Package Insert: Information for the User

Bupivacaine B. Braun 7.5 mg/mL Injectable Solution

Bupivacaine Hydrochloride

Read this package insert carefully before starting to use this medication because it contains important information for you.

• Keep this package insert as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they appear in this package insert. See section 4.

Bupivacaine is a medication belonging to the group of amide local anesthetics and is indicated for local anesthesia by infiltration, conduction anesthesia, epidural and spinal anesthesia, diagnostic and therapeutic blocks for pain treatment, and epidural and caudal anesthesia for vaginal delivery.

No use Bupivacaína B. Braun 7,5 mg/ml

If you are allergic to bupivacaine, other local anesthetics of the amide type, or any of the other components of this medication.

Do not use if you have severe problems with heart rhythm conduction, or other heart problems, in patients with degenerative nerve disease or severe blood clotting defects.

The local anesthetic should not be injected into infected areas.

Consider general and specific contraindications for different local and regional anesthesia methods.

Warnings and precautions

Inform your doctor of any allergy or medical problem 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 have vascular narrowing disease, arteriosclerosis (hardening of the arteries), or nervous system disease due to diabetes (a disease that causes high blood sugar).

Use in children

Bupivacaine B. Braun 7,5 mg/ml should not be used in children.

Use in the elderly

Elderly patients require lower doses than young or middle-aged adults.

Use of Bupivacaína B. Braun 7,5 mg/ml with other medications

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

The administration of Bupivacaine B. Braun with the following medications may require adjusting the dose of one or the other or interrupting treatment.

- Medications that cause vasoconstriction (reduction of blood vessel diameter).

- Heparin, anticoagulant medications (that prevent blood clotting), anti-inflammatory non-steroidal medications, and plasma substitutes (products used in cases of blood loss).

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

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

Bupivacaine passes into breast milk, but in such small quantities that they do not pose a risk to the infant.

Driving and operating machinery

Bupivacaine B. Braun may temporarily impair your ability to move, pay attention, and coordinate. Your doctor will indicate if you can drive or operate machinery.

Bupivacaína B. Braun 7,5mg/ml contains sodium

This medication contains 29.9 mg of sodium (main component of table salt/for cooking) in 10 ml. This is equivalent to 1.5% of the maximum daily sodium intake recommended for an adult.

Bupivacaine B. Braun 7.5 mg/ml is administered via epidural and retrobulbar block.

It will be administered by healthcare personnel only, and your doctor will determine the most suitable dose for you. The smallest dose required to produce the desired anesthesia should always be used. Dosage should be adjusted individually according to the patient's age, weight, and specific case characteristics.

In patients with liver, kidney, heart diseases, and in the elderly, the dose needs to be adjusted.

If you use more Bupivacaine B. Braun 7.5 mg/ml than you should

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

Symptoms of the stimulation phase:

Mild intoxication

CNS

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

CV

palpitations, hypertension, tachycardia, tachypnea.

Moderately severe intoxication:

CNS

speech alterations, drowsiness, insomnia, tremors, choreiform movements, tonic-clonic seizures, mydriasis, nausea, vomiting, tachypnea.

CV

tachycardia, arrhythmia, pallor, cyanosis.

Symptoms of the paralysis phase:

Severe intoxication:

CNS

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

CV

severe cyanosis, hypotension, cardiac arrest, bradycardia/asytocia.

The appearance of one or more symptoms requires immediate action.

1. Stop administering the local anesthetic.

2. Ensure and maintain an open airway. Administer oxygen that should not be interrupted when symptoms disappear, but should continue for several minutes more.

3. If convulsions appear, inject a barbiturate with ultra-short action, such as thiopental (50-100 mg) or diazepam (5-10 mg), intravenously in small repeated doses, but only until convulsions 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 respiration with 100% O2.

4. Immediately control blood pressure, pulse, and pupil diameter.

5. If hypotension exists, lower the patient's head immediately and administer a vasoconstrictor that stimulates the myocardium preferentially. Additionally, administer fluids (e.g., electrolyte solution).

6. A total spinal anesthesia may occur by accidental intrathecal injection during epidural anesthesia. The first symptoms are agitation and somnolence, which may progress to unconsciousness and respiratory arrest. The treatment of total spinal anesthesia consists of ensuring and maintaining an open airway, administering oxygen, and - if necessary - establishing assisted and controlled respiration.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at 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 everyone will experience them.

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

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

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. These plasma concentrations may appear with excessive doses (too high concentration or too large volume), after accidental intravascular injection, or after administration of standard doses to patients in a deteriorated general condition or with liver or kidney disease.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Human Medicines Pharmacovigilance Systemwww.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Bupivacaína B. Braun after the expiration date shown on the packaging (after CAD). The expiration date is the last day of the month indicated.

The contents of the ampoules must be used immediately after opening. Once the packaging is opened, discard the unused portion of the solution.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

Composition of Bupivacaine Injectable B. Braun 7.5 mg/ml

The other components are: sodium chloride, sodium hydroxide, and water for injection in sufficient quantity.

Appearance of the product and contents of the package

Bupivacaine B. Braun 7.5 mg/ml is an injectable solution that is presented in polyethylene ampoules (Mini-Plasco) of 5 and 10 ml. It is presented in containers containing 100 ampoules.

Holder of the marketing authorization and responsible for manufacturing

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Last review date of this prospectus:April 2021.

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

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This information is intended solely for doctors or healthcare professionals

Always use the smallest dose required to produce the desired anesthesia:

- Epidural anesthesia:

The dosing instructions that follow refer to a single administration to adults weighing 70 kg. Repeat or intermittent administration is possible.

Maximum recommended dose for single administration:

Up to 20 ml ofbupivacaine hydrochloride7.5 mg/ml or up to 2 mg ofbupivacaine hydrochlorideper kg of body weight, corresponding to a maximum dose of 150 mg.

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

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

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

Due to the prolonged effect of bupivacaine 0.75%, the repetition of the injection for the disappearance of analgesia only requires at least 4 hours; this practice can be performed intermittently or continuously. In general, solutions of lower concentration, e.g. bupivacaine 0.25%, are administered for this purpose.

- Retrobulbar block:

From 15 to 30 mg (2 – 4 ml).

For the administration of Bupivacaine B. Braun, the following should be taken into account:

1. Choose the smallest possible dose.

2. Use an appropriate-sized needle.

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

4. Do not inject in infected areas.

5. Monitor blood pressure.

6. Consider premedication. Premedication should include the prophylactic administration of atropine and - especially if large amounts of local anesthetic are to be injected - a short-acting barbiturate.

7. If necessary, suspend the administration of anticoagulants before administering the local anesthetic.

8. Observe general and specific contraindications for various methods of local or regional anesthesia.

Handle in the usual conditions of asepsis when using injectable solutions.