Summary of Product Characteristics: Information for the User

Ropivacaína Kabi 2 mg/ml infusion solution EFG

Ropivacaína, hydrochloride

Read this leaflet carefully before you receive this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, nurse or any other healthcare professional.
• If you experience any side effects, consult your doctor, nurse or any other healthcare professional, even if they are not listed in this leaflet. See section 4.

The name of this medicine is “Ropivacaína Kabi 2 mg/ml infusion solution EFG”, but in the rest of this leaflet it will be called “Ropivacaína Kabi”.

• Ropivacaína Kabi contains hydrochloride of ropivacaína
• Ropivacaína Kabi belongs to a group of medicines called local anesthetics

Ropivacaína Kabi 2 mg/ml infusion solutionis indicated in adults and children of all ages for the treatment of acute pain. It numbs (anesthesia) parts of the body, for example, after surgery.

You will not be administered Ropivacaína Kabi

• if you areallergic (hypersensitive) to hydrochloride ropivacaineor to any of the other components of this medication (listed in section 6)
• if you are allergic to any other local anesthetic of the same class (such as lidocaine or bupivacaine)
• if you have been told that you have aplasma volume decrease(hypovolemia)
• directly into the bloodstreamto anesthetize a specific area of your body
• or in the cervixto relieve pain during childbirth

If you are unsure whether any of the above applies to you, consult your doctor before Ropivacaína Kabi is administered to you.

Warnings and precautions

Special care should be taken toavoid any injectionof Ropivacaína Kabidirectly into the bloodstreamto prevent any immediate toxic effects. Do not inject into inflamed areas.

Inform your doctor, nurse, or any other healthcare professional before Ropivacaína Kabi is administered to you:

• if yourhealth status is not gooddue to age or other factors
• if you haveheart problems(complete or partial heart block)
• if you haveadvanced liver disease
• if you havesevere kidney problems

Inform your doctor if you have any of these problems, as it may be necessary to adjust the dose of Ropivacaína Kabi.

Inform your doctor, nurse, or any other healthcare professional before Ropivacaína Kabi is administered to you:

• if you haveacute porphyria(problems with red blood pigment production, which can sometimes produce neurological symptoms)

Inform your doctor if you or a family member has porphyria, as it may be necessary to use another anesthetic.

Inform your doctor about any medical condition or illness you have before starting treatment.

Children

Special care should be taken:

• In newborns as they are more susceptible to Ropivacaína Kabi 2 mg/ml solution for infusion
• In children under 12 years old as some injections of Ropivacaína Kabi 2 mg/ml solution for infusion have not been established for anesthetizing body parts

Use of Ropivacaína Kabi with other medications

Inform your doctor or healthcare professional that you are using, have used recently, or may need to use any other medication.This is because Ropivacaína Kabi may affect how some medications work, and other medications may affect Ropivacaína Kabi.

Especially, inform your doctor if you are using any of the following medications:

• Other local anesthetics
• Potent pain medications, such as morphine or codeine
• Medications used to treat irregular heartbeats(arrhythmia), such as lidocaine or mexiletine

Your doctor needs to know this to calculate the correct dose of Ropivacaína Kabi to administer to you.

Also, inform your doctor if you are using any of the following medications:

• Depression medications (such as fluvoxamine)
• Antibiotics to treat bacterial infections (such as enoxacine)

This is because your body takes longer to eliminate Ropivacaína Kabi if you are using these medications. If you are using any of these medications, avoid prolonged use of Ropivacaína Kabi.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before this medication is administered to you.

The effects of ropivacaine on pregnancy or breastfeeding are unknown.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Ropivacaína Kabi may cause drowsiness and affect your reaction time. Do not drive or use tools or machinery after taking Ropivacaína Kabi, until the next day.

Ropivacaína Kabi contains sodium chloride.

This medication contains 3.4 mg of sodium (main component of table salt/for cooking) in each milliliter. This is equivalent to 0.17% of the recommended daily maximum sodium intake for an adult.

Ropivacaína Kabi will be administered by a doctor. The dose administered by your doctor will depend on the type of pain relief you need. It will also depend on your size, age, and physical condition.

Ropivacaína Kabi will be administered as an infusion. The part of the body where it will be used will depend on why Ropivacaína Kabi is being administered. Your doctor will administer Ropivacaína Kabi in one of the following locations:

• The part of the body that needs to be numbed
• Near the part of the body that needs to be numbed
• In an area away from the part of the body that needs to be numbed. This is the case if you are receiving an epidural infusion (in the area near the spine)

When Ropivacaína Kabi is used in this way, it prevents nerves from transmitting pain messages to the brain. It prevents you from feeling pain, heat, or cold where it is used, but you may still be able to feel other sensations such as pressure or touch.

Your doctor knows the correct way to administer this medication.

Dosage

The dose used will depend on why the medication is being administered and your health, age, and weight.

Treatment duration

The administration of ropivacaína usually lastsbetween 0.5 and 6 hours, but it may lastup to 72 hoursin the case ofpain reliefduring and after surgery.

If you receive more Ropivacaína Kabi than you should

Severe side effects due to the administration of too much Ropivacaína Kabi require special treatment, and the doctor treating you is prepared to handle these situations.

The first signs that you have received too much Ropivacaína Kabi are usually the following:

• Ear and vision problems (vision)
• Numbness of lips, tongue, and around the mouth
• Dizziness or mild dizziness
• Tickling
• Speech difficulties characterized by poor articulation (dysarthria)
• Muscle stiffness, muscle spasms, convulsions
• Low blood pressure
• Irregular or slow heart rate

These symptoms may precede a heart attack, respiratory arrest, or severe convulsions.

To reduce the risk of severe side effects, your doctor will stop administering Ropivacaína Kabi as soon as these signs appear. This means that if any of these signs occur to you,or you think you may have received too much Ropivacaína Kabi, inform your doctor or healthcare staff immediately.

More severe side effects from receiving too much Ropivacaína Kabi include speech problems, muscle stiffness, tremors, agitation, seizures, and loss of consciousness.

Inform your doctor or healthcare professional if you notice any of the above symptoms.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Important side effects to be aware of:

Theallergic reactionsthat can be life-threatening(such as anaphylaxis, including anaphylactic shock) are rare, as they affect between 1 and 10 patients out of every 10,000. Possible symptoms include:

• Sudden appearance of hives,
• Itching or irritation (urticaria),
• Swelling of the face, lips, tongue, or other parts of the body,
• Lack of breath, difficulty breathing,
• Sensation of loss of consciousness.

If you consider that Ropivacaína Kabi is causing 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
• Nausea

Common(may affect up to 1 in 10 people)

• Prickling (paresthesia)
• Sensation of dizziness
• Headache
• Slow or fast heart rate (bradycardia, tachycardia)
• High blood pressure (hypertension)
• Vomiting
• Difficulty urinating (urinary retention)
• High temperature (fever), shivering (chills)
• Muscle stiffness (rigor)
• Back pain

Rare(may affect up to 1 in 100 people)

Anxiety

Decreased sensitivity in the skin

Fainting

Difficulty breathing

Low body temperature (hypothermia)

Some symptoms may occur if the infusion is administered in a blood vessel by mistake, or if you have been given too much Ropivacaína Kabi (see also section 3 “If you are given more Ropivacaína Kabi than you should” above). This includes seizures (attacks), sensation of dizziness or lightheadedness, numbness of the lips and around the mouth, tongue numbness, hearing problems, vision problems, speech problems, muscle stiffness, and tremors

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

• Heart attack (cardiac arrest)
• Irregular heartbeat (cardiac arrhythmias)

Frequency not known(cannot be estimated from available data):

Other possible side effects include:

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

• Uncontrolled muscle movements (dyskinesia)

Side effects detected with other local anesthetics that may also be caused by Ropivacaína Kabi, including:

• Nerve damage. Rarely (affecting between 1 and 10 patients out of every 10,000), this can cause permanent problems
• If Ropivacaína Kabi is administered in the spinal fluid, the entire body may become numb (anesthetized)
• Receiving an epidural injection (injection in the space around the spinal nerves) may cause a disruption of a nerve pathway from the brain to the head and neck, especially in pregnant women, which can sometimes cause a condition called Horner's syndrome. This is characterized by a constricted pupil, drooping eyelid, and lack of sweat gland function. It will resolve on its own when treatment is discontinued

Children

In children, side effects are the same as in adults except for low blood pressure, which occurs less frequently in children (affects between 1 and 10 children out of 100) and general discomfort, which occurs more frequently in children (affects more than 1 in 10)

Reporting of side effects:

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the bag. The expiration date is the last day of the month indicated.

Keep below 30°C.

Do not use this medication if you observe a precipitate in the infusion solution.

Normally your doctor or the hospital will store Ropivacaína Kabi and are responsible for the quality of the product once opened if not used immediately. They are also responsible for disposing of any unused Ropivacaína Kabi correctly.

Medicines should not be thrown down the drains or in the trash. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Ropivacaína Kabi

• The active ingredient is ropivacaína hydrochloride 2 mg/ml. Each plastic bag of 100 ml contains 200 mg of ropivacaína (hydrochloride).

Each plastic bag of 200 ml contains 400 mg of ropivacaína (hydrochloride).

• The excipients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injection.

Appearance of the product and contents of the pack

Ropivacaína Kabi infusion solution is a transparent and colourless infusion solution.

Ropivacaína Kabi 2 mg/ml infusion solution is available in transparent plastic bags of 100 ml and 200 ml.

Pack sizes:

1 bag with overwrap

5 bags with overwrap

10 bags with overwrap

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005 Barcelona

Spain

Manufacturer responsible

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last update of the summary of product characteristics: November 2024

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”

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This information is intended solely for healthcare professionals:

Handling

Ropivacaína Kabi should only be used by, or under the supervision of, experienced clinical staff in regional anaesthesia (see section 3)

Shelf-life after openingUse immediately.

The Ropivacaína Kabi products are intended for single use. Discard any unused solution.

The medicinal product should be inspected visually before use. The solution should only be used if it is transparent, practically free of particles and if the container is not damaged.

The intact container should not be re-autoclaved. A container in blister pack should be chosen when a sterile environment is required.

Incompatibilities

No incompatibilities have been investigated with other solutions other than those mentioned below.

Precipitation may occur in alkaline solutions, as ropivacaína has low solubility at pH > 6.0.

Compatibility

Ropivacaína infusion solution in plastic bags for infusion is chemically and physically compatible with the following medicinal products: