Sedaconda 100% liquid for vapor inhalation

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sedaconda 100% liquid for vapour inhalation

isoflurane

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

1. What Sedaconda is and what it is used for

This medicine contains the active substance isoflurane, which belongs to a group of medicines called anaesthetics. It is used to provide sedation (a state of calmness, drowsiness, or sleep) in adult and pediatric patients aged 3 years and older who require mechanical ventilation (a treatment using special equipment to assist patients with breathing) during their stay in intensive care.

2. What you need to know before using Sedaconda

Do not use Sedaconda

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

Warnings and precautions

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

• You have ever had QT interval prolongation (an abnormal reading on the electrocardiogram), or torsade de pointes (a potentially life-threatening irregular heartbeat). Isoflurane has been known to cause these conditions.
• You have a mitochondrial disease. Mitochondrial diseases are a group of rare genetic disorders that occur when 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 previously received an inhaled anaesthetic, especially within 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 tumour, or another condition. Sedaconda may further increase pressure inside the skull.
• You have low blood pressure, low blood volume, or are weak. You may require a lower dose of Sedaconda.
• You have liver disease.
• You have a condition affecting your nerves and muscles (a neuromuscular disorder, e.g. Duchenne muscular atrophy or myasthenia gravis).
• You are taking medicines called muscle relaxants (see section “Other medicines and Sedaconda”).

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

Sedaconda may, rarely, cause hyperkalaemia (increased serum potassium levels) (see section 4). Patients with neuromuscular disorders appear to be more vulnerable.

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

Children and adolescents

This medicine should 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 need to take any other medicines.

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

• Certain medicines for depression, called non-selective monoamine oxidase inhibitors, MAO inhibitors, such as isocarboxazid, nialamide, phenelzine, etc. Your doctor will not give you Sedaconda for at least 15 days after you have taken MAO inhibitors.
• Medicines called beta-sympathomimetics (a broad group of medicines that affect the part of the nervous system that functions automatically), for example, isoprenaline, adrenaline, noradrenaline. Taking these medicines with Sedaconda may cause irregular heartbeats.
• Medicines called indirectly 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 conditions). Taking these medicines with Sedaconda may affect so-called cardiac compensatory responses (responses that help your body compensate for reduced blood and oxygen supply 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 conditions) 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 become pregnant, consult your doctor before using this medicine.

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

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

Driving and using machines

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

You must not drive or use machines until your doctor advises you that it is safe to do so.

3. How to use Sedaconda

Sedaconda will only be administered by qualified and experienced medical personnel. Your doctor will decide the appropriate dose for you depending on your age, health condition, and the level of sedation (drowsiness) you require.

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

Sedaconda is a liquid that turns into vapor (gas) when used with a vaporizer. It is for inhalation use, meaning 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 become slow and ineffective. Your 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 adverse effects

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

Adverse 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, facial swelling),
• elevated levels of blood sugar or potassium,
• mood changes,
• mental impairment and convulsion, a medical condition in which the body's muscles contract and relax rapidly and repeatedly, resulting in uncontrollable body movements,
• irregular heartbeat, slow heartbeat, cardiac arrest (a condition in which the heart suddenly stops beating), QT interval prolongation (an abnormal reading on the electrocardiogram), and torsade de pointes (potentially fatal irregular heartbeats),
• bronchospasm (contraction of the muscles in the airways leading to breathing difficulties), difficulty breathing, wheezing, slow and shallow breathing, laryngospasm (contraction of the vocal cords temporarily making speech or breathing difficult),
• intestinal obstruction, vomiting, nausea,
• liver cell death (hepatic necrosis) or liver damage, elevated levels of bilirubin (a breakdown product of red blood cells) in the blood,
• blood test results showing changes in kidney function: elevated creatinine levels and decreased urea levels,
• rapid and significant increase 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 number of white blood cells, elevated fluoride levels, and decreased cholesterol levels,
• abnormal electroencephalogram results (a test assessing electrical activity in the brain),
• presence of myoglobin (a muscle protein) in the urine, rhabdomyolysis (severe muscle damage).

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

• rapid heartbeat
• agitation, delirium (sudden change in mental status, such as confusion, agitation, personality change, and difficulties with comprehension and memory), during or after sedation
• low blood pressure
• increased levels of creatine phosphokinase in the blood (a substance from muscles)
• dizziness, vomiting

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

• • hypotension

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton and on the label of the vial following EXP. The expiry date refers to the last day of the month indicated.

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

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

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

6. Contents of the pack and other information

Composition of Sedaconda

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

Appearance of the product and contents of the pack

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

Pack sizes:

6 x 100 ml

6 x 250 ml

Only certain pack 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
The Netherlands

Local representative:

Sedana Medical AB, Branch in Spain
Calle Edgar Neville, 27
28020, Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

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

Cedaconda: Austria, France

Date of the most recent review of this summary of product characteristics: June 2025

This information is intended for healthcare professionals only:

Sedaconda 100% liquid for vapor inhalation

Administration

Sedaconda must only be administered and inhaled via the Sedaconda ACD (Anaesthetic Conservation Device) delivery device, using the Sedaconda filling adapter, and should only be used in intubated or tracheotomized patients with protected airways. Sedaconda must only be administered by medical personnel experienced in managing mechanically ventilated patients, familiar with the Sedaconda ACD, and knowledgeable about the pharmacodynamics of isoflurane.

Isoflurane must only be administered in a properly equipped environment by personnel trained in the handling of volatile anaesthetic agents. To minimize leakage and spills during the use of Sedaconda, adequate general ventilation in the intensive care unit, a well-designed scavenging system, appropriate work practices, and routine equipment maintenance are essential.

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

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

Read the Sedaconda Summary of Product Characteristics and the Instructions for Use provided with the Sedaconda ACD and the Sedaconda Filling Adapter before setting up the Sedaconda ACD delivery system and initiating sedation.