Please read this leaflet carefully before you receive Sevoflurane. It gives a summary of the information available on Sevoflurane. If you have any questions or are not sure about anything, ask your ward doctor, surgeon or anaesthetist.
What’s in Sevoflurane?
Sevoflurane is a clear colourless liquid. Water is present at a sufficient concentration to provide protection from environmental Lewis acids (substances that can cause the breakdown of Sevoflorane). When it is put into a special anaesthetic machine (vaporiser)
it becomes a gas that mixes with the oxygen you will be breathing.
Sevoflurane comes in brown bottles of 250ml, and can only be given to you by a qualified anaesthetist.
Marketing Authorisation Holder and Manufacturer:
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Berkshire
Manufacturer
What is Sevoflurane used for?
Sevoflurane is a breathed in (inhalation) anaesthetic, used to induce and maintain a deep, pain-free sleep (general anaesthesia) in adults and children during an operation.
Before receiving Sevoflurane
Tell your doctor, surgeon or anaesthetist if you have been told that you are sensitive or have an allergy to Sevoflurane or any other anaesthetic, or if you know you or any member of your family has experienced a condition called malignant hyperthermia (rapid rise in body temperature) during an operation.
Under certain clinical circumstances, Sevoflurane forms low levels of by-products. One of these has been shown to cause some harm to the kidneys of some rats when given in high doses, but this has not been found in man during clinical trials.
Tell your ward doctor, surgeon or anaesthetist if you have previously had general anaesthetics, particularly if repeated over a short period of time. Some anaesthetics can occasionally cause problems in the liver which can cause yellowing of the skin (jaundice).
Tell your ward doctor, surgeon or anaesthetist if you are suffering from any illness, other than those connected with your operation, such as any kidney, brain or heart problems, severe headaches, nausea, vomiting, or a neuromuscular disease (a condition that affects
muscles e.g Duchenne muscular dystrophy).
As with all drugs, it is important that you tell your ward doctor or anaesthetist which medications you are taking and if you are pregnant, could be pregnant or if you are breast feeding.
Your ability to drive or to operate machinery may be impaired for some time after the procedure for which you have received Sevoflurane. You should not drive until your doctor advises that you may do so.
Receiving Sevoflurane
The dose of Sevoflurane that you receive will be decided by your anaesthetist and will vary depending on your age, weight and the type of operation that you are having.
Sevoflurane is a breathed in (inhalation) anaesthetic gas. Sevoflurane liquid is changed to gas in a vaporiser. Occasionally patients may be asked to breathe in the Sevoflurane gas via a mask but usually they will receive an injection of another anaesthetic to make them go to sleep before they receive Sevoflurane. Sevoflurane has a pleasant smell and you will go to sleep very rapidly and smoothly.
What problems can Sevoflurane cause?
Like all medicines, Sevoflurane can cause side effects, although not everybody gets them. It is however, important to consult your ward doctor or anaesthetist if you are feeling unwell.
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 common side effects of Sevoflurane include;
restlessness (Agitation)
slow heart rate (Bradycardia)
low blood pressure (Hypotension)
coughing
nausea and vomiting
Common side effects of sevoflurane include;
drowsiness (somnolence)
dizziness
headache
fast heart rate (tachycardia)
increased blood pressure (hypertension)
slow shallow breathing (respiratory depression), wheezing or breathlessness
throat spasm
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 **
* If you have a blood or urine test, you may be told that you have raised liver enzymes, raised creatinine or raised levels of white blood cells. 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.
Other occasional side-effects seen in clinical trials were: palpitations or irregular heart beat, wheezing and breathlessness, confusion, difficulty in passing water. Malignant hyperthermia, kidney failure, allergic reactions, such as contact dermatitis, rash, shortness of breath, wheezing, chest discomfort, swelling face and itching of the skin, and very severe allergic reactions (anaphylaxis) have been reported very rarely.
Liver problems have been reported rarely. Repeated exposure to Sevoflurane within a short space of time may increase the risk of damage to the liver. Accumulation of fluid in the lungs may occur extremely rarely. Convulsions, particularly in children, may also occur extremely rarely. Twitching and jerking movements, may also occur, in children, but these are short term with no long term harmful effects. Isolated cases of increased heart rate have been reported in children with Pompe's disease.
Other side effects which may occur while you are under the anaesthetic will be managed by your doctor, as necessary.
After receiving Sevoflurane.
You will come round or wake up within a few minutes. Children in particular, may be restless on awakening. Tell your doctor or anaesthetist if you need additional pain relief.
If you have any other unusual or unexpected symptoms after receiving Sevoflurane anaesthesia, tell your ward doctor or anaesthetist immediately.
If you have any questions about Sevoflurane which are not answered by this leaflet, ask your ward doctor or anaesthetist.
How should Sevoflurane be stored ?
Do not store above 25°C. The product should be stored in a tightly closed container and should not be refrigerated.
Product will not be used after the expiry date shown on the product label.
This leaflet applies only to Sevoflurane and was prepared in January 2010.
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