Bupivacaine hyperbaric B. Braun 5 mg/ml injectable solution in mini-plasco

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bupivacaine Hiperbárica B. Braun 5 mg/ml solution for injection in Mini-Plasco®

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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Bupivacaína Hiperbárica B. Braun 5 mg/ml contains the active substance bupivacaine hydrochloride, which belongs to a group of medicines known as long-acting amide-type local anesthetics. It produces a pronounced blockade of nerve fibers.

Bupivacaína Hiperbárica B. Braun is used for spinal anesthesia indicated in procedures on the lower limbs and perineum, surgeries in the lower abdomen, normal vaginal delivery, cesarean section, and reconstructive surgery of the lower limbs.

2. What you need to know before starting to use Bupivacaine Hyperbaric B. Braun 5 mg/ml Mini-Plasco

Do not use Bupivacaine Hyperbaric B. Braun 5 mg/ml Mini-Plasco

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

• If you have:

• cardiovascular diseases, especially cardiac block or shock,

• chronic back pain,

• pre-existing central nervous system disorders due to infection, tumors, or other causes,

• blood coagulation disorders, or are undergoing anticoagulant therapy,

• headache, especially if you have a history of migraines,

• low or high blood pressure (hypertension or hypotension),

• sensory disturbances resulting from persistent central nervous system injuries (such as persistent tingling, numbness, etc.),

• spinal deformities or anatomical characteristics that may interfere with the administration and/or effectiveness of the anesthetic,

• hemorrhagic cerebrospinal fluid (the fluid surrounding the brain and spinal cord), or

• history of malignant hyperthermia (elevated body temperature and severe muscle contractions).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Bupivacaine Hyperbaric B. Braun.

Use with caution if the patient suffers from any disease (e.g., heart failure) or is concurrently receiving any therapy that may reduce hepatic blood flow.

Use of Bupivacaine Hyperbaric B. Braun 5 mg/ml Mini-Plasco with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

It is important to inform your doctor if you are taking any of the following medicines, as they may interact:

• Heparin (a medicine used to prevent blood clots).
• Oral steroidal anti-inflammatory drugs (NSAIDs) (prevent blood clotting) (acenocoumarol, warfarin).
• Plasma substitutes (used to restore blood volume after hemorrhage).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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 evaluation of the indications.

When anesthesia is performed during normal delivery or cesarean section, the recommended doses for these types of patients should be administered.

It is not precisely known whether bupivacaine passes into breast milk; however, as no risks to the infant have been reported, caution is recommended when administering to breastfeeding mothers.

Driving and use of machines

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

Bupivacaine Hyperbaric B. Braun 5 mg/ml Mini-Plasco contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 1 milliliter; therefore, it is essentially "sodium-free".

3. How to use Bupivacaine Hiperbárica B. Braun 5 mg/ml Mini-Plasco

This medicine will always be administered by healthcare professionals via injection into the cerebrospinal fluid through the lumbar space (intrathecal route).

The dosage of bupivacaine hydrochloride varies depending on the type and duration of surgical procedure, as well as the individual patient's response.

The usual doses should be reduced in children, elderly or debilitated patients, and in patients with hepatic and/or cardiac diseases.

The lowest effective dose required to achieve the desired effect should always be used.

If you are given more Bupivacaine Hiperbárica B. Braun 5 mg/ml Mini-Plasco than you should

As with other local anesthetics, excessive dosage, rapid absorption, or accidental intravascular injection may lead to signs of toxicity, which may manifest as:

• On the central nervous system:

Characterized by tongue anesthesia, mild loss of consciousness, dizziness, blurred vision, headache, tremors, followed by drowsiness, seizures, and unconsciousness.

• On the respiratory system:

Rapid breathing, followed by respiratory difficulty or respiratory arrest.

• On the cardiovascular system:

Peripheral vasodilation, hypotension, myocardial depression, delayed atrio-ventricular conduction, arrhythmias, and even cardiac arrest.

Emergency treatment, antidotes

If toxic effects occur, the first step is to discontinue administration of the local anesthetic and initiate symptomatic treatment, including assisted ventilation if necessary.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91.562 04 20, indicating the name of the medicine and the amount used. Bring this leaflet with you.

4. Possible adverse effects

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

In most cases, these are related to high doses, accidental injection into blood vessels, or allergic reactions or reduced tolerance on the part of the patient.

At the recommended doses and with appropriate anesthetic procedures, no significant side effects have been observed.

Unlike other anesthetics containing bupivacaine, cases of decreased blood hemoglobin have not been described, and allergic reactions are very rare.

Side effects due to overdose or difficulties with the anesthetic technique may cause back pain or headache, fecal and/or urinary incontinence, hypotension, altered sensation, paralysis of the lower limbs, respiratory problems, and slow heart rate.

If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 Bupivacaína Hiperbárica B. Braun 5 mg/ml Mini-Plasco

No special storage conditions are required.

Discard the solution if it appears cloudy or contains sediment.

Do not use if the container shows any visible signs of damage.

Keep out of the sight and reach of children.

Do not use Bupivacaína Hiperbárica B. Braun after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and other information

Composition of Bupivacaine Hiperbárica B. Braun 5 mg/ml Mini-Plasco:

• The active substance is bupivacaine hydrochloride. Each ml of solution contains 5 mg of bupivacaine hydrochloride.
• The other components are monohydrate glucose, sodium hydroxide (for pH adjustment), and water for injections.

Appearance of the product and contents of the container

Bupivacaine Hiperbárica 5 mg/ml Mini-Plasco is an injectable solution supplied in polyethylene ampoules (Mini-Plasco®) of 4 ml.

It is available in pack sizes containing 20 and 100 ampoules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

The most recent revision of this summary of product characteristics was in: October 2025

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

This information is intended exclusively for physicians or healthcare professionals:

Single-use containers. Discard any unused residue remaining after completion of the infusion.

The solution should only be used if the container seal is intact and the solution is homogeneous.

Administration method

The following points are essential to consider:

• Use the lowest possible dose.
• Use a needle of appropriate size.
• Inject slowly with repeated aspirations in two planes (rotate the needle 180º).
• Do not inject into infected areas.
• Monitor blood pressure when high doses are administered.
• Administer sedatives in moderate doses prior to anesthetic medication.
• Ensure resuscitation equipment is readily available to manage any potential complications.
• Perform a test injection with 5%-10% of the total dose.
• Maintain verbal contact with the patient and monitor cardiovascular signs. If signs of toxicity occur, discontinue administration immediately.

Use with caution in patients with underlying diseases (e.g., cardiac failure) or those receiving concomitant therapies that reduce hepatic blood flow.

Hepatic dysfunction, with reversible increases in alanine aminotransferase (ALT), alkaline phosphatase (FA), and bilirubin, has been observed following repeated injections or prolonged 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 remains unclear, immediate discontinuation of bupivacaine has resulted in rapid clinical improvement. If signs of hepatic dysfunction occur during bupivacaine administration, the drug should be discontinued.

Exercise caution with dosing in cases of hypoxia, elevated serum potassium levels, or acidosis, as these conditions increase the risk of bupivacaine cardiotoxicity. This also applies to children under 12 years of age, elderly patients, and individuals with renal or hepatic impairment.

Dosage:

In general, a dose of 10 mg per surgical procedure is usually sufficient; however, certain patients and specific procedures may require higher or lower doses.

The following are typical dosages:

Type of anesthesia | mg | ml
---|---|---
Procedures on lower limbs and perineum | 7.5–10 | 1.5–2
Lower abdominal surgery. Urology | 12 | 2.4
Normal vaginal delivery | 6 | 1.2
Caesarean section | 7.5–10 | 1.5–2
Orthopedics and Traumatology | 15 | 3

Emergency treatment, antidotes

If toxic effects occur, the first step is to stop administration of the local anesthetic.

Subsequent treatment consists of controlling seizures and ensuring adequate respiration with oxygen, using assisted ventilation if necessary. If seizures occur, they may be treated with 5–10 mg of diazepam. In the event of hypotension, administer a vasopressor intravenously, for example, 15–30 mg of ephedrine.