Suprane

SUPRANE is a breathed in (inhalation) anaesthetic used to induce and maintain a deep, pain - free sleep (general anaesthesia) in adults during operations. SUPRANE is also used for maintenance of anaesthesia in intubated infants and children, but is not recommended for induction purposes.

SUPRANE should not be administered to you:

• If you are hypersensitive (allergic) to desflurane or to any other inhaled anaesthetic.
• If you or any member of your family has experienced a condition called malignant hyperthermia (rapid rise in body temperature) during an operation.
• If you have previously developed hepatitis (inflammation of the liver) or developed an unexplained moderate to severe liver dysfunction (e.g. jaundice (yellow colouring of the skin and eyes as a result of liver disease) associated with fever and/or eosinophilia (increased eosinophil count in the blood)) after receiving an inhalation anaesthetic.
• SUPRANE should not be used as an induction agent in paediatric patients, because of the frequent occurrence of cough, breath holding, apnoea (breathing difficulty), laryngospasm (uncontrolled contraction of the laryngeal cords in the throat) and increased secretions.

Warnings and precautions

Take special care with SUPRANE: Tell your doctor, surgeon or anaesthetist if you have previously been anaesthetised, especially if it was recently. SUPRANE may increase your chances of having liver problems.

• Tell your doctor, surgeon or anaesthetist if you are suffering from any illness, other than those connected with your operation, such as:
• liver, kidney, brain, blood pressure and heart problems;
• coronary artery disease (narrowing of arteries);
• severe headaches;
• nausea;
• vomiting;
• asthma or a recent upper airway infection (particularly in children); or
• a neuromuscular disease (a condition that affects muscles e.g. Duchenne muscular dystrophy);
• an alteration of the electrical activity of your heart (QT prolongation).

Tell your doctor, surgeon or anaesthetist if you are pregnant, as SUPRANE should not be used in obstetric procedures (surgery relating to the pregnancy or childbirth).

Other medicines and SUPRANE

Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor or anaesthetist if you are taking:

• Beta blockers (a group of medicines used to control the heart rhythm or treat high blood pressure); and/or
• Monoamine Oxidase Inhibitors (a group of medicines used to treat depression and other psychiatric disorders).

SUPRANE with food and drink

SUPRANE is a medicine to make and keep you asleep so you can undergo surgery. You should ask your doctor, surgeon or anaesthetist when and what you can eat or drink after you wake up.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor or anaesthetist for advice before receiving this medicine. Safety of SUPRANE in pregnancy and breastfeeding has not been established. SUPRANE is a uterine-relaxant and reduces the uterine-placental blood-flow and is not recommended for obstetric operations.

Driving and using machines

SUPRANE will affect your ability to drive and operate machinery and as such, you must avoid such tasks for a period of at least 24 hours after recovering from SUPRANE anaesthesia. No alcohol should be taken for 24 hours and no legal decisions should be made for 24 hours.

You will not be expected to give yourself SUPRANE. It will be given to you by a person qualified to do so. The dose of SUPRANE that you receive will be decided by your anaesthetist and will vary depending on your age, weight, health, response and type of operation that you will be having. SUPRANE is a breathed in (inhalation) anaesthetic gas. SUPRANE liquid is changed to gas in a vaporizer. Occasionally, patients may be asked to breathe in the SUPRANE gas via a mask, but usually they will receive an injection of another anaesthetic to make them go to sleep, before they receive SUPRANE.

If you receive more SUPRANE than you should Since a healthcare professional will administer this medicine, he/she will control the dosage. However, in the event of overdosage, your doctor will manage the overdosage.

SUPRANE can have side effects. Not all side effects reported for SUPRANE are included in this leaflet. Should your general health worsen or if you experience any untoward effects after receiving SUPRANE, please consult your doctor, pharmacist or other healthcare professional for advice.

The following serious side effects may occur after receiving SUPRANE:

• Malignant hyperthermia. This is when you suddenly develop a dangerously high body temperature during or shortly after surgery. The symptoms of malignant hyperthermia include:
• too much carbon dioxide in the blood (hypercapnia)
• muscle stiffness (rigidity)
• increased heart rate (tachycardia)
• increased breathing rate (tachypnoea)
• blue coloured skin (cyanosis)
• irregular heartbeats (arrhythmias)
• increases or decreases in blood pressure
• fever
• Allergic reaction. The symptoms of allergic reaction include:
• rash
• swelling of the face
• wheezing

These are all serious side effects. You may need urgent medical attention.

Frequent side effects are:

• Breath holding
• Breathing difficulty (apnoea)
• Uncontrolled contraction of the laryngeal cords in the throat (laryngospasm)
• Cough
• Nausea and vomiting
• Watering mouth (salivary hypersecretion)
• Inflammation of the back of the throat (pharyngitis)
• Headache
• Conjunctivitis (pink eye)
• Slow heart beat (bradycardia)
• Fast heart rate (tachycardia)
• High blood pressure (hypertension)
• A heart rhythm condition originating from the atrioventricular node (specialised heart muscle fibres) (nodal dysrrhythmia)
• Increase in creatinine phosphokinase values (an enzyme found in the body)
• Abnormal ECG (electrocardiogram) (a measurement of the electrical activity of the heart)

Less frequent side effects are:

• An oxygen shortage in the body (hypoxia)
• Feeling irritable (agitation)
• Dizziness
• Heart rhythm conditions (dysrrhythmias)
• Heart attack (myocardial infarction)
• Decreased blood flow to the heart muscle (myocardial ischemia)
• Vasodilation (widening of blood vessels)
• Muscle pain (myalgia)

The frequency of the following side effects are unknown:

• Blood clotting or bleeding disorder (coagulopathy)
• High or low blood potassium levels (hyperkalaemia or hypokalaemia respectively)
• Metabolic acidosis (when the body is producing too much acid or the kidneys are not removing enough acid from the body)
• Convulsions (fits)
• Yellowing of the eyes (ocular icterus)
• Heart failure or cardiac arrest (a condition where the heart stops beating)
• Torsade de pointes (a type of abnormal heart rhythm)
• Ventricular hypokinesia (decreased contraction ventricle region of the heart)
• Irregular and often abnormally fast heart rate (atrial fibrillation)
• Rapid rise in blood pressure (malignant hypertension)
• Bleeding (haemorrhage)
• Low blood pressure (hypotension)
• Shock
• Inability to breathe (respiratory failure or respiratory arrest)
• Difficulty to breathe
• Bronchospasm (a spasm of the muscles in the lungs)
• Coughing up blood (haemoptysis)
• Sudden inflammation of the pancreas (acute pancreatitis)
• Stomach pain
• Liver (hepatic) failure or hepatic necrosis (death of liver cells)
• Hepatitis (inflammation of the liver)
• A decrease in the flow of bile (cholestasis)
• Jaundice (yellow colouring of the skin and eyes as a result of liver disease)
• Abnormal liver function
• Liver disorder
• A skin rash with raised, itchy lumps (urticaria)
• Reddening (erythema) or burning sensation of the skin
• The breakdown of muscle tissue and the release of the muscle fibre contents into the blood (rhabdomyolysis)
• Rapid rise in body temperature (malignant hyperthermia)
• General feeling of discomfort (malaise)
• ECG (electrocardiogram) (a measurement of the electrical activity of the heart) changes
• Increases of various enzymes in the blood, including transaminase, alanine aminotransferase, aspartate aminotransferase
• Increased bilirubin (the break down product of red blood cells) and ammonia in the blood
• Abnormal coagulation (blood clotting) test results
• Feeling irritable (agitation), tired (fatigue) or weak (asthenia)
• Dizziness
• Migraine
• Irregular heart beat
• Burning, red, irritated or painful eyes
• Blindness which comes and goes
• Reduced vision
• Ulceration of the eye
• Encephalopathy (a condition affecting the function of the brain)
• Accidental exposure or medicine administration error

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SUPRANE.

Store all medicines out of reach of children. Store at or below 30 °C. Store in an upright position. To avoid leakage apply bottle cap firmly to valve. Keep in original container until immediately prior to use.