SEDACONDA 100% Inhalation solution

Зміст інструкції

1. Sedaconda 100% V/V vapor for inhalation, liquid
   1. What is Sedaconda and what is it used for?
   2. What you need to know before you are given Sedaconda
   3. How Sedaconda will be administered to you
   4. Possible side effects
   5. How to store Sedaconda
   6. Contents of the pack and other information

Sedaconda 100% V/V vapor for inhalation, liquid

Isoflurane

Read this leaflet carefully before you are given this medicine as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:
What Sedaconda is and what it is used for
What you need to know before you are given Sedaconda
How Sedaconda will be given to you
Possible side effects
How to store Sedaconda
Contents of the pack and other information

1. What is Sedaconda and what is it used for?

Sedaconda contains the active ingredient isoflurane, which belongs to a group of medicines called
anaesthetics. It is used to induce sedation (a state of calm, drowsiness or sleep) in adult and
paediatric patients from 3 years of age who require mechanical ventilation (treatment with a
special machine that helps patients to breathe) during intensive care.

2. What you need to know before you are given Sedaconda

Sedaconda will not be given to you
if you are allergic to isoflurane or other halogenated anaesthetics
if you or someone in your family has ever experienced a rapid increase 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 receiving Sedaconda if:
you have ever had a prolongation of the QT interval (abnormal reading on an electrocardiogram)
or torsades de pointes (a life-threatening irregular heartbeat). Isoflurane is sometimes known
to cause these effects.
you suffer from a mitochondrial disease. Mitochondrial diseases are a group of rare
genetic conditions that occur when the mitochondria (small structures in cells) fail to produce
enough energy for the body to function properly.
you suffer from heart disease (e.g. coronary artery disease).
you have previously been given an inhalational anaesthetic, particularly in the
last 3 months. You may be at greater risk of liver damage.
you have high intracranial pressure (pressure around the brain) due to a head injury,
a brain tumour or another condition. Sedaconda may further increase the
pressure inside the skull.
you suffer from low blood pressure, low blood volume or are debilitated. A lower dose of
Sedaconda may be needed.
you suffer from liver disorders.
you suffer from a disease that affects the nerves and muscles (a neuromuscular disease,
for example Duchenne muscular dystrophy or myasthenia gravis).
You are taking medicines called muscle relaxants (see section “Other medicines and
Sedaconda”).
Sedaconda can cause malignant hyperthermia, which consists of a rapid and significant increase in
body temperature accompanied by muscle rigidity and other symptoms (see section 4).
Sedaconda can cause hyperkalaemia (increased serum potassium levels) in rare cases (see
section 4). Patients with neuromuscular disease appear to be the most vulnerable.
Sedaconda can cause difficulty 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 in this age group is limited.

Other medicines and Sedaconda
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines.
This is particularly important if you are taking any of the following medicines:
Some medicines for depression, called non-selective monoamine oxidase inhibitors
(MAOIs), such as isocarboxazide, nialamide, phenelzine, etc. Your doctor will not give you
Sedaconda for at least 15 days after taking MAO inhibitors.
Medicines called beta-sympathomimetics (a large group of medicines that act on
a part of the autonomic nervous system), e.g. isoprenaline, adrenaline,
noradrenaline. Taking these medicines with Sedaconda can cause an irregular heartbeat.
Sympathomimetic medicines with indirect action such as amphetamines and their derivatives,
stimulants, appetite suppressants, ephedrine and its derivatives. Taking these
medicines with Sedaconda can cause high blood pressure.
Beta-blockers (a group of medicines used to treat high blood pressure and some heart
diseases). Taking these medicines with Sedaconda may impair so-called
cardiac compensatory reactions (reactions that help the body compensate for reduced blood
supply and oxygen caused by heart failure).
Isoniazid (an antibiotic used to treat tuberculosis), which can increase the risk of liver
damage.
Calcium channel blockers (used to treat high blood pressure and some heart diseases) such as
amlodipine, diltiazem, nifedipine, verapamil.
Opioids (e.g. morphine, fentanyl), benzodiazepines (e.g. midazolam, diazepam) and other
sedative medicines, which can cause slow and ineffective breathing.
Medicines used to relax muscles (e.g. suxamethonium, pancuronium, atracurium, vecuronium).
Sedaconda may increase their effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before you are given this medicine.
Sedaconda can cause increased blood loss, for example if you need an operation
on the uterus or are in labour. Your doctor will not give you this medicine unless the
potential benefit outweighs the potential risks to you and your baby.
If you have breastfed before receiving Sedaconda, you should stop breastfeeding until the
medicine has been eliminated from your body. Your doctor will tell you when it is safe for you
to continue breastfeeding.

Driving and using machines
Sedaconda can impair your ability to drive and use machines for up to 6 days.
Do not drive or use machines until your doctor advises you that it is safe to do so.

3. How Sedaconda will be administered to you

Sedaconda will only be administered by qualified and experienced medical personnel. The doctor will decide
the appropriate dose for you based on your age, your health conditions and the level of sedation
(drowsiness) you need.
The doctor will give you the correct initial dose to achieve the required level of sedation by carefully observing
your responses and vital signs (such as pulse, blood pressure and breathing, etc.).
Sedaconda is a liquid that turns into vapor (gas) with the use of a vaporizer. It is for use
by inhalation, which means you will breathe it in as vapor.

If you are given too much Sedaconda
If you are given too much Sedaconda and you 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 doubts 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 everyone will experience them.
Side effects whose frequency is not known (cannot be defined based on available data):
anaphylactic reaction (a severe allergic reaction, potentially life-threatening), other
allergic reactions (manifesting with reddened skin, itching, blisters, dry or
cracked skin, rash, shortness of breath, wheezing, chest discomfort, swelling of the
face),
high levels of sugar or potassium in the blood,
mood changes,
mental deterioration and convulsions, which is a medical condition in which the muscles of the body
contract and relax rapidly and repeatedly, causing uncontrolled actions of the
body,
irregular heartbeat, slow heartbeat, cardiac arrest (a condition in which the heart
suddenly stops beating), prolonged QT interval (abnormal reading
on the electrocardiogram) and torsade de pointes (life-threatening irregular heartbeat),
bronchospasm (tightening of the airway muscles resulting in breathing problems),
lack of breath, wheezing, shallow and rapid breathing, laryngospasm (tightening
of the vocal cords making it temporarily difficult to speak or breathe),
intestinal blockage, vomiting, nausea,
death or damage to liver cells (hepatic necrosis), high levels of bilirubin
(breakdown product of red blood cells) in the blood,
blood test results showing a change in kidney function: high
levels of creatinine and reduced levels of urea,
rapid and significant increase in body temperature (malignant hyperthermia). This is a
serious condition that will be treated immediately by the doctor.
chest discomfort, chills,
changes in blood test results: abnormal levels of certain liver enzymes,
increased number of white blood cells, increased levels of fluoride and decreased levels
of cholesterol,
abnormal results in the electroencephalogram (a test that evaluates electrical activity in the brain),
presence of myoglobin (a muscle protein) in the urine, rhabdomyolysis (severe muscle
damage).
Side effects reported as common (may affect up to 1 in 10 people) in a clinical
trial:
fast heartbeat
agitation, delirium (sudden change in mental state, which may be confusion,
agitation, personality change and difficulty understanding and memory) during or after
sedation
low blood pressure
increased blood levels of creatine phosphokinase (a substance in the muscles)
feeling unwell, vomiting
Side effects reported as very common in children (may affect more than 1 in 10 people)
in a clinical trial:
low blood pressure

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . 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 which is stated on the package and on the label of the
vial after “Exp.”. The expiry date refers to the last day of that month.
The shelf life of Sedaconda after connecting the Sedaconda filling adapter is
14 days.
Do not store at a temperature above 30°C. Store the vial in the outer packaging to
protect it from light.
Any unused medicine or waste material must be disposed of in accordance with
local requirements.

6. Contents of the pack and other information

What Sedaconda contains
The active ingredient is Isoflurane 100% V/V. There are no other ingredients.

Description of the appearance of Sedaconda and contents of the pack
Sedaconda is an inhalation vapor, liquid. It is a clear and colorless liquid available in amber glass bottles
of 100 ml and 250 ml.
Packs of:
6 x 100 ml
6 x 250 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria:Cedaconda 100 % V/V liquid for the preparation of vapor for inhalation

Belgium:Sedaconda 100 % V/V liquid for inhalation by vapor; Sedaconda 100% V/V vloeistof
for inhalation vapor; Sedaconda 100 % V/V liquid for the preparation of vapor for inhalation

Croatia:Sedaconda 100% V/V for inhalation, liquid

Denmark:Sedaconda

Finland:Sedaconda 100 % V/V inhalation vapor, liquid

France:Cedaconda 100 % V/V liquid for inhalation by vapor

Germany:Sedaconda 100 % V/V liquid for the preparation of vapor for inhalation

Ireland:Sedaconda 100% V/V inhalation vapour, liquid

Italy:Sedaconda

Netherlands:Sedaconda 100% V/V vloeistof voor inhalation vapor

Norway:Sedaconda 100 % V/V liquid for inhalation vapor

Poland:Sedaconda, 100 % V/V, liquid for preparing inhalation vapor

Portugal:Sedaconda 100% V/V liquid for vaporization inhalation

Slovenia:Sedaconda 100 % V/V for inhalation, liquid

Spain:Sedaconda 100% liquid for inhalation of the vapor

Sweden:Sedaconda 100 % V/V inhalation vapor, liquid

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The following information is intended exclusively for healthcare professionals:
Sedaconda 100% V/V inhalation vapor, liquid

Administration
Sedaconda must be administered and inhaled only via the Sedaconda ACD (Anesthetic Conserving Device),
using the Sedaconda filling adapter and must only be used with intubated or tracheostomized patients
with a protected airway. Sedaconda must only be administered by medically trained personnel
experienced in the management of mechanically ventilated patients, Sedaconda ACD and the
pharmacodynamics of Isoflurane.
Isoflurane must only be administered in a suitably equipped environment by personnel trained in
handling volatile anesthetic agents. To minimize leakage and spillage during the use of Sedaconda,
adequate general ventilation in the intensive care unit, a well-designed scavenging system, work
practices and regular equipment maintenance are necessary.
The Sedaconda ACD is a modified passive heat and moisture exchanger (HME) and as such adds
anatomical dead space to the breathing circuit. The patient's ventilatory status must be taken into
consideration when selecting the size of the Sedaconda ACD, see the Instructions for Use (IFU)
supplied with the Sedaconda ACD.
Complete information on how to use the Sedaconda ACD and the Sedaconda filling adapter is
provided in the IFU document supplied with the devices.
Please read the Summary of Product Characteristics of Sedaconda and the IFU supplied with the
Sedaconda ACD and the Sedaconda filling adapter before setting up the Sedaconda ACD delivery
system and initiating sedation.