Desflurane Baxter 100% liquid for inhalation vapour

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Desflurane Baxter 100% solution for inhalation vapour

Read all of 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, ask your doctor, pharmacist or nurse.

• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Desflurane is and what it is used for

Desflurane is a general anaesthetic used to keep you asleep during surgery (referred to as maintenance of anaesthesia). It is administered as a vapour for inhalation. Breathing in this vapour allows you to remain in a deep, pain-free sleep during surgery. It is used in adults, adolescents aged 12 to 17 years, infants and children under 12 years of age who are intubated. Intubation is when a tube is inserted into the airway to assist breathing.

2. What you need to know before using Desflurane Baxter

Desflurane must only be administered by healthcare professionals trained in the administration of general anaesthesia under the supervision of an anaesthetist.

Do not use desflurane:

• If you are allergic to desflurane or other anaesthetics.
• 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 history of liver problems caused by previous anaesthetics (e.g. hepatitis, jaundice associated with fever and/or elevated white blood cell count).
• As the sole anaesthetic agent to induce sleep (called induction) if you are at risk of coronary artery disease.
• As the sole anaesthetic agent to induce sleep (called induction) if tachycardia or increased blood pressure are undesirable.
• As the sole anaesthetic agent to induce sleep (called induction) in children or adolescents. This is due to the frequent occurrence of coughing, breath-holding, laryngospasm, and increased mucous/saliva secretion.

If any of the above conditions apply to you, inform your anaesthetist before receiving this medicine.

Warnings and precautions

Talk to your doctor or nurse before using desflurane:

• In the rare and unexpected event that you develop malignant hyperthermia—a sudden and dangerous rise in body temperature during or shortly after surgery. Symptoms may include elevated blood carbon dioxide levels, muscle rigidity, palpitations, rapid breathing, skin mottling due to oxygen deficiency, and irregular heart rate and/or blood pressure. In such a case, the anaesthetist will stop administering desflurane and will give you a medication to treat malignant hyperthermia (known as sodium dantrolene), along with supportive therapy. Death due to malignant hyperthermia has been reported.
• If you have high blood potassium levels. This may cause an irregular pulse and can be fatal after surgery. In this case, your doctor will initiate immediate drug treatment. Inform your doctor if you have Duchenne muscular dystrophy, as these patients are at higher risk.
• If you are a child or adolescent:
  • due to respiratory side effects, desflurane should not be used as maintenance anaesthesia in children under 6 years of age (unless a plastic tube has been inserted into the trachea).
  • desflurane should be used with caution in children and adolescents with asthma or recent upper respiratory tract infection due to the risk of airway narrowing.
  • when children wake up from anaesthesia, a brief period of confusion and agitation may occur, which could affect cooperation.
• If you are pregnant or in labour (obstetric anaesthesia); see also section "Pregnancy and lactation".
• If you have hepatitis, cirrhosis, or any other liver disease, or have previously had liver disease.
• If you have elevated intracranial pressure.
• If used to induce anaesthesia and you are at risk of coronary artery disease or if an undesirable increase in pulse or blood pressure occurs. 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 debilitated.
• If you have previously received an inhaled anaesthetic, especially if administered more than once within a short period (repeated use).
• If you are at risk of bronchospasm, which is similar to an asthma attack.
• If you have serious cardiac arrhythmias with a fast and irregular pulse.

Pain after surgery

After anaesthesia with desflurane, you will wake up quickly. If postoperative pain is expected, your doctor will administer an analgesic. This may also be given at the end of surgery or during the recovery phase.

Inform your doctor, pharmacist, or nurse if any of the above conditions apply to you. You may require a thorough evaluation and a change in treatment.

Other medicines and desflurane

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

Tell your doctor:

• If you are taking muscle relaxants (medications to relax muscles). The effect of these medicines may be enhanced.
• If you are taking medications called opioids (for pain), such as fentanyl. The effect of desflurane may be enhanced when used together with these medicines.
• If you are taking medications called benzodiazepines (for anxiety, epilepsy, and insomnia, among other conditions), such as midazolam. The effect of desflurane may be enhanced when used together with these medicines.

Use of desflurane with food and drink

Desflurane is a medicine used to put you to sleep and keep you asleep so you can undergo surgery. Consult your doctor, pharmacist, or nurse about when and what you may eat or drink after waking up.

Pregnancy and lactation

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

Desflurane is generally not administered if you are pregnant or breastfeeding. The doctor will evaluate each case individually.

Driving and using machines

Be aware of how this medicine may affect you. After anaesthesia, you must not drive or operate tools or machinery for 24 hours after surgery.

3. How to use Desflurane Baxter

Desflurane will be administered by an anaesthetist, who will also decide the amount and frequency of administration. This will depend on your age, weight, type of surgery you require, and other medications that will be given during the operation. Your doctor may inform you of the dose to be administered and how often it should be given. If you have any doubts, consult your doctor or healthcare professional. Only the doctor can change the dose.

Desflurane is a liquid administered using a vaporizer specifically calibrated for this product. You will be asked to breathe the desflurane vapour through a mask to induce sleep. You may also be given another anaesthetic by injection to put you to sleep before desflurane is administered via a mask or a tube inserted into the throat.

The anaesthetist will decide when desflurane treatment should be stopped.

Use in children and adolescents

Desflurane must not be used in children for induction of anaesthesia, but only to keep them asleep during anaesthesia (known as maintenance of anaesthesia).

If you use more desflurane than you should

Healthcare professionals will administer desflurane, so it is highly unlikely that an overdose will occur. If this does happen, the anaesthetist will take the necessary measures.

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

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

4. Possible adverse effects

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

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

Serious adverse effects (may be life-threatening)

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

Frequent (may affect more than 1 in 10 patients)

• Irregular breathing with pauses in breathing.
• Throat spasms with breathing difficulty. 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 blood oxygen levels. Contact your doctor or emergency team immediately.

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

• Cardiac arrest.
• Serious disturbances in heart rhythm with a fast and irregular pulse (Torsade de Pointes).
• Blockage of electrical activity in the heart.
• Slow contractions of the heart chambers.
• Intermittent breathing.
• Asthma-like attacks 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 severe stomach pain due to inflammation of the pancreas. Contact your doctor or emergency team.
• Muscle pain, muscle weakness, or brown-colored urine due to muscle breakdown. This may lead to kidney failure. Contact your doctor or emergency team.
• Headache, fatigue, nausea, or vomiting due to excessive acid levels in the blood. In severe cases, loss of consciousness with deep and labored breathing. Contact your doctor or emergency team immediately.
• Confusion, severe headache, restlessness, disturbances in consciousness, possible unconsciousness, coma due to brain disorders. Contact your doctor or emergency team immediately.
• Eye pain and blurred vision due to traumatic injury/wound/perforation of the cornea. Contact your doctor or emergency team.
• Malignant hypertension (high blood pressure). Consult your doctor. High blood pressure must be treated. Excessively high blood pressure is serious.
• Circulatory failure (shock).
• Malignant hyperthermia. Symptoms may include muscle rigidity, rapid heartbeat, labored breathing, skin mottling due to oxygen deficiency and/or changes in blood pressure.
• Liver necrosis, hepatitis, jaundice, cholestasis (problems with liver or gallbladder excretion), lethargy, possible unconsciousness due to liver failure. Contact your doctor or emergency team.
• Mental confusion.

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

Other adverse 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. May be serious or become serious. Consult your doctor.
• Slow pulse. May become serious. If your pulse is very slow or you begin to feel unwell or lose consciousness, contact your doctor or emergency service.
• Fast pulse. May become serious. If you have a fast or irregular pulse or begin to feel unwell or lose consciousness, contact your doctor or emergency service.
• Increased blood pressure. Consult your doctor. High blood pressure must be treated. Excessively high blood pressure is serious.
• Headache.
• Eye inflammation with red, watery eyes.
• Cough.
• Excessive saliva production.
• Pharyngitis/throat irritation.
• The following abnormalities may be observed in laboratory tests: increased blood levels of creatine phosphokinase, abnormal ECG.

Uncommon (may affect more than 1 in 100 patients)

• Dizziness.
• Muscle pain.
• Enlargement of blood vessels.
• Agitation.

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

• Tendency to bleed because blood takes longer to clot.
• Seizures.
• Yellowish discoloration of the eyeballs (sign of jaundice).
• Shortness of breath/difficulty breathing.
• Abdominal pain.
• Red rash.
• Hives (urticaria).
• Muscle weakness, confusion, speech problems due to excessive potassium levels in blood.
• Muscle weakness and reduced muscle strength due to low potassium levels in blood.
• Migraine.
• Palpitations.
• Itching in the eyes.
• Temporary loss of vision.
• Redness of the eyes.
• Decreased visual acuity.
• Eye irritation.
• Eye pain.
• Fatigue.
• Burning sensation in the skin.
• Dizziness, possibly due to low blood pressure.
• Loss of strength and weakness.
• General malaise.
• Impaired liver function/liver disorders.
• The following abnormalities may be observed in laboratory tests: elevated blood levels of alanine aminotransferase, increased blood levels of aspartate aminotransferase, abnormal coagulation test (blood's ability to clot), increased blood ammonia levels, increased blood bilirubin levels (may cause yellowing of the skin and eyes).
• Unexpected disorder following surgery.

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

Inform your doctor or nurse immediately if you experience any serious adverse effects. If you experience adverse effects not listed in this leaflet, consult your doctor, pharmacist, or nurse.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet.

You may 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 desflurane

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 indicated.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desflurane Baxter

The active substance is desflurane 100% (v/v).

It contains no other components.

Appearance of the product and contents of the pack

Desflurane is a clear, colourless liquid for inhalation of vapour.

It is supplied in aluminium bottles with a protective coating.

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

Available pack sizes: 1 bottle or 6 bottles.

Some pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under 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 vapour, liquid
Hungary | Suprane folyadék inhalációs gőzképzéshez
Iceland | Desflurane Baxter 100 % innöndunargufa, vökvi
Latvia | Suprane 100% inhalācijas tvaiki, šķidrums
Lithuania | Suprane 100 % ikvepiamieji garai, skystis
Malta | Suprane 100% Inhalation vapour, solution
Norway | Desflurane Baxter
Romania | Suprane 100% vapori de inhalat, lichid
Slovakia | SUPRANE 100 % kvapalina na paru na inhaláciu
Slovenia | Suprane 100 % V/V za inhaliranje, tekočina
Spain | Desflurano Baxter 100% liquid for inhalation of vapour
Sweden | Desflurane Baxter

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

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

This information is intended for healthcare professionals only:

Desflurane must only be administered via special vaporizers designed for desflurane. It has been reported that desflurane, like other halogenated inhaled anaesthetics, may interact with dry soda lime in the carbon dioxide absorbent and form carbon monoxide. In a breathing system, this may increase the risk of elevated carboxyhaemoglobin levels. Therefore, fresh (moist) soda lime must be used in the carbon dioxide absorbent. Case reports have shown that barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO₂ canister at high flow rates for many hours or days.

In individuals accidentally exposed to desflurane who were not the intended patient, adverse reactions such as dizziness, headache, tachyarrhythmia, palpitations, eye burns, transient blindness, encephalopathy, ulcerative keratitis, ocular hyperaemia, reduced visual acuity, eye irritation, eye pain, fatigue, and skin burning sensation have been observed. Equipment and resources for maintaining airway patency, artificial ventilation, oxygen supplementation, and circulatory resuscitation must be immediately available.

For complete information on dosage, warnings and precautions, overdose, etc., please refer to the Summary of Product Characteristics (SmPC).