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DESFLURANE 100% INHALATION VAPOUR LIQUID

Active substance(s): DESFLURANE / DESFLURANE

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Package leaflet: Information for the user

Desflurane 100% Inhalation vapour, liquid
Desflurane
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
–– Keep this leaflet. You may need to read it again.
–– If you have any further questions, ask your doctor, anaesthetist
or nurse.
–– If you get any side effects, talk to your doctor, anaesthetist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Desflurane is and what it is used for
What you need to know before you are given Desflurane
How Desflurane is given
Possible side effects
How to store Desflurane
Contents of the pack and other information

1. What Desflurane is and what it is used for
Desflurane contains desflurane. 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 sleep. It also
maintains a deep sleep (general anaesthesia) during which you
can undergo surgery. Desflurane is indicated as an inhalation
agent for maintenance of anesthesia for inpatient and outpatient
surgery in intubated adults, infants and children.

2. What you need to know before you are given
Desflurane
Desflurane must not be given:
–– if you have or have ever had medical reasons for not receiving
general anaesthetics.
–– if you are allergic to halogenated anesthetics.
–– if you or any member of your family has experienced a rapid
and significant rise in body temperature during an operation (a
condition called malignant hyperthermia).
–– if you are an adult, child or infant to maintain anaesthesia
unless you are intubated. Intubation is when a tube is placed
into the airways to help breathing.
–– if in the past after receiving inhalation anaesthesia, you had
problems with liver function, unexplained fever or an increased
number of certain white blood cells (leukocytosis).
–– if you are undergoing dental procedures outside a hospital or
day care unit.
Before receiving this medicine, tell your doctor or anaesthetist if
any of the above applies to you.
Warnings and precautions
Talk to your doctor or anaesthetist before receiving Desflurane:
–– if you have a risk of increased pressure inside the head.
–– if you have a tendency to suffer from bronchoconstriction
(a tightening of the lungs and airways leading to coughing,
wheezing or shortness of breath).
–– if you are at a risk for coronary artery disease (when the blood
vessels do not transport enough blood and oxygen to the heart
muscle).
–– if you are pregnant or breast feeding, or if this medicine is
administered during delivery (also see “Pregnancy and breastfeeding”).
–– if you suffer from a condition that affects the muscles (a
neuromuscular disease such as Duchenne muscular
dystrophy). You may be given a muscle relaxant at the same
time as Desflurane.
–– if you have previously received general anaesthetics, especially
if given multiple doses over a short time period.
–– If you are a child with a recent infection of respiratory tract.
Your doctor may administer less Desflurane:
–– in case of a low blood volume (hypovolemia).
–– in case of a low blood pressure (hypotension).
–– in case of weakness.
Your doctor can decide not to give you Desflurane and will choose
another type of anaesthesia:
–– if you have liver disease due to alcohol abuse (cirrhosis).
–– if you have viral hepatitis (a virus-induced liver disease).
–– if you have other types of liver diseases.
After anaesthesia with Desflurane you will wake up again quickly.
If pain is anticipated after the operation, your doctor will give you a
painkiller. Your doctor can do this either at the end of the operation
or during the recovery phase.

Your doctor must proceed with special care if an inhalational
anaesthetic medicine was administered previously especially if it
was multiple times during a short time interval (repeated use).
Desflurane can cause a rapid and significant rise in body
temperature during an operation (malignant hyperthermia).
Middle ear surgeries
Desflurane, as well as other volatile anaesthetics increase middle
ear pressure especially in children, and hence it is recommended
that middle ear pressure be monitored during anaesthesia with
desflurane.
Other medicines and Desflurane
Tell your doctor or anaesthetist if you are using, have recently
used or might use any other medicines, including medicines
obtained without a prescription.
Special care is required if any of the following medicines are being
taken:
–– Muscle relaxants (such as Suxamethonium, Pancuronium,
Atracurium, Vecuronium). These medicines help to relax the
muscles. The anaesthetist might possibly adjust the dosage.
–– Opioids (such as Fentanyl, Morphine, Remifentanil). These
medicines are strong painkillers and frequently used during full
anaesthesia.
–– Benzodiazepines (such as Midazolam, Diazepam,
Nitrazepam). These are tranquilisers, used to relax a patient
who is agitated before surgery.
–– Beta Sympathomimetics (isoprenaline) and alpha- and betaagonists (epinephrine, or adrenalin;
–– norepinephrine or noradrenaline).
–– Nitrous oxide (laughing gas). This medicine can be used during
full anaesthesia so that the patient sleeps and eases pain.
Pregnancy and breast-feeding
Desflurane is a uterine relaxant and reduces the uterine-placental
blood flow. There are no adequate and well-controlled studies in
pregnant women. Limited animal data do not indicate direct or
indirect harmful effects with respect to reproductive toxicity. Since
animal studies are not always predictive of human response,
Desflurane should be used during surgeries in pregnant women
after the potential risks and benefits are weighed for each patient.
There are no adequate data from the use of Desflurane in breastfeeding women and it is not known whether the drug passes into
breast milk. Before prescribing Desflurane, anaesthetist should
carefully weigh the potential risks and benefits for each patient.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, tell your doctor or anaesthetist
before being given this medicine.
Driving and using machines
Desflurane can affect your alertness and ability to respond for
some time after receiving the medicine. Therefore, do not drive or
operate machinery for 24 hours after your operation.

3. How Desflurane is given
Desflurane will always be administered to you by an anaesthetist.
The anaesthetist will decide on the dose you will receive
depending on your age, body weight and the type of operation
you are having. During anaesthesia, the anaesthetist will check
your blood pressure and heart rate. If required, the anaesthetist
will adjust your dose.
Most commonly Desflurane is administered through a tube which
is placed into the airways after you have been given an injection
of another anaesthetic that induces sleep;

Only in rare cases you may be asked to breathe in the
Desflurane vapors through a mask to induce sleep.
Waking-up after anaesthesia
After the operation, the anaesthetist stops giving you Desflurane.
You will wake up within a few minutes.
If you receive more Desflurane than you should
If you receive more Desflurane than you should, administration is
stopped. Pure oxygen will be provided. Your blood pressure and
heart function will be carefully checked while you wake up.
If you have any further questions on the use of this medicine, ask
your doctor, anaesthetist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Most side effects are mild to moderate in severity and last a short
time. However, some side effects can also be serious.
Desflurane can cause a slight increase in the level of the blood
sugar during anaesthesia.
Possible side effects include:
Very common (may affect more than 1 in 10 people)
–– Nausea
–– Vomiting
Common (may affect up to 1 in 10 people)
–– Inflammation of the back of the throat (pharyngitis)
–– Temporary breath holding
–– Headache
–– Inflammation of the outer layer of the eye and inner surface of
the eyelids (conjunctivitis)
–– Irregular heartbeat or abnormal heart rhythm
–– Slower heartbeat (bradycardia)
–– Faster heartbeat (tachycardia)
–– High blood pressure (hypertension)
–– Temporary stopping breathing (apnoea), cough and excessive
saliva production
–– Sudden spasm of the vocal cords that affects breathing and
speaking (laryngospasm)
–– Increased blood counts of certain enzymes called creatine
phosphokinase
–– Abnormal recording of the heartbeat (abnormal ECG)
–– Prolongation of QTc interval (abnormal ECG)
Uncommon (may affect up to 1 in 100 people)
–– Agitation
–– Dizziness
–– Heart attack (myocardial infarction)
–– Reduced blood flow to the heart muscle (myocardial ischemia)
–– Irregular heartbeat (arrhythmia)
–– Enlarged blood vessels (vasodilatation)
–– Reduced oxygen supply (hypoxia)
–– Muscle pain (myalgia)
Not known (frequency cannot be estimated from the available
data)
–– Blood clotting disorder (coagulopathy)
–– Increased or decreased levels of potassium in the blood
(hyperkalemia / hypokalemia)
–– Too much acid in the body fluids (metabolic acidosis)
–– Seizures (convulsions)
–– Yellowing of the eyeball (ocular icterus)
–– Heart failure (when the heart is having difficulty beating) or
cardiac arrest (when the heart stops beating)
–– Life threatening irregular heart beat (torsades-de-pointes
–– Ventricular malfunction (when two of your heart’s chambers do
not work so well or they stop working)
–– Reduced heart muscle contraction (ventricular hypokinesia)
–– Very high blood pressure (malignant hypertension)
–– Bleeding (haemorrhage)
–– Low blood pressure (hypotension)
–– When your body tissues do not get enough blood (shock)
–– Difficulty breathing (respiratory failure) or stopping breathing
(respiratory arrest)
–– Sudden tightening of muscles in the airways (bronchospasm)
–– Coughing up blood from the lungs (haemoptysis)
–– Sudden inflammation of the pancreas (acute pancreatitis)
–– Stomach pain (abdominal pain)
–– Death of liver tissue (hepaticnecrosis)
–– Inflammation of the liver (cytolytic Hepatitis)
–– Blocked flow of bile from the liver (cholestasis)
–– Yellowing of the skin or eyeball (jaundice)
–– Disturbances in liver function or liver disease
–– Hives (urticaria)
–– Redness of the skin (erythema)
–– Muscle fibre breakdown (rhabdomyolysis)
–– Rapid and significant rise in body temperature during an
operation (malignant hyperthermia). The signs of illness
include:
–– Excess carbon dioxide in the blood (hypercapnia)
–– Muscle stiffness (rigidity)
–– Increased heartbeat (tachycardia)
–– Increased breathing (tachypnea)
–– Blue colouration of the skin (cyanosis)
–– Irregular heartbeat or abnormal heart rhythm (arrhythmia)
–– Low or high blood pressure and fever
–– Feeling of weakness (asthenia)
–– General discomfort
–– Changes in the recording of the cardiac activity (changes of
the ST-T-measurements or inversion of the T wave in the ECG)
–– Increase in the liver enzymes (increased alanine- or aspartateaminotransferase values)

––
––
––
––

Blood clotting disorder (abnormal clotting values)
Increased ammonia values
Elevated levels of bilirubin increased
Liver failure

Accidental exposure
The following side effects occurred in patients who were
accidentally exposed to Desflurane:
–– Dizziness
–– Severe headache (migraine)
–– Irregular, faster heartbeat (tachyarrhythmia)
–– Palpitations
–– Burning sensation in the eyes
–– Temporary blindness
–– Brain disease (encephalopathy)
–– Inflammation or infection of part of the eye (ulcerative keratitis)
–– Bloodshot eyes (ocular hyperemia)
–– Reduced visual sharpness and clarity
–– Eye irritation
–– Eye pain
–– Fatigue
–– Burning sensation of the skin
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the Yellow
Card Scheme at Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Desflurane
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the label, after ‘EXP.’. The expiry date refers to the last day of that
month.
No special storage conditions.
Store in an upright position with cap firmly in place. Replace after
each use.

6. Contents of the pack and other information
What Desflurane contains
–– The active substance is desflurane 100% (v/v).
–– There are no other ingredients.
What Desflurane looks like and contents of the pack
Desflurane is an inhalation vapour liquid.
Desflurane is a clear, colourless liquid.
250-mL amber-colored plastic coated glass bottles containing
240ml of desflurane, sealed with a semitransparent valve
assembly and aluminum ferrule, and secured with PET sealing
film.
Packaged product is supplied in boxes of 6.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cadiasun Pharma GmbH
Lendersweg 27, 47877 Willich,
Germany
Manufacturer
Wave Pharma Limited
4th Floor Cavendish House,
369 Burnt Oak Broadway,
Edgware, HA85AW,
United Kingdom
This leaflet was last revised in 03/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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