ROPIVACAINE B. BRAUN

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Ropivacaine hydrochloride
Please read 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 or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS ROPIVACAINE B. BRAUN AND WHAT IS IT USED FOR?

The active substance is ropivacaine hydrochloride.
Ropivacaine B. Braun belongs to a group of medicines called local anaesthetics (numbing agents).
Ropivacaine B. Braun injection solution or for infusion is used in adults and children of all ages for the management of acute pain. It numbs (anaesthetizes) parts of the body, e.g. after surgical procedures.

2. WHAT YOU SHOULD KNOW BEFORE RECEIVING ROPIVACAINE B. BRAUN

Ropivacaine B. Braun must not be administered to you 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 present as skin rash, itching, difficulty breathing, or swelling of the face, lips, throat or tongue.
• You are allergic to another local anaesthetic of the same class (e.g. lidocaine or bupivacaine).
• For injection into a blood vessel to numb a specific area of the body or into the cervix to control pain during childbirth.
• If you have been diagnosed with reduced blood volume (hypovolemia).

If you are unsure whether any of these conditions apply to you, consult your doctor before receiving Ropivacaine B. Braun.

Warnings and precautions

Before receiving Ropivacaine B. Braun, consult your doctor. Talk to 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 been diagnosed with a rare blood pigment disorder called "porphyria" or if anyone in your family has this condition. Your doctor may need to administer a different anaesthetic.
• If your general health is poor due to advanced age or other reasons.
• Regarding any medical conditions you currently have or have had in the past.

Children

Your doctor will exercise particular caution:

• In newborn infants, as they are more sensitive to ropivacaine.
• In children under 12 years of age, because certain ropivacaine injections used to numb parts of the body have not yet been established in younger children. The doctor will adjust the dose required for your child and monitor them closely.

Other medicines and Ropivacaine B. Braun

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important with the following medicines, which may increase the effect 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 taking:

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

Even in these cases, you may still receive Ropivacaine B. Braun. However, your doctor must be informed about these medicines in order to decide what is appropriate for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before being given any medicine. It is not known whether ropivacaine is excreted in breast milk or whether it could harm breastfed infants.

Driving and using machines

Ropivacaine B. Braun may cause drowsiness and affect reaction speed. If you have been given this medicine, do 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 (the main component of table salt) per ml. This is equivalent to 0.17% of the maximum daily dietary intake of sodium for an adult.

3. HOW TO USE ROPIVACAINA B. BRAUN

This medicine will be administered to you by a doctor or under the supervision of an experienced doctor.
Ropivacaina B. Braun will be given to you by injection or as an infusion. The part of the body where it
will be administered depends on the reason for which this medicine is being given to you.
Your doctor will inject it into one of the following areas:

• The part of the body that needs to be numbed.
• Near the part of the body that needs to be numbed.
• An area distant from the part of the body that needs to be numbed. This applies to epidural injection or infusion administered in the lower or middle back near the spine.
  You will be closely monitored by healthcare professionals while Ropivacaina B. Braun is being administered.
  This medicine blocks the nerves, preventing them from sending pain signals to the brain. It prevents you from feeling pain, heat, or cold in the area where the drug is used, but you will still perceive other sensations such as pressure or touch.

Dosage
Your doctor will determine the dose of Ropivacaina B. Braun to administer. The dosage depends on the type of pain to be controlled or other factors such as body size, age, and physical condition.

If you receive more Ropivacaina B. Braun than you should

Since this medicine is generally administered by a doctor under carefully controlled conditions, it is unlikely that you will receive too much of the medicine or that a dose will be forgotten.
Side effects from excessive administration of Ropivacaina B. Braun require special treatment, and the attending physician is prepared to manage these situations.
The first signs indicating that you have received too much Ropivacaina B. Braun are usually the following:

• dizziness or feeling lightheaded;
• numbness of the lips and around the mouth;
• numbness of the tongue;
• hearing problems;
• vision problems.

Your doctor will stop administering this medicine as soon as these symptoms appear, in order to reduce the risk of serious side effects. This means that if you experience any of these symptoms, or think you have received too much Ropivacaina B. Braun, you must inform your doctor immediately.
More severe side effects resulting from excessive administration of this medicine include difficulty speaking, muscle spasms, tremors, seizures (convulsions), and loss of consciousness. In case of acute toxicity, appropriate corrective measures will be taken by healthcare professionals.
If you have any doubts about the use of this medicine, consult your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
All medicines, including Ropivacaine B. Braun, can rarely cause life-threatening allergic reactions (may occur in more than 1 in 1,000 people). Inform your doctor immediately if any of the following symptoms occur after administration of this medicine:

• sudden appearance of skin rash, itching, or hives,
• swelling of the eyes, face, lips, tongue, throat, or any other part of the body,
• difficulty breathing, sudden wheezing, dizziness.

Other possible adverse reactions

Very common (occurs in more than 1 in 10 people)

• low blood pressure (hypotension) (you may feel dizzy or lightheaded);
• feeling unwell (nausea).

Common (occurs in up to 1 in 10 people)

• paresthesia;
• dizziness;
• feeling unwell (vomiting);
• slow or fast heart rate (bradycardia, tachycardia);
• high blood pressure (hypertension);
• elevated body temperature (fever) or chills;
• back pain;
• headache;
• difficulty urinating.

Uncommon (occurs in up to 1 in 100 people)

• anxiety;
• fainting;
• difficulty breathing;
• low body temperature (hypothermia);
• certain symptoms may occur if the injection is accidentally administered into a blood vessel or if too much Ropivacaine B. Braun is given (see also "If you receive more Ropivacaine B. Braun than you should" above). These include seizures (convulsions), dizziness or lightheadedness, numbness of the lips, around the mouth and tongue, hearing problems, vision problems (visual disturbances), speech difficulties, muscle stiffness, reduced skin sensitivity or sensation, and tremors.

Rare (occurs in up to 1 in 1,000 people)

• heart attack (cardiac arrest);
• irregular heartbeat (arrhythmia).

Not known (frequency cannot be estimated from available data)

• jerky movements (dyskinesia)

Possible side effects observed with other local anesthetics that could also be caused by Ropivacaine B. Braun

• Nerve damage. This rarely causes permanent problems.
• The entire body may become numb (anesthetized), if too high a dose of Ropivacaine B. Braun has been injected into the spinal fluid.

Children
In infants and children, adverse reactions are the same as those seen in adults, except for low blood pressure, which is less frequent in infants and children (occurs in up to 1 in 10 children), and vomiting, which is more frequent in children (occurs in more than 1 in 10 children).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE ROPIVACAINA 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 carton and label after "Exp.". The expiry date refers to the last day of that month.
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. PACK CONTENTS AND OTHER INFORMATION

What Ropivacaine B. Braun contains
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 injectable solution/for infusion contains 20 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.
1 vial of 20 ml injectable solution/for infusion contains 40 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.
1 bottle of 100 ml injectable solution/for infusion contains 200 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.
1 bottle of 200 ml injectable solution/for infusion contains 400 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.
1 bottle of 400 ml injectable solution/for infusion contains 800 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.
1 bottle of 500 ml injectable solution/for infusion 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.

Description of the appearance of Ropivacaine B. Braun and pack contents
Ropivacaine B. Braun is a clear, colourless injectable or infusion solution 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.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun Strasse, 1
34212 Melsungen
Germany

Manufacturer
B. Braun Melsungen AG
Mistelweg, 2
12357 Berlin
Germany
B. Braun Medical S.A.
Crta. de Terrassa, 121 (Rubí (Barcelona))
08191 – Spain

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria, Germany, Luxembourg: Ropivacain-HCl B. Braun 2 mg/ml Injektions-/Infusionslösung;
Belgium: Ropivacaïn HCl B. Braun 2 mg/ml, oplossing voor injectie of infusie;
Denmark: Ropivacain B. Braun 2 mg/ml;
Estonia: Ropivacaine B. Braun 2 mg/ml, süste-/infusioonilahus;
Finland: Ropivacaine B. Braun 2 mg/ml, injektio-/infuusioneste, liuos;
France: Ropivacaine B Braun 2 mg/ml, solution injectable/pour perfusion;
Greece: Ropivacain HCI B. Braun 2 mg/ml, solution for injection/infusion;
Hungary: Ropivacain B. Braun 2 mg/ml oldatos injekció;
Italy: Ropivacaina B. Braun 2 mg/ml, soluzione iniettabile o per infusione;
Latvia: Ropivacaine B. Braun 2 mg/ml šķīdums injekcijām/infūzijām;
Lithuania: Ropivacaine B. Braun 2 mg/ml injekcinis ar infuzinis tirpalas;
Netherlands: Ropivacaïne HCl B. Braun 2 mg/ml, oplossing voor injectie of infusie;
Portugal: Ropivacaína B. Braun 2 mg/ml, solução injetável ou para perfusão;
Spain: Ropivacaina B. Braun 2 mg/ml solución inyectable y para perfusión;
Sweden: Ropivacaine B. Braun 2 mg/ml injektions-/infusionsvätska, lösning.

This leaflet was last approved in 06/2018.

The following information is intended for healthcare professionals only:

Method of administration
Careful aspiration is recommended before and during injection to prevent intravascular injection. When a large dose is to be administered, a test dose of lidocaine with adrenaline (epinephrine) is recommended. Unintended intravascular injection may be recognized by a transient increase in heart rate, and accidental intrathecal injection by signs of spinal block.
Ropivacaine hydrochloride must 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 toxic symptoms occur, the injection must be stopped immediately.

Warnings
Regional anaesthetic procedures must always be performed in appropriately equipped areas with trained personnel.
Equipment and medicinal products necessary for monitoring and emergency resuscitation must be immediately available.
Patients receiving major blocks should be in optimal condition and have an intravenous line inserted before the block procedure.
The responsible clinician must take necessary precautions to avoid intravascular injection (see Summary of Product Characteristics, section 4.2) and must be adequately trained and experienced in the diagnosis and management of adverse effects, systemic toxicity, and other complications (see Summary of Product Characteristics, sections 4.8 and 4.9), as accidental subarachnoid injection may cause high spinal block with apnoea and hypotension.
Seizures may very commonly occur after brachial plexus block and epidural block. This is likely due to either accidental intravascular injection or rapid absorption from the injection site.
Major peripheral nerve blocks may involve administration of large volumes of local anaesthetic in highly vascular areas, often near large vessels, where there is a high risk of intravascular injection and/or rapid systemic absorption, potentially leading to high plasma concentrations.
Patients with hypovolaemia due to any cause may develop immediate and severe hypotension during epidural anaesthesia, regardless of the local anaesthetic used.

Handling
Unused or waste medicinal product must be disposed of in accordance with local requirements.
For single use only.
This medicinal product should be inspected visually before use.
Use only if the solution is clear and transparent and the container and closure are intact.

Stability after first opening of the container
From a microbiological standpoint, although the method of opening minimizes 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 information on incompatibilities and complete prescribing information.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ropivacaine B. Braun 5 mg/ml solution for injection

Ropivacaine hydrochloride
Please read this leaflet carefully before receiving 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 or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

7. What Ropivacaine B. Braun is and what it is used for.
8. What you need to know before receiving Ropivacaine B. Braun.
9. How Ropivacaine B. Braun will be administered to you.
10. Possible side effects.
11. How Ropivacaine B. Braun is stored.
12. 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 (numbing medicines).
Ropivacaine B. Braun is administered as an injection into the area around the spinal cord (intrathecal injection). It is used to numb (anaesthetize) the part of the body where surgery will be performed. It is injected into the lower part of the spine. This immediately blocks the sensation of pain from the waist down for a short period of time (usually 1 to 2 hours). This effect is known as a "spinal block" (or "spinal anaesthesia").

2. What you need to know before 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 present as skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• If you are allergic to another local anaesthetic of the same class (e.g. lidocaine or bupivacaine).
• For injection into a blood vessel to numb a specific area of the body or into the cervix to control pain during childbirth.
• If you have been diagnosed with reduced blood volume (hypovolaemia).

If you are unsure whether any of these conditions apply to you, you must consult your doctor before being administered Ropivacaine B. Braun.
Warnings and precautions
Talk to your doctor before receiving Ropivacaine B. Braun. Consult 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 been diagnosed with a rare blood pigment disorder called "porphyria" or if someone in your family has it, your doctor may need to administer a different anaesthetic.
• If your general health is poor due to advanced age or other reasons.
• For any medical conditions you currently have or have had in the past.

Children
Ropivacaine B. Braun injections into the lower spine have not been studied in infants, toddlers, or children.
Caution is recommended when administering Ropivacaine B. Braun to children under 1 year of age, as the use of ropivacaine in injections to numb specific body areas has not yet been established in younger children.

Other medicines and Ropivacaine B. Braun
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important with the following medicines, which may increase the effect 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 taking:

• medicines used to treat depression (e.g. fluvoxamine);
• antibiotics used to treat bacterial infections (e.g. enoxacin).
  Even in these cases, you may still receive Ropivacaine B. Braun. Your doctor must be informed about these medicines in order to decide what is appropriate for you.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine. It is not known whether ropivacaine is excreted in breast milk or whether it could cause harm to breastfed infants.

Driving and using machines
Ropivacaine B. Braun may cause drowsiness and affect reaction speed. If you have been given this medicine, do not drive, operate machinery, or work in hazardous situations until the following day.

Ropivacaine B. Braun contains sodium
This medicine contains 3.1 mg of sodium (the main component of table salt) per ml. This corresponds to 0.16% of the maximum daily sodium intake for an adult.

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

This medicine will be administered to you by a doctor or under the supervision of an experienced doctor.
Ropivacaine B. Braun will be given to you by injection.
The injection will be administered intrathecally, that is, through a needle into an area of the lower or middle back near the spinal column.
You will be closely monitored by healthcare professionals while Ropivacaine B. Braun is being administered. This medicine blocks the nerves, preventing them from sending pain signals to the brain. It prevents you from feeling pain, heat, or cold in the area where the drug is used, but you will still experience other sensations such as pressure or touch.

Dosage
Your doctor will determine the dose of Ropivacaine B. Braun to be administered. The dosage depends on your body size, age, and physical condition.

If you receive more Ropivacaine B. Braun than you should
Since this medicine is generally administered by a doctor under carefully controlled conditions, it is unlikely that you will receive too much medicine or that a dose will be forgotten.
Serious side effects due to excessive administration of Ropivacaine B. Braun require special treatment, and your doctor is prepared to manage these situations.
The first signs of having received too much Ropivacaine B. Braun are generally the following:

• dizziness or feeling lightheaded;
• numbness of the lips and around the mouth;
• numbness of the tongue;
• hearing disturbances;
• visual disturbances.

Your doctor will stop administering this medicine as soon as these symptoms appear, in order to reduce the risk of serious side effects. This means that if you experience any of these symptoms, or if you think you have received too much Ropivacaine B. Braun, you must inform your doctor immediately. More severe side effects resulting from excessive administration of this medicine include speech difficulties, muscle spasms, tremors, seizures (convulsions), and loss of consciousness. In case of acute toxicity, healthcare personnel will immediately take appropriate corrective actions.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
All medicines, including Ropivacaine B. Braun, can rarely cause life-threatening allergic reactions (may occur in up to 1 in 1,000 people). Inform your doctor immediately if any of the following symptoms occur after administration of this medicine:

• sudden appearance of skin rash, itching, or hives,
• swelling of the eyelids, face, lips, tongue, throat, or any other part of the body,
• difficulty breathing, sudden wheezing, dizziness.

Other possible side effects:
Very common (affects more than 1 in 10 people)

• low blood pressure (hypotension) (you may feel dizzy or lightheaded);
• feeling unwell (nausea);

Common (affects up to 1 in 10 people)

• paresthesia;
• dizziness;
• feeling unwell (vomiting)*;
• slow or fast heart rate (bradycardia*, tachycardia);
• high blood pressure (hypertension);
• elevated body temperature (fever) or chills;
• back pain;
• headache*;
• difficulty urinating*.

Uncommon (affects 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 also "If you receive more Ropivacaine B. Braun than you should" above). These include seizures, convulsive seizures (convulsive attacks), dizziness or lightheadedness, numbness of the lips, around the mouth and tongue, hearing problems, vision problems (vision), speech difficulties, reduced skin sensitivity or sensation*, muscle twitching and muscle spasm.

Rare (affects up to 1 in 1,000 people)

• heart attack (cardiac arrest);
• irregular heartbeat (arrhythmia);
  Not known (frequency cannot be estimated from the available data)
• jerky movements (dyskinesia)

* These reactions are more frequent than indicated after intrathecal administration.
Possible side effects of other local anesthetics that could also be caused by Ropivacaine B. Braun

• Nerve damage. Rarely causes permanent problems.
• It is possible that your entire body becomes numb (anesthetized), if too high a dose of Ropivacaine B. Braun has been injected into the spinal fluid.

Children
In infants and children, side effects are the same as those seen in adults, except for low blood pressure, which is less common in infants and children (affects less than 1 in 10 children), and vomiting, which is more common in children (affects more than 1 in 10 children).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. How Ropivacaine B. Braun is stored

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following "Exp.". The expiry date refers to the last day of that month.
Do not freeze.
The doctor or pharmacist is responsible for the storage of this medicine. They are also responsible for the proper disposal of any unused medicine.

6. Package contents and other information

What Ropivacaine B. Braun contains
The active substance is ropivacaine hydrochloride.
1 ml of Ropivacaine B. Braun contains 5 mg of ropivacaine hydrochloride (as monohydrate
ropivacaine hydrochloride).
One 10 ml vial of injectable solution contains 50 mg of ropivacaine hydrochloride (as
ropivacaine hydrochloride).
One 20 ml vial of injectable solution contains 100 mg of ropivacaine hydrochloride (as
ropivacaine hydrochloride).
The excipients are sodium chloride, hydrochloric acid 0.36% (for pH adjustment), sodium hydroxide
0.4% (for pH adjustment), and water for injections.

Description of the appearance of Ropivacaine B. Braun and package contents
Ropivacaine B. Braun is a clear, colourless injectable solution.
Ropivacaine B. Braun 5 mg/ml solution for injection is available in:

• Polyethylene vials of 10 ml in packs of 20;
• Polyethylene vials of 20 ml in packs of 20.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun Strasse, 1
34212, Melsungen
Germany

Manufacturer
B. Braun Melsungen AG
Mistelweg, 2
12357 Berlin
Germany

This medicinal product is authorised in the European Economic Area countries under the
following names:
Austria, Germany, Luxembourg: Ropivacain-HCl B. Braun 5 mg/ml Injektionslösung;
Belgium: Ropivacaïn HCl B. Braun x mg/ml, oplossing voor injectie;
Bulgaria: Ropivacain HCI B. Braun 5 mg/ml solution for injection;
Denmark: Ropivacain B. Braun 5 mg/ml;
Finland: Ropivacaine B. Braun 5 mg/ml injektioneste, liuos;
Greece: Ropivacain HCI B. Braun 5 mg/ml solution for injection;
Italy: Ropivacaina B. Braun 5 mg/ml soluzione iniettabile;
Spain: Ropivacaina B.Braun 5 mg/ml solución inyectable;
Sweden: Ropivacaine 5 mg/ml injektionsvätska, lösning

This leaflet was last approved in 06/2018

---

The following information is intended exclusively for physicians or healthcare professionals:

Method of administration
Intrathecal injection must be performed after the subarachnoid space has been identified and cerebrospinal fluid flows out or can be aspirated through the spinal needle.
To avoid intravascular injection, careful aspiration is recommended before and during injection. Accidental intravascular injection may be recognized by a transient increase in heart rate.

Warnings
Regional anaesthesia procedures must always be performed in adequately equipped areas by qualified personnel. Equipment and medicinal products necessary for monitoring and emergency resuscitation must be immediately available.
Patients undergoing major blocks must be in optimal condition and must have an intravenous catheter inserted before the block procedure.
The responsible anaesthetist must take appropriate precautions to avoid intravascular injection (see section 4.2 of the SmPC), and must have adequate experience and knowledge regarding the diagnosis and treatment of adverse effects, systemic toxicity, and other complications (see sections 4.8 and 4.9 of the SmPC). After intrathecal administration, systemic toxicity is not expected due to the low dose administered. However, an excessive dose administered into the subarachnoid space may cause spinal block (see section 4.9 of the SmPC).
Patients with hypovolaemia, for any reason, may develop sudden and severe hypotension during intrathecal anaesthesia with this local anaesthetic.

Handling
Any unused product or waste material must be disposed of in accordance with local regulations.
The product is for single use only. The product must be visually inspected before use. Use only if the solution is clear, colourless, free from visible particles, and the container and its closure are intact.

Shelf-life after first opening
From a microbiological standpoint, unless the method of opening excludes the risk of microbiological contamination, the product should be used immediately.
If not used immediately, the times and conditions of in-use storage are the responsibility of the user.

Refer to the product's summary of characteristics for information on incompatibilities and complete prescribing information.

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Ropivacaine B. Braun 7.5 mg/ml solution for injection

Ropivacaine hydrochloride
Please read this leaflet carefully before receiving 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 or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

13. What Ropivacaine B. Braun is and what it is used for.
14. What you need to know before receiving Ropivacaine B. Braun.
15. How Ropivacaine B. Braun will be administered to you.
16. Possible side effects.
17. How to store Ropivacaine B. Braun.
18. 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 injectable solution is used in adults and adolescents (over 12 years of age) to numb (anaesthetize) parts of the body. It is used to prevent the onset of pain or to stop existing pain. It may be used for:

• Numbing parts of the body during surgical procedures, including caesarean section.
• Reducing pain during childbirth, after surgery, or after an injury.

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

Ropivacaine B. Braun must not be administered to you 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 skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• You are allergic to another local anaesthetic of the same class (e.g. lidocaine or bupivacaine).
• For injection into a blood vessel to numb a specific area of the body or into the cervix to control pain during childbirth.
• If you have been diagnosed with reduced blood volume (hypovolemia).

If you are unsure whether any of these conditions apply to you, consult your doctor before receiving Ropivacaine B. Braun.

Warnings and precautions

Talk to your doctor before receiving Ropivacaine B. Braun. Consult 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 been diagnosed with a rare blood pigment disorder called "porphyria" or if anyone in your family has it. Your doctor may need to administer a different anaesthetic.
• If your general health is poor due to advanced age or other reasons.
• For any medical conditions or diseases you currently have or have had in the past.

Children

In children aged 12 years and younger, lower concentrations (2 mg/ml, 5 mg/ml) may be more appropriate.

Other medicines and Ropivacaine B. Braun

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

This is particularly important with the following medicines, which may increase the effect 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 taking:

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

Even in these cases, you might still receive Ropivacaine B. Braun. However, your doctor must be informed about these medicines in order to decide what is suitable for you.

Pregnancy and breastfeeding

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

It is not known whether ropivacaine is excreted in breast milk or whether it could harm breastfed infants.

Driving and using machines

Ropivacaine B. Braun may cause drowsiness and affect reaction speed. If you have been given this medicine, do not drive, operate machinery, or work in hazardous situations until the following day.

Ropivacaine B. Braun contains sodium

This medicine contains 2.9 mg of sodium (the main component of table salt) per ml. This is equivalent to 0.15% of the maximum daily recommended intake of sodium for an adult.

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

This medicine will be administered to you by a doctor or under the supervision of an experienced doctor.
Ropivacaine B. Braun will be given to you by injection. The part of the body where it will be used
depends on the reason for which you are receiving the medicine. Your doctor will administer the
medicine into one of the following areas:

• The part of the body that needs to be numbed.
• Near the part of the body that needs to be numbed.
• An area distant from the part of the body that needs to be numbed. This is the case with epidural injection or infusion administered in the lower or middle back near the spinal column.

You will be closely monitored by healthcare professionals while Ropivacaine B. Braun is being
administered to you. This medicine blocks nerves, preventing them from sending pain signals to the
brain. It prevents you from feeling pain, heat, or cold in the area where the drug is used, but you will
still feel other sensations such as pressure or touch.
Dosage
Your doctor will decide the dose of Ropivacaine B. Braun to be administered to you. The dosage
depends on the type of pain to be controlled or other factors such as body size, age, and physical
condition.
If you receive more Ropivacaine B. Braun than you should
Since this medicine is administered by a doctor under carefully controlled conditions, it is unlikely that
you will receive too much medicine or that a dose will be forgotten.
Side effects caused by excessive administration of Ropivacaine B. Braun require special treatment, and
your doctor is prepared to manage these situations.
The first signs of having received too much Ropivacaine B. Braun are generally the following:

• dizziness or feeling faint;
• numbness of the lips and around the mouth;
• numbness of the tongue;
• hearing problems;
• vision problems.

Your doctor will stop administering this medicine as soon as these symptoms appear, in order to reduce
the risk of serious side effects. This means that if you experience any of these symptoms or if you think
you have received too much Ropivacaine B. Braun, you must inform the doctor immediately.
More severe side effects resulting from excessively high doses of this medicine include speech
difficulties, muscle spasms, tremors, seizures (convulsions), and loss of consciousness.
In case of acute toxicity, healthcare personnel will immediately take appropriate corrective actions.
If you have further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines, including Ropivacaine B. Braun, can rarely cause potentially life-threatening allergic reactions (may occur in up to 1 in 1,000 people). Inform your doctor immediately if any of the following symptoms occur after administration of this medicine:

• sudden appearance of skin rash, itching, or hives,
• swelling of the eyes, face, lips, tongue, throat, or any other part of the body,
• difficulty breathing, sudden wheezing, dizziness.

Other possible side effects
Very common (affects more than 1 in 10 people)

• low blood pressure (hypotension) (you may feel dizzy or lightheaded);
• feeling unwell (nausea).

Common (affects up to 1 in 10 people)

• paresthesia;
• dizziness;
• feeling unwell (vomiting);
• slow or fast heart rate (bradycardia, tachycardia);
• high blood pressure (hypertension);
• high body temperature (fever) or chills;
• back pain;
• headache;
• difficulty urinating.

Uncommon (affects 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 also "If you receive more Ropivacaine B. Braun than you should" above). These include seizures, convulsive seizures (convulsions), dizziness or lightheadedness, numbness of the lips, around the mouth and tongue, hearing problems, vision problems (vision), speech difficulties, stiffness, reduced skin sensitivity or sensations, and muscle spasms.

Rare (affects up to 1 in 1,000 people)

• heart attack (cardiac arrest);
• irregular heartbeat (arrhythmia). Not known (frequency cannot be estimated from the available data)
• jerky movements (dyskinesia)

Possible side effects observed with other local anesthetics that could also be caused by
Ropivacaine B. Braun

• Nerve damage. Rarely causes permanent problems.
• The entire body may become numb (anesthetized), if too high a dose of Ropivacaine B. Braun has been injected into the spinal fluid.

Children
In infants and children, side effects are the same as those seen in adults, except for low blood pressure, which is less frequent in infants and children (affects up to 1 in 10 children), and vomiting, which is more frequent in children (affects more than 1 in 10 children).
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
Reporting side effects helps provide more information on the safety of this medicine.

5. How Ropivacaine B. Braun is stored

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Do not freeze.
The doctor or pharmacist is responsible for the storage of this medicine. They are also responsible for the proper disposal of any unused medicine.

6. Package contents and other information

What Ropivacaine B. Braun contains
The active substance is ropivacaine hydrochloride.
1 ml of Ropivacaine B. Braun contains 7.5 mg of ropivacaine hydrochloride (as monohydrate ropivacaine hydrochloride).
A 10 ml vial of injectable solution contains 75 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.
A 20 ml vial of injectable solution contains 150 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.
The excipients are sodium chloride, hydrochloric acid 0.36% (for pH adjustment), sodium hydroxide 0.4% (for pH adjustment), and water for injections.

Description of the appearance of Ropivacaine B. Braun and contents of the pack
Ropivacaine B. Braun is a clear, colourless injectable solution.
Ropivacaine B. Braun 7.5 mg/ml solution for injection is available in:

• 10 ml polyethylene vials in packs of 20;
• 20 ml polyethylene vials in packs of 20.
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun Strasse, 1
34212 Melsungen
Germany

Manufacturer
B. Braun Melsungen AG
Mistelweg, 2
12357 Berlin
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Germany, Luxembourg: Ropivacain-HCl B. Braun 7,5 mg/ml Injektionslösung;
Belgium: Ropivacaïn HCl B. Braun 7.5 mg/ml, oplossing voor injectie;
Bulgaria: Ropivacain HCI B. Braun 7,5 mg/ml solution for injection;
Denmark: Ropivacain B. Braun 7,5 mg/ml;
Estonia: Ropivacaine B. Braun 7,5 mg/ml;
Finland: Ropivacaine B. Braun 7,5 mg/ml injektioneste, liuos;
France: Ropivacaine B. Braun 7,5 mg/ml, solution injectable en ampoule;
Greece: Ropivacain HCI B. Braun 7,5 mg/ml solution for injection;
Italy: Ropivacaina B. Braun 7,5 mg/ml;
Latvia: Ropivacaine B. Braun 7,5 mg/ml šķīdums injekcijām;
Lithuania: Ropivacaine B. Braun 7.5 mg/ml injekcinis tirpalas;
Netherlands: Ropivacaïne HCl B. Braun 7,5 mg/ml, oplossing voor injectie;
Portugal: Ropivacaína B. Braun 7,5 mg/ml solução injetável;
Spain: Ropivacaina B.Braun 7,5 mg/ml solución inyectable;
Sweden: Ropivacain 7,5 mg/ml injektionsvätska, lösning

This leaflet was last approved in 06/2018.

---

The following information is intended exclusively for physicians or healthcare professionals:
Method of administration
To avoid intravascular administration, careful aspiration is recommended before and during injection. When a high dose is to be administered, a test dose of lidocaine with adrenaline (epinephrine) is advised. Accidental intravascular injection may be recognized by a transient increase in heart rate, whereas accidental intrathecal injection may be identified by signs of spinal block.
Ropivacaine hydrochloride must be injected slowly or in fractionated doses at a rate of 25–50 mg per minute, with close monitoring of vital signs and maintenance of verbal contact. If symptoms of toxicity occur, administration must be immediately discontinued.

Warnings
Regional anaesthesia procedures must always be performed in adequately equipped areas by qualified personnel. Equipment and medications necessary for monitoring and emergency resuscitation must be immediately available.
Patients undergoing major blocks must be in optimal condition and must have an intravenous catheter inserted prior to the block procedure.
The responsible anaesthetist must take appropriate precautions to avoid intravascular injection (see section 4.2 of the SmPC) and must have adequate experience and knowledge regarding the diagnosis and management of adverse effects, systemic toxicity, and other complications (see sections 4.8 and 4.9 of the SmPC), such as accidental subarachnoid injection, which may lead to high spinal block with apnoea and hypotension. Seizures may occur more frequently after brachial plexus block and epidural block. This is likely due to accidental intravascular injection or rapid absorption from the injection site.
Blocking major peripheral nerves may involve administering a larger volume of local anaesthetic into a highly vascularized area, often near large blood vessels, where there is an increased risk of intravascular injection and/or rapid systemic absorption, potentially leading to high plasma concentrations.
Patients with hypovolaemia, for any reason, may develop sudden and severe hypotension during epidural anaesthesia, regardless of the local anaesthetic used.

Handling
Unused or waste product must be disposed of in accordance with local regulations.
The product is for single use only.
The product must be visually inspected before use.
Use only if the solution is clear and colourless and the container and closure are intact.
Stability 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 in use are the responsibility of the user.
Refer to the Summary of Product Characteristics for instructions on incompatibilities and complete prescribing information.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ropivacaine B. Braun 10 mg/ml solution for injection

Ropivacaine hydrochloride
Read this leaflet carefully before receiving 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 or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

19. What Ropivacaine B. Braun is and what it is used for.
20. What you need to know before receiving Ropivacaine B. Braun.
21. How Ropivacaine B. Braun will be administered to you.
22. Possible side effects.
23. How to store Ropivacaine B. Braun.
24. 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 injectable solution is used in adults and adolescents (over 12 years of age) to numb (anaesthetize) parts of the body. It is used to prevent pain from occurring or to stop existing pain. It may be used for:

• Numbing parts of the body during surgical procedures, including caesarean section.
• Relieving pain during childbirth, after surgery, or following an injury.

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

You must not be given 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 present as skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• If you are allergic to another local anaesthetic of the same class (e.g. lidocaine or bupivacaine).
• For injection into a blood vessel to numb a specific area of the body or into the cervix to control pain during childbirth.
• If you have been diagnosed with reduced blood volume (hypovolemia).

If you are unsure whether any of these conditions apply to you, consult your doctor before receiving Ropivacaine B. Braun.
Warnings and precautions
Talk to your doctor before receiving Ropivacaine B. Braun. Consult 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 been diagnosed with a rare blood pigment disorder called "porphyria" or if anyone in your family has it. Your doctor may need to administer a different anaesthetic.
• If your general health is poor due to advanced age or other reasons.
• Regarding any medical conditions you currently have or have had in the past.

Children
In children aged 12 years or younger, lower concentrations (2 mg/ml, 5 mg/ml) may be more appropriate.
Other medicines and Ropivacaine B. Braun
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important with the following medicines, which may increase the effect 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 taking:

• Medicines used to treat depression (e.g. fluvoxamine);
• Antibiotics used to treat bacterial infections (e.g. enoxacin).
  Even in these cases, you may still receive Ropivacaine B. Braun. Your doctor must be informed about these medicines in order to decide what is suitable for you.

Pregnancy and breastfeeding
Before receiving this medicine, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. It is not known whether ropivacaine is excreted in breast milk or whether it may harm breastfed infants.
Driving and using machines
Ropivacaine B. Braun may cause drowsiness and affect reaction speed. If you have been given this medicine, do not drive, operate machinery, or work in hazardous situations until the following day.
Ropivacaine B. Braun contains sodium
This medicine contains 2.7 mg of sodium (a main component of table salt) per ml. This is equivalent to 0.14% of the maximum daily recommended sodium intake for an adult.

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

This medicine will be administered to you by a doctor or under the supervision of an experienced doctor.
Ropivacaine B. Braun will be given to you by injection. The part of the body where it will be administered
depends on the reason for which the medicine is being given to you. Your doctor will administer the
medicine in one of the following areas:

• 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 with epidural injection or infusion administered in the lower or middle back, near the spine.

You will be closely monitored by healthcare professionals while Ropivacaine B. Braun is being
administered to you. This medicine blocks nerves, preventing them from sending pain signals to the
brain. It prevents you from feeling pain, heat, or cold in the area where the drug is used, but you will
continue to 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 to be controlled or other factors such as body size, age, and physical
condition.
If you receive more Ropivacaine B. Braun than you should
Since this medicine is administered by a doctor under closely controlled conditions, it is unlikely that
you will receive too much medicine or that a dose will be missed.
Serious adverse effects caused by excessive administration of Ropivacaine B. Braun require special
treatment, and your doctor is prepared to manage such situations.
The first signs of having received too much Ropivacaine B. Braun are generally the following:

• dizziness or feeling lightheaded;
• numbness of the lips and around the mouth;
• numbness of the tongue;
• hearing disturbances;
• visual disturbances.

Your doctor will stop administering this medicine as soon as these symptoms appear, in order to reduce
the risk of serious side effects. This means that if you experience any of these symptoms or if you think
you have received too much Ropivacaine B. Braun, you must inform your doctor immediately.
More severe side effects resulting from excessive administration of this medicine include difficulty
speaking, muscle spasms, tremors, seizures (convulsions), and loss of consciousness.
In case of acute toxicity, healthcare staff will immediately take appropriate corrective actions.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
All medicines, including Ropivacaine B. Braun, can rarely cause potentially life-threatening allergic reactions (may occur in up to 1 in 1,000 people). Inform your doctor immediately if any of the following symptoms occur after administration of this medicine:

• sudden appearance of skin rash, itching, or hives;
• swelling of the eyes, face, lips, tongue, throat, or any other part of the body;
• difficulty breathing, sudden wheezing, dizziness.

Other possible side effects
Very common (affects more than 1 in 10 people)

• low blood pressure (hypotension) (you may feel dizzy or lightheaded);
• feeling unwell (nausea).

Common (affects up to 1 in 10 people)

• paresthesia;
• dizziness;
• feeling unwell (vomiting);
• slow or fast heart rate (bradycardia, tachycardia);
• high blood pressure (hypertension);
• elevated body temperature (fever) or chills;
• back pain;
• headache;
• difficulty urinating.

Uncommon (affects 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 also "If you receive more Ropivacaine B. Braun than you should" above). These include seizures, convulsive seizures (convulsive attacks), dizziness or lightheadedness, numbness of the lips, around the mouth and tongue, hearing problems, vision problems (vision), speech difficulties, stiffness, reduced skin sensitivity or sensation, and muscle spasms.

Rare (affects up to 1 in 1,000 people)

• heart attack (cardiac arrest);
• irregular heartbeat (arrhythmia).

Not known (frequency cannot be estimated from the available data)

• jerky movements (dyskinesia)

Possible side effects observed with other local anesthetics that could also be caused by
Ropivacaine B. Braun

• Nerve damage. Rarely causes permanent problems.
• It is possible for the entire body to become numb (anesthetized) if too high a dose of Ropivacaine B. Braun has been injected into the spinal fluid.

Children
In infants and children, side effects are the same as those seen in adults, except for low blood pressure, which is less frequent in infants and children (affects less than 1 in 10 children), and vomiting, which is more frequent in children (affects more than 1 in 10 children).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ropivacaine B. Braun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Do not freeze.
The doctor or pharmacist is responsible for the storage of this medicine. They are also responsible for the proper disposal of any unused medicine.

6. Package contents and other information

What Ropivacaine B. Braun contains
The active substance is ropivacaine hydrochloride.
1 ml of Ropivacaine B. Braun contains 10 mg of ropivacaine hydrochloride (as monohydrate ropivacaine hydrochloride).
One 10 ml vial of injectable solution contains 100 mg of ropivacaine hydrochloride as monohydrate ropivacaine hydrochloride.
One 20 ml vial of injectable solution contains 200 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.

Description of the appearance of Ropivacaine B. Braun and contents of the pack
Ropivacaine B. Braun is a clear, colourless injectable solution.
Ropivacaine B. Braun 10 mg/ml solution for injection is available in:

• 10 ml polyethylene vials in packs of 20;
• 20 ml polyethylene vials in packs of 20.
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun Strasse, 1
34212 Melsungen
Germany

Manufacturer
B. Braun Melsungen AG
Mistelweg, 2
12357 Berlin
Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria, Germany, Luxembourg: Ropivacain-HCl B. Braun 10 mg/ml Injektionslösung;
Belgium: Ropivacaïn HCl B. Braun 10 mg/ml, oplossing voor injectie;
Denmark: Ropivacain B. Braun 10 mg/ml;
Finland: Ropivacaine B. Braun 10 mg/ml injektioneste, liuos;
France: Ropivacaine B. Braun 10 mg/ml, solution injectable en ampoule;
Greece: Ropivacain HCI B. Braun 10 mg/ml solution for injection;
Italy: Ropivacaina B. Braun 10 mg/ml soluzione iniettabile;
Netherlands: Ropivacaïne HCl B. Braun 10 mg/ml, oplossing voor injectie;
Portugal: Ropivacaína B. Braun 10 mg/ml solução injetável;
Spain: Ropivacaína B. Braun 10 mg/ml solução inyectable;
Sweden: Ropivacain 10 mg/ml injektionsvätska, lösning

This leaflet was last approved in 06/2018

---

The following information is intended exclusively for physicians or healthcare professionals:

Method of administration
To avoid intravascular administration, careful aspiration is recommended before and during injection. When a high dose must be injected, a test dose of lidocaine with adrenaline (epinephrine) is advised. Accidental intravascular injection may be recognized by a temporary increase in heart rate, while accidental intrathecal injection may be indicated by signs of spinal block.
Ropivacaine hydrochloride must be injected slowly or in fractionated doses, at a rate of 25–50 mg/minute, with close monitoring of vital signs and maintenance of verbal contact. If symptoms of toxicity occur, administration must be immediately discontinued.

Warnings
Regional anaesthesia procedures must always be performed in adequately equipped areas by qualified personnel. Equipment and medications necessary for monitoring and emergency resuscitation must be immediately available.
Patients undergoing major blocks must be in optimal condition and must have an intravenous catheter inserted before the block procedure.
The responsible anaesthetist must take adequate precautions to avoid intravascular injection (see section 4.2 of the SmPC), and must have adequate experience and knowledge regarding the diagnosis and treatment of adverse effects, systemic toxicity, and other complications (see sections 4.8 and 4.9 of the SmPC), such as accidental subarachnoid injection, which may lead to high spinal block with apnoea and hypotension. Seizures may occur more frequently after brachial plexus block and epidural block. This is likely due to accidental intravascular injection or rapid absorption from the injection site.
Peripheral major nerve blocks may involve administration of a larger volume of local anaesthetic into a highly vascularized area, often near large blood vessels, where there is an increased risk of intravascular injection and/or rapid systemic absorption, potentially leading to high plasma concentrations.
During epidural anaesthesia, patients with hypovolaemia due to any cause may experience sudden and severe hypotension, regardless of the local anaesthetic used.

Handling
Unused or waste material must be disposed of in accordance with local regulations.
The product is for single use only.
The medicinal product must be visually inspected before use.
Use only if the solution is clear and colourless and the container and its closure are intact.

Microbiological stability after first opening
From a microbiological standpoint, unless the method of opening excludes the risk of contamination, the product should be used immediately.
If not used immediately, the responsibility for in-use storage times and conditions lies with the user.
Refer to the Summary of Product Characteristics for instructions on incompatibilities and complete prescribing information.