Leaflet: information for the user

Bupivacaine Hiperbárica B. Braun 5 mg / ml injectable solution

Bupivacaine Hydrochloride

Read this leaflet carefully before you start using 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isBupivacaine Hiperbárica B. Braun 5 mg/mland for what it is used

2. What you need to know before usingBupivacaine Hiperbárica B. Braun 5 mg/ml

3. How to useBupivacaine Hiperbárica B. Braun 5 mg/ml

4. Possible side effects

5. Storage ofBupivacaine Hiperbárica B. Braun 5 mg/ml

6. Contents of the pack and additional information

Bupivacaine is a long-acting local anesthetic. It produces a pronounced block of nerve fibers.

Bupivacaína Hiperbárica B. Braun is used for spinal anesthesia indicated in lower limb and perineal interventions, lower abdominal interventions, normal vaginal delivery and cesarean section, and reconstructive surgery of the lower limbs.

No use Bupivacaína Hiperbárica B. Braun 5 mg/ml

• If you are allergic (hypersensitive) to the active ingredients or to any of the other components of Bupivacaína Hiperbárica B. Braun.

• If you have:

•cardiovascular diseases, especially heart block or shock,

•chronic back pain,

•pre-existing central nervous system disease attributable to infection, tumors, or other causes,

•blood clotting disorders, anticoagulant treatment,

•headache, especially if there is a history of migraines,

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

•sensory alterations as a result of persistent central nervous system injuries (continuous tingling, numbness, etc.),

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

•hemorrhagic cerebrospinal fluid (fluid that surrounds the brain and spinal cord) or

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to useBupivacaína Hiperbárica B. Braun.

Use with caution if the patient has any disease (e.g. heart failure) or is receiving therapy that reduces blood flow to the liver at the same time.

Use ofBupivacaína Hiperbárica B. Braun 5 mg/mlwith other medications

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

It is essential to inform your doctor if you are using any of the following medications, as they may interact:

• Heparin (medication used to prevent blood clot formation).
• Oral anti-inflammatory steroids (AINES) (prevent blood clot formation) such as acenocoumarol or warfarin.
• Plasma substitutes (used to recover blood volume after bleeding).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

During the early stages of pregnancy, it should only be administered after strict consideration of the indications.

When anesthesia is performed during normal delivery or cesarean section, the indicated doses for this type of patient should be administered.

The exact passage of bupivacaine into breast milk is not known, although no risks have been described for the infant; it is recommended to use with caution in breastfeeding mothers.

Driving and operating machinery

Bupivacaína Hiperbárica B. Braun may temporarily alter your ability to move, attention, and coordination. Your doctor will indicate if you can drive or operate machinery.

.

Bupivacaína Hiperbárica B. Braun 5mg/ml contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per milliliter; it is essentially “sodium-free”.

This medication will always be administered by healthcare personnel via injection into the cerebrospinal fluid through the lumbar space. Intrathecal route.

The dosage of hydrochloride bupivacaine varies depending on the type of surgical intervention and its duration and the individual response of each patient.

The most commonly used doses should be reduced when treating children, elderly or debilitated patients, and patients with liver and/or heart diseases.

Always use the lowest dose required to produce the desired effect.

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

Like other local anesthetics, due to excessive dosing, rapid absorption, or accidental injection into blood vessels, symptoms of intoxication may occur, which may manifest as:

- On the central nervous system:

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

- On the respiratory system:

Accelerated breathing, followed by respiratory difficulty or arrest.

- On the circulatory system:

Peripheral vasodilation, hypotension, myocardial depression, delayed atrioventricular conduction, and arrhythmias, including cardiac arrest.

Emergency treatment, antidotes

If toxic effects occur, the first measure is to stop administering the local anesthetic, and to treat the present symptoms, including, if necessary, assisted respiration.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service phone: 91.562 04 20, indicating the medication and the amount used. Bring this leaflet with you.

Like all medications, this medication may produce adverse effects, although not all people experience them.

Most cases are related to high doses, accidental injection into blood vessels, or allergic reactions or decreased tolerance by the patient.

No significant secondary effects have been observed at the recommended doses and with proper anesthetic procedures.

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

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

If you experience adverse effects, consult your doctor or nurse, even if they do not appear in this prospectus..

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No requires special storage conditions.

Discard the solution if it presents turbidity or sedimentation.

Do not use if the container shows visible signs of deterioration.

Keep out of the sight and reach of children.

Do not use Bupivacaína Hiperbárica B. Braun after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed ofthrough drains or in the trash. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

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

Composition in 1 ml:

Bupivacaine hydrochloride 5.0 mg

The other components are: glucose monohydrate, sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the package:

Bupivacaine Hiperbárica 5 mg/ml is a injectable solution that is presented in glass ampoules of 2 ml and 10 ml.

It is presented in packages containing 1 and 100 ampoules. It may not be marketed in all formats.

Marketing Authorization Holder:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing:

B. BRAUN MEDICAL, S.A.

Ronda de los Olivares, Parcela 11, Industrial Park Los Olivares (Jaén (Jaén)) – 23009 - Spain

Last review of this leaflet was in: April 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http//www.aemps.gob.es

-----------------------------------------------------------------------------------------------------------------------------

This information is intended solely for doctors or healthcare professionals

Single-use containers. Dispose of any remaining unused content after completing the infusion.

Only use the solution if the package seal is not damaged and the solution is homogeneous.

Administration form:

It is essential to consider the following:

• Choose the lowest possible dose.

• Use an appropriately sized needle.

• Inject slowly with multiple aspirations in two planes (rotate the needle 180°).

• Do not inject into infected areas.

• Monitor blood pressure if high doses are administered.

• Administer tranquilizers in moderate doses before administering anesthetic medication.

• Have the necessary equipment for resuscitation available to treat any complications that may occur.

• Perform a 5-10% test injection of the dose.

• Maintain verbal contact with the patient and monitor cardiovascular signs. If toxic symptoms occur, stop administration.

Use with caution if the patient has any disease (heart failure) or is receiving any therapy that reduces blood flow to the liver.

Exercise caution with doses in cases of hypoxia, increased hematocrit potassium levels, or acidosis, as these situations increase the risk of cardiac toxicity of bupivacaine, as well as in children under 12 years old, the elderly, and individuals with renal or hepatic insufficiency.

Dosage:

In general, a dose of 10 mg per surgical procedure is sufficient, but certain patients and special procedures may require more or less.

The following are the usual doses:

Lower limb and perineal interventions

7.5-10 1.5-2

Abdominal interventions

Lower. Urology 12 2.4

Normal vaginal delivery 6 1.2

Cesarean section 7.5-10 1.5-2

Orthopedics and Traumatology 15 3

Emergency treatment, antidotes:

If toxic effects occur, the first measure is to stop administering the local anesthetic.

The subsequent treatment consists of stopping seizures and ensuring adequate respiration with oxygen, if necessary by assisted respiration. If seizures occur, they can be treated with 5-10 mg of diazepam. If hypotension occurs, administer intravenously a vasopressor, for example 15-30 mg of ephedrine.