride generally lasts between 2 and 6 hours when used for anaesthesia prior to certain surgical procedures.
It is administered by injection into the lower part of the spinal column (intrathecal administration).
If you are given more Ropivacaine Kabi than you should have
The first symptoms of an overdose of ropivacaine hydrochloride are usually:

hearing and vision disturbances,
numbness around the mouth,
dizziness or lightheadedness,
tingling,
speech difficulties characterized by impaired articulation (dysarthria),
muscle stiffness, muscle spasms, seizures (convulsions),
low blood pressure,
slow or irregular heartbeat. These symptoms may precede cardiac arrest, respiratory arrest, or severe seizures. If you experience any of these symptoms or think you have been given too much Ropivacaine Kabi, inform your doctor or healthcare professional immediately.

In case of acute toxicity, appropriate corrective measures will be taken immediately by healthcare personnel.
Due to the low dose administered during injection into the lower part of the spinal column (intrathecal administration), systemic adverse effects are generally not expected.
If you have any further 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 everyone gets them.
Serious side effects that require attention:
Life-threatening allergic reactions (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, breathing difficulties or trouble breathing.

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

Common (may affect up to 1 in 10 patients)

Headache, tingling (paraesthesia), dizziness
Slow or fast heartbeat (bradycardia, tachycardia)
High blood pressure (hypertension)
Feeling sick (vomiting)
Difficulty passing urine (urinary retention)
Back pain, elevated temperature, muscle stiffness (rigor)

Uncommon (may affect up to 1 in 100 patients)

Anxiety
Some symptoms may occur if the injection is accidentally administered into a blood vessel, or if you have been given an excessive dose of Ropivacaine Kabi (see also “If you use more Ropivacaine Kabi than you should” above). These include seizures (convulsions, fits), dizziness or lightheadedness, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems (visual disturbances), speech problems (dysarthria), muscle spasms and tremor, reduced sense of touch (hypoesthesia)
Fainting (syncope)
Breathing difficulties (dyspnoea)
Low body temperature

Rare (may affect up to 1 in 1000 patients)

Cardiac arrest, irregular heartbeat (cardiac arrhythmias)

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

Numbness, due to nerve irritation caused by the needle or injection. This usually does not last long.
Nerve damage. Rarely, this may lead to permanent problems.
If an excessive amount of Ropivacaine Kabi is administered into the spinal fluid, numbness (anaesthesia) may spread throughout the entire body.

Adolescents
In adolescents, the side effects are the same as in adults, except for low blood pressure, which occurs less frequently in adolescents (affects fewer than 1 in 10), and nausea, which occurs more frequently in adolescents (affects more than 1 in 10). Ropivacaine Kabi must not be used for injection into the lower part of the spine in neonates and children under 12 years of age.
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, nurse, or other healthcare professional.

5. How to store Ropivacaine 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 Ropivacaine Kabi and are responsible for maintaining the product quality once it has been opened and is not used immediately. They are also responsible for the proper disposal of unused Ropivacaine Kabi.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ropivacaine 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 components 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, colourless solution.
Ropivacaine Kabi 5 mg/ml injectable solution is available in transparent 10 ml polypropylene vials.
Pack sizes:
1, 5, 10 vials in blister packs
Not all pack sizes may be marketed.

This medicinal product is authorised in the European Economic Area Member States under the following names:

Member State Name	Medicinal Product Name
Netherlands	Ropivacaine Fresenius Kabi 5 mg/ml solution for injection
Belgium	Ropivacaine Fresenius Kabi 5 mg/ml solution for injection/injectable solution/Injektionslösung
Bulgaria	Ropivacaine Kabi 5 mg/ml, injectable solution
Cyprus	Ropivacaine Kabi 5 mg/ml, solution for injection
Denmark	Ropivacaine Fresenius Kabi, solution for injection, 5 mg/ml
Greece	Ropivacaine Kabi 5 mg/ml, solution for injection
Finland	Ropivacaine Fresenius Kabi 5 mg/ml, solution for injection
France	Ropivacaine Kabi 5 mg/ml, solution for injection
Italy	Ropivacaine Kabi 5 mg/ml Solution for injection
Norway	Ropivacaine Fresenius Kabi 5 mg/ml, solution for injection
Romania	Ropivacaine Kabi 5 mg/ml, solution for injection
Sweden	Ropivacaine Fresenius Kabi 5 mg/ml, solution for injection

This summary of product characteristics was updated on Date to be determined

The following information is intended exclusively for healthcare professionals:

Handling
Ropivacaine Kabi must be used only by, or under the supervision of, physicians experienced in regional anesthesia (see section 3).

Shelf life
Shelf life before opening: 3 years.

Shelf life after opening
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and storage conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C.
Ropivacaine Kabi products are preservative-free and are intended for single use only.
Any unused solution should be discarded.

This medicinal product should be inspected visually before use. The solution should only be used if it is clear, practically free from particulate matter, and if the container is undamaged.
Intact containers must not be resterilized in an autoclave.

Dosage
Adults and adolescents (> 12 years of age)
The following table provides dosage guidelines for intrathecal block in adults. The lowest dose required to achieve effective block should always be used. Clinical experience and knowledge of the patient's physical condition are important factors in determining the appropriate dose.

	Concentration	Volume	Dose mg	Onset in	Duration in
	mg/ml	ml		minutes	hours
SURGICAL ANESTHESIA Intrathecal administration Surgery	5.0	3-5	15-25	1-5	2-6

The doses in the table are those considered necessary to produce effective block and should be regarded as
a guideline for use in adults. Individual variations in onset and duration of anaesthetic effect may occur.
The numbers in the “Dose” column represent the average dose range required. Reference texts should be
consulted for factors relating to specific block techniques and individual patient requirements.

Method of administration
Intrathecal use only by injection.
Careful aspiration before and during injection is recommended to prevent intravascular injection.
Accidental intravascular injection may be recognized by a transient increase in heart rate.
Aspiration should be performed before and during administration of the main dose, which must be injected slowly at a rate of 25–50 mg/min, while closely monitoring the patient’s vital functions and maintaining verbal contact. If signs of toxicity occur, the injection must be immediately discontinued.
Intrathecal injection should be performed after the subarachnoid space has been identified and cerebrospinal fluid is seen to flow from or can be aspirated through the spinal needle.

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Precipitation may occur in alkaline solutions, since ropivacaine hydrochloride has poor solubility at pH > 6.0.

Disposal
Unused medicinal product and waste material arising from this medicinal product must be disposed of in accordance with current local regulations.