Desflurane Piramal 100% liquid for inhalation EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Desflurane

Read the entire 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, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Desflurane Piramal is and what it is used for
2. What you need to know before using Desflurane Piramal
3. How to use Desflurane Piramal
4. Possible adverse effects
5. How to store Desflurane Piramal
6. Contents of the pack and other information

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

Desflurano Piramal contains desflurane and belongs to the group of halogenated hydrocarbons. Desflurano Piramal is a colourless liquid used as a general anaesthetic in surgery. It is an inhalation anaesthetic (administered as a vapour for you to breathe). Breathing desflurane vapour causes you to go into a deep sleep. It also maintains deep sleep (general anaesthesia) during which you can undergo surgery. In adults, Desflurano Piramal is used for the induction and maintenance of anaesthesia. In infants and children, it is used only for the maintenance of anaesthesia.

2. What you need to know before using Desflurane Piramal

Do not use Desflurane Piramal:

• if there are or have been medical reasons why you should not receive general anaesthetics.
• if you are allergic to halogenated anaesthetics.
• if you or a family member has ever experienced a rapid and significant rise in body temperature during or shortly after surgery (a condition known as malignant hyperthermia).
• if you are a child for the induction of anaesthesia due to the significant risk of laryngospasm.
• if you are a child (under 6 years of age) for the maintenance of anaesthesia, unless intubated. Intubation is when a tube is placed into the airways to assist breathing.
• if you are at risk of increased heart rate or high blood pressure, desflurane should not be used as the sole anaesthetic agent.
• if in the past, after receiving inhalational anaesthetics, you developed unexplained liver problems of moderate or severe degree, unexplained fever, or an increase in certain white blood cells (leucocytosis).
• if you are undergoing dental procedures outside of a hospital or day-care unit.

Before receiving this medicine, inform your doctor or anaesthesiologist if any of the above conditions apply to you.

Warnings and precautions

Consult your doctor or anaesthesiologist before starting Desflurane Piramal:

• if you are at risk of increased intracranial pressure.
• if you have a tendency to bronchoconstriction (a narrowing of the lungs and airways causing coughing, wheezing, or shortness of breath).
• if you are at risk of coronary artery disease (when blood vessels do not deliver enough blood and oxygen to the heart muscle).
• if you are pregnant or breastfeeding, or if this medicine is to be administered during childbirth (see also “Pregnancy and breastfeeding”).
• if you have a muscle disorder (a neuromuscular disease such as Duchenne muscular dystrophy). You may be given a muscle relaxant along with Desflurane Piramal.
• if you have an abnormality in the electrical activity of your heart known as “QT interval prolongation”.
• if you have previously received general anaesthetics, especially if you received multiple doses within a short period of time.
• if you are a child who has recently had a respiratory infection.

Your doctor may administer a lower dose of Desflurane Piramal:

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

Your doctor may decide not to administer desflurane and will choose another type of anaesthesia:

• 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 (yellowing of the skin and eyes)

fever

hepatocellular necrosis.

After anaesthesia with Desflurane Piramal, you will wake up quickly. If postoperative pain is expected, the doctor will give you an analgesic. The doctor may also administer this at the end of surgery or during the recovery phase. In such cases, the anaesthesiologist (doctor) will stop administering Desflurane Piramal, you will be given a medication to treat malignant hyperthermia (known as dantrolene), and you will receive additional supportive therapy.

Special caution must be exercised by the doctor if you have previously received an inhalational anaesthetic, especially if administered multiple times within a short period (repeated use).

Desflurane Piramal can cause a rapid and significant increase in body temperature during surgery (malignant hyperthermia).

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

Middle ear surgery

Desflurane, like other volatile anaesthetics, increases middle ear pressure, especially in children. Therefore, it is recommended to monitor middle ear pressure during desflurane anaesthesia.

Children

• Desflurane should be used with caution in children with asthma or a recent history of upper respiratory tract infection due to the potential for airway narrowing and increased airway resistance.
• Desflurane Piramal must not be used for the induction of anaesthesia in infants (see also section 2).
• .
• Emergence from anaesthesia may cause a brief period of agitation in children, making them uncooperative.
• Desflurane Piramal may be administered for the maintenance of anaesthesia only if a breathing tube is inserted into the airway to assist breathing (intubation). In these cases, caution must be exercised when removing the laryngeal mask after deep anaesthesia to avoid side effects such as coughing or muscle spasm of the vocal cords known as laryngospasm.

If any of the above conditions apply to you or your child, consult your doctor, nurse, or pharmacist. Close monitoring and possible modification of treatment may be required.

Use of Desflurane Piramal with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Special care is needed if you are taking any of the following medicines:

• Muscle relaxants (such as suxamethonium, pancuronium, atracurium, vecuronium). These medicines help relax muscles. The anaesthesiologist may adjust the dosage.
• Opioids (such as fentanyl, morphine, remifentanil). These are potent analgesics frequently used during general anaesthesia.
• Benzodiazepines (such as midazolam, diazepam, nitrazepam). These are sedatives used to calm an agitated patient before surgery.
• Nitrous oxide (laughing gas). This medicine may be used during general anaesthesia to induce sleep and relieve pain.

Taking Desflurane Piramal with food and drink

Desflurane Piramal is a medicine used to induce and maintain sleep so you can undergo surgery. You should ask your doctor, surgeon, or anaesthesiologist when and what you may eat or drink before anaesthesia and after waking up.

Pregnancy and breastfeeding

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

There are insufficient data on the use of desflurane in pregnant or breastfeeding women; therefore, the use of desflurane is not recommended during pregnancy and breastfeeding. Thus, desflurane should only be used in pregnant or breastfeeding women when considered absolutely necessary. Breastfeeding should be avoided for approximately 24 hours after desflurane anaesthesia.

Driving and using machines

Desflurane Piramal may affect alertness and response capability for some time after receiving the medicine. Therefore, do not drive or operate machinery for 24 hours after surgery.

3. How to use Desflurane Piramal

Desflurane Piramal must be used under cardiorespiratory supervision and in the presence of an anesthesiologist, with technical equipment available to provide anesthesia and resuscitation. Desflurane Piramal will always be administered by an anesthesiologist. The anesthesiologist will determine the dose you will receive, based on your age, body weight, and the type of surgery you are undergoing. During anesthesia, the anesthesiologist will monitor your blood pressure and heart rate. If necessary, the anesthesiologist will adjust your dose.

In most cases, Desflurane Piramal is administered through a tube inserted into your airway after you have received an injection of another anesthetic agent to induce unconsciousness. Only in rare cases might you be asked to inhale the vapors of Desflurane Piramal through a mask to induce anesthesia.

Desflurane Piramal is a liquid for inhalation vapor administered using a vaporizer specifically calibrated for this product, allowing precise control of the administered concentration.

Waking up after anesthesia

After surgery, the anesthesiologist will stop administering Desflurane Piramal. You will wake up within a few minutes.

If you use more Desflurane Piramal than you should

If you receive more Desflurane Piramal than you should, administration will be stopped immediately. 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and the amount ingested.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Most side effects are mild to moderate in intensity and short-lived. However, some side effects can also be serious.

Serious adverse effects (Frequency not known) such as:

• Rupture of muscle fibres (rhabdomyolysis),
• Irregular heartbeat or abnormal heart rhythm (arrhythmia) in children,
• Rapid and significant increase in body temperature during surgery (malignant hyperthermia). Signs of illness include: Excess carbon dioxide in the blood (hypercapnia), muscle rigidity (rigidity), increased heart rate (tachycardia), increased breathing rate (tachypnea), bluish discoloration of the skin (cyanosis), irregular heartbeat or abnormal heart rhythm (arrhythmia), high or low blood pressure, and fever.

Most of these serious side effects may occur while under anaesthesia and under the care of healthcare professionals.

Desflurane Piramal may cause a slight increase in blood sugar levels during anaesthesia.

Possible adverse effects include:

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

• Nausea
• Vomiting

These occur during induction and maintenance of anaesthesia with Desflurane Piramal.

Common (may affect up to 1 in 10 patients)

• Inflammation of the back of the throat (pharyngitis)
• Temporary cessation of breathing. This has occurred during induction and maintenance of anaesthesia with Desflurane Piramal.
• Headache
• Inflammation of the outer layer of the eye and inner surface of the eyelids (conjunctivitis)
• Irregular heartbeat or abnormal heart rhythm
• Slower heartbeat (bradycardia)
• Faster heartbeat (tachycardia)
• High blood pressure (hypertension)
• Temporary interruption of breathing (apnea), cough, and excessive production of saliva (hypersalivation). These have occurred during induction and maintenance of anaesthesia with Desflurane Piramal.
• Sudden spasm of the vocal cords affecting breathing and speech (laryngospasm)
• Increased blood levels of an enzyme called creatine phosphokinase
• Abnormal heartbeat reading (abnormal ECG)
• Abnormal heart rhythm (prolongation of QTc interval (abnormal ECG))

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

• Agitation
• Dizziness
• Heart attack (myocardial infarction)
• Reduced blood flow to the heart muscle (myocardial ischaemia)
• Irregular heartbeat (arrhythmia)
• Enlargement of blood vessels (vasodilation)
• Reduced oxygen supply (hypoxia). This has occurred during induction and maintenance of anaesthesia with Desflurane Piramal.
• Muscle pain (myalgia)

Frequency not known (cannot be estimated from available data)

• Blood clotting disorder (coagulopathy)
• High or low levels of potassium in the blood (hyperkalaemia/hypokalaemia)
• Excess acid in body fluids (metabolic acidosis)
• Seizure (convulsions)
• Yellowing of the eyeball (ocular jaundice)
• Heart failure (when the heart has difficulty beating) or cardiac arrest (when the heart stops beating)
• Serious disturbances in heart rhythm with fast and irregular pulse (torsade de pointes)
• Ventricular failure (when two heart chambers function poorly or stop functioning)
• Reduced heart muscle contraction (ventricular hypokinesia)
• Irregular heartbeat (atrial fibrillation)
• Very high blood pressure (malignant hypertension)
• Bleeding (haemorrhage)
• Low blood pressure (hypotension)
• When body tissues do not receive enough blood (shock)
• Breathing difficulty (respiratory failure) or cessation of breathing (respiratory arrest)
• Sudden narrowing of the muscles in the airways (bronchospasm)
• Coughing up blood from the lungs (haemoptysis)
• Sudden inflammation of the pancreas (acute pancreatitis)
• Stomach pain (abdominal pain)
• Death of liver tissue (hepatic necrosis)
• Inflammation of the liver (cytolytic hepatitis)
• Blockage of bile flow from the liver (cholestasis)
• Yellowing of the skin or eyeball (jaundice)
• Changes in liver function or liver disease
• Hives (urticaria)
• Redness of the skin (erythema)
• Feeling of weakness (asthenia)
• General malaise
• Changes in the recording of heart activity (ST-T segment measurement abnormalities or T-wave inversion on ECG)
• Increased liver enzymes (elevated levels of alanine or aspartate aminotransferase)
• Blood clotting disorder (abnormal coagulation values)
• High levels of ammonia
• Elevated bilirubin levels
• Liver failure
• Sensation of spinning and loss of balance (vertigo)
• Palpitations
• Burning sensation in the eyes
• Temporary blindness
• Brain disease (encephalopathy)
• Inflammation or infection of part of the eye (ulcerative keratitis)
• Bloodshot eyes (ocular hyperaemia)
• Reduced visual acuity and clarity
• Eye irritation
• Eye pain
• Fatigue
• Burning sensation on the skin
• Postoperative agitation

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es.

By reporting adverse effects, you can help provide 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 Desflurane Piramal. Some side effects may require treatment.

5. Storage of Desflurane Piramal

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

Do not use this medicine after the expiry date stated on the label after "EXP". The expiry date is the last day of the month indicated.

Store below 30 °C.

Store the bottle in an upright position with the cap securely closed.

6. Contents of the pack and other information

Composition of Desflurane Piramal

• The active substance is desflurane 100 % (v/v).
• It contains no other components.

This medicine contains fluorinated greenhouse gases.

Each container contains 360 g of desflurane, equivalent to 0.9324 tonnes of CO2 (global warming potential GWP = 2950).

Appearance of Desflurane Piramal and contents of the pack

Desflurane Piramal is a liquid for inhalation of vapour.

Desflurane Piramal is a clear, colourless liquid.

Amber glass bottle of type III, with PVC coating on the outside of the bottle, closure made of HDPE/EPDM (ethylene propylene diene monomer), and aluminium seal.

Pack sizes of 1 and 6 bottles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Piramal Critical Care B.V.,

Rouboslaan 32, 2252 TR,

Voorschoten,

Netherlands

Or

(Manufacturer for the United Kingdom only)

Piramal Critical Care Limited

Suite 4, Ground Floor,

Heathrow Boulevard - East Wing,

280 Bath Road, West Drayton,

UB7 0DQ,

United Kingdom.

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Euromed Pharma Spain, S.L

C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Tel: +34 932 684 208

Fax: +34 933 150 469

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 03/2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/