Skip to Content

DESFLURANE 100% V/V INHALATION VAPOUR LIQUID

Active substance(s): DESFLURANE

View full screen / Print PDF » Download PDF ⇩
Transcript
You must not be given Suprane 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 Suprane are undesirable, like:
– an increase in your heart rate
– an increase in your blood pressure

1. What Suprane is and what it is used
for

Suprane contains desflurane. Suprane is a general
anaesthetic used in surgery. It is an inhalation
anaesthetic (it is given to you as a vapour for you
If any of the above applies to you, please inform
to breathe in). Breathing in desflurane vapour
your doctor, surgeon or anaesthetist before you are
causes you to fall into a deep, painless sleep. It
treated with this medicine.
also maintains a deep, painless sleep (general
anaesthesia) during which you can undergo
surgery. In adults, Suprane is used for induction and
maintenance of anaesthesia. In infants and children
it is used for maintenance of anaesthesia only.
1

LU-30-01-101

N/A

N/A

N/A
Date

What Suprane is and what it is used for
Before you are given Suprane
How you will be given Suprane
Possible side effects
How to store Suprane
Further information

Signature

1.
2.
3.
4.
5.
6.

Country

In this leaflet:

RA TO APPROVE LAYOUT
AND FORMAT

• 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.

ARTWORK APPROVAL

Do NOT have Suprane if:

EUROPEAN LABELLING CENTRE

2. Before you are given Suprane

• 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.

1st DRAFT

Read all of this leaflet carefully before you start
using this medicine.

DATE 07 Jan 2015

Active substance: desflurane

Name

Suprane 100% Volatile liquid for administration by inhalation

PLANT APPROVAL HALLE
ONLY
N/A

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Suprane.
Some of these medicines are given to you during
your surgery by your anaesthetist, as indicated in
the description.

Suprane 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.

2

LU-30-01-101

N/A

N/A

N/A
Date

PLANT APPROVAL HALLE
ONLY
N/A

DATE 07 Jan 2015

Signature

Using other medicines:

Name

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.

Country

Your doctor may decide not to use Suprane 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 Suprane
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.

RA TO APPROVE LAYOUT
AND FORMAT

Your doctor may need to give you less Suprane if:
• you have a low blood volume (hypovolaemia)
• you have low blood pressure (hypotension)
• you are weakened (debilitated).

1st DRAFT

• you have a brain tumour
• following anaesthesia with Suprane 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). Suprane
may increase your blood glucose levels during
anaesthesia.

ARTWORK APPROVAL

Special information for the treatment of children
• Very rarely Suprane 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 Suprane to bring on (induce)
anaesthesia. This is because using Suprane
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
Suprane to maintain anaesthesia unless they
have been intubated. Intubation is when a tube
is placed into the airways to help breathing.

EUROPEAN LABELLING CENTRE

Your doctor will take special care when
giving you Suprane if:

• 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 Suprane.
• nitrous oxide: This is a medicine used during
general anaesthesia that will cause you to
sleep and will ease your pain.

Consult your doctor, surgeon or anaesthetist if
you are pregnant, might be pregnant, or if you are
breast-feeding.

4. Possible side effects

Driving and using machines
Do not drive or operate tools or machines after
your operation if you were given Suprane.
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.

Like all medicines, Suprane 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.

3

LU-30-01-101

N/A

N/A

N/A
Date

DATE 07 Jan 2015

Signature

If you are given too much Suprane the medicine
will be stopped. You will be given pure oxygen.
Your blood pressure and heart function will be
carefully checked while you recover.

You should not be given Suprane if you are
pregnant or if you are breast-feeding.

Name

If you receive more Suprane than you should

Pregnancy and breast-feeding

Country

After your surgery, your anaesthetist will stop
giving you Suprane. You will then wake up in a few
minutes.

RA TO APPROVE LAYOUT
AND FORMAT

Suprane 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.

1st DRAFT

Using Suprane with food and drink

ARTWORK APPROVAL

Suprane is produced from liquid desflurane in a
vaporiser. You may receive Suprane in one of two
ways:
• you may be given an injection of another
anaesthetic to make you sleep before being
given Suprane through a mask. This is the
most common way that you may receive
Suprane.
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 Suprane.

EUROPEAN LABELLING CENTRE

Suprane 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.

PLANT APPROVAL HALLE
ONLY
N/A

3. How you will be given Suprane

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
Suprane.
• Muscle pain (myalgia).

4

LU-30-01-101

N/A

N/A

N/A

Name

Signature

Date

PLANT APPROVAL HALLE
ONLY
N/A

DATE 07 Jan 2015

Country

RA TO APPROVE LAYOUT
AND FORMAT

Common (affects 1 to 10 users in 100):
• Inflamed throat (pharyngitis)
• Breath holding. This has occurred during
induction and maintenance of anaesthesia with
Suprane.
• 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
Suprane.
• Muscle spasm of the vocal chords (voicebox)
called a laryngospasm. This has occurred
during induction of anaesthesia with Suprane.
• Increased blood levels of an enzyme called
creatinine phosphokinase
• Abnormal heart tracing (abnormal ECG).

1st DRAFT

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 Suprane.

ARTWORK APPROVAL

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:

EUROPEAN LABELLING CENTRE

The following side effects may also occur
during treatment. The evaluation of the
side effects is based on the following
frequencies:

What Suprane looks like and contents of the
pack
Suprane 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

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 Suprane, please inform your doctor
or pharmacist. Some side effects may need
treatment.

Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER
Baxter Healthcare Limited
Caxton Way, Thetford
Norfolk IP24 3SE, UK

5

LU-30-01-101

N/A

There are no other ingredients.

Date

The active substance is desflurane.

N/A

What Suprane contains

N/A

6. Further information

The following side effects have occurred after
Suprane 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.

Signature

Ask your pharmacist how to dispose of medicines
no longer required. These measures will help to
protect the environment.

Name

Medicines should not be disposed of via
wastewater or household waste.

PLANT APPROVAL HALLE
ONLY
N/A

DATE 07 Jan 2015

The expiry date refers to the last day of that month.

Country



Do not use Suprane after the expiry date that is
printed on the label after the term 'Use before'.

RA TO APPROVE LAYOUT
AND FORMAT



This medicine should be stored in the upright
position with the cap firmly in place.

1st DRAFT



Keep out of reach and sight of children.

ARTWORK APPROVAL



5. How to store Suprane

EUROPEAN LABELLING CENTRE





– 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.

MANUFACTURER

6

LU-30-01-101

N/A

N/A

N/A

Name

Signature

Date

Baxter and Suprane are trademarks of Baxter
International Inc.

Country

For information about Suprane or to
request this leaflet in formats such as
audio or large print please contact the
Marketing Authorisation Holder:
Tel: 01635 206345

1st DRAFT

EUROPEAN LABELLING CENTRE

This leaflet was last revised in May 2015

ARTWORK APPROVAL

For any information about this medicinal product,
please contact the local representative of the
Marketing Authorisation Holder.

RA TO APPROVE LAYOUT
AND FORMAT

DATE 07 Jan 2015

Baxter Manufacturing Sp. z o.o.
Lublin, Poland

PLANT APPROVAL HALLE
ONLY
N/A

Baxter S.A.
Lessines, Belgium

Expand view ⇕

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.

Hide