Mepivacaine B. Braun 10 mg/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Mepivacaine B. Braun 10 mg/ml solution for injection

Mepivacaine Hydrochloride

Read the entire leaflet carefully before you start using this medicine, as 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.

• If you experience any side effects, talk to your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Mepivacaine B. Braun 10 mg/ml is and what it is used for
2. What you need to know before using Mepivacaine B. Braun 10 mg/ml
3. How to use Mepivacaine B. Braun 10 mg/ml
4. Possible side effects
5. How to store Mepivacaine B. Braun 10 mg/ml
6. Contents of the pack and other information

1. What Mepivacaína B. Braun 10 mg/ml is and what it is used for

Mepivacaine is a medicine belonging to the group of amide-type local and regional anaesthetics, indicated for local infiltration anaesthesia, epidural and caudal anaesthesia, and for peripheral nerve, plexus, and paravertebral blocks.

Depending on the amount used, it will either completely block pain or cause a partial loss of sensation.

It is used prior to surgery or various medical examinations to prevent or relieve pain in the area of the body where the procedure will be performed.

2. What you need to know before using Mepivacaine B. Braun 10 mg/ml

Do not administer Mepivacaine B. Braun 10 mg/ml if:

• you are allergic to mepivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• you are allergic to other local anesthetics, e.g., bupivacaine, lidocaine;
• you have severe coagulation disorders (blood clotting problems);
• you suffer from degenerative nerve disease;
• you have serious conduction disturbances of the heart impulse or other cardiac problems;
• you have uncontrolled epilepsy;
• you have increased intracranial pressure;

Warnings and precautions

Consult your doctor or nurse before receiving Mepivacaine B. Braun 10 mg/ml:

• if you have serious heart rhythm problems or any heart disease;
• if you suffer from degenerative nerve disease;
• if you are elderly;
• if you are in poor general health;
• if you have liver disease (liver problems);
• if you have impaired renal function (kidney problems);
• if you suffer from vascular disease, such as arteriosclerosis (hardening of the arteries);
• if you may be at risk of malignant hyperthermia (a complication involving sudden high fever, muscle rigidity, and kidney failure);
• if you suffer from epilepsy;
• if you have inflammation and/or infection at the injection site;
• if you have a blood disorder called porphyria.

The dose you will receive will be carefully controlled to prevent mepivacaine from causing toxic reactions affecting your heart, nerves, or brain.

You will be closely monitored during administration of mepivacaine to detect as early as possible any complications that may affect cardiac function, blood circulation, or nervous and brain functions, and to provide any necessary treatment should such complications occur.

Other medicines and Mepivacaine B. Braun 10 mg/ml

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Administration of Mepivacaine B. Braun 10 mg/ml together with the following medicines may require adjustment of the dose or discontinuation of treatment:

• strong analgesics;
• other local anesthetics;
• certain medicines used to treat heart rhythm disorders;
• general anesthetics such as ether;
• medicines that cause vasoconstriction (reduction in the diameter of blood vessels);
• heparin, anticoagulant medicines (which prevent blood clotting), non-steroidal anti-inflammatory drugs (NSAIDs), and plasma substitutes (products used in cases of blood loss). Your blood coagulation function will be carefully monitored if you are receiving any of these medicines;
• cytochrome P450 1A2 inhibitors (such as ciprofloxacin, enoxacin, or fluvoxamine);
• medicines used to treat stomach and intestinal burning or ulcers (such as cimetidine);
• propranolol.

Mepivacaine is generally not combined with other local anesthetics.

Use in children and elderly

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

This medicine must not be used in children under 1 year of age.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine.

During pregnancy, Mepivacaine B. Braun 10 mg/ml will only be administered after strict evaluation of the indications and only if your doctor considers it absolutely necessary. Your doctor will take all possible precautions to avoid harm to you or your unborn child.

Mepivacaine is not the drug of choice for epidural anesthesia in obstetrics.

This medicine will only be administered during breastfeeding if your doctor considers it necessary. If administration is required, breastfeeding should be interrupted for 24 hours after completion of treatment.

Driving and using machines:

Mepivacaine B. Braun 10 mg/ml may temporarily impair your motor skills, attention, and coordination. Your doctor will advise you whether you may drive or operate machinery.

Mepivacaine B. Braun 10 mg/ml contains sodium

5 ml vials:

This medicine contains less than 23 mg of sodium (1 mmol) per 5 ml vial, which is essentially “sodium-free”.

10 ml vials:

This medicine contains 27.6 mg of sodium (main component of table/cooking salt) in each 10 ml vial. This corresponds to 1.4% of the maximum recommended daily sodium intake for an adult.

20 ml vials:

This medicine contains 55.1 mg of sodium (main component of table/cooking salt) in each 20 ml vial. This corresponds to 2.8% of the maximum recommended daily sodium intake for an adult.

3. How to use Mepivacaine B. Braun 10 mg/ml

Mepivacaine B. Braun 10 mg/ml is administered by intradermal, subcutaneous, intramuscular, periarticular, epidural, or perineural routes.

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

Special caution and careful dose adjustment are necessary in patients with liver, kidney, or heart disease, in those with general poor health, and in elderly patients.

Your doctor will ask you to talk to them while administering the medication to ensure that you remain conscious.

Your blood pressure may be monitored from time to time.

If you are given more Mepivacaine B. Braun 10 mg/ml than you should:

Overdose may cause signs and symptoms of toxicity. The severity of signs and symptoms depends on the dose administered. The following may occur:

1. Central nervous system symptoms:

Mild toxicity:

Tingling and numbness in the area of the mouth, metallic taste, disturbances in hearing and vision, yawning, anxiety, restlessness, chills, muscle spasms, nausea, vomiting, disorientation.

Moderate toxicity:

Speech disturbances, drowsiness, nausea, vomiting, dizziness, somnolence, confusion, tremor, choreiform movements, seizures, mydriasis, tachypnea.

Severe toxicity:

Vomiting (risk of asphyxiation), sphincter paralysis, loss of muscle tone and reactivity, stupor, irregular breathing, respiratory paralysis, coma, death.

2. Cardiovascular system symptoms

Mild toxicity:

Palpitations, hypertension, tachycardia, tachypnea.

Moderate toxicity:

Tachycardia, cardiac arrhythmias, hypoxia, pallor.

Severe toxicity:

Severe hypoxia and cyanosis, primary cardiac failure, hypotension, cardiac arrhythmias (bradycardia, atrial fibrillation, asystole).

In such cases, necessary treatment will be provided first to normalize and stabilize heart, circulation, and respiration, followed by management of seizures and other severe neurological symptoms. This includes administration of oxygen and additional medications, primarily aimed at restoring normal heart function and circulation.

In case of overdose or accidental ingestion, contact your doctor, nurse, or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 652 04 20, stating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Common (may affect up to 1 in 10 people):

• Burning sensation, prickling, and tingling of the skin (paraesthesia), and dizziness.
• Slow and irregular heart rate (bradycardia).
• Hypotension.
• Hypertension.
• Nausea.
• Vomiting.

Uncommon (may affect up to 1 in 100 people):

• Dizziness (mild lightheadedness).
• Tremor.
• Central Nervous System depression.
• Loss of consciousness.
• Seizures (including epileptic fits).
• Speech disorders such as difficulty articulating sounds and words (dysarthria) and excessive talkativeness (logorrhea).
• Visual disturbances.
• Ringing in the ears (tinnitus).

Rare (may affect up to 1 in 1,000 people):

• Anaphylactic/anaphylactoid reactions.
• Allergic reactions.
• Pain due to nerve injury (neuropathy).
• Peripheral neural damage.
• Arachnoiditis.
• Diplopia (paralysis of ocular muscles).
• Cardiac arrest.
• Angina pectoris.
• Coordination problems in heart rhythm (atrioventricular block).
• Cardiac arrhythmia.
• Difficulty breathing.

Frequency not known (frequency cannot be estimated from available data):

• Euphoria.
• Anxiety/nervousness.
• Inability of the heart to contract effectively (myocardial depression).

Adverse effects due to use errors

Extensive (total) spinal anaesthesia may occur due to inadvertent intrathecal injection during planned epidural anaesthesia, resulting from the use of too large a volume or incorrect patient positioning (when non-isobaric solutions are used).

The first signs are restlessness, murmuring, and somnolence, which may progress to loss of consciousness and respiratory arrest.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mepivacaine B. Braun 10 mg/ml

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Mepivacaine B. Braun 10 mg/ml after the expiry date stated on the container (after EXP). The expiry date refers to the last day of the month indicated.

The contents of the ampoules must be used immediately after opening. After opening, discard any unused portion of the solution. For single use only. Do not use this medicine if particles are observed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Mepivacaine B. Braun 10 mg/ml

The other excipients are: sodium chloride, sodium hydroxide (for pH adjustment), and water for injections to make up the volume.

Appearance of the medicinal product and contents of the container

Mepivacaíne B. Braun 10 mg/ml is an injectable solution supplied in polyethylene ampoules (Mini-Plasco) of 5, 10 and 20 ml. It is packaged in packs containing 1 ampoule and 100 ampoules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

• Braun Medical, S.A.
  Ctra. de Terrassa, 121
  08191-Rubí (Barcelona)
  Spain

Date of the most recent revision of this summary: July 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

Mepivacaíne B. Braun 10 mg/ml should only be used by physicians experienced in regional anesthesia and resuscitation techniques, or under their supervision. Resuscitation equipment must be readily available whenever local anesthetics are administered. The lowest effective dose required to achieve the desired effect should always be used. The dose must be individually adjusted according to the specific circumstances of each case.

Dosage

The smallest dose required to achieve the desired anesthesia should always be used. Dosage must be individually adjusted according to the patient's age, weight, and individual circumstances.

Maximum dose for adults:

Infiltration anesthesia

The dose should not exceed 200 mg. Only in limited cases, involving tissues with low vascularity, doses up to 400 mg may be used, provided the benefit/risk ratio of such high doses has been carefully considered.

Caudal and epidural anesthesia, peripheral nerve blocks:

The dose should not exceed 300 mg.

The maximum daily dose is 1 g.

Mepivacaíne B. Braun 10 mg/ml injectable solution may be administered continuously.

The following doses are recommended for different types of use:

• When anesthetizing multiple segments, the total dose must not exceed the recommended maximum dose.

For further details on doses to be administered for the anesthesia of specific nerves or for specific anesthetic techniques, consult standard textbooks.

Elderly patients

Lower doses may be required for elderly patients or those in poor general condition.

Pediatric population

Maximum doses for children from one year of age:

• Maximum dose: 5 mg/kg body weight.
• Injections into tissues with marked systemic absorption: up to 3 mg/kg body weight.
• Caudal anesthesia: 5 mg/kg body weight.

Hepatic impairment

In patients with hepatic impairment, dose reduction is not necessary for surgical anesthesia.

When prolonged blocks are used, e.g., by repeated administration, repeated doses of mepivacaine should be reduced by 50% in patients with Child-Pugh class C hepatic disease, and the total dose within 24 hours must not exceed 750 mg of mepivacaine.

Renal impairment

Dose reduction is not necessary for surgical anesthesia within 24 hours in patients with renal dysfunction.

Administration:

• Intradermal, subcutaneous, intramuscular, periarticular for infiltration anesthesia.
• Perineural or epidural for nerve conduction blockade.

Before injection, it must be ensured that the needle is not positioned intravascularly. The injection must be performed slowly and in fractions.

Basic guidelines to follow:

1. Choose the lowest possible dosage.
2. Use a needle of appropriate size.
3. Inject slowly with multiple aspirations in two planes (rotate the needle 180º).

Great care must be taken to avoid accidental intravascular injection. Careful aspiration is essential.

1. Monitor blood pressure.
2. Consider premedication. Premedication should include prophylactic administration of atropine and—depending on the appropriate amounts of local anesthetic to be injected—a short-acting barbiturate.
3. If necessary, discontinue anticoagulant therapy prior to administration of the local anesthetic.
4. Observe general and specific contraindications for the various methods of local or regional anesthesia.

For epidural anesthesia, a test dose consisting of 3–4 ml of a local anesthetic with added adrenaline (1:200,000) should be administered before the full dose, since intravascular injection of adrenaline is rapidly recognized due to the increase in heart rate. Heart rate must be measured repeatedly for up to 5 minutes after administration of the test dose.

Precautions must be taken to avoid accidental intravascular injection. Careful aspiration and a test dose are essential.

Verbal contact with the patient must be maintained, and heart rate must be monitored repeatedly for up to 5 minutes after administration of the test dose. Aspiration must be repeated before administering the main dose. The main dose must be injected slowly, and especially when increasing the dose, constant contact with the patient must be maintained. Administration must be stopped immediately at the first signs of toxicity.

Before administering a local anesthetic, it must be ensured that resuscitation equipment, e.g., oxygen source, airway maintenance devices, and emergency medications for the treatment of toxic reactions, is immediately available.