100% V / V inhalation vapor , liquid
isoflurane
Read all of this leaflet carefully befo
What Sedaconda is and what it is used for
Sedaconda contains an active substance called isoflurane and belongs to a group of medicines called anesthetics. It is used to provide sedation (a state of calm, drowsiness, or sleep) in adults who need a respirator (treatment with a special machine that helps patients breathe) during intensive care.
Isoflurane contained in Sedaconda may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you get Sedaconda
You will not receive Sedaconda
- If you are allergic to isoflurane or other halogenated anesthetics.
- If you, or anyone in your family, have ever experienced a rapid rise in body temperature during sedation or anesthesia (a rare condition called malignant hyperthermia ). See “Possible side effects”, for more information.
Warnings and cautions
Talk to your doctor or nurse before receiving Sedaconda if:
- you have ever had QT prolongation (change seen on an electrocardiogram ( ECG ) reading) or torsade de pointes (life-threatening irregular heartbeat). Isoflurane has in some cases been able to cause these.
- you have a mitochondrial disease. Mitochondrial diseases are a group of rare genetic conditions that occur when mitochondria (small structures in the cells) do not produce enough energy for the body to function properly.
- you have heart disease (eg coronary heart disease).
- you have previously received an anesthetic to inhale, especially within the last three months. This can lead to an increased risk of liver damage.
- you have an increased intracranial pressure (pressure around your brain) due to head injury, brain tumor, or other condition. Sedaconda can further increase the pressure inside your skull.
- you have low blood pressure, low blood volume, or are weakened. You may need a lower dose of Sedaconda.
- you have liver disease.
- you have a condition that affects the nerves and muscles (a neuromuscular disease, such as 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 is a rapid and marked increase in body temperature accompanied by muscle stiffness and other symptoms (see section 4).
Sedaconda may in rare cases cause hyperkalemia ( increased serum potassium ) (see section 4). Patients with the neuromuscular disease appear to be most at risk.
Sedaconda may cause breathing difficulties ( respiratory depression ) (see section 4).
Children and young people
This medicine should not be given to children and adolescents under 18 years of age, as there is limited experience with this medicine 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:
- Some antidepressants, so-called non-selective monoamine oxidase (MAO) inhibitors, such as isocarboxazid, nialamide, phenelzine, etc. Your doctor will not give you Sedaconda for at least 15 days after taking an MAOI.
- Drugs called beta- sympathomimetics (a broad group of drugs that affect the part of the nervous system that works automatically), e.g. isoprenaline, adrenaline, noradrenaline. If you take these medicines with Sedaconda, your heartbeat may become irregular.
- Drugs called indirectly acting sympathomimetics such as amphetamines and their closely related drugs, psychostimulants, appetite suppressants, ephedrine, and closely related drugs. Taking these medicines with Sedaconda can lead to high blood pressure.
- Beta-blockers (a group of medicines used to treat high blood pressure and certain heart diseases). Taking these medicines with Sedaconda can worsen so-called cardiac compensation reactions (reactions that help your body compensate for reduced blood and oxygen supply caused by heart failure ).
- Isoniazid ( antibiotics for tuberculosis ) 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, and verapamil.
- Opioids (eg morphine, fentanyl ), benzodiazepines (eg midazolam, diazepam ), and other sedatives can cause slow and ineffective breathing.
- Muscle relaxants (eg 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 are planning to have a baby, ask your doctor for advice before taking this medicine.
Sedaconda can cause increased blood loss, such as if you are undergoing uterine surgery or giving birth. Your doctor will not give you this medicine unless the potential benefit outweighs the potential risks to you and your child.
If you have been breastfeeding before receiving Sedaconda, you should stop breastfeeding until the medicine has disappeared from your body. Your doctor will tell you when it is safe for you to continue breastfeeding.
Driving and using machines
Sedaconda may impair your ability to drive and use machines for up to 6 days. Do not drive or use machines until your doctor tells you to.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to get Sedaconda
Sedaconda will only be given to you by qualified and experienced medical staff. Your doctor will determine the appropriate dose for you depending on your age, state of health, and sedation depth (sleepiness) that you need.
Your doctor will give you the right starting dose to achieve the desired sedation depth by carefully following your reactions as well as vital signs (such as heart rate, blood pressure, respiration, etc.).
Sedaconda is a liquid that is converted to steam (gas) using a carburetor. It is intended for inhalation, which means you will inhale it like a vapor.
If you take more Sedaconda than you should
If you take too much Sedaconda and are deeply anesthetized, your blood pressure may drop ( hypotension ) and your breathing may become slow and ineffective. Your doctor will take steps to correct your blood pressure and breathing.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions that have been reported (occurring in an unknown number of users):
- anaphylactic reaction (a severe, potentially life-threatening allergic reaction ), other allergic reactions (manifested as red, itchy, windy, dry or cracked skin, rash, shortness of breath, wheezing, chest discomfort, swelling of the face),
- elevated blood sugar or potassium levels,
- mood swings,
- impaired mental function and seizures, which is a medical condition in which the body muscles contract and quickly relax repeatedly, resulting in uncontrolled body movements,
- irregular heartbeats, slow heartbeats, cardiac arrest (a condition in which the heart suddenly stops beating), QT prolongation (change seen on an electrocardiogram ( ECG ) reading), and torsade de pointes (life-threatening irregular heartbeats),
- bronchospasm (contraction of the respiratory muscles leading to respiratory problems), shortness of breath, wheezing, slow shallow breathing, laryngospasm (contraction of the vocal cords which temporarily makes it difficult to speak or breathe),
- intestinal blockage, vomiting, nausea,
- liver cell death (liver necrosis) or damage, elevated levels of bilirubin ( red blood cell breakdown product ) in the blood,
- blood test results show a change in renal function: elevated creatinine levels and decreased urea levels,
- a rapid and marked 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, increased fluoride levels, and decreased cholesterol levels,
- abnormal electroencephalogram ( EEG ) results (a test that evaluates the electrical activity of the brain),
- presence of myoglobin (a muscle protein) in the urine, and rhabdomyolysis (severe muscle damage).
Common side effects (may affect up to 1 in 10 people) reported in a clinical study:
- fast heartbeat
- anxiety, delirium (sudden change in mental state, which can be confusion, anxiety, personality change, and difficulty understanding and remembering), during or after sedation
- low blood pressure
- increased levels of creatine phosphokinase (CK) (a muscle substance) in the blood
- nausea, vomiting
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 carton and bottle cap after “EXP”.
The expiration date is the last day of the specified month.
Sedaconda’s shelf life after the Sedaconda refill adapter is attached is 14 days.
Do not store above 30 ° C. Store the bottle in the outer carton. Sensitive to light.
Any unused product or waste material should be disposed of by local requirements.
Contents of the packaging and other information
Content declaration
The active substance is isoflurane 100% V / V. There are no additional ingredients.
What the medicine looks like and the contents of the pack
Sedaconda is an inhalation vapororor liquid It is a clear, colorless liquid available in 100 ml and 250 ml amber glass bottles.
Pack sizes:
6 x 100 ml
6 x 250 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Piramal Critical Care BV
Rouboslaan 32 (ground floor)
2252 TR, Advances
Netherlands
This medicinal product is authorized under the European Economic Area under the names:
Sedaconda: Austria, Belgium, Croatia, Denmark, Finland, Germany, Ireland, Norway, the Netherlands, Poland, Portugal, Slovenia, Spain, and Sweden
Cedaconda: France