SEDACONDA 100% LIQUID FOR INHALATION

2. What you need to know before you start using Sedaconda

Do not use Sedaconda

• If you are allergic to isoflurane or other halogenated anesthetics.
• If you or a family member have ever experienced a rapid rise in body temperature during sedation or anesthesia (a rare condition known as malignant hyperthermia). For more information, see the section "Possible side effects".

Warnings and Precautions

Talk to your doctor or nurse before you start using this medicine if:

• You have ever had a prolonged QT interval (abnormal electrocardiogram reading), or Torsades de Pointes(potentially life-threatening irregular heartbeat). Isoflurane has been known to cause these conditions on some occasions.
• You have a mitochondrial disease. Mitochondrial diseases are a group of rare genetic disorders that occur when the mitochondria (small cellular structures) do not produce enough energy for the body to function properly.
• You have heart disease (e.g., coronary heart disease).
• You have been given an inhaled anesthetic before, especially in the last 3 months. This may increase the risk of liver damage.
• You have increased intracranial pressure (pressure around the brain) due to brain injury, brain tumor, or other condition. Sedaconda may further increase the pressure inside the skull.
• You have low blood pressure, low blood volume, or are weak. You may need a lower dose of Sedaconda.
• You have liver disease.
• You have a condition that affects your nerves and muscles (a neuromuscular disease, e.g., Duchenne muscular dystrophy or myasthenia gravis).
• You are taking muscle relaxant medications (see section "Other medicines and Sedaconda").

Sedaconda may cause malignant hyperthermia, a rapid and significant rise in body temperature accompanied by muscle stiffness and other symptoms (see section 4).

Sedaconda may cause hyperkalemia (elevated serum potassium levels) in rare cases (see section 4). Patients with neuromuscular disease seem to be the most vulnerable.

Sedaconda may cause breathing difficulties (respiratory depression) (see section 4).

Children and Adolescents

This medicine must not be given to children under 3 years of age, as experience with this medicine is limited in this age group.

Other Medicines and Sedaconda

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

This is especially important if you are taking any of the following medicines:

• Certain medicines for depression, called non-selective monoamine oxidase inhibitors (MAOIs), such as isocarboxazid, nialamide, phenelzine, etc. Your doctor will not give you Sedaconda for at least 15 days after taking MAOIs.
• Medicines called beta-sympathomimetics (a broad group of medicines that affect the part of the nervous system that works automatically), such as isoprenaline, adrenaline, noradrenaline. Taking these medicines with Sedaconda may cause irregular heartbeats.
• Medicines called indirect-acting sympathomimetics, such as amphetamines and their derivatives, psycho-stimulants, appetite suppressants, ephedrine, and its derivatives. Taking these medicines with Sedaconda may cause high blood pressure.
• Beta-blockers (a group of medicines used to treat high blood pressure and certain heart diseases). Taking these medicines with Sedaconda may affect cardiac compensation reactions (reactions that help your body compensate for the reduced blood supply and oxygen caused by heart failure).
• Isoniazid (an antibiotic used to treat tuberculosis), which may increase the risk of liver damage.
• Calcium channel blockers (used to treat high blood pressure and certain heart diseases), such as amlodipine, diltiazem, nifedipine, verapamil.
• Opioids (e.g., morphine, fentanyl), benzodiazepines (e.g., midazolam, diazepam), and other sedative medicines, which may cause slow and ineffective breathing.
• Medicines used to relax muscles (e.g., suxamethonium, pancuronium, atracurium, vecuronium). Sedaconda may increase their effects.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Sedaconda may cause increased blood loss, for example, if you are going to have a uterine operation or give birth. Your doctor will not give you this medicine unless the potential benefit outweighs the potential risks for you and your baby.

If you have been breast-feeding before receiving Sedaconda, you must stop breast-feeding until the medicine has been eliminated from your body. Your doctor will tell you when it is safe for you to continue breast-feeding.

Driving and Using Machines

This medicine may affect your ability to drive and use machines for up to 6 days.

Do not drive or use machines until your doctor tells you it is safe to do so.

3. How to Use Sedaconda

Sedaconda will only be given to you by qualified and experienced medical personnel. The doctor will decide the correct dose for you based on your age, health condition, and the level of sedation (drowsiness) you need.

The doctor will give you the correct starting dose to achieve the required level of sedation, carefully observing your responses and vital signs (such as pulse, blood pressure, and breathing, etc.).

Sedaconda is a liquid that turns into vapor (gas) using a vaporizer. It is for inhalation use, which means you will breathe it in as a vapor.

If you receive more Sedaconda than you should

If you are given too much Sedaconda and are in deep sedation, your blood pressure may drop (hypotension) and your breathing may be slow and ineffective. The doctor will take supportive measures to correct blood pressure and breathing.

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

4. Possible Side Effects

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

Side effects of unknown frequency (cannot be estimated from the available data):

• anaphylactic reaction (a severe, potentially life-threatening allergic reaction), other allergic reactions (manifesting as redness, itching, blisters, dry or cracked skin, rash, difficulty breathing, wheezing, chest discomfort, swelling of the face),
• high blood sugar or potassium levels,
• mood changes,
• mental deterioration and convulsions, a medical condition in which the body's muscles contract and relax rapidly and repeatedly, resulting in uncontrolled body movements,
• irregular heartbeats, slow heartbeats, cardiac arrest (a condition in which the heart suddenly stops beating), prolonged QT interval (abnormal electrocardiogram reading) and Torsades de Pointes (potentially life-threatening irregular heartbeats),
• bronchospasm (contraction of the airway muscles resulting in breathing difficulties), difficulty breathing, wheezing, slow and shallow breathing, laryngospasm (contraction of the vocal cords that temporarily makes speaking or breathing difficult),
• intestinal obstruction, vomiting, nausea,

• liver cell death (necrosis) or damage, high bilirubin levels (breakdown product of red blood cells) in the blood,
• blood test results showing a change in kidney function: high creatinine levels and low urea levels,
• a rapid and significant rise in body temperature (malignant hyperthermia). This is a serious condition that will be treated immediately by your doctor.
• chest discomfort, chills,
• changes in blood test results: abnormal levels of certain liver enzymes, increased white blood cell count, high fluoride levels, and low cholesterol levels,
• abnormal electroencephalogram (EEG) results (a test that evaluates the electrical activity in the brain),
• presence of myoglobin (a muscle protein) in the urine, rhabdomyolysis (severe muscle damage).

Side effects reported as frequent (may affect up to 1 in 10 people) in a clinical trial:

• rapid heartbeats
• agitation, delirium (sudden change in mental state, such as confusion, agitation, personality change, and difficulties with understanding and memory), during or after sedation
• low blood pressure
• increased creatine phosphokinase levels in the blood (a muscle substance).
• dizziness, vomiting.

Side effects reported as very frequent in children (may affect more than 1 in 10 people) in a clinical trial:

• hypotension

Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sedaconda

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 carton and on the label of the vial after EXP. The expiry date is the last day of the month shown.

The shelf life of Sedaconda after connection to the Sedaconda Filling Adapter is 14 days.

Do not store above 30°C. Store the vial in the outer packaging to protect it from light.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.

6. Package Contents and Additional Information

Composition of Sedaconda

• The active substance is isoflurane 100%. There are no other ingredients.

Appearance and Package Contents

Sedaconda is a liquid for vapor inhalation. It is a colorless and transparent liquid, available in 100 ml and 250 ml amber glass bottles.

Package sizes:

6 x 100 ml

6 x 250 ml

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sedana Medical AB

Svärdvägen 3A, SE-182 33 Danderyd

Sweden

Manufacturer

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor)

2252 TR, Voorschoten

Netherlands

Local Representative:

Sedana Medical AB, Spanish Branch

Calle Edgar Neville, 27

28020, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Sedaconda:Germany, Belgium, Croatia, Denmark, Slovenia, Spain, Italy, Norway, Netherlands, Poland, and Sweden.

Cedaconda:Austria, France

Date of Last Revision of this Package Leaflet:June 2025

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This information is intended only for healthcare professionals:

Sedaconda 100% Liquid for Vapor Inhalation

Administration

Sedaconda should only be administered and inhaled through the Sedaconda ACD Administration Device, using the Sedaconda Filling Adapter, and should only be used with intubated or tracheotomized patients with protected airways. Sedaconda should only be administered by medical personnel familiar with the management of patients with mechanical ventilation, with Sedaconda ACD, and with the pharmacodynamics of isoflurane.

Isoflurane should only be administered in an adequately equipped environment, by trained personnel in the management of volatile anesthetic agents. To minimize leaks and spills during the use of Sedaconda, adequate general ventilation in the intensive care room, as well as a well-designed exhaust system, appropriate work practices, and routine equipment maintenance, should be ensured.

Sedaconda ACD is a modified passive heat and moisture exchanger (HME) and, as such, adds dead space to the respiratory circuit. The patient's ventilatory status should be taken into account when selecting the size of Sedaconda ACD; refer to the instructions for use provided with Sedaconda ACD.

Complete information on how to use Sedaconda ACD and the Sedaconda Filling Adapter is presented in the Instructions for Use document provided with the devices.

Read the Sedaconda package leaflet and the Instructions for Use provided with Sedaconda ACD and the Sedaconda Filling Adapter before configuring the Sedaconda ACD administration system and starting sedation.