Desfluran Piramal

Patient Information Leaflet: User Information

Desfluran Piramal, 100% (v/v), Liquid for Vapor Inhalation

Desfluran

Please read the contents of this leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Desfluran Piramal and what is it used for
• 2. Important information before using Desfluran Piramal
• 3. How to use Desfluran Piramal
• 4. Possible side effects
• 5. How to store Desfluran Piramal
• 6. Package contents and other information

1. What is Desfluran Piramal and what is it used for

Desfluran Piramal contains desfluran, which belongs to the group of halogenated hydrocarbons. Desfluran Piramal is a colorless liquid used for general anesthesia during surgical procedures. It is an inhalational anesthetic (administered to the patient to inhale in the form of vapor). Inhaling desfluran vapor causes the patient to fall into a deep sleep. Additionally, the medicine maintains the aforementioned deep sleep (general anesthesia), during which the patient can undergo a surgical procedure. In adults, Desfluran Piramal is used for induction and maintenance of anesthesia. In infants and children, it is used only for maintenance of anesthesia.

2. Important information before using Desfluran Piramal

Desfluran Piramal should only be administered by medical personnel qualified to administer general anesthesia under the supervision of an anesthesiologist or by an anesthesiologist.

When not to use Desfluran Piramal:

• if the patient has or has had reasons not to administer general anesthetics;
• if the patient is allergic to desfluran or other halogenated anesthetics, such as isoflurane or sevoflurane;
• if the patient or their relative has experienced a rapid and significant increase in body temperature during or after surgery (a condition called malignant hyperthermia);
• for induction of anesthesia if the patient is a child, due to the significant risk of coughing, breath-holding, laryngospasm, and excessive secretions in the airways;
• for maintenance of anesthesia if the patient is a child (under 6 years old), unless the patient is intubated. Intubation is a procedure involving the insertion of a special tube into the airways to help the patient breathe;
• as the only anesthetic in case of increased risk of tachycardia and hypertension in the patient;
• if the patient has a history of hepatitis or liver function disorders of unknown origin of moderate to severe severity (e.g., jaundice accompanied by fever of unknown origin and/or an increase in the number of a certain type of white blood cell after inhalation anesthesia, e.g., isoflurane or sevoflurane;
• if the patient is undergoing dental surgery outside the hospital or day surgery unit.

If the patient has any of the above conditions, they should inform their doctor or anesthesiologist before receiving the medicine.

Warnings and precautions

Before starting Desfluran Piramal, the patient should discuss the following with their doctor or anesthesiologist:

• if the patient has an increased risk of elevated intracranial pressure, such as a brain tumor;
• if the patient has a history of bronchospasm (constriction of the lungs and airways leading to coughing, wheezing, or shortness of breath);
• if the patient has an increased risk of coronary artery disease (when the blood vessels do not supply enough blood and oxygen to the heart muscle);
• if the patient is pregnant or breastfeeding, or if the medicine is administered during childbirth (see also "Pregnancy and breastfeeding");
• if the patient has muscle disease (neuromuscular disorder, e.g., Duchenne muscular dystrophy). In this case, the patient may receive a muscle relaxant simultaneously with Desfluran Piramal;
• if the patient has heart rhythm disorders, known as "QT interval prolongation";
• if the patient has been anesthetized previously, especially multiple times in short intervals;
• if the patient is a child who has recently had a respiratory infection.

The doctor may administer a lower dose of Desfluran Piramal:

• in case of low blood volume (hypovolemia);
• in case of low blood pressure (hypotension);
• in case of weakness.

The doctor may decide not to administer Desfluran Piramal to the patient and use another anesthetic instead:

• if the patient has liver disease due to alcohol abuse (cirrhosis of the liver);
• if the patient has viral hepatitis (liver disease caused by a virus);
• if the patient has another type of liver disease (e.g., liver function disorders of unknown origin after anesthesia, such as jaundice, fever, and/or an increase in the number of a certain type of white blood cell).

Desfluran Piramal may cause a rapid and significant increase in body temperature during surgery, which may be accompanied by muscle stiffness and other symptoms (malignant hyperthermia). In such cases, the anesthesiologist will stop administering Desfluran Piramal, and the patient will receive a medicine used to treat malignant hyperthermia (known as dantrolene) and other supportive therapy. The doctor must exercise particular caution if the patient has been anesthetized previously, especially multiple times in short intervals. After Desfluran Piramal anesthesia, the patient will wake up quickly. If pain is expected after surgery, the doctor will administer a pain reliever to the patient. The doctor may do this at the end of the procedure or during the recovery from anesthesia.

• Desfluran Piramal may cause a slight increase in blood glucose levels during anesthesia.

Middle Ear Surgery

Desfluran, like other inhalational anesthetics, can cause an increase in middle ear pressure, especially in children. Therefore, it is recommended to monitor middle ear pressure during desfluran anesthesia.

Children and Adolescents

• Desfluran should be used with caution in children with asthma or recent upper respiratory tract infections, as they are at increased risk of airway constriction and increased airway resistance.
• Desfluran Piramal 100% should not be used for induction of anesthesia in infants (see also section 2).
• Recovery from anesthesia may cause a short-term state of agitation in children, making them uncooperative.
• Desfluran Piramal may be used for maintenance of anesthesia only if the patient has been intubated. In such cases, caution should be exercised when removing the laryngeal mask after deep anesthesia to avoid adverse reactions, such as coughing or laryngospasm.

If any of the above conditions apply to the patient or their child, they should consult a doctor, nurse, or pharmacist. There may be a need for a thorough examination and change of treatment.

Desfluran Piramal and Other Medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription. It is essential to exercise particular caution if the patient is taking any of the following medicines:

• Muscle relaxants (e.g., suxamethonium, pancuronium, atracurium, vecuronium). These medicines cause muscle relaxation. The anesthesiologist may adjust the dosage;
• Opioids (e.g., fentanyl, morphine, remifentanil). These are potent pain relievers often used in general anesthesia. Even if the patient is taking these pain relievers for other conditions, they should inform their doctor;
• Benzodiazepines (e.g., midazolam, diazepam, nitrazepam). These are sedatives used to calm the patient before surgery. Even if the patient is taking these sedatives for other conditions, they should inform their doctor;
• Nitrous oxide (commonly known as laughing gas). This medicine may be used during general anesthesia to facilitate sleep and reduce pain.
• Medicines used to treat high blood pressure or heart failure (such as beta-adrenergic blockers).

Desfluran Piramal with Food and Drink

Desfluran Piramal is a medicine that causes the patient to fall asleep and maintains the patient in a state of sleep so that they can undergo a surgical procedure. The patient should ask their doctor, surgeon, or anesthesiologist when and what they can eat or drink before the surgical procedure and after waking up.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. There is insufficient data on the use of desfluran in pregnant or breastfeeding women. Therefore, desfluran should only be used in pregnant or breastfeeding women if the doctor considers it absolutely necessary. The patient should not breastfeed for approximately 24 hours after desfluran anesthesia.

Driving and Operating Machines

Desfluran Piramal may affect the patient's state of consciousness and reaction time for some time after administration. Therefore, the patient should not drive vehicles or operate machines for 24 hours after surgery.

3. How to Use Desfluran Piramal

Desfluran Piramal should be used under the control of cardiovascular and respiratory functions and in the presence of an anesthesiologist with access to anesthesia and resuscitation equipment. Desfluran Piramal will always be administered to the patient by an anesthesiologist. The anesthesiologist will determine the dose based on the patient's age, weight, and the type of surgical procedure. During anesthesia, the anesthesiologist will monitor the patient's blood pressure and heart rate. If necessary, the anesthesiologist will adjust the administered dose. Desfluran Piramal is usually administered through a special tube inserted into the patient's airways after the patient has received an injection of another anesthetic that causes sleep. Only in rare cases may the patient be asked to inhale Desfluran Piramal vapor through a mask to induce sleep. Desfluran Piramal is a liquid for vapor inhalation, which is administered through a vaporizer specifically calibrated for use with this product, allowing for precise control of the delivered concentration.

Recovery from Anesthesia

When the surgery is complete, the anesthesiologist will stop administering Desfluran Piramal to the patient. After a few minutes, the patient will wake up.

Overdose of Desfluran Piramal

If a larger dose of Desfluran Piramal is administered to the patient than recommended, the administration of the medicine will be stopped. The patient will be given pure oxygen. During recovery, blood pressure and heart function will be closely monitored. If there are any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Desfluran Piramal can cause side effects, although not everybody gets them. Most side effects are mild to moderate and disappear quickly. However, some side effects can be severe (serious). Severe side effects (frequency not known)such as:

• muscle breakdown (rhabdomyolysis);
• irregular heartbeat or abnormal heart rhythm (arrhythmia) in children;
• rapid and significant increase in body temperature during surgery (malignant hyperthermia). Symptoms of the disease include excess carbon dioxide in the blood (hypercapnia), muscle stiffness, rapid heart rate (tachycardia), rapid breathing (tachypnea), blue discoloration of the skin (cyanosis), irregular heartbeat or abnormal heart rhythm (arrhythmia), low or high blood pressure, and fever.

Most of these severe side effects can occur during anesthesia and when the patient is under the care of medical personnel. Desfluran Piramal may cause a slight increase in blood glucose levels during anesthesia. Possible side effects include:

Very Common (may affect more than 1 in 10 patients)

• Nausea.
• Vomiting. These occur during induction and maintenance of anesthesia with Desfluran Piramal.

Common (may affect up to 1 in 10 patients)

• Inflammation of the back of the throat (pharyngitis).
• Transient breath-holding. This occurred during induction and maintenance of anesthesia with Desfluran Piramal.
• Headache.
• Inflammation of the outer layer of the eye and the inner surface of the eyelids (conjunctivitis).
• Irregular heartbeat or abnormal heart rhythm.
• Slow heart rate (bradycardia).
• Rapid heart rate (tachycardia).
• High blood pressure (hypertension).
• Transient pauses in breathing (apnea), coughing, and excessive salivation (hypersecretion). These occurred during induction and maintenance of anesthesia with Desfluran Piramal.
• Sudden constriction of the vocal cords affecting breathing and speech (laryngospasm).
• Increased activity of the enzyme in the blood called creatine phosphokinase.
• Abnormal heart tracing (abnormal EKG).
• Abnormal heart rhythm (prolonged QTc interval abnormal EKG).

Uncommon (may affect up to 1 in 100 patients)

• Restlessness (agitation).
• Dizziness.
• Heart attack (myocardial infarction).
• Reduced blood flow to the heart muscle (myocardial ischemia).
• Irregular heartbeat (arrhythmia).
• Vasodilation.
• Inadequate oxygen supply to tissues (hypoxia). This occurred during induction and maintenance of anesthesia with Desfluran Piramal.
• Muscle pain (myalgia).

Rare (may affect up to 1 in 1,000 patients)

• Blood clotting disorders (coagulopathy).
• Increased or decreased potassium levels in the blood (hyperkalemia or hypokalemia).
• Excess acid in the body fluids (metabolic acidosis).
• Seizures (convulsions).
• Yellowing of the eye (scleral icterus).
• Heart failure (a condition in which the heart beats weakly) or cardiac arrest (a condition in which the heart stops beating).
• Severe heart rhythm disorders with rapid and irregular heartbeat (torsade de pointes).
• Failure of the heart chambers (a condition in which two of the heart chambers are weakened or fail to function).
• Weakened heart muscle contractions (hypokinesia of the heart chambers).
• Irregular heartbeat (atrial fibrillation).
• Very high blood pressure (malignant hypertension).
• Bleeding (hemorrhage).
• Low blood pressure (hypotension).
• A condition in which the body's tissues do not receive enough blood (shock).
• Difficulty breathing (respiratory failure) or cessation of breathing.
• Sudden constriction of the muscles in the walls of the airways (bronchospasm).
• Coughing up blood from the lungs (hemoptysis).
• Sudden inflammation of the pancreas (acute pancreatitis).
• Abdominal pain.
• Death of liver tissue (liver necrosis).
• Liver inflammation.
• Blockage of bile flow from the liver (cholestasis).
• Yellowing of the skin or eye (jaundice).
• Liver function disorders or liver disease.
• Hives.
• Redness of the skin (flushing).
• Weakness (asthenia).
• General discomfort.
• Changes in heart tracing (changes in the ST-T segment or inversion of the T wave in the EKG).
• Increased activity of liver enzymes (increased alanine and aspartate aminotransferase activity).
• Blood clotting disorders (abnormal coagulation parameters).
• Increased ammonia levels.
• Increased bilirubin levels.
• Liver failure.
• Dizziness (vertigo of labyrinthine origin).
• Pounding heart (palpitations).
• Burning sensation in the eyes.
• Transient blindness.
• Brain disease (encephalopathy).
• Inflammation or infection of the eye (ulcerative keratitis).
• Eye congestion.
• Decreased visual acuity.
• Irritation of the eyes.
• Pain in the eyeball.
• Fatigue.
• Burning sensation of the skin.
• Postoperative agitation.

Reporting Side Effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 collected on the safety of the medicine. The patient should inform their doctor, pharmacist, or nurse if they notice any changes in their well-being after receiving Desfluran Piramal. Some side effects may require treatment.

5. How to Store Desfluran Piramal

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label after "EXP". The expiry date refers to the last day of the month. Store at a temperature below 30°C. Store the bottle in a vertical position, tightly closed.

6. Package Contents and Other Information

What Desfluran Piramal Contains

• The active substance of the medicine is desfluran 100% (v/v).
• The medicine does not contain any other ingredients.

What Desfluran Piramal Looks Like and What the Package Contains

Desfluran Piramal is a liquid for vapor inhalation. Desfluran Piramal is a clear, colorless liquid. The bottle has a capacity of 250 ml, made of orange glass type III, with a PVC coating on the outside of the bottle, with an HDPE/ethylene propylene diene monomer (EPDM) closure and an aluminum seal. Package size: 1 bottle or 6 bottles. Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Piramal Critical Care B.V.

Rouboslaan 32, 2252 TR Voorschoten, Netherlands, Email: [email protected]

This Medicine is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Leaflet: 03.2024