Sevoflurane Baxter 100% liquid for inhalation EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sevoflurane Baxter 100% solution for inhalation vapour EFG

Active substance: Sevoflurane

Read the entire leaflet carefully before you start using 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.

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

Leaflet contents:

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

2. What you need to know before using Sevoflurane Baxter

3. How to use Sevoflurane Baxter

4. Possible adverse effects

5. How to store Sevoflurane Baxter

6. Contents of the pack and other information

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

Sevoflurano Baxter contains sevoflurane. Sevoflurane is a general anaesthetic used in surgery for both adults and children. It is an inhaled anaesthetic (administered as a vapour for inhalation). Breathing in this vapour produces a deep, pain-free sleep. It also maintains a deep, pain-free state (general anaesthesia) during which surgery can be performed.

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

2. What you need to know before using Sevoflurane Baxter

Sevoflurane must only be administered by healthcare professionals trained in the administration of general anesthesia, under the supervision of an anesthetist or by the anesthetist themselves.

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

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

Inform your anesthetist (doctor) before this medicine is administered if any of the above conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before using Sevoflurane Baxter if:

• you have previously received an inhaled anesthetic, especially if on multiple occasions or within a short period of time (repeated use).
• you have low blood pressure.
• you suffer from hypovolemia (reduced blood volume) or are weak.
• you have kidney failure.
• you are pregnant, breastfeeding, or when this medicine is used 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 previously had liver problems such as hepatitis (liver inflammation) or jaundice.
• you have been treated with medicines that may cause liver problems.
• there is a history of seizures (epileptic fits) or a risk of them occurring.
• in the rare and unexpected event that you develop malignant hyperthermia (a sudden and dangerous rise in body temperature during or shortly after surgery). In such a case, the anesthetist (doctor) will stop administering sevoflurane and you will be given a medicine to treat malignant hyperthermia (known as dantrolene) and receive supportive therapy. Death due to malignant hyperthermia has been reported with the use of Sevoflurane.
• you have a neuromuscular disease, for example, Duchenne muscular dystrophy.
• you have a cellular disorder (a condition known as mitochondrial disorder).

Children

• you have Down syndrome.

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

Use of Sevoflurane Baxter with other medicines:

Inform your doctor, pharmacist, surgeon, or anesthetist if you are taking, have recently taken, or might need to take any other medicines. This also includes herbal medicines, vitamins, and minerals.

The following medicines or active substances may interact with Sevoflurane Baxter and alter each other's effects when used together. Some of these medicines will be administered by the anesthetist during the procedure, as described below.

• Nitrous oxide: a medicine used during general anesthesia to induce sleep and relieve pain.
• Opioids (e.g., morphine, fentanyl, remifentanil): these are potent painkillers frequently used during general anesthesia.
• Non-depolarizing muscle relaxants (e.g., pancuronium, atracurium): these medicines are used during general anesthesia to relax muscles.
• Benzodiazepines (e.g., diazepam, lorazepam): sedative medicines with a calming effect, used when a patient is anxious before a procedure.
• Adrenaline: this medicine is commonly used to treat allergic reactions, but may also be used during general anesthesia.
• Verapamil: a heart medicine used to treat high blood pressure or irregular heart rhythm.
• Beta-blockers (e.g., atenolol, propranolol): heart medicines frequently used to treat high blood pressure.
• Indirect sympathomimetic medicines, 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 medicines).
• Isoniazid: a medicine used to treat tuberculosis (TB).
• Alcohol
• St. John’s wort: a herbal remedy used for depression.

Sevoflurane Baxter with food and drinks

Sevoflurane Baxter is a medicine used to induce sleep so that surgery can be performed. Consult your doctor, surgeon, or anesthetist about when and what you may eat or drink after waking up.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Sevoflurane Baxter significantly affects your ability to drive and operate machinery. Do not drive or operate tools or machinery until your doctor tells you it is safe to do so. Administration of anesthesia may affect your attention for several days. This may impair your ability to perform tasks requiring alertness.

Consult your anesthetist about when it will be safe for you to drive and resume using machinery.

3. How to use Sevoflurano Baxter

An anaesthetist will administer Sevoflurano Baxter to you. The anaesthetist will decide the amount and frequency of administration. The dose will vary depending on your age, weight, type of surgery required, and other medications given during the procedure.

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

Your anaesthetist will decide when to stop administering Sevoflurano Baxter. Afterwards, you will wake up within a few minutes.

If you receive more Sevoflurano Baxter than you should

A healthcare professional will administer Sevoflurano Baxter to you, and it is unlikely that you will receive an excessive dose. If this were to happen, the anaesthetist will take the necessary measures.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

Serious adverse effects (may be life-threatening)

• anaphylaxis and anaphylactoid reactions (see the section on adverse effects of unknown frequency for further information).

If these symptoms occur while Sevoflurano Baxter is being administered, the anaesthetist will take the necessary measures.

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

• agitation (feeling restless and disturbed)
• slow heart rate
• low blood pressure
• cough
• nausea (feeling sick) and vomiting (being sick)

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

• numbness or drowsiness
• headache
• dizziness
• fast heart rate
• high blood pressure
• breathing disorders
• airway obstruction
• slow, shallow breathing
• throat cramps
• increased salivation
• fever
• chills
• increase or decrease in white blood cell count, which could affect the immune system, i.e., increased susceptibility to infections
• increased blood glucose (sugar) levels, detected by blood test
• increased liver enzymes, detected by blood test
• increased blood fluoride levels, detected by blood test
• decreased body temperature

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

• confusion
• irregular or very rapid heartbeat
• AV block (a disorder of the heart's electrical conduction)
• apnea (cessation of breathing)
• asthma
• hypoxia (low oxygen levels in the blood)
• increased blood creatinine levels (an indicator of kidney impairment), detected by blood test

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

• allergic reactions, such as:
• rash
• skin redness
• urticaria (hives)
• itching
• eyelid swelling
• difficulty breathing
• anaphylaxis and anaphylactoid reactions. These allergic reactions occur rapidly and may be life-threatening. Symptoms of anaphylaxis may include:
• angioedema (swelling of the skin of the face, limbs, lips, tongue or throat)
• difficulty breathing
• low blood pressure
• urticaria (hives)
• confusion
• seizures resembling epilepsy
• sudden movements
• cardiac failure
• spasms 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
• dangerous increase in body temperature
• chest discomfort
• increased pressure inside the skull
• irregular heartbeat or palpitations
• inflammation of the pancreas
• increased blood potassium levels, detected by blood test
• muscle rigidity
• yellowish skin
• kidney inflammation (may include symptoms such as fever, confusion or drowsiness, skin rash, swelling, changes in urine volume, and presence of blood in urine)
• swelling

Epileptic-like seizures (convulsions) may occasionally occur. These may happen during administration of Sevoflurano Baxter or up to one day after recovery. They occur mostly in children and young adults.

In children with Down's syndrome receiving sevoflurane, a decrease in heart rate may occur.

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 adverse effects may require treatment.

Reporting of adverse effects

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

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sevoflurane Baxter

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

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

6. Contents of the container and other information

Composition of Sevoflurane Baxter

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

It contains no other ingredients.

Appearance of the medicine and contents of the container

Sevoflurane is an inhalation liquid, yielding a colorless and transparent vapor.

It is supplied in 250 ml aluminum bottles with a protective lining.

The bottle may be closed with:

• a plastic screw cap, or

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

Pack sizes of 1 and 6 bottles.

Only certain 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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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

The last revision of this leaflet was in November 2023.

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