Leaflet: information for the user

Desflurane Piramal 100 % (v/v) Liquid for inhalation of vapor EFG

Desflurane

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Desflurano Piramal contains desflurane and belongs to the group of halogenated hydrocarbons. Desflurano Piramal is a colorless liquid that is used as a general anesthetic used in surgery. It is an inhalation anesthetic (administered in the form of vapor to be breathed). Breathing in desflurane vapor causes deep sleep. It also maintains deep sleep (general anesthesia) during which an operation can be performed. In adults, Desflurano Piramal is used for the induction and maintenance of anesthesia. In infants and children, it is used only to maintain anesthesia.

No use Desflurano Piramal:

• If you have or have had medical reasons for not receiving general anesthetics.
• If you are allergic to halogenated anesthetics.
• If you or a family member has experienced a rapid and significant increase in body temperature during an operation or shortly after (a condition known as malignant hyperthermia).
• If you are a child to induce anesthesia due to the significant risk of laryngospasm.
• If you are a child (under 6 years) to maintain anesthesia, unless you are intubated. Intubation is when a tube is placed in the airways to help breathe.
• If you have a risk of high heart rate or high blood pressure, Desflurano should not be used as the sole anesthetic.
• If in the past, after receiving inhalational anesthetics or suffering from moderate or severe liver problems of unknown origin, unknown fever, or increase in certain white blood cells (leukocytosis).
• If you are to undergo dental procedures outside the hospital or day care unit.

Inform your doctor or anesthesiologist if you meet any of the conditions mentioned above before receiving this medication.

Warnings and Precautions

Consult your doctor or anesthesiologist before starting to use Desflurano Piramal:

• If you have a risk of high blood pressure.
• If you are prone to bronchoconstriction (a narrowing of the lungs and airways that causes coughing, wheezing, or shortness of breath).
• If you have a risk of coronary disease (when the blood vessels do not transport enough blood and oxygen to the heart muscle).
• If you are pregnant or breastfeeding, or if this medication is administered during delivery (see also "Pregnancy and Lactation").
• If you have a muscle disorder (a neuromuscular disease such as Duchenne muscular dystrophy). You may be given a muscle relaxant at the same time as Desflurano Piramal.
• If you have a heart condition called "prolongation of the QT interval."
• If you have received general anesthetics previously, especially if you were given multiple doses in a short period of time.
• If you are a child and have recently had a respiratory infection.

Your doctor may administer less Desflurano Piramal:

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

Your doctor may decide not to administer Desflurano and choose another type of anesthesia:

• If you have liver disease due to alcoholism (cirrhosis).
• If you have viral hepatitis (a liver disease caused by a virus).
• If you have other types of liver disease.

Jaundice (yellow skin and eyes)

Fever

Cellular necrosis of the liver.

After anesthesia with Desflurano Piramal, you will wake up quickly. If pain is expected after the operation, your doctor will give you an anesthetic. Your doctor may also do this at the end of the operation or during the recovery phase.Your anesthesiologist will stop administering Desflurano Piramal, give you a medication to treat malignant hyperthermia (called dantrolene), and receive another maintenance therapy.

Your doctor should proceed with special caution if you have been given an inhalational anesthetic previously, especially if you have been given multiple doses in a short period of time (repeated use).

Desflurano Piramal may cause a rapid and significant increase in body temperature during an operation (malignant hyperthermia).

Desflurano should be used with caution in patients without intubated airways.

Ear, Nose, and Throat Operations

Desflurano, as well as other volatile anesthetics, increases middle ear pressure, especially in children, and therefore it is recommended to control middle ear pressure during anesthesia with desflurano.

Children

• Desflurano should be used with caution in children with asthma or recent history of upper respiratory tract infection due to the potential for airway narrowing and increased airway resistance.
• Desflurano Piramal should not be used to induce anesthesia in infants (see also section 2).
• .
• Waking up from anesthetics may cause a brief state of agitation in children, making them less cooperative.
• Desflurano Piramal can be administered for the maintenance of anesthesia only if a breathing tube is placed in the airways to help breathe (intubation). In these cases, caution should be exercised when removing the laryngeal mask after a deep anesthesia to avoid secondary effects, such as coughing or vocal cord muscle spasm called laryngospasm.

If any of the above conditions apply to you or your child, consult your doctor, nurse, or pharmacist. You may need to be closely monitored and your treatment modified.)

Use of Desflurano Piramal and Other Medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those obtained without a prescription.

You should exercise special caution if you take any of the following medications:

• Muscle relaxants (such as suxamethonium, pancuronium, atracurium, vecuronium). These medications help relax muscles. Your anesthesiologist may adjust the dosage.
• Opioids (such as fentanyl, morphine, remifentanil). These medications are potent analgesics that are often used during general anesthesia.
• Benzodiazepines (such as midazolam, diazepam, nitrazepam). These are tranquilizers used to relax an agitated patient before surgery.
• Nitrous oxide (laughing gas). This medication may be used during general anesthesia to put the patient to sleep and relieve pain.

Taking Desflurano Piramal with Food and Drink

Desflurano Piramal is a medication to put you to sleep and keep you asleep so you can undergo surgery. You should ask your doctor, surgeon, or anesthesiologist when and what you can eat or drink before anesthesia and after waking up.

Pregnancy and Lactation

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

There is insufficient data on the use of desflurano in pregnant women or breastfeeding women, and therefore the use of desflurano is not indicated during pregnancy and lactation.Therefore, desflurano should only be used in pregnant women and breastfeeding women when absolutely necessary. You should avoid breastfeeding for approximately 24 hours after anesthesia with desflurano.

Driving and Operating Machines

Desflurano Piramal may affect your alertness and ability to respond for a time after receiving the medication. Therefore, do not drive or operate machines for 24 hours after the operation.

Desflurane Piramal must be used under cardiorrespiratory supervision and in the presence of an anesthesiologist with technical means that allow anesthesia and resuscitation.Desflurane Piramal will always be administered by an anesthesiologist. The anesthesiologist will decide the dose to be received, based on age, body weight, and type of operation to be performed. During anesthesia, the anesthesiologist will check blood pressure and heart rate. If necessary, the anesthesiologist will adjust the dose.

In most cases, Desflurane Piramal is administeredthrough a tube placed in the respiratory tract after receiving an injection of another anesthetic that induces sleep. In rare cases, they may ask you to breathe the vapors of Desflurane Piramal through a mask to induce sleep.

Desflurane Piramal is a vapor inhalation liquid that is administered through a specifically calibrated vaporizer for the use of this product, so that the administered concentration can be controlled with precision.

Waking up after anesthesia

After the operation, the anesthesiologist will stop giving Desflurane Piramal. You will wake up in a few minutes.

If you use more Desflurane Piramal than you should

If you receive more Desflurane Piramal than you should, administration will be interrupted.Pure oxygen will be administered. Your blood pressure and cardiac function will be closely monitored while you wake up.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

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.

Most side effects are of mild to moderate intensity and short duration. However, some side effects can also be severe.

Severe side effects (Unknown frequency) such as:

-muscle fiber rupture (rhabdomyolysis),

-irregular heartbeats or abnormal heart rhythm (arrhythmia) in children.

-rapid and significant increase in body temperature during surgery (malignant hyperthermia). The signs of illness include: excessive carbon dioxide in the blood (hypercapnia), muscle stiffness (rigidity), increased heart rate (tachycardia), increased breathing (tachypnea), blue discoloration of the skin (cyanosis), irregular heartbeats or abnormal heart rhythm (arrhythmia), high or low blood pressure, and fever

Most of these severe side effects can occur while under anesthesia and under the care of healthcare professionals.

Desflurano Piramal may cause a mild increase in blood sugar levels during anesthesia.

Possible side effects include:

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

• Nausea
• Vomiting

These occur during the induction and maintenance of anesthesia with Desflurano Piramal

Common(may affect up to 1 in 10 patients)

• Posterior throat inflammation (pharyngitis)
• Temporary respiratory retention. This has occurred during the induction and maintenance of anesthesia with Desflurano Piramal.
• Headache
• Conjunctivitis, an inflammation of the outer layer of the eye and the inner surface of the eyelids.
• Irregular or abnormal heart rhythm
• Slower heart rate (bradycardia)
• Faster heart rate (tachycardia)
• High blood pressure (hypertension)
• Temporary interruption of breathing (apnea), cough, and excessive saliva production (hypersalivation). These have occurred during the induction and maintenance of anesthesia with Desflurano Piramal.
• Sudden spasms of the vocal cords that affect breathing and speech (laryngospasm).
• Increased blood levels of an enzyme called creatine phosphokinase.
• Abnormal ECG reading
• Abnormal heart rhythm (Prolongation of the QTc interval)

Uncommon(may affect up to 1-10 in 100 patients)

• Agitation
• Dizziness
• Heart attack (myocardial infarction)
• Reduced blood flow to the heart muscle (myocardial ischemia)
• Irregular heart rhythm (arrhythmia)
• Widening of blood vessels (vasodilation)
• Reduced oxygen supply (hypoxia). This has occurred during the induction and maintenance of anesthesia with Desflurano Piramal.
• Muscle pain (myalgia)

Unknown frequency(cannot be estimated from available data)

• Blood clotting disorder (coagulopathy)
• High or low potassium levels in the blood (hyperkalemia/hypokalemia)
• Excessive acid in body fluids (metabolic acidosis)
• Seizure (convulsion)
• Yellowing of the eyeball (ocular icterus)
• Heart failure (when the heart has difficulty beating) or cardiac arrest (when the heart stops beating)
• Severe heart rhythm disturbances with rapid and irregular pulse (torsades de pointes)
• Left ventricular failure (when two heart chambers do not function well or stop functioning)
• Reduced muscle contraction of the heart (hypokinesia ventricular)
• Irregular heart rhythm (atrial fibrillation).
• Very high blood pressure (malignant hypertension)
• Bleeding (hemorrhage)
• Low blood pressure (hypotension)
• When tissues do not receive enough blood (shock)
• Difficulty breathing (respiratory insufficiency) or cessation of breathing (apnea)
• Sudden narrowing of the respiratory tract muscles (bronchospasm)
• Coughing up blood from the lungs (hemoptysis)
• Sudden inflammation of the pancreas (acute pancreatitis)
• Abdominal pain (abdominal pain)
• Death of liver tissue (hepatic necrosis)
• Inflammation of the liver (hepatitis cytolytic)
• Bile duct obstruction (cholestasis)
• Yellowing of the skin or eyeball (icterus)
• Alterations in liver function or liver disease
• Hives (urticaria)
• Redness of the skin (erythema)
• Weakness (asthenia)
• General discomfort
• Alterations in ECG recordings (alterations in ST-T segment measurements or inversion of the T wave)
• Increased liver enzymes (elevated alanine or aspartate aminotransferase)
• Blood clotting disorder (abnormal coagulation values)
• High ammonia levels
• Elevated bilirubin levels
• Liver insufficiency
• Dizziness and loss of balance (vertigo)
• Palpitations
• Burning sensation in the eyes
• Temporary blindness
• Brain disease (encephalopathy)
• Inflammation or infection of the eye (ulcerative keratitis)
• Eye injection with blood (ocular hyperthermia)
• Reduced visual acuity and clarity
• Irritation of the eye
• Eye pain
• Fatigue
• Burning sensation in the skin
• Postoperative agitation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Usewww.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine

Inform your doctor, pharmacist, or nurse if you notice any change in how you feel after receiving Desflurano Piramal. Some side effects may require treatment.

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

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

Store below 30 °C.

Store the vial in an upright position with the cap perfectly closed.

Composition of Desflurane Piramal

• The active ingredient is desflurane 100 % (v/v).
• It does not contain any other component.

Appearance of Desflurane Piramal and packaging contents

Desflurane Piramal is a vapor inhalation liquid.

Desflurane Piramal is a transparent and colorless liquid.

Amber Type III glass bottle of 250 ml with PVC coating on the exterior of the bottle and HDPE/Ethylene propylene diene monomer (EPDM) cap and aluminum collar.

Packaging of 1 and 6 bottles.

It is possible that not all packaging sizes are marketed.

Marketing Authorization Holder and Responsible Manufacturer

Piramal Critical Care B.V.,

Rouboslaan 32, 2252 TR,

Voorschoten ,

Netherlands

Or

(Manufacturer only for the United Kingdom)

Piramal Critical Care Limited

Suite 4, Ground Floor,

Heathrow Boulevard - East Wing,

280 Bath Road, West of Drayton,

UB7 0DQ,

United Kingdom.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Euromed Pharma Spain, S.L

C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Phone: + 34 932 684 208

Fax: + 34 933 150 469

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

Last review date of this leaflet: 03/2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/