Ropivacaine B. Braun 2 mg/ml solution for injection and infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ropivacaine B. Braun 2 mg/ml solution for injection and infusion EFG

Ropivacaine hydrochloride

Read the entire leaflet carefully before you start receiving 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 or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ropivacaine B. Braun is and what it is used for

The active substance is ropivacaine hydrochloride.

Ropivacaine B. Braun belongs to a group of medicines called local anaesthetics (medicines for numbing). Ropivacaine B. Braun injection and infusion solution is used in adults and children of any age for the relief of acute pain. It numbs (anaesthetizes) parts of the body, e.g. after surgery.

2. What you need to know before you start receiving Ropivacaine B. Braun

Do not use Ropivacaine B. Braun

• If you are allergic to ropivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• If you are allergic to any other local anaesthetic of the same class (e.g. lidocaine or bupivacaine).
• For injection into a blood vessel to numb a specific area of your body, or into the cervix to relieve pain during childbirth.
• If you have been told you have reduced blood volume (hypovolemia).

If you are unsure whether any of the above apply to you, speak with your doctor before receiving Ropivacaine B. Braun.

Warnings and precautions

Talk to your doctor before starting treatment with Ropivacaine B. Braun. Inform your doctor:

• If you have heart, liver, or kidney problems. Your doctor may need to adjust the dose of Ropivacaine B. Braun.
• If you have ever been diagnosed with a rare blood pigment disorder called "porphyria" or if anyone in your family has it. Your doctor may need to give you a different anaesthetic medicine.
• If you are in a weakened state due to advanced age or other reasons.
• About any medical condition or health problem you currently have or have had in the past.

Children

Your doctor will exercise special caution:

• With newborns, as they are more sensitive to ropivacaine.
• With children aged 12 years or younger, as the use of ropivacaine injections to numb parts of the body has not been established in younger children.

Your doctor will carefully adjust the required dose for your child and will monitor them closely.

Use of Ropivacaine B. Braun with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is especially important with the following medicines, which may increase the effects of Ropivacaine B. Braun:

• Other local anaesthetics (e.g. lidocaine),
• Strong painkillers (e.g. morphine),
• Medicines used to treat irregular heartbeat (e.g. amiodarone, mexiletine).

Prolonged use of ropivacaine should be avoided if you are being given:

• Medicines used to treat depression (e.g. fluvoxamine),
• Antibiotics used to treat bacterial infections (e.g. enoxacin).

It may still be appropriate for you to receive Ropivacaine B. Braun while on these treatments. Your doctor needs to know so they can decide what is suitable for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine.

It is unknown whether ropivacaine passes into breast milk or if it could harm a nursing infant.

Driving and use of machines

Ropivacaine B. Braun may cause drowsiness and affect your reaction ability. After receiving this medicine, you must not drive, operate machinery, or work in hazardous situations until the following day.

Ropivacaine B. Braun contains sodium

This medicine contains 3.3 mg of sodium (main component of table/cooking salt) per ml.

This corresponds to 0.17% of the maximum recommended daily sodium intake for an adult.

3. How Ropivacaine B. Braun will be administered to you

This medicine will be administered to you by an experienced doctor or under the supervision of one. Ropivacaine B. Braun will be given as an injection or infusion. The part of the body where it will be administered depends on the reason for which this medicine is being used.

Your doctor will administer this medicine 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.
• At a site distant from the part of the body that needs to be numbed. This is the case when you receive an epidural injection or infusion in the middle or lower back near the spine.

While you are receiving Ropivacaine B. Braun, you will be closely monitored by healthcare professionals. This medicine prevents nerves from transmitting pain signals to the brain. You will no longer feel pain, heat, or cold in the treated area, but you may still perceive other sensations such as pressure or touch.

Dosage

Your doctor will determine the dose of Ropivacaine B. Braun to be administered to you. The dosage depends on the type of pain relief you require and other factors such as body build, age, and physical condition.

If you are given more Ropivacaine B. Braun than you should

Since this medicine will be administered by a doctor under carefully controlled conditions, it is unlikely that you will receive too high a dose or that a dose will be omitted.

Serious side effects due to receiving too much Ropivacaine B. Braun require special treatment. Your doctor is trained to manage such situations.

The first signs of having received too much Ropivacaine B. Braun usually include:

• feeling dizzy or lightheaded,
• numbness of the lips and around the mouth,
• numbness of the tongue,
• hearing disturbances,
• vision problems.

Your doctor will stop administering this medicine as soon as these signs appear, in order to reduce the risk of serious adverse effects. This means that if you experience any of these symptoms or think you have received too much Ropivacaine B. Braun, you must inform your doctor immediately.

More serious adverse effects from receiving an excessive amount of this medicine may include, among others, speech difficulties, muscle spasms, tremors, shivering (seizures), and loss of consciousness.

In case of acute toxicity, healthcare professionals will immediately take appropriate corrective actions.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

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

All medicines, including Ropivacaine B. Braun, may rarely cause allergic reactions such as anaphylaxis, including anaphylactic shock (may affect up to 1 in 1,000 people). You must inform your doctor immediately if you experience any of the following symptoms after receiving this medicine:

• sudden appearance of rash, itching, or hives;
• swelling of the eyelids, face, lips, tongue, throat, or other parts of the body;
• difficulty breathing, sudden wheezing, dizziness;
• a feeling of losing consciousness.

Other possible adverse effects

Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

• Tingling.
• Dizziness.
• Feeling sick (vomiting).
• Slow or fast heartbeat (bradycardia, tachycardia).
• High blood pressure (hypertension).
• High body temperature (fever) or chills (shivering).
• Back pain.
• Headache.
• Difficulty urinating.

Uncommon (may affect up to 1 in 100 people)

• Anxiety.
• Fainting.
• Difficulty breathing.
• Low body temperature (hypothermia).
• Some symptoms may occur if the injection is accidentally administered into a blood vessel or if too much Ropivacaine B. Braun is given (see section "If you are given more Ropivacaine B. Braun than you should" above). These include, among others, seizures, fits, feeling dizzy or lightheaded, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, speech problems, rigid muscles, decreased skin sensitivity or sensation, and tremor.

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

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

Frequency not known (cannot be estimated from available data)

• Involuntary movements (dyskinesia)

Possible adverse effects observed with other local anaesthetics that could also be caused by Ropivacaine B. Braun:

• Nerve damage. Rarely, this may lead to permanent problems.
• The entire body may become numb (anaesthetized) if too much Ropivacaine B. Braun is injected into the cerebrospinal fluid.

Children

In infants and children, adverse effects are the same as in adults, except for low blood pressure, which occurs less frequently in infants and children (affects up to 1 in 10 children), and feeling sick, which occurs more frequently in children (affects more than 1 in 10 children).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ropivacaine B. Braun

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container and label after "EXP". The expiry date refers to the last day of the month indicated.

Do not freeze.

Your doctor or pharmacist is responsible for the storage of this medicine. They are also responsible for the proper disposal of any unused medicine.

6. Contents of the container and other information

Composition of Ropivacaine B. Braun

The active substance is ropivacaine hydrochloride.

1 ml of Ropivacaine B. Braun contains 2 mg of ropivacaine hydrochloride (as monohydrate ropivacaine hydrochloride).

1 vial of 10 ml solution contains 20 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.

1 vial of 20 ml solution contains 40 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.

1 bottle of 100 ml solution contains 200 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.

1 bottle of 200 ml solution contains 400 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.

1 bottle of 400 ml solution contains 800 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.

1 bottle of 500 ml solution contains 1000 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.

The other components are sodium chloride, hydrochloric acid 0.36% (for pH adjustment), sodium hydroxide 0.4% (for pH adjustment), and water for injections.

Presentation of the product and contents of the pack

Ropivacaine B. Braun is a clear, colourless solution for injection and infusion, available in:

• Polyethylene vials of 10 ml in packs of 20.

• Polyethylene vials of 20 ml in packs of 20.

• Polyethylene bottles of 100 ml in packs of 1 and 10.

• Polyethylene bottles of 200 ml in packs of 1 and 10.

• Polyethylene bottles of 400 ml in packs of 1 and 10.

• Polyethylene bottles of 500 ml in packs of 1 and 10.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

• Braun Melsungen AG

Carl-Braun-Strasse 1 Postal address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Telephone: +49/5661/71-0

Fax: +49/5661/71-4567

Manufacturer

• Braun Melsungen AG

Carl-Braun-Strasse 1 Postal address:

34212 Melsungen, Germany 34209 Melsungen, Germany

• Braun Medical, SA

Carretera de Terrassa, 121

08191 – Rubí (Barcelona) – Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

1. Ropivacaine B. Braun 2 mg/ml solution for injection and infusion

Austria, Germany, Luxembourg: Ropivacain-HCl B. Braun 2 mg/ml Injektions-/Infusionslösung

Denmark: Ropivacaine B. Braun

Estonia: Ropivacaine B. Braun 2 mg/ml

1. Finland: Ropivacaine B. Braun 2 mg/ml injektio-/infuusioneste, liuos
2. France: Ropivacaine B. Braun 2 mg/ml, solution injectable/pour perfusion
3. Italy: Ropivacaina B. Braun 2 mg/ml soluzione iniettabile o per infusione
4. Latvia: Ropivacaine B. Braun 2 mg/ml škidums injekcijam/infuzijam
5. Lithuania: Ropivacaine B. Braun 2 mg/ml injekcinis ar infuzinis tirpalas
6. Sweden: Ropivacaine B. Braun 2 mg/ml injektions-/infusionsvätska, lösning
7. Netherlands: Ropivacaïne HCl B. Braun 2 mg/ml, oplossing voor injectie of infusie
8. Portugal: Ropivacaína B. Braun 2 mg/ml, solução injetável ou para perfusão
9. Spain: Ropivacaina B. Braun 2 mg/ml solución inyectable y para perfusión

Date of the most recent revision of this leaflet: 10/2023

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

This information is intended for healthcare professionals only:

Method of administration

Careful aspiration is recommended before and during injection to prevent intravascular injection. When administering a higher dose, a test dose of lidocaine with adrenaline (epinephrine) is advised. Accidental intravascular injection may be recognized by a temporary increase in heart rate, and accidental intrathecal injection by signs of spinal block.

Ropivacaine hydrochloride should be injected slowly or in incremental doses at a rate of 25–50 mg/min, with continuous monitoring of the patient's vital functions and maintenance of verbal contact. If symptoms of toxicity occur, administration must be stopped immediately.

Warnings

Regional anaesthesia procedures should always be performed in adequately equipped areas with trained personnel. Equipment and medications necessary for monitoring and emergency resuscitation must be readily available at all times.

Patients undergoing major blocks should be in optimal general condition and should have an intravenous line inserted before the block procedure.

The responsible physician must take necessary precautions to avoid intravascular injection (see section 4.2 of the Summary of Product Characteristics) and must be adequately trained and familiar with the diagnosis and treatment of adverse effects, systemic toxicity, and other complications (see sections 4.8 and 4.9 of the Summary of Product Characteristics), such as accidental subarachnoid injection, which may result in high spinal block with apnoea and hypotension. Seizures have occurred more frequently following brachial plexus block and epidural block, likely due to accidental intravascular injection or rapid absorption from the injection site.

Nerve trunk blocks may involve administration of a large volume of local anaesthetic in highly vascularized areas, often near large vessels, where there is a higher risk of intravascular injection and/or rapid systemic absorption, potentially leading to high plasma concentrations.

Patients with hypovolaemia due to any cause may develop sudden, severe hypotension during epidural anaesthesia, regardless of the local anaesthetic used.

Handling

Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.

For single use only.

The medicine should be inspected visually before use.

It should only be used if the solution is clear and colourless and if the vials and their closures are intact.

Shelf life after first opening of the container

From a microbiological standpoint, unless the method of opening excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the times and conditions of storage during use are the responsibility of the user.

Refer to the Summary of Product Characteristics for instructions on incompatibilities and all prescribing-related information.