Ropivacaine Kabi 2 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ropivacaïne Kabi 2 mg/ml solution for infusion EFG

Ropivacaine hydrochloride

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or any other healthcare professional.
• If you get any side effects, talk to your doctor, nurse or any other healthcare professional. This includes any side effects not listed in this leaflet. See section 4.

The name of this medicine is “Ropivacaïne Kabi 2 mg/ml solution for infusion EFG”, but it will be referred to as “Ropivacaïne Kabi” throughout the rest of this leaflet.

Contents of this leaflet:

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

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

• Ropivacaine Kabi contains ropivacaine hydrochloride
• It belongs to a group of medicines called local anaesthetics

Ropivacaine Kabi 2 mg/ml solution for infusion is indicated in adults and children of all ages for the treatment of acute pain. It numbs (anaesthetizes) parts of the body, e.g., after surgery.

2. What you need to know before Ropivacaine Kabi is administered to you

Ropivacaine Kabi will not be given to you if:

• you are allergic (hypersensitive) to ropivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
• you are allergic to any other local anaesthetic of the same class (such as lidocaine or bupivacaine)
• you have been diagnosed with reduced plasma volume (hypovolemia)
• it is intended to be injected directly into the bloodstream to numb a specific area of your body
• or into the cervix to relieve pain during childbirth

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

Warnings and precautions

Special care must be taken to avoid any injection of Ropivacaine Kabi directly into the bloodstream, to prevent any immediate toxic effects. It must not be injected into inflamed areas.

Inform your doctor, nurse, or any other healthcare professional before Ropivacaine Kabi is administered:

• if your general health condition is poor due to age or other factors
• if you have heart problems (complete or partial blockage of cardiac conduction)
• if you have severe liver disease
• if you have severe kidney problems

Inform your doctor if you have any of these conditions, as a dose adjustment of Ropivacaine Kabi may be necessary.

Inform your doctor, nurse, or any other healthcare professional before Ropivacaine Kabi is administered:

• if you suffer from acute porphyria (a disorder in the production of blood pigment, which may sometimes cause neurological symptoms)

Inform your doctor if you or a family member has porphyria, as another anaesthetic may need to be used.

Tell your doctor about any medical conditions or illnesses you have before starting treatment.

Children

Special caution is required:

• In newborns, as they are more susceptible to Ropivacaine Kabi 2 mg/ml solution for infusion
• In children under 12 years of age, as certain uses of Ropivacaine Kabi 2 mg/ml solution for infusion for numbing body parts have not yet been established

Use of Ropivacaine Kabi with other medicines

Tell your doctor or healthcare professional if you are taking, have recently taken, or might need to take any other medicines. This is because Ropivacaine Kabi may affect how some medicines work, and other medicines may affect Ropivacaine Kabi.

In particular, inform your doctor if you are taking any of the following medicines:

• Other local anaesthetics
• Strong painkillers, such as morphine or codeine
• Medicines used to treat irregular heartbeats (arrhythmia), such as lidocaine or mexiletine

Your doctor needs to know this in order to calculate the correct dose of Ropivacaine Kabi for you.

Additionally, inform your doctor if you are taking any of the following medicines:

• Medicines for depression (such as fluvoxamine)
• Antibiotics used to treat bacterial infections (such as enoxacin)

This is because your body eliminates Ropivacaine Kabi more slowly if you are taking these medicines. If you are taking any of these medicines, prolonged use of Ropivacaine Kabi should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before this medicine is administered.

It is unknown whether ropivacaine affects pregnancy or passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Ropivacaine Kabi may cause drowsiness and affect your reaction speed. Do not drive or operate tools or machinery after receiving Ropivacaine Kabi until the following day.

Ropivacaine Kabi contains sodium chloride.

This medicine contains 3.4 mg of sodium (a main component of table/cooking salt) per millilitre. This corresponds to 0.17% of the maximum daily recommended sodium intake for an adult.

3. How to use Ropivacaine Kabi

Ropivacaine Kabi will be administered to you by a doctor. The dose your doctor gives you will depend on the type of pain relief you need, as well as your size, age, and physical condition.

Ropivacaine Kabi will be given as an infusion. The part of the body where it is administered will depend on why you are receiving Ropivacaine Kabi. Your doctor will administer Ropivacaine Kabi at one of the following sites:

• The part of the body that needs to be numbed
• Near the part of the body that needs to be numbed
• In an area distant from the part of the body that needs to be numbed. This is the case when an epidural infusion (into the area near the spine) is given

When Ropivacaine Kabi is used in one of these ways, it prevents nerves from sending pain signals to the brain. It prevents you from feeling pain, heat, or cold in the treated area, but you may still experience other sensations such as pressure or touch.

Your doctor knows the correct way to administer this medicine.

Dosage

The dose used will depend on why the medicine is being given, as well as your health, age, and weight.

Duration of treatment

Administration of ropivacaine usually lasts between 0.5 and 6 hours, but may last up to 72 hours in cases of pain relief during and after surgery.

If you are given more Ropivacaine Kabi than you should

Serious adverse effects due to receiving too much Ropivacaine Kabi require special treatment, and the doctor treating you is prepared to manage such situations.

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

• Ear and vision (visual) disturbances
• Numbness of lips, tongue, and around the mouth
• Dizziness or mild lightheadedness
• Tingling
• Speech disturbances characterized by poor articulation (dysarthria)
• Muscle stiffness, muscle twitching, seizures
• Low blood pressure
• Slow or irregular heart rate

These symptoms may precede cardiac arrest, respiratory arrest, or severe seizures.

To reduce the risk of serious adverse effects, your doctor will stop the administration of Ropivacaine Kabi as soon as these signs appear. This means that if any of these signs occur in you, or if you think you may have received too much Ropivacaine Kabi, inform your doctor or healthcare professional immediately.

More serious adverse effects from receiving too much Ropivacaine Kabi include speech difficulties, muscle stiffness, tremors, agitation, seizures (fits), and loss of consciousness.

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

4. Possible adverse effects

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

Important adverse effects to be aware of:

Sudden life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare, affecting between 1 and 10 out of 10,000 patients. Possible symptoms include:

• sudden appearance of rash,
• itching or irritation (urticaria),
• swelling of the face, lips, tongue, or other body parts,
• shortness of breath, difficulty breathing,
• feeling faint or losing consciousness.

If you think Ropivacaine Kabi is causing you an allergic reaction, inform your doctor or healthcare professional immediately.

Other possible adverse 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)

• Tingling (paraesthesia)
• Dizziness
• Headache
• Slow or fast heart rate (bradycardia, tachycardia)
• High blood pressure (hypertension)
• Vomiting
• Difficulty urinating (urinary retention)
• High body temperature (fever), trembling (chills)
• Muscle stiffness (rigor)
• Back pain

Uncommon (may affect up to 1 in 100 people)

• Anxiety
• Decreased skin sensitivity
• Fainting
• Breathing difficulties
• Low body temperature (hypothermia)

Some symptoms may occur if the infusion is accidentally administered into a blood vessel, or if too much Ropivacaine Kabi has been given (see also section 3 “If you are given more Ropivacaine Kabi than you should” above). These include seizures (fits), feeling dizzy or lightheaded, numbness of the lips and around the mouth, tongue numbness, hearing problems, vision problems, speech difficulties, 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):

• Horner’s syndrome

Other possible side effects include:

• Numbness due to nerve irritation caused by the needle or injection. This is usually not long-lasting
• Involuntary muscle movements (dyskinesia)

Possible adverse effects observed with other local anaesthetics that may also occur with Ropivacaine Kabi include:

• Nerve damage. Rarely (affects between 1 and 10 out of 10,000 patients), this may cause permanent problems
• If Ropivacaine Kabi is administered into the spinal fluid, the entire body may become numb (anaesthetized)
• Receiving an epidural injection (injection into the space around the spinal nerves) may interrupt a nerve pathway from the brain to the head and neck, especially in pregnant women, which may sometimes lead to a condition called Horner’s syndrome. This is characterized by reduced pupil size, drooping of the upper eyelid, and lack of sweating from the sweat glands. It will resolve on its own once treatment is stopped.

Children

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

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ropivacaine Kabi

Keep 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 indicated.

Store below 30°C.

Do not use this medicine if a precipitate is observed in the infusion solution.

Normally, your doctor or hospital will store Ropivacaine Kabi and is responsible for maintaining the quality of the product once opened, if it is not used immediately. They are also responsible for the proper disposal of any unused Ropivacaine Kabi.

Medicines must not be disposed of via wastewater or household waste. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ropivacaine Kabi

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

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

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

Appearance of the product and contents of the pack

Ropivacaine Kabi solution for infusion is a clear, colourless solution for infusion.

Ropivacaine Kabi 2 mg/ml solution for infusion 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 Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005 Barcelona

Spain

Manufacturer

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

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

Date of the most recent review of this leaflet: November 2024

"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS): http://www.aemps.gob.es/"

This information is intended for healthcare professionals only:

Handling

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

Shelf life after opening Use immediately.

Ropivacaine Kabi products are for single use only. Any unused solution should be discarded.

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

Intact containers must not be re-autoclaved. A blister pack container should be selected when a sterile environment is required.

Incompatibilities

Compatibility with solutions other than those mentioned below has not been investigated.

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

Compatibility

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

• The concentration ranges indicated in the table are wider than those used in clinical practice. Epidural infusions of Ropivacaína Kabi/sufentanil citrate, Ropivacaína Kabi/morphine sulfate, and Ropivacaína/clonidine have not been evaluated in clinical studies.

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

Disposal

Disposal of unused medicinal product and of all materials that have come into contact with it must be carried out in accordance with local regulations.