SEVOFLURANE ^®

IMPORTANT INFORMATION

Sevoflurane belongs to a group of medicines called general anaesthetics. These work by temporarily reducing the activity of the body’s central nervous system. This causes a complete loss of sensation in the body, including loss of consciousness allowing surgery to be carried out without pain or distress.

Sevoflurane is a clear colourless liquid, that when put into a special anaesthetic machine (vaporiser) becomes a gas. This mixes with the oxygen you will be breathing in.

Once breathed in (inhaled), Sevoflurane will induce and maintain a deep, pain-free sleep (general anaesthesia) in adults and children.

Sevoflurane will ALWAYS be administered to you by an anaesthetist. They will decide on the dose you will receive, depending on your age, weight and the type of operation you are having.

Sevoflurane will send you to sleep quickly and smoothly. It also has a pleasant smell.

As with all anaesthetics, Sevoflurane can cause side effects.

These can occur both during and after your operation.

The frequency of side effects is classified as follows:

Very common: more than 1 out of 10 persons treated;

Common: less than 1 out of 10, but more than 1 out of 100 persons treated;

Uncommon: less than 1 out of 100, but more than 1 out of 1,000 persons treated;

Rare: less than 1 out of 1,000, but more than 1 out of 10,000 persons treated.

Very rare: less than 1 out of 10,000 persons treated.

Unknown: when an estimation of frequency is not possible.

The following side effects with Sevoflurane are serious and will be managed by your surgeon or anaesthetist, as necessary, during the operation. If you experience any of these side effects after your operation get medical help immediately.

Those occurring with unknown frequency:

• Allergic reactions with symptoms such as rash, swelling of the face, wheezing
• Rapid rise in body temperature (malignant hyperthermia)
• Wheezing and breathlessness

Those occurring very commonly:

• Slow heart rate (bradycardia)

Those occurring commonly

• Throat spasm

Those occurring uncommonly

• Heart disorders (AV block), which will be closely monitored by your anaesthetist during your operation and may be recognized by dizziness after your operation

The frequency of other side effects observed following the use of Sevoflurane are:

Very common frequency:

• agitation
• decreased blood pressure (hypotension)
• cough
• nausea
• vomiting

Common frequency:

• drowsiness (somnolence)
• dizziness
• increased blood pressure (hypertension)
• headache
• fast heart rate (tachycardia)
• slow shallow breathing (respiratory depression)
• watering mouth (salivary hypersecretion)
• chills
• fever (pyrexia)
• low body temperature (hypothermia)
• abnormal sugar (glucose) level
• abnormal liver function test*
• white blood cell count abnormal
• blood fluoride increased **
• delirium

Uncommon frequency:

• a decrease or increase in the number of certain white blood cells. A decrease in the number of white blood cells may be associated with dizziness, fatigue, weakness, mouth ulcers and a tendency towards infections.
• confusion
• abnormal heart rhythm
• pauses in breathing
• inadequate amount of oxygen
• asthma
• difficulty in passing urine
• glucose in the urine***
• abnormal kidney function test*

Unknown frequency:

• convulsions (fits), particularly in children
• twitching and jerking movements
• fluid in the lungs
• inflammation or damage to the liver. People with liver disease may have abdominal pain or fullness, dark urine, pale or white-coloured stool, fatigue, general itching, yellowing of the eyes, nausea and vomiting
• kidney failure. People with kidney disease may have tiredness, swelling or puffiness in the face, abdomen, thighs or ankles, passing less urine or problems urinating and back pain
• skin rashes
• heart arrhythmia (irregular heartbeat or abnormal heart rhythm) known as QT prolongation

*If you have a blood test, you may be told that you have changes in your liver or kidney enzymes or other products found in the blood. These will not normally cause any symptoms.

**Levels of fluoride in the blood may be raised slightly during and immediately after anaesthesia, due to the body breaking down sevoflurane, but these levels are not believed to be harmful and soon return to normal.

*** If you have a urine test you may be told that you have glucose in your urine. You may not have any symptoms.

There have been very rare reports of cardiac arrest, a condition where the heart stops beating.

After surgery, some children may have irregular heart rhythms, which can potentially be life-threatening, due to changes in blood potassium levels.

Children with Pompe’s disease, a disease that they are born with, may have irregular heart rhythm during anaesthesia with Sevoflurane.

Sevoflurane should be stored in a tightly closed container NOT above 25°C. Do NOT use after the expiry date printed on the packaging.