Summary of Product Characteristics: Information for the User

Ropivacaína Kabi 10 mg/ml injectable 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 10 mg/ml injectable solution EFG”, but in the rest of the 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 10 mg/ml injectable solution is indicated in adults and adolescents over 12 years for insensitizing (anesthetizing) specific parts of the body during 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 if 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 effect. 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 enoxacina)

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, consultyour 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 2.8 mg of sodium (main component of table salt/for cooking) in each milliliter. This is equivalent to 0.14% of the maximum daily sodium intake recommended for an adult.

Ropivacaine 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.

Ropivacaine Kabi will be administered as an injection. The part of the body where it will be used will depend on why you are receiving Ropivacaine Kabi. Your doctor will administer Ropivacaine 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 a zone 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 spinal column)

When Ropivacaine 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 in the area 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 you are receiving the medication and your health, age, and weight.

Treatment duration

The administration of ropivacaine usually lastsbetween 2 and 10 hoursin the case ofpreoperative anesthesiafor certain surgical procedures andup to 72 hoursin the case ofpain reliefduring and after surgery.

If you receive more Ropivacaine Kabi than you should

Severe adverse effects due to the administration of more Ropivacaine Kabi than necessary require special treatment, and the doctor treating you is prepared to handle these situations.

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

• Ear and vision problems (vision)
• Insensitivity 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 cardiac arrest, respiratory arrest, or severe convulsions.

To reduce the risk of severe adverse effects, your doctor will stop administering Ropivacaine 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 Ropivacaine Kabi, inform your doctor or healthcare personnel immediately.

More severe adverse effects from receiving too much Ropivacaine 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 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(can affect more than 1 in 10 people)

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

Common(can affect up to 1 in 10 people)

• Tickling (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(can 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 injection is administered into a blood vessel by mistake, or if too much Ropivacaína Kabi has been administered (see also section 3 “If you receive 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(can 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 10,000), this can cause permanent problems
• If Ropivacaína Kabi is administered into the spinal fluid, the entire body may become numb (anesthetized)
• Receiving an epidural injection (injection into 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 may sometimes cause a condition called Horner 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 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 Vigilance 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.

This medication does not require special storage conditions.

Keep out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the blister, ampoule or box. The expiration date is the last day of the month indicated.

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

Medications should not be thrown down the drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition of Ropivacaine Kabi

• The active ingredient is ropivacaine hydrochloride 10mg/ml. Each 10 ml polypropylene ampoule contains 100 mg of ropivacaine (hydrochloride).

Each 20 ml polypropylene ampoule contains 200 mg of ropivacaine (hydrochloride).

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

Appearance of the product and contents of the package

Ropivacaine Kabi injectable solution is a transparent and colourless solution for injection.

Ropivacaine Kabi 10 mg/ml injectable solution is available in transparent polypropylene ampoules of 10 ml and 20 ml.

Package sizes:

1, 5 and 10 ampoule(s)

1, 5 and 10 ampoule(s) in blister pack

Only some package 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

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) with the following names:

Last review date of this leaflet: 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

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

Shelf-life after opening

Use immediately.

Ropivacaine 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.

Incompatibilities

In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.

Precipitation may occur in alkaline solutions, since ropivacaine has low solubility at pH > 6.0.

Disposal

The unused medicinal product and all materials that have been in contact with it will be disposed of in accordance with local regulations.