Sevoflurane Baxter 100 %

SEVOFLURANE BAXTER contains sevoflurane. Sevoflurane is a general anaesthetic used in surgery in adults and children. It is an inhalation anaesthetic given to you as a vapour for you to breathe in. Breathing in sevoflurane vapour causes you to fall into a deep, painless sleep. It also maintains a deep, painless sleep (general anaesthesia) during which you can undergo surgery.

SEVOFLURANE BAXTER should be administered only by health care professionals appropriately trained in the administration of general anaesthesia under the supervision of or by an anaesthetist.

SEVOFLURANE BAXTER should not be administered to you:

• If you are allergic (hypersensitive) to sevoflurane or other inhalation anaesthetics.
• If you have a history of confirmed inflamed liver (hepatitis) due to sevoflurane or other inhalation anaesthetics or you have a history of unexplained liver problems with jaundice, fever, and an increased number of a certain type of white blood cells.
• If you have a known or suspected susceptibility to malignant hyperthermia (a sudden and dangerously high increase in body temperature during or shortly after surgery).
• If you have a neuromuscular disease e.g. Duchenne muscular dystrophy.
• If there are medical reasons why you should not be given a general anaesthetic.

If any of the above applies, please inform your doctor or anaesthetist before you are given this medicine.

Warnings and precautions

Tell your doctor or health care provider before being given SEVOFLURANE BAXTER:

• If you have previously been given an inhalation anaesthetic, particularly if this was more than once and fairly recently (repeated use).
• If you have low blood pressure.
• If you are hypovolemic (reduced blood volume) or are weak.
• If you have impaired kidney function.
• If you are pregnant or breastfeeding or when this medicine is given for obstetrical anaesthesia (delivery of a baby) (see also section entitled “Pregnancy and breastfeeding”).
• If you have a coronary artery disease (narrowed or blocked arteries).
• If you have ever had QT prolongation (prolongation of a specific time interval in an ECG) or torsade de pointes (a specific type of heart rhythm), which may also be associated with QT prolongation, or are at risk of getting these heart conditions.
• If you have a risk of increased pressure within the brain.
• If you have or previously had liver problems, e.g. hepatitis (inflamed liver) or jaundice.
• If you are being treated with a medicine that may cause liver problems.
• If you have had or are at risk of having seizures (fits).
• If you have a disorder of the cells (a condition called mitochondrial disorder).

In the rare and unforeseen instance that you may develop malignant hyperthermia (a sudden and dangerously high increase in body temperature during or shortly after surgery), your doctor (anaesthetist) will stop the administration of SEVOFLURANE BAXTER and will treat the condition, together with the provision of supportive therapy. There have been reports of deaths as a result of malignant hyperthermia, following sevoflurane administration.

Interference with daily activities may continue for up to 24 hours after having been given SEVOFLURANE BAXTER. You should not make any legal or contractual decisions within at least 24 hours after receiving SEVOFLURANE BAXTER. Alcohol should also be avoided for the same time period. You may experience small changes in mood for several days after receiving anaesthesia.

Children and adolescents

In addition to the warnings and precautions above, if SEVOFLURANE BAXTER is to be given to your child, tell their doctor (anaesthetist), nurse or surgeon if they:

• Have Down syndrome (a condition in which the child has an extra chromosome, which may result in growth delays and intellectual disability).
• Have Pompe’s disease (a rare metabolic disorder, which results in the accumulation of glycogen in the body).

If any of the above apply to you or your child, check with your doctor, anaesthetist or health care provider. You or your child may need to be checked carefully and treatment may be changed. After your child has woken up from the anaesthesia they may be agitated, experience involuntary muscle movements or cramping. This should resolve without treatment.

Other medicines and SEVOFLURANE BAXTER

Always tell your health care provider if you are taking any other medicine (this includes complementary or traditional medicines). The medicines or active substances included in the medicines listed below, may influence each other’s effect when used together with SEVOFLURANE BAXTER. Some of these medicines are given to you during your surgery by your anaesthetist, as indicated in the description.

You will not be expected to give yourself SEVOFLURANE BAXTER. It will be given to you by a person who is qualified to do so. SEVOFLURANE BAXTER will be given to you by an anaesthetist. The anaesthetist will decide on how much you need and when it is to be given. The dose will vary according to your age, weight, the type of surgery you need, and other medicines given to you during surgery.

SEVOFLURANE BAXTER is produced from liquid sevoflurane in a vaporiser, specifically designed for use with sevoflurane. You may be asked to breathe the sevoflurane vapour through a mask to make you fall asleep. You may also be given an injection of another anaesthetic to make you sleep before being given SEVOFLURANE BAXTER through a mask or a tube in your throat.

Your anaesthetist will decide when to stop giving you SEVOFLURANE BAXTER. You will then wake up a few minutes after administration is stopped.

If you are given more SEVOFLURANE BAXTER than you should Since a health care provider will administer SEVOFLURANE BAXTER, he / she will control the dosage. However, in the event of overdosage your doctor or anaesthetist will manage the overdosage.

SEVOFLURANE BAXTER can have side effects. Not all side effects reported for SEVOFLURANE BAXTER are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving SEVOFLURANE BAXTER, please consult your health care provider for advice. Most side effects are mild to moderate in their severity and are brief, but there may be some serious side effects.

If any of the following happens after being given SEVOFLURANE BAXTER, tell your doctor or anaesthetist immediately, or if you have left the hospital following your operation, go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting
• yellowing of the skin and eyes, also called jaundice

These are all very serious side effects. If you have them, you may have had a serious reaction to SEVOFLURANE BAXTER. You may need urgent medical attention or hospitalisation if you are no longer in the hospital.

The following side effects have been observed frequently:

• Agitation (being restless, irritated and disturbed)
• Dizziness
• Drowsiness or feeling very sleepy
• Headache
• Slow (bradycardia) or fast (tachycardia) heart rate
• High or low blood pressure
• Cough
• Breathing disorder;

The following side effects have been observed less frequently:

• Lower levels of white blood cells in the blood (seen in a blood test), which can increase your risk for infections
• Higher levels of white blood cells in the blood (seen in a blood test)
• Feeling confused
• Atrioventricular block of the heart (a disorder of the electrical conduction of the heart) – you may experience dizziness, fainting, tiredness and shortness of breath
• Heart thumping or irregular heart beat
• Apnoea (when you stop breathing)
• Asthma
• Hypoxia (a low level of oxygen in the blood) – you may experience headache, shortness of breath and fast heartbeat
• Problems with urination
• Extreme hunger, thirst and frequent urination
• Increased blood creatinine levels (an indicator of poor kidney function), as detected by a blood sample test
• Increased levels of alanine transaminase (ALT) in the blood (seen in a blood test)
• Increased levels of lactate dehydrogenase (LDH) in the blood (seen in a blood test)

The following side effects have been observed with unknown frequency (frequency cannot be estimated from the available data)

• Increases in blood potassium levels as detected by a blood sample test
• Seizures (fits)
• Sudden twitching of muscles without being able to control them
• A rise in the pressure inside the skull (increased intracranial pressure)
• Cardiac arrest (the heart stops beating)
• Irregular heart beat or palpitations (strong irregular heartbeat, feeling like your heart is beating too fast or skipping a beat)
• QT prolongation (prolongation of a specific time interval in an ECG, which measures the electrical activity of the heart), seen in an ECG test
• Cramping of the airways
• Difficulty in breathing
• Wheezing
• Breath holding
• Excess fluid in the lungs, which makes it difficult to breathe
• Inflammation of the pancreas (symptoms may include upper stomach pain, which moves round to the back, stomach pain that feels worse after you have eaten, tenderness if you touch the stomach, fever, nausea and vomiting)
• Reduced liver function or hepatitis (inflamed liver), characterised by e.g. loss of appetite, fever, nausea, vomiting, abdominal discomfort, jaundice and dark urine
• Muscle stiffness
• Inflammation of the kidneys (symptoms may include fever, confusion or sleepiness, rash, swelling, more or less urine than normal, and blood in the urine)
• Dangerously raised body temperature

Sometimes seizures (fits) are seen. These can occur when receiving SEVOFLURANE BAXTER, or up to a day later during recovery. They occur mostly in children and young adults. In children with Down Syndrome who are given SEVOFLURANE BAXTER, a slowing of the heart rate can occur. Levels of fluoride in the blood may be raised slightly during and immediately after anaesthesia, but these levels are not thought to be harmful and soon return to normal. If you notice any change in the way you feel after receiving SEVOFLURANE BAXTER, please inform your doctor or pharmacist. Some side effects may need treatment. If you notice any side effects not mentioned in this leaflet, please inform your doctor, anaesthetist or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, anaesthetist, 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 SEVOFLURANE BAXTER.

Store at or below 30 °C. Do not use SEVOFLURANE BAXTER after the expiry date that is printed on the label. Store all medicines out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).