Desflurane 100%V/V Inhalation Vapour Liquid
L
15 9*
PACKAGE LEAFLET: INFORMATION FOR THE USER
Desflurane 100% v/v Inhalation vapour, liquid
Active substance: desflurane
Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Desflurane is and what it is used for
2. Before you are given Desflurane
3. How you will be given Desflurane
4. Possible side effects
5. How to store Desflurane
6. Further information
1. What Desflurane is and what it is used for
Desflurane is a general anaesthetic used in surgery. It is an inhalation anaesthetic (it is given to you as a vapour for you to breathe in). Breathing in desflurane 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. In adults, desflurane is used for induction and maintenance of anaesthesia. In infants and children it is used for maintenance of anaesthesia only.
2. Before you are given Desflurane
Do NOT have Desflurane if:
• you are allergic (hypersensitive) to desflurane or other inhalation anaesthetics such as isoflurane, sevoflurane, halothane and enflurane
• there are medical reasons why you should not be given a general anaesthetic
• you, or any relative suffer from a condition called malignant hyperthermia. Malignant hyperthermia is when you suddenly develop a dangerously high body temperature during or shortly after surgery in which you have received an anaesthetic by inhalation.
You must not be given Desflurane to bring on
(induce) your anaesthesia if:
• you are at risk of coronary artery disease. Coronary artery disease is when the blood vessels to your heart muscle do not deliver enough blood and oxygen.
• your doctor considers that the likely side effects of Desflurane are undesirable, like:
- an increase in your heart rate
- an increase in your blood pressure
If any of the above applies to you, please inform
your doctor, surgeon or anaesthetist before you are
treated with this medicine.
Your doctor will take special care when giving you Desflurane if:
• you have a brain tumour
• following anaesthesia with desflurane in the past, you have had unexplained liver problems with:
- jaundice (yellowing of the skin and white of the eyeballs)
- fever
- dead liver tissue (necrosis). This has been fatal in some cases.
• you have high blood sugar (diabetes). Desflurane may increase your blood glucose levels during anaesthesia.
Your doctor may need to give you less Desflurane if:
• you have a low blood volume (hypovolaemia)
• you have low blood pressure (hypotension)
• you are weakened (debilitated).
Your doctor may decide not to use Desflurane if you have:
• cirrhosis (alcoholic liver disease)
• viral hepatitis (a liver disease caused by a virus)
• other types of liver disease
In this case your doctor may use a different type of anaesthetic.
Your doctor should take particular care if you have previously been given an inhalation anaesthetic, particularly if this was more than once over a short period of time (repeated use).
You should tell your doctor, surgeon or anaesthetist if you have had a general anaesthetic recently.
Pain after your operation
You will recover from anaesthesia with Desflurane quickly. If you are expected to have pain after your operation, your doctor will give you painkilling medicines. He may do this at the end of your operation or when you are recovering after your operation.
Desflurane can cause malignant hyperthermia (when you suddenly develop a dangerously high body temperature during or shortly after surgery).
Your doctor will make sure that the blood supply to your heart muscle is not affected during treatment.
Special information for the treatment of children
• Very rarely Desflurane can cause problems with heart rhythm in children. This can result in death in the period immediately after the operation. These problems are seen in children that suffer from a disease of the nerves and muscles (neuromuscular disease), particularly a disease called ‘Duchenne muscular dystrophy'. In most, but not all of these cases a muscle relaxant named suxamethonium was given at the same time.
• Children under 12 years old should not be given Desflurane to bring on (induce) anaesthesia. This is because using Desflurane in this way can cause more unwanted side effects such as:
- coughing
- holding one's breath
- stopping breathing (apnoea)
- a muscle spasm of the vocal chords (voice box) called a laryngospasm
- increased secretions in the airways.
• Children under 6 years old should not be given Desflurane to maintain anaesthesia unless they have been intubated. Intubation is when a tube is placed into the airways to help breathing.
If any of the above apply to you or your child check with your doctor, nurse or pharmacist. You may need to be checked carefully and your treatment may be changed.
Using other medicines:
Please inform your doctor, pharmacist, surgeon or anaesthetist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This also applies to herbal medicinal products, vitamins and minerals.
The medicines or active substances contained in the medicines listed below may influence each other's effect when used together with Desflurane. Some of these medicines are given to you during your surgery by your anaesthetist, as indicated in the description.
• muscle relaxants (e.g. suxamethonium, pancuronium, atracurium, vecuronium): These medicines are used during general anaesthesia to relax your muscles.
Your anaesthetist may need to adjust the dose of these medicines.
• opioids (e.g. fentanyl, morphine, remifentanil): These medicines are strong pain killers and are often used during general anaesthesia.
You may also use these pain killers at other times and you should tell your doctor if this is the case.
• benzodiazepines (e.g. midazolam, diazepam, nitrazepam): These are sedative medicines, which have a calming effect. They are used when you feel nervous, for instance before your surgery, although you may also use these sedatives at other times. If you are taking any of these medicines your should tell your doctor before being given Desflurane.
• nitrous oxide: This is a medicine used during general anaesthesia that will cause you to sleep and will ease your pain.
Using Desflurane with food and drink
Desflurane 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 and breast-feeding
You should not be given Desflurane if you are pregnant or if you are breast-feeding.
Consult your doctor, surgeon or anaesthetist if you are pregnant, might be pregnant, or if you are breast-feeding.
Driving and using machines
Do not drive or operate tools or machines after your operation if you were given Desflurane. Receiving an anaesthetic may influence your alertness. This may affect your ability to carry out normal tasks. You should not drive or operate tools or machines for 24 hours after your operation.
3. How you will be given Desflurane
Desflurane 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 and the type of surgery you need. Your anaesthetist will check your blood pressure and heart rate during your anaesthesia. This will help him to adjust your dose when necessary.
Desflurane is produced from liquid desflurane in a vaporiser. You may receive Desflurane in one of two ways:
• you may be given an injection of another anaesthetic to make you sleep before being given Desflurane through a mask. This is the most common way that you may receive Desflurane.
or
• you may be asked to breathe the desflurane vapour through a mask to make you sleep. You will fall asleep quickly and very easily. This is a less common way to receive Desflurane.
After your surgery, your anaesthetist will stop giving you Desflurane. You will then wake up in a few minutes.
If you receive more Desflurane than you should
If you are given too much Desflurane the medicine will be stopped. You will be given pure oxygen.
Your blood pressure and heart function will be carefully checked while you recover.
4. Possible side effects
Like all medicines, Desflurane can have side effects.
Most side effects are mild to moderate in their severity and are brief, but there may be some serious side effects.
The following side effects may also occur during treatment. The evaluation of the side effects is based on the following frequencies:
Very common (affects more than 1 user in 10):
• Nausea (feeling sick) and vomiting (being sick). These have occurred during induction and maintenance of anaesthesia with Desflurane.
Common (affects 1 to 10 users in 100):
• Inflamed throat (pharyngitis)
• Breath holding. This has occurred during induction and maintenance of anaesthesia with Desflurane.
• Headache
• Inflammation of the lining of the eyelid (conjunctivitis)
• Irregular heart rhythm (nodal arrhythmia)
• Slow heartbeat (bradycardia)
• Rapid heartbeat (tachycardia)
• High blood pressure (hypertension)
• Stopping breathing (apnoea); Cough; producing more saliva than usual (salivary hypersecretion). These have occurred during induction and maintenance of anaesthesia with Desflurane.
• Muscle spasm of the vocal chords (voicebox) called a laryngospasm. This has occurred during induction of anaesthesia with Desflurane.
• Increased blood levels of an enzyme called creatinine phosphokinase
• Abnormal heart tracing (abnormal ECG).
Uncommon (affects 1 to 10 users in 1,000):
• Restlessness (agitation)
• Dizziness
• Heart attack (myocardial infarction)
• Lack of blood flow to the heart muscle (myocardial ischemia)
• Irregular heart rhythm (arrythmia)
• When your blood vessels widen (vasodilation)
• When your body is lacking an adequate oxygen supply (hypoxia). This has occurred during induction and maintenance of anaesthesia with Desflurane.
• Muscle pain (myalgia).
Unknown frequency (frequency cannot be
estimated from available data):
• Blood clotting disorder (coagulopathy)
• High blood levels of potassium (hyperkalemia)
• Low blood levels of potassium (hypokalemia)
• When your body produces too much acid (metabolic acidosis)
• Fits (convulsions)
• Yellowing of the eyeballs (ocular icterus)
• When the heart stops beating (cardiac arrest)
• A disorder of conduction of the heartbeat (torsade de pointes)
• When two of your heart's chambers stop working (ventricular failure)
• When two of your heart's chambers do not work so well (ventricular hypokinesia)
• Very high blood pressure (malignant hypertension)
• Bleeding (hemorrhage)
• Low blood pressure (hypotension)
• When your body tissues do not get enough blood (shock)
• Stopping breathing (respiratory arrest)
• When your breathing fails to provide enough oxygen for your body (respiratory failure/ respiratory distress)
• Sudden spasm of the airways (bronchospasm)
• Coughing up blood (hemoptysis)
• Sudden inflammation of the pancreas (acute pancreatitis)
• Pain in the abdomen (abdominal pain)
• Death of liver tissue (hepatic necrosis)
• Inflammation of the liver (cytolytic hepatitis)
• When the bile does not flow properly (cholestasis)
• Yellowing of the skin or the eyeballs (jaundice)
• Abnormal liver function (abnormal hepatic function)
• Liver disorder
• Hives (urticaria)
• Redness (erythema)
• A muscle disease (rhabdomyolysis)
• Malignant hyperthermia. This is when you suddenly develop a dangerously high body temperature during or shortly after surgery. Symptoms 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
• Weakness (asthenia)
• Feeling generally unwell (malaise)
• Changes to your heart tracing (electrocardiogram ST-T change)
• Changes to your heart tracing (electrocardiogram T wave inversion)
• Increases in liver enzymes (alanine aminotransferase increased; aspartate aminotransferase increased)
• Abnormal blood clotting (coagulation test abnormal)
• Levels of ammonia increased.
The following side effects have occurred after Desflurane was given accidentally to non-patients.
• Dizziness
• Severe headache (migraine)
• Irregular and rapid heart beat (tachyarrhythmia)
• When you feel your heartbeat (palpitations)
• Eye burns
• Temporary blindness (transient blindness)
• Brain disorder (encephalopathy)
• Ulcer of the white (cornea) of the eye (ulcerative keratitis)
• Bloodshot eyes (ocular hyperemia)
• Sight problems (visual acuity reduced)
• Eye irritation
• Eye pain
• Tiredness (fatigue)
• Skin burning sensation.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
If you notice any change in the way you feel after receiving Desflurane, please inform your doctor or pharmacist. Some side effects may need treatment.
5. How to store Desflurane
Keep out of reach and sight of children.
This medicine should be stored in the upright position with the cap firmly in place.
Do not use Desflurane after the expiry date that is printed on the label after the term 'Use before'.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Desflurane contains
The active substance is desflurane.
There are no other ingredients.
What Desflurane looks like and contents of the pack
Desflurane is a liquid.
It is supplied in amber glass bottles with a protective PVC coating or aluminium bottles which are internally coated with epoxyphenolic resin.
The bottle may be closed with either
- a resin and plastic cap
- a valve to connect with the vaporiser
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER
Baxter Healthcare Limited
Caxton Way, Thetford Norfolk IP24 3SE, UK
3 0 0 1
15 9*
MANUFACTURER
Baxter S.A.
Lessines, Belgium
Baxter Manufacturing Sp. z o.o.
Lublin, Poland
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in October 2015
For information about Desflurane or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder:
Tel: 01635 206345
Baxter is a trademark of Baxter International Inc.
LU-30-01-159
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