DESFLURANE BAXTER 100% LIQUID FOR INHALATION

Introduction

Package Leaflet: Information for the User

Desflurane Baxter 100% Liquid for Vapor Inhalation

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Desflurane Baxter and what is it used for
2. What you need to know before you start using Desflurane Baxter
3. How to use Desflurane Baxter
4. Possible side effects
5. Storage of Desflurane Baxter
6. Contents of the pack and other information

1. What is Desflurane and what is it used for

Desflurane is a general anesthetic that is used to keep you asleep during surgery (called maintenance of anesthesia). It is administered as a vapor for inhalation. Breathing this vapor allows you to remain in a deep, painless sleep during surgery. It is used in adults, adolescents from 12 to 17 years, infants, and children under 12 years who are intubated. Intubation is when a tube is placed in the airways to help you breathe.

2. What you need to know before you start using Desflurane Baxter

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

Do not use desflurane:

• If you are allergic to desflurane or other anesthetics.
• If you have a known or suspected susceptibility to malignant hyperthermia (a sudden and dangerous increase in body temperature during or shortly after surgery).
• If you have a history of liver problems caused by previous anesthetics (e.g., hepatitis, jaundice associated with fever and/or increased white blood cells).
• As the only anesthetic used to put you to sleep (called induction) if you are at risk of coronary artery disease.
• As the only anesthetic used to put you to sleep (called induction) if there is an undesirable increase in heart rate or blood pressure.
• As the only anesthetic used to put you to sleep (called induction) if you are a child or adolescent. This is due to the frequent occurrence of coughing, respiratory difficulty, throat spasms, and increased mucous/saliva secretion.

If any of the above conditions apply to you, inform your anesthesiologist before you are given this medicine.

Warnings and precautions

Talk to your doctor or nurse before you start using desflurane:

• In the rare and unexpected event that you develop malignant hyperthermia. This is a sudden and dangerous increase in body temperature during or shortly after surgery. Symptoms may include high levels of carbon dioxide in the blood, muscle stiffness, palpitations, agitated breathing, skin discoloration due to lack of oxygen, and/or irregular heart rate and/or blood pressure. In this case, the anesthesiologist will stop the administration of desflurane and give you a medicine to treat malignant hyperthermia (known as sodium dantrolene) and you will receive other maintenance therapy. Death due to malignant hyperthermia has been reported.
• If you have high levels of potassium in your blood. This can cause an irregular pulse and can be fatal after surgery. In this case, your doctor will immediately start medication treatment. If you have Duchenne muscular dystrophy, you should inform your doctor, as these patients are more exposed.
• If you are a child or adolescent:
• • due to side effects on the airways, desflurane should not be used for maintenance of anesthesia in children under 6 years (unless they have a plastic tube inserted in the trachea).
  • desflurane should be used with caution in children and adolescents with asthma or recent upper respiratory infection due to the risk of airway narrowing.
  • when children wake up from anesthesia, there may be a brief state of confusion and agitation that can alter cooperation.
• If you are pregnant or breastfeeding (obstetric anesthesia), see also section "Pregnancy and breastfeeding".
• If you have liver inflammation, cirrhosis, or any other liver disease or have previously had liver disease.
• If you have high cranial pressure.
• If it is used to induce anesthesia and you are at risk of coronary artery disease or if there is an undesirable increase in pulse or blood pressure. In these cases, desflurane should be used in combination with other medications (opioids and hypnotics).
• If you have low blood volume, low blood pressure, or are weakened.
• If you have previously been given an inhaled anesthetic, especially if it has been on more than one occasion during a short period (repeated use).
• If you are at risk of bronchospasm, which is similar to an asthma attack.
• If you have severe heart rhythm disorders with a fast and irregular pulse.

Pain after the operation

After anesthesia with desflurane, you will wake up quickly. If pain is expected after the operation, the doctor will give you an anesthetic. The doctor may also do this at the end of the operation or during the recovery phase.

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

Other medicines and desflurane

Tell your doctor or healthcare professional if you are taking, have recently taken, or might take any other medicines.

Tell your doctor:

• If you are taking muscle relaxants (medicines to relax muscles). The effect of these medicines is enhanced.
• If you are taking medicines called opioids (for pain), such as fentanyl. The effect of desflurane may be enhanced if used at the same time as these types of medicines.
• If you are taking medicines called benzodiazepines (for anxiety, epilepsy, and insomnia, among other disorders), such as midazolam. The effect of desflurane may be enhanced if used at the same time as these types of medicines.

Using desflurane with food and drinks

Desflurane is a medicine to make you sleep and keep you asleep so that you can have surgery. Talk to your doctor, pharmacist, or nurse about when and what you can eat or drink after waking up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor, pharmacist, or nurse before using this medicine.

Desflurane will not normally be given to you if you are pregnant or breastfeeding. Your doctor will assess each case individually.

Driving and using machines

You should be aware of how this medicine may affect you. If you have been anesthetized, do not drive or operate tools or machinery for a period of 24 hours after the operation.

3. How to use Desflurane Baxter

An anesthesiologist will administer desflurane and decide on the amount and frequency of administration. This will depend on your age, weight, type of surgery you need, and other medications that will be administered during the operation. The doctor may tell you the dose that will be administered and how often it should be administered. If you have any questions, ask your doctor or healthcare professional. Only your doctor can change the dose.

Desflurane is a liquid that is administered through a specially calibrated vaporizer for use with this product. You will be asked to breathe in the desflurane vapor through a mask to induce sleep. You may also be injected with another anesthetic to make you fall asleep before desflurane is administered through a mask or tube inserted in the throat.

The anesthesiologist will decide when to stop treatment with desflurane.

Use in children and adolescents

Desflurane should not be used in children for induction of anesthesia, but only for maintenance of anesthesia.

If you use more desflurane than you should

Healthcare professionals will administer desflurane, so it is very unlikely that too much medicine will be given. If this happens, the anesthesiologist will take the necessary measures.

If you have any further questions on the use of this medicine, ask your doctor, anesthesiologist, or nurse.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Depending on the dose, desflurane can weaken breathing and pulse. Most of its side effects are of mild to moderate intensity and short duration, but serious side effects can occur.

Serious side effects (can be life-threatening)

Most of these side effects can occur while you are under the effects of anesthesia and under the care of a healthcare professional.

Common (may affect more than 1 in 10 patients)

• Irregular breathing with pauses in breathing.
• Throat spasms with breathing difficulties. Contact your doctor or emergency team immediately.

Uncommon (may affect more than 1 in 100 patients)

• Shortness of breath, anxiety, chest pain radiating to the neck or arms due to a blood clot in the heart.
• Drop in oxygen levels in the blood. Contact your doctor or emergency team immediately.

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

• Cardiac arrest.
• Severe heart rhythm disorders with a fast and irregular pulse (Torsade de Pointes).
• Blockage of electrical activity in the heart.
• Slow contractions of the heart chambers.
• Interrupted breathing.
• Asthma-like crises with shortness of breath. Contact your doctor or emergency team immediately.
• Coughing up blood from the lungs. Contact your doctor or emergency team immediately.
• Fever and acute stomach pain due to pancreatitis. Contact your doctor or emergency team immediately.
• Muscle pain, muscle weakness, or brown urine due to muscle breakdown. This can lead to kidney failure. Contact your doctor or emergency team immediately.
• Headache, fatigue, nausea, or vomiting due to excessive acid in the blood. In severe cases, loss of consciousness with deep and agitated breathing. Contact your doctor or emergency team immediately.
• Confusion, severe headache, restlessness, effects on consciousness, possible loss of consciousness, coma due to brain disorders. Contact your doctor or emergency team immediately.
• Pain and blurred vision due to traumatic injury/lesion/orifice in the cornea. Contact your doctor or emergency team immediately.
• Malignant hypertension (high blood pressure). Consult your doctor. High blood pressure should be treated. Very high blood pressure is serious.
• Circulatory failure (shock).
• Malignant hyperthermia. Symptoms may include muscle stiffness, palpitations, agitated breathing, skin discoloration due to lack of oxygen, and/or changes in blood pressure.
• Liver necrosis, hepatitis, jaundice, cholestasis (problems with liver or bile duct excretion), lethargy, possible loss of consciousness due to liver failure. Contact your doctor or emergency team immediately.
• Confusional state.

If any of these symptoms occur during treatment with desflurane, your anesthesiologist will take the necessary precautions.

Other side effects

Very common (may affect more than 1 in 10 patients) to common (may affect up to 1 in 10 patients)

• Vomiting.
• Nausea.
• Irregular pulse. Can be serious or become serious. Consult your doctor.
• Slow pulse. Can become serious. If you have a very slow pulse or start to feel unwell or lose consciousness, contact your doctor or emergency team.
• Fast pulse. Can become serious. If you have a fast or irregular pulse or start to feel unwell or lose consciousness, contact your doctor or emergency team.
• High blood pressure. Consult your doctor. High blood pressure should be treated. Very high blood pressure is serious.
• Headache.
• Ocular inflammation with red and watery eyes.
• Cough.
• Increased saliva production.
• Pharyngitis/throat irritation.
• In investigations, the following disorders may be observed: increased levels of creatine phosphokinase in the blood, abnormal ECG.

Uncommon (may affect more than 1 in 100 patients)

• Dizziness.
• Muscle pain.
• Increased size of blood vessels.
• Agitation.

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

• Tendency to bleed because the blood takes longer to clot.
• Seizures.
• Yellow discoloration of the eyeballs (sign of jaundice).
• Shortness of breath/breathing difficulties.
• Abdominal pain.
• Red rash.
• Hives (urticaria).
• Muscle weakness, confusion, speech problems due to high levels of potassium in the blood.
• Muscle weakness and decreased muscle strength due to low levels of potassium in the blood.
• Migraine.
• Palpitations.
• Itching in the eyes.
• Temporary loss of vision.
• Redness of the eyes.
• Decreased visual acuity.
• Ocular irritation.
• Ocular pain.
• Fatigue.
• Burning sensation on the skin.
• Dizziness, possibly due to low blood pressure.
• Loss of strength and weakness.
• General malaise.
• Liver function disorder/liver disorders.
• In investigations, the following disorders may be observed: elevated levels of alanine aminotransferase in the blood, increased levels of aspartate aminotransferase in the blood, abnormal coagulation test (blood clotting ability), increased levels of ammonia in the blood, increased levels of bilirubin in the blood (can cause yellow discoloration of the skin and eyes).
• Unexpected disorder after surgery.

Reactions reported after negligent exposure to desflurane (not under anesthesia): dizziness, migraine, irregular and agitated heartbeats (tachyarrhythmias), sensations of heartbeats (palpitations), ocular swelling, temporary loss of vision, brain damage (encephalopathy), corneal inflammation, ocular redness, decreased visual acuity, ocular irritation, ocular pain, fatigue, burning sensation on the skin.

Tell your doctor or nurse immediately if you have serious side effects. If you experience side effects that are not listed in this leaflet, talk to your doctor, pharmacist, or nurse.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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 help provide more information on the safety of this medicine.

5. Storage of Desflurane Baxter

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

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 stated.

Store in an upright position with the cap perfectly closed. This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Desflurano Baxter

The active ingredient is desflurano 100% (v/v).

It does not contain other components.

Appearance of the Product and Container Contents

Desflurano is a clear, colorless liquid for vapor inhalation.

It is presented in aluminum bottles with a protective coating.

The bottles contain 240 ml of desflurano and are closed with an integrated valve that connects directly to a compatible vaporizer.

The presentations are 1 bottle or 6 bottles.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Baxter S.L.

Polígono Industrial Sector 14. Pouet de Camilo, 2

46394 Ribarroja del Turia,

Valencia

Spain

Manufacturer:

Baxter S.A.

Boulevard Rene Branquart 80,

B‑7860 Lessines

Belgium

This medicinal product is authorized in the Member States of theEconomic European Areawith the following names:

Member State Name

Bulgaria ?????? 100 % ??????? ?? ????????? ? ????

Croatia Suprane 100 % V/V for inhalation, liquid

Czech Republic Suprane

Denmark Suprane

Estonia Suprane

Finland Desflurane Baxter 100 % inhalation vapor, liquid

Hungary Suprane liquid for inhalation vapor formation

Iceland Desflurane Baxter 100 % inhalation vapor, liquid

Latvia Suprane 100% inhalation vapor, liquid

Lithuania Suprane 100 % inhalation vapor, liquid

Malta Suprane 100% Inhalation vapor, solution

Norway Desflurane Baxter

Romania Suprane 100% inhalation vapor, liquid

Slovakia SUPRANE 100 % liquid for inhalation vapor formation

Slovenia Suprane 100 % V/V for inhalation, liquid

Spain Desflurano Baxter 100% liquid for vapor inhalation

Sweden Desflurane Baxter

Date of the last revision of this prospectus: November 2023.

Detailed 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.

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This information is intended only for healthcare professionals:

Desflurane will only be supplied through special vaporizers designed for desflurane. It has been reported that desflurane, like other halogenated inhalation anesthetics, interacts with soda lime in the carbon dioxide absorber and forms carbon monoxide. In a respiratory system, this can increase the risk of high levels of carboxyhemoglobin. Therefore, fresh (humid) soda should be used in the carbon dioxide absorber. Case reports have shown that barium hydroxide lime and soda lime dry out when fresh gases are passed through the CO2 bottle at high flow rates for many hours or days.

In individuals who were accidentally exposed to desflurane and were not the patient, reactions such as dizziness, migraine, tachyarrhythmia, palpitations, eye burns, transient blindness, encephalopathy, ulcerative keratitis, ocular hyperemia, reduced visual acuity, ocular irritation, eye pain, fatigue, and skin burning sensation were observed. Resources and equipment to maintain open airways, artificial ventilation, oxygen supplementation, and circulatory resuscitation equipment should be available immediately.

For complete information on dosage, warnings, precautions, overdose, etc., consult the Medicinal Product Data Sheet.