Suprane 100% liquid for inhalation vapor

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Suprane 100% liquid for vapour inhalation

Desflurane

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

Leaflet Contents

1. What Suprane is and what it is used for
2. What you need to know before using Suprane
3. How to use Suprane
4. Possible adverse effects
5. How to store Suprane
6. Contents of the pack and other information

1. What Suprane is and what it is used for

Suprane is a medicine 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 you to fall into a deep, painless sleep (general anesthesia), during which you can undergo surgery.

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

2. What you need to know before using Suprane

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

Your anesthesiologist (doctor) will not give you Suprane:

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

Suprane must not be used to induce anesthesia if:

• you are at risk of coronary artery disease. Coronary disease
  occurs when the blood vessels supplying your heart muscle do not deliver enough blood and oxygen.

• your doctor considers the potential adverse effects of Suprane to be undesirable, for example:

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

• it is to be used in a child.

Inform your anesthesiologist (doctor) before receiving this medicine if any of the above conditions apply to you.

Warnings and precautions

Talk to your doctor or nurse before starting Suprane if:

• you have previously received an inhaled anesthetic, especially if it was on more than one occasion within a short period of time (repeated use).
• 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 this case, the anesthesiologist (doctor) will stop administering Suprane, you will be given a medication to treat malignant hyperthermia (known as dantrolene), and you will receive additional supportive 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 medicine is used for obstetric anesthesia (childbirth) (see also the section titled “Pregnancy and breastfeeding”).

• you have previously had liver problems, such as hepatitis (liver inflammation) or
  jaundice.

• you have been treated with medications that may cause liver problems.

• there is a risk of increased intracranial pressure.

• you have acute coronary disease.

• you have low blood pressure (hypotension).

• you have hypovolemia (reduced blood volume) or are weak.

• you have an abnormality in the electrical activity of your heart called "QT interval prolongation."

Pain after your surgery

You may wake up quickly from anesthesia with Suprane. If you expect to have pain after your surgery, your doctor will give you pain-relieving medications. This will be done at the end of your surgery or while you are recovering from it.

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 into the airway to assist breathing. In these cases, caution must be exercised when removing the laryngeal mask after deep anesthesia to avoid adverse effects such as coughing or a muscle spasm of the vocal cords called laryngospasm.

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

Use of Suprane with other medicines:

Tell your doctor, pharmacist, surgeon, or anesthesiologist if you are taking, have recently taken, or might need to take any other medicine.

The following medicines or active substances may interact with each other when administered together with Suprane. Some of these medicines will be administered by the anesthesiologist during surgery, as indicated in the description.

• Muscle relaxants (e.g., succinylcholine, pancuronium, atracurium, vecuronium): These medicines are used during general anesthesia to relax muscles. Your anesthesiologist may need to adjust the dose of these medicines.
• Opioids (e.g., morphine, fentanyl, remifentanil): these are strong painkillers frequently used during general anesthesia.
• Benzodiazepines (e.g., midazolam, diazepam, nitrazepam): sedative medicines that have a calming effect. They are used when the patient is anxious before a procedure.
• Nitrous oxide: a medicine used during general anesthesia to induce sleep and relieve pain.

Use of Suprane with food and drink

Suprane is a medicine used to induce sleep so that you can undergo surgery. Consult your doctor, surgeon, or anesthesiologist 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 anesthesiologist before receiving this medicine.

Driving and using machines

Suprane 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. Administration of anesthesia may affect your attention for several days. This may impair your ability to perform tasks requiring alertness.

Consult your anesthesiologist about when it will be safe to drive and resume operating machinery.

3. How to use Suprane

An anaesthetist will administer Suprane to you and 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.

Suprane is a liquid for inhalation of vapour, administered via a vapouriser specially calibrated for this product, so that the released concentration can be precisely controlled.

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. If this does occur, the anaesthetist will take the necessary measures.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicinal product and the amount ingested.

4. Possible adverse effects

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

Most of the adverse effects are mild to moderate in severity and temporary in nature, although serious adverse effects may also occur.

The following adverse effects may also occur during treatment. The assessment of adverse effects is based on the following frequency categories:

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

• Nausea (feeling unwell) and vomiting. These have occurred during induction and maintenance of anaesthesia with Suprane.

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

• Inflammation of the throat (pharyngitis).
• Respiratory arrest. This has occurred during induction and maintenance of anaesthesia with Suprane.
• Headache.
• Inflammation of the lining of the eyelid conjunctiva (conjunctivitis).
• Irregular heart rhythm (nodal arrhythmia).
• Slow heart rate (bradycardia).
• Fast heart rate (tachycardia).
• High blood pressure (hypertension).
• Cessation of breathing (apnea), cough, excessive production of saliva (sialorrhea). These have occurred during induction and maintenance of anaesthesia with Suprane.
• Muscle spasm of the vocal cords (larynx), known as laryngospasm. This has occurred during induction of anaesthesia with Suprane.
• Increased blood levels of an enzyme called creatine phosphokinase.
• Abnormal results in heart tests (abnormal ECG).

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

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

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

• Blood clotting disorder (coagulopathy).

• High levels of potassium (hyperkalemia).

• Low levels of potassium (hypokalemia).

• Excessive production of acid by the body (metabolic acidosis).

• Seizures (convulsions).

• Yellowing of the eyes (ocular jaundice).

• Cessation of heartbeat (cardiac arrest).

• A disorder in the conduction of heartbeats (Torsade de Pointes).

• Inability of two chambers of the heart to perform their function (ventricular failure).

• Poor function of two chambers of the heart (ventricular hypokinesia).

• Heart rhythm disorder (atrial fibrillation).

• Very high blood pressure (malignant hypertension).

• Bleeding (haemorrhage).

• Low blood pressure (hypotension).

• Inadequate blood supply to body tissues (shock).

• Cessation of breathing (respiratory arrest).

• Reduced ability to take up oxygen (respiratory failure / breathing difficulty).

• Sudden spasm of the airways (bronchospasm).

• Coughing up blood (haemoptysis).

• Sudden inflammation of the pancreas (acute pancreatitis).

• Abdominal pain (abdominal pain).

• Death of liver tissue (hepatic necrosis).

• Inflammation of the liver (cytolytic hepatitis).

• Impaired bile flow (cholestasis).

• Yellowing of the skin or eyes (jaundice).

• Abnormal liver function (abnormal liver function).

• Liver disorder (liver failure).

• Urticaria.

• Redness (erythema).

• A muscle disorder (rhabdomyolysis).

• Malignant hyperthermia: when body temperature suddenly rises to dangerously high levels during or shortly after surgery. Symptoms include:

• Excess carbon dioxide in the blood (hypercapnia).

• Muscle rigidity (rigidity).

• Increased heart rate (tachycardia).

• Increased respiratory rate (tachypnea).

• Bluish skin (cyanosis).

• Irregular heartbeats (arrhythmias).

• Increases or decreases in blood pressure.

• Fever.

• Weakness (asthenia).

• General malaise (malaise).

• Abnormal results in heart tests (ST-T electrocardiogram changes).

• Abnormal results in heart tests (T-wave inversion on electrocardiogram).

• Increases in liver enzymes (increased alanine aminotransferase and aspartate aminotransferase).

• Abnormal blood clotting (abnormal coagulation test).

• Increased ammonia levels.

• Confused mental state.

The following adverse effects have occurred after Suprane was accidentally administered to patients for whom it was not intended:

• Dizziness.
• Severe headache (migraine).
• Irregular and rapid heartbeats (tachyarrhythmias).
• Sensations of heartbeats (palpitations).
• Burning sensation in the eyes.
• Temporary blindness (transient blindness).
• Brain disorder (encephalopathy).
• Ulceration of the cornea of the eye (ulcerative keratitis).
• Bloodshot eyes (ocular hyperemia).
• Vision problems (reduced visual acuity).
• Eye irritation.
• Eye pain.
• Tiredness (fatigue).
• Burning sensation on the skin.

Reporting of adverse effects

If you experience any adverse effects, 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 via 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 Suprane

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

This medicine must be stored in an upright position with the cap securely in place.

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

Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.

6. Contents of the pack and other information

Composition of Suprane

The active substance is desflurane 100%.

It contains no other ingredients.

Appearance of the product and contents of the container

Suprane is a clear liquid for vapor inhalation.

It is supplied in 240 ml amber glass bottles or in aluminum bottles with a protective PVC layer. The bottle may be sealed with:

• a resin and a plastic cap, or
• a valve for connection to a vaporizer.

Pack sizes are:

6 bottles of 240 ml per box.

1 bottle of 240 ml.

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), Spain

Manufacturer

Baxter SA,

Boulevard Rene Branquart 80,

B-7860 Lessines, Belgium

Date of the most recent revision of this leaflet: November 2023

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