BUPIVACAINE B. BRAUN 7.5 mg/ml INJECTABLE SOLUTION

Introduction

Leaflet: Information for the user

Bupivacaine B. Braun 7.5 mg/ml injectable solution

Bupivacaine Hydrochloride

Read the entire leaflet carefully before starting to use this medication because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication 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 side effects that appear in this leaflet. See section 4.

Contents of the leaflet

1. What Bupivacaine B. Braun 7.5 mg/ml is and what it is used for
2. What you need to know before using Bupivacaine B. Braun 7.5 mg/ml
3. How to use Bupivacaine B. Braun 7.5 mg/ml
4. Possible side effects
5. Storage of Bupivacaine B. Braun 7.5 mg/ml
6. Package contents and additional information

1. What Bupivacaine B. Braun 7.5 mg/ml is and what it is used for

Bupivacaine is a medication 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 7.5 mg/ml

Do not use Bupivacaine 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 serious problems with impulse conduction of the heart or other heart problems, in patients with degenerative nervous disease or with severe defects in blood coagulation.

The local anesthetic should not be injected into infected areas.

General and specific contraindications for the 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

Bupivacaine B. Braun 7.5 mg/ml should not be used in children.

Use in the elderly

The elderly require lower doses than young or middle-aged adults.

Use of Bupivacaine 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 together with the following medications may make it necessary to modify the dose of one of them or interrupt treatment.

• Medications that produce vasoconstriction (reduction of blood vessel diameter).
• Heparin, anticoagulant medications (which prevent blood coagulation), 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 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 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, attention, and coordination. Your doctor will indicate if you can drive or use machines.

Bupivacaine B. Braun 7.5 mg/ml contains sodium

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

3. How to use Bupivacaine B. Braun 7.5 mg/ml

Bupivacaine B. Braun 7.5 mg/ml is administered by 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. The dosage should be adjusted individually according to the patient's age, weight, and 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 7.5 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 administration of 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 an ultrashort-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, lower the patient's head immediately 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 phone: 91 562 04 20, indicating the medication and the amount used. Carry this leaflet with you.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 amide-type local anesthetics may occur.

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 does not appear in this leaflet. You can also report them directly through the Human Medicines Pharmacovigilance System www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bupivacaine B. Braun 7.5 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 that appears on the packaging (after EXP). The expiration date is the last day of the month indicated.

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

Medications should not be thrown away in drains or trash. Ask your pharmacist how to dispose of packages and medications that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Bupivacaine Injectable B. Braun 7.5 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 7.5 mg/ml is an injectable solution that comes in polyethylene ampoules (Mini-Plasco) of 5 and 10 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 medication 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 doctors or healthcare professionals

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

• Epidural anesthesia:

The dosage 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 20 ml of bupivacaine hydrochloride 7.5 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 epidural anesthesia, the dose depends on age; children and the elderly require lower doses than young or middle-aged adults. The following is a dosage 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%, repetition of the injection due to disappearance of analgesia is only required after 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:

15-30 mg (2-4 ml).

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

1. Choose the smallest possible dosage.
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 the administration of the local anesthetic.
8. Observe the general and specific contraindications for the different methods of local and regional anesthesia.

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