Prospecto:information for the user

Sevoflurano Baxter 100% liquid for inhalation of vapor EFG

Active ingredient: Sevoflurano

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

Keep this prospectus,as you may need to read it again.

If you have any questions, consult your doctor, pharmacist or nurse

If you experience adverse effects, consult your doctor, pharmacist or nurse,even if they are not listed in this prospectus. See section 4.

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

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

3.How to use Sevoflurano Baxter

4.Possible adverse effects

5.Storage of Sevoflurano Baxter

6.Contents of the package and additional information

Sevoflurano Baxter contains sevoflurane. Sevoflurane is a general anesthetic that is used in surgery in both adults and children. It is an inhalation anesthetic (administered in the form of vapor for inhalation). The inhalation of 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.

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 same.

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 it).
• There are medical reasons why you should not receive general anesthesia.

Inform your anesthesiologist (doctor) before they administer 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 already been administered an inhalation anesthetic, especially if it has been done more than once or in a short period of time (repeated use).
• You have low blood pressure.
• You have hypovolemia (reduced blood volume) or are weak.
• You have kidney insufficiency.
• 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 disease.
• There is a risk of increased intracranial pressure.
• You have had previous liver problems, such as hepatitis (liver inflammation) or jaundice.
• You have been treated with medications that can cause liver problems.
• There is a record of you having seizures (epileptic crises) or there is a risk of them occurring.
• In the rare and unexpected case of developing malignant hyperthermia (a sudden and dangerous increase in body temperature during surgery or shortly after it). In this case, the anesthesiologist (doctor) will stop administering sevoflurane and give you a medication to treat malignant hyperthermia (known as dantrolene) and receive another maintenance therapy. Deaths due to malignant hyperthermia have been reported with the use of Sevoflurane.
• You have a neuromuscular disease, for example, Duchenne muscular dystrophy.
• You have a disorder of cells (a condition known as a mitochondrial disorder).

Children

• You have Down syndrome.

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

Use of Sevoflurane Baxter with other medications:

Inform your doctor, pharmacist, surgeon, or anesthesiologist if you are taking, have taken recently, or may need to take any other medication. This also applies to medications based on plants, vitamins, and minerals.

The medications or active principles contained in the medications listed below may alter your effects when administered together with Sevoflurane Baxter. Some of these medications will be administered by the anesthesiologist during the intervention, as indicated in the description.

• Nitrous oxide: a medication used during general anesthesia to induce sleep and relieve pain.
• Opioids (for example, morphine, fentanyl, remifentanil): these medications are very potent analgesics that are often used during general anesthesia.
• Non-depolarizing muscle relaxants (for example, pancuronium, atracurium): these medications are used during general anesthesia to relax muscles.
• Benzodiazepines (for example, 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 that is administered to treat high blood pressure or when the patient has an irregular heart rhythm.
• Beta-blockers (for example, atenolol, propranolol): cardiac medications that are often administered to treat high blood pressure.
• Indirect sympathomimetics, such as amphetamines (used to treat attention deficit hyperactivity disorder (ADHD) or narcolepsy) or ephedrine (used as a decongestant and often found in cold and cough medications)
• Isoniazid: a medication used to treat tuberculosis (TB).
• Alcohol
• St. John's Wort:this is a medicinal plant 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 fertilityand

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

Driving and operating machines

Sevoflurane Baxter significantly affects your ability to drive and operate machinery. Do not drive or operate machinery until your doctor tells you it is safe. Anesthesia administration can affect attention for several days. This can affect your ability to perform tasks that require vigilance.

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

A licensed anesthesiologist will administer Sevoflurano Baxter. The anesthesiologist will decide on the amount and frequency of administration. The dose will vary based on age, weight, type of surgery needed, and other medications administered during the procedure.

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

Your anesthesiologist will decide when to stop administering Sevoflurano Baxter: You will wake up within a few minutes.

If you receive more Sevoflurano Baxter than you should

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The majority of adverse reactions have a mild to moderate severity and are of a transient nature, although severe side effects can occur.

Severe side effects(may pose a risk to life)

• anaphylaxis and anaphylactoid reactions (see the section on side effects ofunknown frequencyfor more information).

If these symptoms occur while Sevoflurano Baxter is being administered, 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
• coughing
• nausea (feeling of illness) and vomiting (being sick).

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

• drowsiness or feeling sleepy
• headache
• dizziness
• fast heart rate
• high blood pressure
• respiratory disturbances
• breathing obstruction
• slow, shallow breathing
• throat cramps
• increased salivation
• fever
• chills
• increase or decrease in the number ofwhite blood cells, which couldaffect the immune system, that is,an increased susceptibility toinfections
• increase in the level ofglucose (sugar)in the blood, which is detected by a blood test.
• increase inliver enzymes, which is detected by a blood test.
• increase in the level offluoride in the blood, which is detected by a blood test.
• decreased body temperature

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

• confusion
• irregular or very intense heart rhythm
• AV block (conduction disorder of the heart)
• apnea (when breathing stops)
• asthma
• hypoxia (low oxygen level in blood)
• increase in creatinine levels in blood (a renal insufficiency indicator), detected by a blood test

Unknown frequency(the frequency cannot be estimated from available data)

• allergic reactions, such as:
• skin rash
• skin redness
• hives
• itching
• swelling of the eyelids
• difficulty breathing
• anaphylaxis and anaphylactoid reactions. These allergic reactions occur rapidly and can pose a risk to life. Symptoms of anaphylaxis include:
• angioedema (swelling of the skin of the face, limbs, lips, tongue, or throat)
• difficulty breathing
• low blood pressure
• hives.
• confusion
• epilepsy-like seizures
• sudden movements
• cardiac arrest
• spasms of therespiratory tract
• difficulty breathing orsibilant sounds
• breathing retention
• shortness of breath
• decreased liver function or hepatitis (inflammation of the liver), characterized, for example, by loss of appetite, fever, nausea, vomiting, abdominal discomfort, jaundice, and dark urine.
• dangerous increase in body temperature
• chest discomfort
• increased intracranial pressure
• irregular heartbeat or palpitations.
• pancreatitis (inflammation of the pancreas)
• increase in potassium levels in blood, detected by a blood test
• muscle stiffness
• yellowish skin
• inflammation of the kidneys (may include symptoms such as fever, confusion, or drowsiness, skin rash, swelling, more or less urine than normal, and presence of blood in urine)
• swelling

In some cases, seizures (epilepsy-like convulsions) may occur. These can occur at the time of administering Sevoflurano or up to a day after recovery. They mostly occur in children and young adults.

In children with Down syndrome who receive Sevoflurano, a decrease in heart rate may occur.

The levels offluoride inthe blood may bea little elevatedduringand immediately afteranesthesia, butthese levels are notbelieved to beharmfuland will soonreturn to normal.

If you experience side effects, consult yourdoctor or pharmacist,even if they are side effects that do not appear in this prospectus.Inform your doctor or pharmacist immediately if you notice any change in how you feel after receiving Sevoflurano. Some side effects may require treatment.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

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

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

Do not use this medication after the expiration date that appears printed on the label after CAD.The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Sevoflurane Baxter Composition

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

It does not contain other ingredients.

Appearance of the product and contents of the container

Sevofluraneis an inhaled vapor colorless and transparent liquid.

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

The bottle may be closed with:

- a plastic screw cap, or

- an integrated valve that connects directly to a suitable vaporizer.

Boxes of 1 and 6 bottles.

Only some container sizes may be marketed.

Marketing Authorization Holder and Responsible 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 medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

For further information about this medicinal product, please contact the local representative of the marketing authorization holder.

This leaflet was last revised in November 2023.

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/