Suprane

Leaflet attached to the packaging: information for the user

SUPRANE, inhalation liquid

Desflurane

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any worsening of side effects or any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What the medicine is and what it is used for
• 2. Important information before using the medicine
• 3. How the medicine will be administered
• 4. Possible side effects
• 5. How to store the medicine
• 6. Contents of the packaging and other information

1. What the medicine is and what it is used for

The medicine contains desflurane. It is a general anesthetic used in surgery.
It is an inhalational anesthetic (administered to the patient as vapor for inhalation).
Inhaling desflurane vapor causes the patient to fall into a deep sleep without feeling pain. This medicine also allows for the maintenance of deep sleep without feeling pain (i.e., general anesthesia), during which the patient can undergo surgery. In adults, the medicine is used for induction and maintenance of anesthesia. In infants and children, the medicine is used only for maintenance of anesthesia.

2. Important information before using the medicine

When NOT to use the medicine:

• if the patient is allergic (hypersensitive) to desflurane or other inhalational anesthetics such as isoflurane, sevoflurane, halothane, and enflurane;
• if there are medical reasons that make it inappropriate for the patient to undergo general anesthesia;
• if the patient or a family member is prone to malignant hyperthermia. Malignant hyperthermia is a life-threatening condition characterized by a sudden increase in body temperature during or shortly after surgery, during which the patient was anesthetized by inhalation. A case of malignant hyperthermia with a fatal outcome has been reported with desflurane;
• if the patient has previously been diagnosed with liver disease (hepatitis) due to the administration of desflurane or another inhalational anesthetic such as isoflurane, sevoflurane, halothane, and enflurane, or if the patient has previously experienced unexplained liver problems of mild to severe intensity (liver function disorders, e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with desflurane or another inhalational anesthetic such as isoflurane, sevoflurane, halothane, and enflurane. When the medicine should NOT be used to induce anesthesia:
• if the patient is at risk of coronary artery disease; coronary artery disease occurs when the blood vessels supplying the heart muscle do not deliver enough blood and oxygen;
• if the doctor considers that the possible side effects of the medicine are undesirable, e.g.,
• increased heart rate,
• increased blood pressure.
• in infants and children due to the frequent occurrence of coughing, breathing difficulties, and respiratory disorders, as well as increased secretion.

If any of these conditions apply to the patient, they should inform their doctor, surgeon, or anesthesiologist before the medicine is administered.

Warnings and precautions

The doctor will exercise particular caution when using the medicine in the following cases:

• if the patient has a brain tumor;
• if the patient has previously experienced unexplained liver problems along with:
• jaundice (yellowing of the skin and whites of the eyes),
• fever,
• liver tissue necrosis, in some cases with a fatal outcome,
• if the patient has changes in the electrical activity of the heart called "QT interval prolongation".

There may be a need for the doctor to administer a lower dose of the medicine:

• if the patient has low blood volume (hypovolemia),
• if the patient has low blood pressure (hypotension),
• if the patient is weakened (exhausted).

The doctor may decide not to use the medicine if the patient has:

• liver cirrhosis (alcoholic liver disease),
• viral hepatitis (liver disease caused by viruses),
• other types of liver disease. In such cases, the doctor may use another anesthetic.

In patients with coronary artery disease, measures should be taken to prevent reduced blood flow to the heart. To this end, the doctor will monitor the patient's pulse and arterial blood pressure. For induction of anesthesia in patients at risk of coronary artery disease and in patients for whom increases in heart rate or blood pressure are undesirable, other medicines should be used, preferably intravenous narcotics and sedatives. The doctor should pay particular attention if the patient has previously been administered an inhalational anesthetic, especially if this has happened more than once in a short period (repeated use). The patient should inform the doctor, surgeon, or anesthesiologist if they have recently undergone general anesthesia. Recovery from anesthesia induced by the medicine is rapid. The doctor will administer painkillers if pain is expected in the patient after surgery. This may occur at the end of surgery or during recovery from anesthesia. The medicine may cause malignant hyperthermia (during or shortly after surgery, the patient's body temperature rises rapidly and dangerously). The medicine can very rarely cause an increase in potassium levels in the blood, during or very shortly after its administration. In most such cases, but not all, a muscle relaxant called succinylcholine was also administered. High potassium levels in the blood can contribute to heart rhythm disorders, some of which can be severe and even fatal. It appears that patients with muscle disorders or dystrophy, especially Duchenne's muscular dystrophy, are most at risk of developing high potassium levels.

Use in children

• Desflurane should be used with caution in children who have asthma or who have or have recently had an upper respiratory tract infection, due to the possibility of bronchospasm and breathing difficulties.
• In children, recovery from anesthesia may cause a short-term state of agitation, which can make cooperation difficult.
• In infants and children (i.e., patients under 12 years of age), the medicine is not used for induction of anesthesia, as it may cause undesirable effects such as:
• coughing,
• apnea (breathing arrest),
• laryngospasm (laryngeal spasm),
• increased production of respiratory secretions.
• In children, the medicine should not be used for maintenance of anesthesia unless the children have been intubated. Intubation involves placing a tube in the airways to assist with breathing. The doctor should exercise caution when using desflurane for maintenance of anesthesia with a laryngeal mask, especially in children under 6 years of age, due to the increased risk of respiratory side effects such as coughing and laryngospasm, especially if the laryngeal mask is removed under deep anesthesia.

If any of the above conditions apply to the patient (including children), they should consult a doctor, nurse, or pharmacist. It may be necessary to examine the patient thoroughly and change the treatment being used. and other medicinesThe patient should tell their doctor, nurse, or anesthesiologist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. This includes herbal medicinal products, vitamins, and minerals.

• Medicines or active substances that are part of the medicines listed below may affect the action of the medicine when used concomitantly. Some of these medicines are administered to the patient during surgery by the anesthesiologist, as indicated in the description.
• Muscle relaxants (e.g., succinylcholine, pancuronium, atracurium, vecuronium): these medicines are used during general anesthesia to relax the patient's muscles. It may be necessary to adjust the dose of these medicines by the anesthesiologist.
• Opioids (e.g., fentanyl, morphine, remifentanil): these medicines are strong painkillers and are often used during general anesthesia. The patient may also use these painkillers in other situations and should inform their doctor about any such use.
• Benzodiazepines (e.g., midazolam, diazepam, nitrazepam): these are sedative medicines used when the patient is anxious, e.g., before surgery. The patient may also use these sedative medicines in other situations. The patient should inform their doctor about any use of these medicines before the medicine is administered.
• Nitrous oxide: this is a medicine used during general anesthesia that induces sleep and relieves pain.

with food and drinkThe medicine is used to induce and maintain sleep, allowing the patient to undergo surgery. The patient should ask their doctor, surgeon, or anesthesiologist when and what they can eat and drink after recovery from anesthesia.

Pregnancy, breastfeeding, and fertility

The medicine should not be administered to pregnant or breastfeeding women. During pregnancy and breastfeeding, or if pregnancy is suspected or planned, the patient should consult their doctor, surgeon, or anesthesiologist before using the medicine.

Driving and using machines

Receiving the anesthetic may affect the patient's alertness, which may alter their ability to perform normal tasks. The patient should not drive vehicles or operate tools and machines for 24 hours after surgery with the medicine.

3. How the medicine will be administered

The medicine will be administered to the patient by an anesthesiologist, who will decide how much medicine the patient needs and when they will receive it. The dose will depend on the patient's age, weight, and the surgery being performed. During anesthesia, the anesthesiologist will monitor the patient's arterial blood pressure and heart rate. This will help them adjust the dose if necessary. The medicine is obtained from liquid desflurane in a vaporizer. The patient may receive the medicine in one of two ways:

• before administering the medicine through a mask, the patient may be injected with another anesthetic to induce sleep. This method of administration is most commonly used. or
• the patient may be asked to inhale desflurane vapor through a mask to induce sleep. The patient will fall asleep quickly and easily. This method of administration is used less frequently.

After surgery, the anesthesiologist will stop administering the medicine. Within a few minutes, the patient will wake up.

Overdose of the medicine

In case of administration of too much medicine, the administration of the medicine will be stopped. The patient will be given pure oxygen. Blood pressure and heart function will be closely monitored during the patient's recovery.

4. Possible side effects

Like all medicines, the medicine can cause side effects. The medicine can cause dose-dependent depression of respiratory and cardiovascular function. Nausea and vomiting, which are common consequences of surgical operations and general anesthesia, have been observed after surgery. There may be many causes: the use of inhalational anesthetics, other anesthetics, and administered medicines, or the post-surgical state. Most of these side effects are transient and mild.

Very common (occurs in more than 1 in 10 patients):

• nausea (vomiting) and vomiting. These effects occurred during induction and maintenance of anesthesia with the medicine.

Common (occurs in no more than 1 in 10 patients):

• pharyngitis;
• apnea. This effect occurred during induction and maintenance of anesthesia with the medicine;
• headache;
• conjunctivitis;
• irregular heart rhythm (nodal arrhythmia);
• slow heart rate (bradycardia);
• fast heart rate (tachycardia);
• high blood pressure (hypertension);
• apnea, coughing, increased salivation. These effects occurred during induction and maintenance of anesthesia with the medicine;
• laryngospasm. This effect occurred during induction of anesthesia with the medicine;
• increased activity of the enzyme phosphocreatine kinase in the blood;
• abnormal electrocardiogram (ECG) recording.

Uncommon (occurs in no more than 1 in 100 patients):

• restlessness;
• dizziness;
• myocardial infarction (heart attack);
• myocardial ischemia (reduced blood flow to the heart muscle);
• irregular heart rhythm;
• vasodilation;
• hypoxia (insufficient oxygen supply to the body). This effect occurred during induction and maintenance of anesthesia with the medicine;
• muscle pain (myalgia).

Frequency not known (frequency cannot be estimated from the available data):

• coagulopathy (blood clotting disorders);
• hyperkalemia (high potassium levels in the blood);
• hypokalemia (low potassium levels in the blood);
• metabolic acidosis (excessive acid production in the body);
• altered state of consciousness;
• seizures;
• jaundice (yellowing of the eyes);
• cardiac arrest (heart stoppage);
• life-threatening irregular heart rhythm (torsades de pointes);
• ventricular failure (pump failure of the heart);
• ventricular hypokinesia (reduced movement of the heart ventricles);
• atrial fibrillation (irregular heart rhythm);
• malignant hypertension (very high blood pressure);
• bleeding (hemorrhage);
• hypotension (low blood pressure);
• shock (insufficient blood supply to the body's tissues);
• apnea (breathing arrest);
• respiratory failure (insufficient oxygen supply to the body);
• bronchospasm (sudden constriction of the airways);
• hemoptysis (coughing up blood);
• acute pancreatitis (sudden inflammation of the pancreas);
• abdominal pain;
• liver failure;
• liver necrosis;
• hepatitis (liver inflammation);
• cholestasis (bile flow disorder);
• jaundice;
• liver function disorders;
• allergic reactions;
• urticaria;
• flushing;
• rhabdomyolysis (muscle disease);
• malignant hyperthermia - a life-threatening condition during or shortly after surgery, characterized by:
• rapidly rising high fever,
• excessive carbon dioxide levels in the blood (hypercapnia),
• muscle stiffness,
• increased heart rate (tachycardia),
• increased respiratory rate (rapid breathing),
• blue discoloration of the skin (cyanosis),
• irregular heart rhythm,
• increased or decreased blood pressure.
• weakness (asthenia);
• general malaise;
• changes in the ECG recording (ST-T segment changes);
• changes in the ECG recording (T-wave inversion);
• increased activity of liver enzymes (increased activity of alanine aminotransferase and aspartate aminotransferase);
• coagulopathy;
• increased ammonia levels;
• increased bilirubin levels in the blood;
• postoperative excitement.

The following side effects have been reported after accidental administration of the medicine to non-patients:

• dizziness;
• severe headache (migraine);
• irregular and rapid heart rhythm (tachyarrhythmia);
• palpitations (feeling of heart beating);
• eye burning;
• temporary (transient) blindness;
• encephalopathy (brain disease);
• corneal ulceration (ulcerative keratitis);
• eye congestion (conjunctival congestion);
• visual disturbances (impaired vision);
• eye irritation;
• eye pain;
• fatigue;
• skin burning sensation.

The patient should inform their doctor or pharmacist if they notice any changes in their condition after receiving the medicine. Some side effects may require treatment.

Reporting side effects

If any side effects occur, including any not listed in the leaflet, the patient should inform their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw tel.: +48 22 49 21 301 fax: +48 22 49 21 309 website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store the medicine

The medicine should be stored out of sight and reach of children. Do not use the medicine after the expiry date stated on the container and outer packaging after "Expiry date". The expiry date refers to the last day of the month. The medicine should be stored in a tightly closed container in a vertical position. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

Active substance: one bottle contains 240 ml of desflurane. It does not contain any excipients.

What the medicine looks like and what the packaging contains

The medicine, inhalation liquid, is packaged in orange glass bottles with a mounted threaded valve closure system or in aluminum bottles coated with epoxyphenolic resin, with a mounted threaded valve closure system in a cardboard box. Packaging sizes: 1 or 6 bottles of 240 ml in a cardboard box. Not all packaging sizes may be marketed.

Marketing authorization holder

Baxter Polska Sp. z o.o. ul. Kruczkowskiego 8 00-380 Warsaw tel. 22 488 37 77

Manufacturer

Baxter S.A. Boulevard René Branquart 80, 7860 Lessines, Belgium Date of last update of the leaflet:November 2023 Baxter and Suprane are trademarks of Baxter International Inc.