Label: Information for the Patient

Sedaconda 100% Liquid for Inhalation of Vapor

isoflurane

Read the entire label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See Section 4.

This medication contains the active substance isoflurane which belongs to a group of medicines called anesthetics. It is used to provide sedation (a state of calmness, drowsiness or sleep) in adult patients who require mechanical ventilation (a treatment with special equipment that helps patients breathe) during their admission to intensive care.

No 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 adverse effects”.

Warnings and precautions

Consult your doctor or nurse before starting to use this medication if:

• You have ever had a prolonged QT interval (abnormal electrocardiogram reading), ortorsades de pointes(potentially fatal irregular heartbeat). Isoflurane has been known to cause these conditions on occasion.
• 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 previously been given an inhaled anesthetic, 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 tumor, or other condition. Sedaconda may increase pressure within the skull further.
• 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 affecting your nerves and muscles (a neuromuscular disease, e.g. Duchenne muscular atrophy or myasthenia gravis).
• You are taking medications called muscle relaxants (see section “Other medications and Sedaconda”).

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

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

Sedaconda may cause respiratory depression (see section 4).

Children and adolescents

This medication should not be administered to children and adolescents under 18 years of age, as experience with this medication is limited in this age group.

Other medications and Sedaconda

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication.

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

• Certain medications 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.
• Medications called beta-sympathomimetics (a wide group of medications affecting the automatic part of the nervous system), for example, isoprenaline, adrenaline, noradrenaline. Taking these medications with Sedaconda may make the heartbeats irregular.
• Medications called indirect-acting sympathomimetics such as amphetamines and their derivatives, psychostimulants, appetite suppressants, ephedrine and its derivatives. Taking these medications with Sedaconda may cause high blood pressure.
• Beta-blockers (a group of medications used to treat high blood pressure and certain heart diseases). Taking these medications with Sedaconda may affect the so-called cardiac compensation reactions (reactions that help your body compensate for the 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 diseases) such as amlodipine, diltiazem, nifedipine, verapamil.
• Opioids (e.g., morphine, fentanyl), benzodiazepines (e.g., midazolam, diazepam), and other sedatives, which may cause slow and ineffective breathing.
• Medications used to relax muscles (e.g., suxamethonium, pancuronium, atracurium, vecuronium). Sedaconda may increase their effects.

Pregnancy, breastfeeding, and fertility

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

Sedaconda may cause increased blood loss, for example if you are undergoing a uterine operation, or if you are giving birth. Your doctor will not give you this medication unless the potential benefits outweigh the potential risks for you and your baby.

If you have been breastfeeding before receiving Sedaconda, you should stop breastfeeding until the medication has been eliminated from your body. Your doctor will inform you when it is safe for you to continue breastfeeding.

Driving and operating machinery

This medication may affect your ability to drive and operate machinery for up to 6 days.

You should not drive or operate machinery until your doctor advises it is safe to do so.

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

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

Sedaconda is a liquid that changes to vapor (gas) with the use of 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 be slow and ineffective. The doctor will take supportive measures to correct your blood pressure and breathing.

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

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

Unknown frequency side effects (cannot be estimated from available data):

• anaphylactic reaction (a severe, potentially fatal allergic reaction), other allergic reactions (manifesting as redness, itching, blisters, dry or cracked skin, skin rash, difficulty breathing, wheezing, chest discomfort, facial swelling),
• high blood sugar or potassium levels,
• mood changes,
• mental deterioration and convulsion, a medical condition in which the body's muscles contract and relax rapidly, resulting in uncontrolled body actions,
• irregular heartbeats, slow heartbeats, cardiac arrest (a condition in which the heart suddenly stops beating), prolonged QT interval (abnormal reading on the electrocardiogram) and torsade de pointes (potentially fatal irregular heartbeats),
• bronchospasm (contraction of the muscles of the airways resulting in respiratory problems), difficulty breathing, wheezing, slow and shallow breathing, laryngospasm (contraction of the vocal cords temporarily impairing speech or breathing),
• intestinal obstruction, vomiting, nausea,

• liver cell death (hepatic necrosis) or damage, high blood bilirubin levels (product of red blood cell breakdown),
• blood test results showing a change in renal function: high creatinine levels and low 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 white blood cell count, high fluoride levels, and low cholesterol levels,
• abnormal electroencephalogram (test evaluating brain electrical activity) results,
• presence of myoglobin (muscle protein) in urine, rhabdomyolysis (severe muscle damage).

Frequent side effects reported in a clinical trial (may affect up to 1 in 10 people):

• 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 blood (muscle substance).
• feeling of dizziness, vomiting.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the bottle label after CAD. The expiration date is the last day of the month indicated.

Sedaconda expirationafter attaching it to the Sedaconda Filling Adapter is 14 days.

Do not store above 86°F (30°C). Store the bottle in the outer packaging to protect it from light.

The disposal of unused medication and all materials that have been in contact with it, will be carried out in accordance with local regulations.

Composition of Sedaconda

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

Appearance of the product and contents of the container

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

Container sizes:

6 x 100 ml

6 x 250 ml

Only some container sizes may be commercially available

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sedana Medical AB

Svärdvägen 3ASE-182 33 Danderyd

Sweden

Responsible for manufacturing

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor)

2252 TR, Voorschoten

Netherlands

Local representative:

SEDANA MEDICAL AB SUCURSAL EN ESPAÑA,

Calle Edgar Neville, 27

28020, Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Cedaconda:Austria, France

Date of the last review of this leaflet:September 2022

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This information is intended solely for healthcare professionals:

Sedaconda 100% vapor inhalation liquid

Administration

Sedaconda should only be administered and inhaled through the Sedaconda ACD (Anesthetic Conservation 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, Sedaconda ACD, and the pharmacodynamics of isoflurane.

Isoflurane should only be administered in a suitably equipped environment, by personnel trained in the handling of volatile anesthetic agents.

SedacondaACDis a modified passive heat and humidity 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 SedacondaACD, consult the Instructions for Use provided with SedacondaACD.

For complete information on how to use SedacondaACDand the Sedaconda Filling Adapter, see the Instructions for Use provided with the devices.

Read the Sedaconda technical data sheet and the Instructions for Use provided with SedacondaACDand the Sedaconda Filling Adapter before configuring the SedacondaACDadministration system and initiating sedation.