Leaflet: information for the user

Suprane 100% liquid for inhalation of vapor

Desflurane

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

1. What is Suprane and what it is used for

2. What you need to know before using Suprane

3. How to use Suprane

4. Possible side effects

5. Storage of Suprane

6. Contents of the pack and additional information

Suprane is a medication that contains desflurane and belongs to the group of halogenated hydrocarbons.

It is used as a general anesthetic and is administered in the form of vapor for inhalation. Breathing this vapor causes a deep and painless sleep (general anesthesia) during which you can undergo surgery.

For adults, Suprane is used for the induction and maintenance of anesthesia. For infants and children, it is used only for the maintenance of anesthesia.

Suprane 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 Suprane to you:

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

Suprane should not be administered to induce anesthesia if:

• you are at risk of developing coronary artery disease. Coronary artery disease appears when the blood vessels of the heart muscles do not supply enough blood and oxygen.

This condition can lead to a heart attack.

• Your doctor considers that the potential adverse effects of Suprane are undesirable, for example:

• an increase in heart rate,
• an increase in your blood pressure.

• It will be used with a child.

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 nurse before starting to use Suprane if:

• You have already been administered an inhalation anesthetic, especially if it has been done more than once in a short period of time (repeated use).
• In the rare and unexpected 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 administering Suprane, give you a medication to treat malignant hyperthermia (known as dantrolene), and provide another maintenance therapy.

Death due to malignant hyperthermia has been reported with the use of Suprane.

• You have a neuromuscular disease, for example, Duchenne muscular dystrophy.
• You are pregnant, breastfeeding, or when this medication is administered for obstetric anesthesia (delivery) (see also the section titled "Pregnancy and breastfeeding").
• You have had previous liver problems, such as hepatitis (inflammation of the liver) or jaundice.

ictericia.

• You have been treated with medications that can cause liver problems.
• There is a risk of increased intracranial pressure.
• You have acute coronary artery disease.
• You have low blood pressure (hypotension)
• You have hypovolemia (reduced blood volume) or are weak.
• You have a heart rhythm disorder called "prolongation of the QT interval".

Postoperative pain

You may recover from anesthesia with Suprane quickly. If you expect to have pain after your operation, your doctor will give you pain relief medications. This will be done at the end of your operation or when you are recovering after the same.

Children

Children under 6 years of age should not receive Suprane to maintain anesthesia unless they have been intubated. Intubation is when a tube is placed in the airways to help breathing. In these cases, caution should be exercised when removing the laryngeal mask after a deep anesthesia to avoid adverse effects, such as coughing or a muscle spasm of the vocal cords called laryngospasm.

Consult with your doctor, nurse, or pharmacist if any of the conditions previously indicated apply to your case or that of your child. It may be necessary to undergo a thorough examination and change the treatment.

Use of Suprane 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.

The medications or active principles shown in the following list may alter its effects when administered together with Suprane. Some of these medications will be administered by the anesthesiologist during the procedure, as indicated in the description.

• Muscle relaxants (for example, succinylcholine, pancuronium, atracurium, vecuronium): These medications are used during general anesthesia to relax muscles. Your anesthesiologist may need to adjust the dose of these medications.
• Opioids (for example, morphine, fentanyl, remifentanil): These medications are very potent pain relievers that are often used during general anesthesia.
• Benzodiazepines (for example, midazolam, diazepam, nitrazepam): Sedative medications that have a calming effect. They are used when the patient is nervous before a procedure.
• Nitrous oxide: A medication used during general anesthesia to induce sleep and relieve pain.

Use of Suprane with food and drinks

Suprane is a medication used to induce sleep in the patient so that they can be operated on. Consult with 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 they administer this medication.

Driving and operating machines

Suprane 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 anesthesiologist will administer Suprane, and it will be their decision as to 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.

Suprane is a liquid for inhalation of vapor that is administered through a specially calibrated vaporizer

so that the released concentration can be controlled exactly.

If you receive more Suprane than you should

A healthcare professional will administer Suprane, and it is unlikely that you will receive an excessive dose of the medication. If this were to happen, the anesthesiologist will take necessary measures.

In the event of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

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

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

The following side effects may also occur during treatment. The evaluation of side effects is based on the following frequencies:

Very common (affects more than 1 in 10 patients):

• Nausea (feeling of discomfort) and vomiting. These have occurred during the induction and maintenance of anesthesia with Suprane.

Common (affects between 1 and 10 in 100 patients):

• Throat inflammation (pharyngitis).
• Respiratory retention. This has occurred during the induction and maintenance of anesthesia with Suprane.
• Headache.
• Conjunctivitis, an inflammation of the conjunctiva of the eyelid.
• Irregular heart rhythm (nodal arrhythmia).
• Slow heart rate (bradycardia).
• Fast heart rate (tachycardia).
• High blood pressure (hypertension).
• Respiratory suspension (apnea), cough, excessive salivation (sialorrhea). These have occurred during the induction and maintenance of anesthesia with Suprane.
• Laryngospasm, a spasm of the vocal cords.
• Increased levels in the blood of an enzyme called creatine phosphokinase.
• Abnormal heart test results (ECG abnormal).

Uncommon (affects between 1 and 10 in 1,000 patients):

• Restlessness (agitation).
• Dizziness.
• Heart attack (myocardial infarction).
• Insufficient blood flow to the heart muscle (myocardial ischemia).
• Irregular heart rhythm (arrhythmia).
• Widening of blood vessels (vasodilation).
• Insufficient oxygen supply (hypoxia). This has occurred during the induction and maintenance of anesthesia with Suprane.
• Muscle pain (myalgia).

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

• Blood clotting disorder (coagulopathy).
• High potassium levels (hyperkalemia).
• Low potassium levels (hypokalemia).
• Metabolic acidosis, excessive acid production by the body.
• Seizures (convulsions).
• Yellow discoloration of the eyes (ocular icterus).
• Cardiac arrest (cardiac arrest).
• Torsades de Pointes, a disorder of heart rhythm.
• Heart failure (ventricular insufficiency).

Heart failure (ventricular hypokinesia).

• Atrial fibrillation, a disorder of heart rhythm.
• Malignant hypertension, very high blood pressure.
• Bleeding (hemorrhage).
• Low blood pressure (hypotension).
• Insufficient blood flow to the body tissues (shock).
• Respiratory arrest (respiratory arrest).
• Respiratory insufficiency/difficulty breathing.

Spasmodic constriction of the airways (bronchospasm).

• Coughing up blood (hemoptysis).
• Acute pancreatitis, inflammation of the pancreas.
• Abdominal pain (abdominal pain).
• Hepatic necrosis, death of liver tissue.
• Cholestatic jaundice, bile flow disorder.
• Jaundice, yellow discoloration of the skin or eyes.

• Abnormal liver function (abnormal liver function).
• Liver insufficiency (hepatic insufficiency).
• Urticaria.
• Erythema, redness.
• Rhabdomyolysis, a muscle disease.
• Malignant hyperthermia, a sudden and dangerous increase in body temperature during or after surgery. Symptoms include:

• Carbon dioxide in the blood (hypercapnia).
• Muscle rigidity (rigidity).
• Increased heart rate (tachycardia).
• Increased respiratory rate (tachypnea).
• Blue skin discoloration (cyanosis).
• Irregular heart rhythm (arrhythmias).
• Changes in blood pressure.
• Fever.

• Weakness (asthenia).
• General discomfort (discomfort).
• Abnormal heart test results (ST-T wave changes).
• Abnormal heart test results (T wave inversion).
• Increased liver enzymes (increased alanine aminotransferase and aspartate aminotransferase).
• Abnormal blood clotting (abnormal coagulation test).
• Increased ammonia levels.
• Confusion.

The following side effects have occurred after accidental administration of Suprane to patients for whom it was not intended.

• Dizziness.
• Severe headache (migraine).
• Irregular and rapid heartbeats (tachyarrhythmias).
• Palpitations, sensations of heartbeats.
• Eye burning.
• Temporary blindness (transient blindness).
• Cerebral disorder (encephalopathy).
• Ulcerative keratitis, a corneal ulcer.
• Eye congestion (ocular hyperemia).
• Visual impairment (decreased visual acuity).
• Irritation of the eyes.
• Eye pain.
• Fatigue (fatigue).
• Burning sensation in the skin.

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 Spanish System for the Vigilance 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.

This medication must be stored in an upright position with the cap firmly in place.

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

The disposal of unused medication and all materials that have been in contact with it will be carried out in accordance with local regulations.

Composition of Suprane

The active principle is desflurane 100%.

It does not contain other ingredients.

Appearance of the product and contents of the packaging

Suprane is a clear inhalation vapor liquid.

It is presented in 240 ml amber glass bottles or in aluminum bottles with a PVC protective coating. The bottle may be closed with:

• a resin and a plastic cap, or
• a valve to connect with the vaporizer.

The presentations are:

6 bottles of 240 ml per box.

1 bottle of 240 ml

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Baxter S.L.

Pouet de Camilo 2,

46394 Ribarroja del Turia (Valencia)

Manufacturer responsible

Baxter SA,

Boulevard Rene Branquart 80,

B-7860 Lessines. Belgium

Last review date of this leaflet: November 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/