SEVOFLURANE BAXTER 100% LIQUID FOR INHALATION

Introduction

Leaflet: information for the user

Sevoflurane Baxter 100% liquid for inhalation vapor EFG

Active ingredient: Sevoflurane

Read the entire leaflet carefully before starting to use this medication, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Sevoflurane Baxter and what is it used for
2. What you need to know before starting to use Sevoflurane Baxter
3. How to use Sevoflurane Baxter
4. Possible side effects
5. Storage of Sevoflurane Baxter
6. Package contents and additional information

1. What is Sevoflurane Baxter and what is it used for

Sevoflurane Baxter contains sevoflurane. Sevoflurane is a general anesthetic used in surgery for both adults and children. It is an inhalation anesthetic (administered in the form of vapor for inhalation). Inhaling this vapor produces a deep and painless sleep. It also maintains a deep and painless sleep (general anesthesia) during which surgery can be performed.

You should consult a doctor if it worsens or does not improve.

2. What you need to know before starting to use Sevoflurane Baxter

Sevoflurane should only be administered by healthcare professionals with adequate training in the application of general anesthesia under the supervision of an anesthesiologist or by the anesthesiologist themselves.

Your anesthesiologist (doctor) will not administer Sevoflurane Baxter if:

• you are allergic (hypersensitive) to sevoflurane or other inhalation anesthetics.
• you have a confirmed history of liver inflammation (hepatitis) caused by sevoflurane or other inhalation anesthetics, or a history of unexplained liver problems with jaundice, fever, and an increase in a certain type of white blood cells.
• you have a known or suspected susceptibility to malignant hyperthermia (a sudden and dangerous increase in body temperature during surgery or shortly after).
• there are medical reasons why you should not receive general anesthesia.

Tell your anesthesiologist (doctor) before administering this medication if any of the above conditions apply to your case.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Sevoflurane Baxter if:

• you have previously been administered an inhalation anesthetic, especially if it has been on more than one occasion or in a short period (repeated use).
• you have low blood pressure.
• you have hypovolemia (reduced blood volume) or are weak.
• you have kidney failure.
• you are pregnant, breastfeeding, or when this medication is administered for obstetric anesthesia (childbirth) (see also the section titled "Pregnancy and breastfeeding").
• you have acute coronary artery disease.
• there is a risk of increased intracranial pressure.
• you have had liver problems in the past, such as hepatitis (liver inflammation) or jaundice.
• you have been treated with medications that can cause liver problems.
• there is a history of seizures (epileptic crises) or a risk of them occurring.
• in the rare and unforeseen case that you develop malignant hyperthermia (a sudden and dangerous increase in body temperature during surgery or shortly after). In this case, the anesthesiologist (doctor) will stop the administration of sevoflurane and you will be given a medication to treat malignant hyperthermia (known as dantrolene) and you will receive other maintenance therapy. Death from malignant hyperthermia has been reported with the use of Sevoflurane.
• you have a muscular disorder, for example, Duchenne muscular dystrophy.
• you have a mitochondrial disorder (a condition known as mitochondrial disorder).

Children

• you have Down syndrome.

Consult your doctor, nurse, or pharmacist if any of the above conditions apply to your case. You may need to undergo a thorough examination and your treatment may need to be changed.

Use of Sevoflurane Baxter with other medications:

Tell your doctor, pharmacist, surgeon, or anesthesiologist if you are taking, have recently taken, or may need to take any other medication. This also applies to herbal medicines, vitamins, and minerals.

Medications or active ingredients that contain the medicines listed in the following list may alter their effects when administered together with Sevoflurane Baxter. Some of these medications will be administered by the anesthesiologist during the procedure, as indicated in the description.

• Nitrous oxide: a medication used during general anesthesia to induce sleep and relieve pain.
• Opioids (e.g., morphine, fentanyl, remifentanil): these are very potent pain relievers used frequently during general anesthesia.
• Non-depolarizing muscle relaxants (e.g., pancuronium, atracurium): these medications are used during general anesthesia to relax muscles.
• Benzodiazepines (e.g., diazepam, lorazepam): sedative medications that have a calming effect. They are used when the patient is nervous before a procedure.
• Adrenaline: this medication is often used to treat allergic reactions, but it can also be used during general anesthesia.
• Verapamil: a cardiac medication administered to treat high blood pressure or when the patient has an irregular heartbeat.
• Beta-blockers (e.g., atenolol, propranolol): cardiac medications often administered to treat high blood pressure.
• Indirect sympathomimetic medications, such as amphetamines (used to treat attention deficit hyperactivity disorder (ADHD) or narcolepsy) or ephedrine (used as a decongestant and commonly found in cough and cold medications).
• Isoniazid: a medication used to treat tuberculosis (TB).
• Alcohol.
• St. John's Wort: a medicinal herb used for depression.

Sevoflurane Baxter with food and drinks

Sevoflurane Baxter is a medication used to induce sleep in the patient so that they can be operated on. Consult your doctor, surgeon, or anesthesiologist about when and what you can eat or drink after waking up.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor, surgeon, or anesthesiologist before administering this medication.

Driving and using machines

Sevoflurane Baxter significantly affects the ability to drive and operate tools. Do not drive or operate tools or machinery until your doctor indicates that it is safe. The administration of anesthesia can influence attention for several days. This can affect the ability to perform tasks that require a state of wakefulness.

Consult your anesthesiologist about when it will be safe to drive and operate machines again.

3. How to use Sevoflurane Baxter

An anesthesiologist will administer Sevoflurane Baxter to you. The anesthesiologist will decide the amount and frequency of administration. The dose will vary depending on age, weight, the type of surgery needed, and the rest of the medications administered during the procedure.

Sevoflurane Baxter is produced from sevoflurane liquid in a vaporizer specifically designed for use with sevoflurane. You may need to inhale sevoflurane vapor through a mask to induce sleep. Additionally, you may receive an injection of another anesthetic to induce sleep before administering Sevoflurane Baxter through a mask or a tube inserted into the throat.

Your anesthesiologist will decide when to stop the administration of Sevoflurane Baxter: you will then wake up in a few minutes.

If you receive more Sevoflurane Baxter than you should

A healthcare professional will administer Sevoflurane Baxter, and it is unlikely that you will receive an excessive dose of the medication. If this happens, the anesthesiologist will take the necessary measures.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Most adverse reactions are mild to moderate in severity and are transient, although serious side effects can occur.

Serious side effects(can be life-threatening)

• anaphylaxis and anaphylactoid reactions (see the section on unknown frequency for more information).

If these symptoms occur while you are being administered Sevoflurane Baxter, the anesthesiologist will take the necessary measures.

Very common side effects(may affect more than 1 in 10 people)

• agitation (feeling of restlessness and disturbance).
• slower heart rate.
• low blood pressure.
• cough.
• nausea (feeling of sickness) and vomiting (being sick).

Common side effects(may affect up to 1 in 10 people)

• drowsiness or feeling of drowsiness.
• headache.
• dizziness.
• fast heart rate.
• high blood pressure.
• breathing disorders.
• respiratory obstruction.
• shallow and slow breathing.
• throat spasms.
• increased salivation.
• fever.
• chills.
• increase or decrease in the number of white blood cells, which could affect the immune system, i.e., increased susceptibility to infections.
• increase in blood glucose levels, detected by a blood test.
• increase in liver enzymes, detected by a blood test.
• increase in blood fluoride levels, detected by a blood test.
• decrease in body temperature.

Uncommon side effects(may affect up to 1 in 100 people)

• confusion.
• irregular or very intense heart rhythm.
• AV block (disorder of the heart's electrical conduction).
• apnea (when you stop breathing).
• asthma.
• hypoxia (low oxygen level in the blood).
• increase in creatinine levels in the blood (an indicator of kidney failure), detected by a blood test.

Unknown frequency(frequency cannot be estimated from available data)

• allergic reactions, such as:
• rash.
• skin redness.
• hives (urticaria).
• itching.
• swelling of the eyelids.
• difficulty breathing.
• anaphylaxis and anaphylactoid reactions. These allergic reactions occur rapidly and can be life-threatening. Among the symptoms of anaphylaxis are:
• angioedema (swelling of the skin of the face, limbs, lips, tongue, or throat).
• difficulty breathing.
• low blood pressure.
• hives (urticaria).
• confused mental state.
• seizures similar to those of epilepsy.
• sudden movements.
• heart failure.
• spasm of the airways.
• difficulty breathing or wheezing.
• breath-holding.
• shortness of breath.
• decreased liver function or hepatitis (liver inflammation), characterized, for example, by loss of appetite, fever, nausea, vomiting, abdominal discomfort, jaundice, and dark urine.
• dangerously high body temperature.
• chest discomfort.
• increased intracranial pressure.
• irregular heartbeat or palpitations.
• pancreatitis (inflammation of the pancreas).
• increased potassium levels in the blood, detected by a blood test.
• muscle stiffness.
• yellowish skin color.
• kidney inflammation (which can include symptoms such as fever, confusion, or drowsiness, skin rash, swelling, more or less urine than usual, and blood in the urine).
• swelling.

Seizures (epileptic crises) can occur. These can occur when Sevoflurane Baxter is administered or up to a day after recovery. They mostly occur in children and young adults.

In children with Down syndrome who receive Sevoflurane, a decrease in heart rate can occur.

Fluoride levels in the blood may be slightly elevated during and immediately after anesthesia, but these levels are not believed to be harmful and will soon return to normal.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. If you notice any change in how you feel after receiving sevoflurane, inform your doctor or pharmacist immediately. Some side effects may require treatment.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sevoflurane Baxter

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the label after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

6. Package contents and additional information

Composition of Sevoflurane Baxter

The active ingredient is sevoflurane 100% (250 ml in a 250 ml bottle).

It does not contain other ingredients.

Appearance of the product and package contents

Sevoflurane is a colorless and transparent liquid for inhalation vapor.

It is presented in 250 ml aluminum bottles with a protective coating.

The bottle may be closed with:

• a plastic screw cap, or

• a built-in valve that connects directly to a suitable vaporizer.

Boxes of 1 and 6 bottles.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

MARKETING AUTHORIZATION HOLDER

Baxter, S.L.

Pouet de Camilo 2,

46394 Ribarroja del Turia (Valencia)

MANUFACTURER

Baxter SA,

Boulevard Rene Branquart 80,

B-7860 Lessines,

Belgium

This medication is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

The last revision of this leaflet was in November 2023.

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/