BUPIVACAINE HYPERBARIC B. BRAUN 5 mg / ml INJECTABLE SOLUTION

2. What you need to know before you start using Bupivacaine Hiperbaric B. Braun 5 mg/ml

Do not use Bupivacaine Hiperbaric B. Braun 5 mg/ml

• If you are allergic (hypersensitive) to the active substances or to any of the other ingredients of Bupivacaine Hiperbaric B. Braun.

• If you have:

• cardiovascular diseases, especially cardiac block or shock,
• chronic back pain,
• pre-existing central nervous system disease due to infection, tumors, or other causes,
• blood coagulation disorders, treatment with anticoagulants,
• headache, especially if there is a history of migraines,
• low or high blood pressure (hypertension or hypotension),
• altered sensitivity due to central nervous system lesions of a persistent nature (continuous tingling, numbness, etc.),
• spinal deformities or characteristics that may interfere with the administration and/or efficacy of the anesthetic,
• hemorrhagic cerebrospinal fluid or
• a history of malignant hyperthermia (elevation of body temperature and intense muscle contractions).

Warnings and precautions

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

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

Using Bupivacaine Hiperbaric B. Braun 5 mg/ml with other medicines

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

It is important that you inform your doctor if you use any of the following medicines, as they may interact:

• Heparin (a medicine used to prevent blood clot formation).
• Oral anti-rheumatic steroids (to prevent blood clot formation) (acenocoumarol, warfarin).
• Plasma substitutes (used to recover blood volume after hemorrhage).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

During the first stages of pregnancy, it should only be administered after careful 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.

It is not known exactly whether bupivacaine passes into breast milk, although no risks have been described for the breastfed infant, it is recommended to use with caution in breastfeeding mothers.

Driving and using machines

Bupivacaine Hiperbaric B. Braun may temporarily alter your ability to move, attention, and coordination. Your doctor will indicate if you can drive or use machines.

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Bupivacaine Hiperbaric B. Braun 5mg/ml contains sodium

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

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

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

The dosage of bupivacaine hydrochloride 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 it comes to children, geriatric patients, or debilitated patients, and patients with liver and/or heart disease.

The lowest dose required to produce the desired effect will always be used.

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

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

• On the central nervous system:

Characterized by anesthesia of the tongue, slight loss of consciousness, fainting, blurred vision, headache, tremors followed by drowsiness, convulsions, and unconsciousness.

• On the respiratory system:

Acceleration of breathing, followed by difficulty/stopping of breathing.

• On the cardiovascular system:

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

Emergency treatment, antidotes

If toxic effects occur, the first measure is to stop the administration of the local anesthetic, and resort to the treatment of the symptoms present, including, if necessary, assisted breathing.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Unlike other anesthetics with bupivacaine, no cases of decreased hemoglobin in the blood have been described, and allergic reactions are very rare.

Side effects due to overdose or difficulties in the 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 side effects, consult your doctor or nurse, even if it is a side effect not listed in this leaflet.

Reporting of side effects

If you experience any side effects, consult your doctor, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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

No special storage conditions are required.

Discard the solution if it is cloudy or sedimented.

Do not use if the packaging is visibly damaged.

Keep out of the sight and reach of children.

Do not use Bupivacaine Hiperbaric B. Braun after the expiration date stated on the packaging after EXP. The expiration date is 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

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

Composition in 1 ml:

Bupivacaine hydrochloride 5.0 mg

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

Appearance of the product and contents of the pack

Bupivacaine Hiperbaric 5 mg/ml is an injectable solution presented in 2 ml and 10 ml glass ampoules.

It is presented in packs containing 1 and 100 ampoules. Not all pack sizes may be marketed.

Marketing Authorization Holder

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

• BRAUN MEDICAL, S.A.

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

This leaflet was last revised in:April 2021

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

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This information is intended only for healthcare professionals

Single-dose containers. Discard unused contents after completion of the infusion.

Only use the solution if the packaging is not damaged and the solution is homogeneous

Method of administration

It is essential to consider:

• Choose the lowest possible dose.
• Use a needle of the appropriate size.
• Inject slowly with several aspirations in two planes (rotate the needle 180º).
• Do not inject into infected areas.
• Monitor blood pressure if the doses are high.
• Administer moderate doses of tranquilizers before anesthetic medication.
• Have the necessary equipment available for resuscitation to treat any complications that may occur.
• Perform a test injection of 5-10% of the dose.
• Maintain verbal contact with the patient and monitor cardiovascular signs. If symptoms of toxicity occur, stop administration.

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

Be cautious with doses in cases of hypoxia, increased blood potassium levels, or acidosis, as these situations increase the risk of cardiac toxicity of bupivacaine, as well as in children under 12 years, the elderly, and subjects with renal or hepatic insufficiency.

Dosage:

In general, it can be said that a dose of 10 mg per surgical act is sufficient, but certain patients and special procedures may require more or less dose.

The following are the usual doses:

Type of anesthesia mg ml

Interventions in lower limbs and perineum 7.5-10 1.5-2

Interventions in lower abdomen. 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 the administration of the local anesthetic.

The subsequent treatment consists of stopping convulsions and ensuring adequate breathing with oxygen, if necessary by assisted breathing. If convulsions occur, they can be treated with 5-10 mg of diazepam. If hypotension exists, a vasopressor, such as 15-30 mg of ephedrine, should be administered intravenously.