Bupivacaine B. Braun 5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bupivacaine B. Braun 5 mg/ml solution for injection

bupivacaine hydrochloride

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Bupivacaine B. Braun 5 mg/ml is and what it is used for
2. What you need to know before using Bupivacaine B. Braun 5 mg/ml
3. How to use Bupivacaine B. Braun 5 mg/ml
4. Possible side effects
5. How to store Bupivacaine B. Braun 5 mg/ml
6. Contents of the pack and other information

1. What Bupivacaína B. Braun 5 mg/ml is and what it is used for

Bupivacaína B. Braun 5 mg/ml contains the active substance bupivacaine hydrochloride, which belongs to a group of medicines known as amide-type local anaesthetics. It is indicated for local infiltration anaesthesia, conduction anaesthesia, epidural and spinal anaesthesia, diagnostic and therapeutic nerve blocks for pain management, and epidural and caudal anaesthesia for vaginal childbirth.

2. What you need to know before using Bupivacaína B. Braun 5 mg/ml

Do not use Bupivacaína B. Braun 5 mg/ml

• If you are allergic to bupivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any other local anesthetic of the amide type.

Do not use if you have serious heart conduction disorders or other cardiac problems, in patients with degenerative neurological disease or with severe blood coagulation disorders.

The local anesthetic must not be injected into infected areas.

General and specific contraindications for different methods of local and regional anesthesia must be taken into account.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Bupivacaína B. Braun 5 mg/ml.

Inform your doctor of any allergies or medical conditions you have or have had, especially:

• if your liver does not function properly, as your doctor will need to adjust the dose,
• if your kidneys do not function properly, as this may increase the risk of toxicity,
• if you suffer from vascular disease, arteriosclerosis (hardening of the arteries), or neurological disease due to diabetes (a condition characterized by excess glucose in the blood).

Use in children and elderly

Children and elderly patients require lower doses than young or middle-aged adults.

Use of Bupivacaína B. Braun 5 mg/ml with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

The administration of Bupivacaína B. Braun together with the following medicines may require dose adjustments or discontinuation of treatment:

• Medicines that cause vasoconstriction (reduction in the diameter of blood vessels).
• Heparin, anticoagulant medicines (which prevent blood clotting), non-steroidal anti-inflammatory drugs, and plasma substitutes (products used in case of blood loss).

Pregnancy, breastfeeding and fertility

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

During early pregnancy, this medicine should only be administered after strict assessment of the indications.

When epidural anesthesia is performed during the last weeks of pregnancy, the dose should be reduced to approximately one-third.

Although exposure is lower with bupivacaine than with other local anesthetics, the newborn should be closely monitored for possible effects of the anesthetic.

Bupivacaine passes into breast milk, but in such small amounts that it poses no risk to the infant.

Driving and use of machines

Bupivacaína B. Braun may temporarily affect your ability to move, concentrate, and coordinate. Your doctor will advise you whether you may drive or operate machinery.

Bupivacaína B. Braun 5 mg/ml contains sodium

5 ml ampoules:

This medicine contains less than 23 mg of sodium (1 mmol) per 5 ml ampoule, i.e., essentially "sodium-free".

10 ml ampoules:

This medicine contains 31.68 mg of sodium (main component of table/cooking salt) in each 10 ml ampoule. This corresponds to 1.58% of the maximum daily sodium intake recommended for an adult.

20 ml ampoules:

This medicine contains 63.36 mg of sodium (main component of table/cooking salt) in each 20 ml ampoule. This corresponds to 3.17% of the maximum daily sodium intake recommended for an adult.

3. How to use Bupivacaine B. Braun 5 mg/ml

Bupivacaine B. Braun 5 mg/ml is administered via subcutaneous, intradermal, intramuscular, periarticular, intra-articular, epidural, intrathecal, perineural, and intraosseous routes.

It will be administered only by healthcare professionals, and your doctor will determine the most appropriate dose for you. Always use the smallest dose required to achieve the desired anesthesia. Dosage must be individually adjusted according to the patient's age and weight, as well as the specific circumstances of each case.

Dosage adjustment is necessary in patients with liver, kidney, or heart disease, and in elderly patients.

If you use more Bupivacaine B. Braun 5 mg/ml than you should

Toxicity affects both the central nervous system (CNS) and the cardiovascular system (CVS). Two phases can be distinguished: mild to moderately severe toxicity is characterized by stimulation, while severe toxicity is characterized by sedation and paralysis. Symptoms are:

Symptoms of the stimulation phase:

Mild toxicity

CNS

tingling of the lips, tongue paresthesia, numbness of the mouth, tinnitus, metallic taste, anxiety, restlessness, tremors, muscle spasms, vomiting.

CVS

palpitations, hypertension, tachycardia, tachypnea.

Moderately severe toxicity:

CNS

speech disturbances, stupor, insomnia, tremors, choreiform movements, tonic-clonic seizures, mydriasis, nausea, vomiting, tachypnea.

CVS

tachycardia, arrhythmia, pallor, cyanosis.

Symptoms of the paralysis phase:

Severe toxicity:

CNS

drowsiness, stupor, irregular breathing, respiratory arrest, loss of muscle tone, vomiting with aspiration, sphincter paralysis, death.

CVS

severe cyanosis, hypotension, cardiac arrest, hypo-/asystole.

The appearance of one or more of these symptoms requires immediate action.

1. Discontinue administration of the local anesthetic immediately.
2. Ensure and maintain an open airway. Administer oxygen, which must not be interrupted once symptoms resolve, but continued for several additional minutes.
3. If seizures occur, administer an ultra-short-acting barbiturate such as thiopental (50–100 mg) or diazepam (5–10 mg) intravenously in small repeated doses, but only until seizures are controlled. It is also recommended to administer a short-acting muscle relaxant such as succinylcholine (1 mg/kg body weight), intubate, and provide artificial ventilation with 100% O2.
4. Immediately monitor blood pressure, pulse, and pupil size.
5. In case of hypotension, immediately lower the patient's head and administer a vasoconstrictor that preferentially stimulates the myocardium. Additionally, administer fluids (e.g., electrolyte solution).
6. Accidental intrathecal injection during epidural anesthesia may result in extensive (total) spinal anesthesia. Initial symptoms include agitation and drowsiness, which may progress to unconsciousness and respiratory arrest. Treatment of extensive (total) spinal anesthesia consists of ensuring and maintaining an open airway, administering oxygen, and, if necessary, initiating assisted and controlled ventilation.

It is assumed that measures to be taken in the event of suspected cardiac arrest are known. In case of a serious incident, it is advisable to consult an anesthesiology and intensive care specialist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount taken. Bring this leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The possible side effects following administration of bupivacaine are essentially the same as those produced by other amide-type local anesthetics.

Allergic reactions to amide-type local anesthetics may very rarely occur (less than 1 in 10,000 people).

Mild systemic toxic reactions are expected at plasma concentrations above 1.6–2 mg/l, while the threshold concentration for seizures is 2–4 mg/l. Such plasma concentrations may occur with excessive doses (concentration too high or volume too large), following inadvertent intravascular injection, or after administration of standard doses in patients with deteriorated general condition or with liver or kidney disease.

Reporting of adverse effects

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

5. Storage of Bupivacaine B. Braun 5 mg/ml

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Bupivacaine B. Braun after the expiry date stated on the container (after EXP). The expiry date refers to the last day of the month indicated.

The contents of the ampoules must be used immediately after opening. After opening the container, discard any unused portion of the solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bupivacaine B. Braun 5 mg/ml

• The active substance is bupivacaine hydrochloride. Each 5 ml of solution contains 25 mg of bupivacaine hydrochloride. Each 10 ml ampoule contains 50 mg of bupivacaine hydrochloride. Each 20 ml ampoule contains 100 mg of bupivacaine hydrochloride.

• The other components are sodium chloride, sodium hydroxide (for pH adjustment), and water for injections.

Appearance of the product and contents of the pack

Bupivacaine B. Braun 5 mg/ml is an injectable solution supplied in polyethylene ampoules (Mini-Plasco) of 5, 10, and 20 ml. It is packaged in containers containing 100 ampoules.

Marketing Authorization Holder and Manufacturer

• Braun Medical, S.A.
  Ctra. de Terrassa, 121
  08191 Rubí (Barcelona),
  Spain

Date of the most recent review of this leaflet: October 2025

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

This information is intended for healthcare professionals only:

The dosing instructions listed below refer to a single administration in adults weighing 70 kg. Repeated or intermittent administration may be possible.

Recommended maximum dose for single administration:

Up to 30 ml of bupivacaine hydrochloride 5 mg/ml or up to 2 mg of bupivacaine hydrochloride per kg of body weight, corresponding to a maximum dose of 150 mg.

In debilitated patients, the dose should be less than 2 mg/kg body weight.

For use in obstetrics, the dose should be reduced by approximately 30% to account for the altered anatomy of the epidural space and increased sensitivity to local anesthetics during pregnancy.

Dosing examples by indication Bupivacaine 5 mg/ml

Infiltration anesthesia up to 30 ml
Brachial plexus block 15 - 30 ml
Intercostal block per segment (2-4) 3 - 5 ml
Paravertebral block 5 - 8 ml
Epidural anesthesia 15 - 20 ml
Epidural analgesia or anesthesia, continuous

• Initial dose 8 - 10 ml
• Maintenance dose at intervals of 50-100 min 5 - 6 ml
  Cervical plexus block per segment and face 3 - 5 ml
  Psoas compartment block 20 - 30 ml
  Saddle block 15 - 20 ml
  Spinal anesthesia 2 - 3 ml
  Trigeminal nerve block 0.5 - 4 ml
  "3 in 1" block 10 - 30 ml

For epidural anesthesia, the dose depends on age; children and elderly patients require lower doses than young or middle-aged adults. The following is a dosing guide for the lumbar region:

5 years: 0.5 ml/segment
10 years: 0.9 ml/segment
15 years: 1.3 ml/segment
20 years: 1.5 ml/segment
40 years: 1.3 ml/segment
60 years: 1.0 ml/segment
80 years: 0.7 ml/segment

Repeated or continuous administration is particularly applicable to epidural and plexus anesthesia. As a guide, for brachial plexus block with catheter, 12 hours after the first injection of the maximum dose (preferably bupivacaine 5 mg/ml), a second injection of 30 ml of bupivacaine 2.5 mg/ml may be given, followed approximately 10 hours later by a third injection of 30 ml of bupivacaine 2.5 mg/ml. For continuous lumbar epidural anesthesia, a dose of 4 - 8 ml of bupivacaine 2.5 mg/ml per hour is appropriate.

The following should be considered when administering Bupivacaine B. Braun:

1. Use the lowest possible dose.
2. Use a needle of appropriate size.
3. Inject slowly with repeated aspirations in two planes (rotate the needle 180º).
4. Do not inject into infected areas.
5. Monitor blood pressure.
6. Take into account premedication. Premedication should include prophylactic administration of atropine and – especially if large volumes of local anesthetic are required – a short-acting barbiturate.
7. If necessary, discontinue anticoagulant therapy prior to administration of the local anesthetic.
8. Observe general and specific contraindications for the various methods of local or regional anesthesia.

Handle under standard aseptic conditions used for injectable solutions.

Hepatic dysfunction, with reversible increases in alanine aminotransferase (ALT), alkaline phosphatase (FA), and bilirubin, has been observed after repeated injections or long-term infusions of bupivacaine. In a small number of published reports, an association between bupivacaine use and drug-induced liver injury (DILI) has been reported, particularly with prolonged use. Although the pathophysiology of this reaction is not yet fully understood, immediate discontinuation of bupivacaine has resulted in rapid clinical improvement. If signs of hepatic dysfunction occur during bupivacaine administration, the drug should be discontinued.