Sedaconda

Package Leaflet: Information for the Patient

Sedaconda, 100% V/V, Liquid for Vaporisation for Inhalation

Isoflurane

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Sedaconda and what is it used for
• 2. Important information 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 is Sedaconda and what is it used for

Sedaconda contains the active substance isoflurane, which belongs to a group of medicines called anaesthetics. It is used to provide sedation (a state of calm, sleepiness, or sleep) in adults and children aged 3 years and above who require mechanical ventilation (a procedure using a special device that helps with breathing) during intensive medical care.

2. Important information before using Sedaconda

When not to use Sedaconda

• If you are allergic to isoflurane or other halogenated anaesthetics.
• If you or a family member have had a previous episode of malignant hyperthermia (a rare condition characterized by a rapid and significant rise in body temperature) during sedation or anaesthesia. See section 4 for more information.

Warnings and precautions

Before starting treatment with Sedaconda, discuss with your doctor or nurse if:

• you have had a previous episode of prolonged QT interval (an abnormality in the electrocardiogram) or arrhythmias of the type torsade de pointes (a life-threatening irregular heartbeat). Isoflurane is known to cause these conditions in some cases.
• you have a mitochondrial disease. Mitochondrial diseases are a group of rare genetic disorders that occur when mitochondria (small structures within cells) do not produce enough energy for the body to function properly.
• you have heart disease (e.g., coronary artery disease).
• you have received an inhaled anaesthetic recently, especially within the last 3 months. You may be at increased risk of liver damage.
• you have increased intracranial pressure (pressure around the brain) due to head injury, brain tumour, or other disease. Sedaconda may further increase intracranial pressure.
• you have low blood pressure, low blood volume, or are weakened. A dose reduction of Sedaconda may be necessary.
• you have liver disease.
• you have a condition that affects the nerves and muscles (neuromuscular disease, e.g., Duchenne muscular dystrophy or myasthenia).
• you are taking muscle relaxants (see section "Sedaconda and other medicines").

Sedaconda may cause malignant hyperthermia, which is characterized by a rapid and significant rise in body temperature, accompanied by muscle stiffness and other symptoms (see section 4). Sedaconda may rarely cause hyperkalaemia (elevated potassium levels in the blood) (see section 4). Patients with neuromuscular diseases seem to be at higher risk. Sedaconda may cause respiratory depression (see section 4).

Children and adolescents

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

Sedaconda and other medicines

Tell your doctor or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is especially important if you are taking any of the following medicines:

• Certain antidepressants, called non-selective monoamine oxidase inhibitors (MAOIs), such as isocarboxazid, nialamide, phenelzine, etc. Your doctor will not administer Sedaconda for at least 15 days after taking an MAOI.
• Medicines called beta-sympathomimetics (a broad group of medicines that act on the part of the nervous system that acts automatically), e.g., isoprenaline, adrenaline, noradrenaline. Taking these medicines with Sedaconda may cause irregular heartbeat.
• Medicines called indirect sympathomimetics, such as amphetamines and their derivatives, psychostimulants, appetite suppressants, ephedrine and its derivatives. Taking these medicines with Sedaconda may cause high blood pressure.
• Beta-adrenergic blockers (a group of medicines used to treat high blood pressure and certain heart diseases). Taking these medicines with Sedaconda may weaken the heart's compensatory reactions (reactions that help the body make up for reduced blood flow and oxygen supply due to 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 sedatives, which may cause slowed and ineffective breathing.
• Muscle relaxants (e.g., suxamethonium, pancuronium, atracurium, vecuronium). Sedaconda may enhance their effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or nurse before using this medicine. Sedaconda may cause increased blood loss, for example, during a necessary operation on the uterus or childbirth. Your doctor will not administer this medicine unless the potential benefits outweigh the potential risks to the mother and child. If you were breastfeeding before receiving Sedaconda, you should stop breastfeeding until the medicine has been eliminated from your body. Your doctor will inform you when it is safe to resume breastfeeding.

Driving and using machines

Sedaconda may affect your ability to drive or operate machines for up to 6 days. Do not drive or operate machines until your doctor says it is safe to do so.

3. How to use Sedaconda

Sedaconda should only be administered by qualified and experienced medical personnel. Your doctor will decide on the appropriate dose for you based on your age, health, and level of sedation (sleepiness) needed. Your doctor will administer the correct initial dose to achieve the required level of sedation, carefully observing your reactions and vital signs (such as heart rate, blood pressure, breathing, etc.). Sedaconda is a liquid that is converted into a vapour (gas) using a vaporizer. The medicine is for inhalation, meaning you breathe it in as a vapour.

Overdose of Sedaconda

If too much Sedaconda is administered and deep sedation occurs, blood pressure may drop (hypotension), and 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 using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Sedaconda 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 (characterized by redness, itching, blisters, dryness or cracking of the skin, rash, difficulty breathing, wheezing, chest discomfort, swelling of the face),
• Increased blood sugar or potassium levels,
• Mood changes,
• Seizures and mental status changes, which are conditions characterized by rapid and repeated muscle contractions and relaxations, causing uncontrolled body movements,
• Irregular heartbeat, slow heartbeat, cardiac arrest (a condition in which the heart suddenly stops beating), prolonged QT interval (an abnormality in the electrocardiogram) and arrhythmias of the type torsade de pointes (life-threatening irregular heartbeat),
• Bronchospasm (constriction of the airway muscles causing difficulty breathing), shortness of breath, wheezing, slow and shallow breathing, laryngospasm (constriction of the vocal cords, which can temporarily make speaking or breathing difficult),
• Intestinal obstruction, vomiting, nausea,
• Death or damage to liver cells (liver necrosis), increased bilirubin levels (a product of red blood cell breakdown) in the blood,
• Blood test results indicating changes in kidney function: increased creatinine and decreased urea levels,
• Rapid and significant rise in body temperature (malignant hyperthermia). This is a severe condition that will be treated immediately by your doctor,
• Chest discomfort, chills,
• Changes in blood test results: abnormal activity of certain liver enzymes, increased white blood cell count, increased fluoride levels, and decreased cholesterol levels,

Uncommon side effects (may affect up to 1 in 100 people) reported in clinical trials:

• Rapid heartbeat,
• Agitation, delirium (a sudden change in mental state that can include confusion, agitation, changes in personality, and difficulty with understanding and memory) during or after sedation,
• Low blood pressure,
• Increased creatine phosphokinase (a substance from muscles) levels in the blood,
• Nausea, vomiting.

Very common side effects (may affect more than 1 in 10 people) reported in clinical trials in children:

• Low blood pressure.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 bottle label after EXP. The expiry date refers to the last day of the month. The shelf life of Sedaconda after connection of the Sedaconda Filling Adapter is 14 days. Do not store above 30°C. Keep the bottle in the outer carton to protect from light. Dispose of any unused medicine or waste material in accordance with local requirements.

6. Contents of the pack and other information

What Sedaconda contains

The active substance is isoflurane 100% V/V. It does not contain any excipients.

What Sedaconda looks like and contents of the pack

Sedaconda is a colourless, clear liquid for inhalation, available in amber glass bottles of 100 mL or 250 mL. Pack sizes: 6 x 100 mL, 6 x 250 mL. Not all pack sizes may be marketed.

Marketing authorisation holder

Sedana Medical AB, Svärdvägen 3A, SE-182 33 Danderyd, Sweden.

Manufacturer/Importer

Piramal Critical Care B.V., Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Netherlands.

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

Sedaconda:Belgium, Croatia, Denmark, Finland, Spain, Netherlands, Ireland, Germany, Norway, Poland, Portugal, Slovenia, Sweden, and Italy. Cedaconda:Austria and France.

Date of last revision of the package leaflet: 12/2024

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Information intended for healthcare professionals only:
Sedaconda, 100% V/V, Liquid for Vaporisation for Inhalation

Administration

Sedaconda should be administered and inhaled only through the Sedaconda ACD (Anaesthetic Conserving Device) medical device, using the Sedaconda Filling Adapter; it should only be used in patients who are intubated or have a tracheostomy with secured airways. Sedaconda should only be administered by medical personnel familiar with the management of mechanically ventilated patients, the Sedaconda ACD device, and the pharmacodynamics of isoflurane. Isoflurane should only be administered in an appropriately equipped environment by personnel trained in the handling of inhaled anaesthetics. To minimize leakage and spillage of Sedaconda during its use, adequate general ventilation on the intensive care unit, a well-designed scavenging system, proper working procedures, and routine maintenance of equipment should be ensured. The Sedaconda ACD device is a modified passive Heat and Moisture Exchanger (HME) and, as such, adds dead space to the breathing circuit. When selecting the size of the Sedaconda ACD device, the patient's ventilation status should be considered, see the Instructions for Use provided with the Sedaconda ACD device. Full information on the use of the Sedaconda Filling Adapter and Sedaconda can be found in the Instructions for Use provided with the devices. Before configuring the Sedaconda ACD administration system and starting sedation, read the Summary of Product Characteristics for Sedaconda and the Instructions for Use provided with the Sedaconda Filling Adapter and Sedaconda.