BUPIVACAINE B. BRAUN 5 mg/ml INJECTABLE SOLUTION

Introduction

Leaflet: information for the user

Bupivacaine B. Braun 5 mg/ml injectable solution

Bupivacaine Hydrochloride

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

Contents of the 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. Storage of Bupivacaine B. Braun 5 mg/ml
6. Package contents and additional information

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

Bupivacaine is a medicine that belongs to the group of local anesthetics of the amide type 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.

2. Before using Bupivacaine B. Braun 5 mg/ml

Do not use Bupivacaine B. Braun 5 mg/ml

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

Do not use if you have severe problems with heart impulse conduction or other heart problems, in patients with degenerative nervous system disease or severe blood coagulation defects.

The local anesthetic should not be injected into infected areas.

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

Warnings and precautions

Inform your doctor of any allergy or medical problem you have or have had, especially:

Use in children and the elderly

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

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

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

The administration of Bupivacaine B. Braun along with the following medicines may require modifying the dose of one of them or interrupting treatment.

• Medicines that produce vasoconstriction (reduction of blood vessel diameter).
• 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, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

During the early stages of pregnancy, it should only be administered after careful 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 amounts that it does not pose a risk to the infant.

Driving and using machines

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

Bupivacaine B. Braun 5 mg/ml contains sodium

Ampoules of 5 ml:

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

Ampoules of 10 ml:

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

Ampoules of 20 ml:

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

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

Bupivacaine B. Braun 5 mg/ml is administered subcutaneously, intradermally, intramuscularly, periarticularly, intraarticularly, epidurally, intrathecally, perineurally, and periosteally.

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

In patients with liver, kidney, heart disease, and in the elderly, it is necessary to adjust the dose.

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

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

CVS

palpitations, hypertension, tachycardia, tachypnea.

Moderately severe intoxication:

CNS

speech disorders, stupor, insomnia, tremors, choreiform movements, tonic-clonic convulsions, mydriasis, nausea, vomiting, tachypnea.

CVS

tachycardia, arrhythmia, pallor, cyanosis.

Symptoms of the paralysis phase:

Severe intoxication:

CNS

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

CVS

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

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, which should not be interrupted when symptoms disappear, but should continue for several minutes longer.
3. If convulsions appear, inject a short-acting barbiturate, such as thiopental (50-100 mg) or diazepam (5-10 mg), intravenously in small repeated doses, but only until the 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 there is hypotension, immediately lower the patient's head and administer a vasoconstrictor that preferably stimulates the myocardium. Additionally, administer fluids (e.g., electrolyte solution).
6. A total spinal anesthesia may occur due to accidental intrathecal injection during epidural anesthesia. The first symptoms are agitation and drowsiness, which can 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, instituting 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 severe 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 Toxicology Information Service at 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 everyone gets them.

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

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Human Medicines Pharmacovigilance System at www.notificaRAM.es. By reporting side 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 sight and reach of children.

No special storage conditions are required.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Bupivacaine B. Braun 5 mg/ml

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

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of the last revision of this leaflet: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

The dosing instructions that follow refer to a single administration to adults weighing 70 kg. Repeated or intermittent administration is 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 of body weight.

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

Examples of dosing by indications 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

Continuous epidural analgesia or anesthesia

• Initial dose 8-10 ml
• Maintenance dose at 50-100 minute intervals 5-6 ml

Cervical plexus block per segment and face 3-5 ml

Psoas compartment block 20-30 ml

Sacral 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 the elderly 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 especially applicable to epidural and plexus anesthesia. As a guide, in the case of arm plexus anesthesia with a catheter, a second injection of 30 ml of bupivacaine 2.5 mg/ml can be administered 12 hours after the first injection of the maximum dose (preferably bupivacaine 5 mg/ml), 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 suitable.

When administering Bupivacaine B. Braun, the following should be taken into account:

1. Choose the smallest possible dose.
2. Use a needle of the appropriate size.
3. Inject slowly with several aspirations in two planes (rotate the needle 180°).
4. Do not inject into infected areas.
5. Control blood pressure.
6. Take into account premedication. Premedication should include the prophylactic administration of atropine and, especially if large amounts of local anesthetic need to be injected, a short-acting barbiturate.
7. If necessary, suspend the administration of anticoagulants before administering the local anesthetic.
8. Observe the general and specific contraindications for the various methods of local or regional anesthesia.

Handle under usual asepsis conditions for the use of injectable solutions.