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AERRANE 100% LIQUID INHALATION VAPOUR

Active substance(s): ISOFLURANE

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EMEA ARTWORK DESIGN CENTRE
1st

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LU-30-01-173

Date: 19 NOV 2015

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Version:

• Keep this leaflet. You may need to read it again.
Your doctor will not give you AErrane if:
• If you have any further questions, ask your
doctor, nurse or pharmacist.
• you are allergic (hypersensitive) to isoflurane
• If you get any side effects, talk to your doctor,
or other inhalation anaesthetics such as
nurse or pharmacist. This includes any possible
desflurane, sevoflurane, halothane and
side effects not listed in this leaflet.
enflurane.
• you, or any relative suffer from a condition
In this leaflet:
called malignant hyperthermia. Malignant
1. What AErrane is and what it is used for
hyperthermia is when you suddenly develop a
2. What you need to know before you are given
dangerously high body temperature during or
AErrane
shortly after surgery.
3. How you will be given AErrane
• following anaesthesia with AErrane or other
4. What will happen after receiving
inhalation anaesthetics (e.g. desflurane,
AErrane?
sevoflurane, halothane) in the past, you have
5. How AErrane is stored
had unexplained liver problems with:
6. Contents of the pack and other information
– jaundice (yellowing of the skin and white of
the eyeballs)
– fever
1. What AErrane is and what it is
– increased levels of white blood cells called
used for
leucocytes (leucocytosis)
– increased levels of a certain type of white
AErrane contains isoflurane. AErrane is a general
blood cells called eosinophils (eosinophilia).
anaesthetic used in surgery. It is an inhalation
You must not be given AErrane for operations
anaesthetic (it is given to you as a vapour for
during pregnancy, childbirth or the period just after
you to breathe in). Breathing in isoflurane vapour
childbirth. AErrane may, however, be used for a
causes you to fall into a deep, painless sleep.
Caesarean section.
It also maintains a deep, painless sleep (general
If any of the above applies to you, please inform
anaesthesia) during which you can undergo
your doctor, surgeon or anaesthetist before you are
surgery.
treated with this medicine.

Artworker: Caroline Berghmans

2. What you need to know before you
are given AErrane

ARTWORK DESIGN CENTRE

Read all of this leaflet carefully before you
are given this medicine. It contains important
information for you.

ARTWORK APPROVAL
1st DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Active substance: isoflurane

PLANT APPROVAL
HALLE ONLY

Package leaflet: Information for the patient
AErrane (isoflurane) Liquid for Inhalation

Warnings and Precautions

– decreases in blood levels of a fat called
cholesterol
– changes in blood enzyme levels

Talk to your doctor, nurse or pharmacist before
being given AErrane.
• Your doctor will take special care with this
medicine if:
• you have a disorder of the cells (a condition
called mitochondrial disorder)
• you suffer from liver problems such as:
– hepatitis (inflamed liver)
– cirrhosis of the liver (replacement of healthy
liver tissue with scar tissue). This can
happen if you drink too much alcohol
– any other liver disease
• you have recently had an operation for which
you received general anaesthesia with an
inhalation anaesthetic
• you are suffering from the symptoms of any
illness other than those connected with your
operation, such as severe headaches, nausea,
vomiting, severe chest pain or a condition that
affects muscles (a neuromuscular disease e.g.
Duchenne muscular dystrophy or myasthenia
gravis).
• you suffer with bronchoconstriction
(a tightening of the lungs and airways leading
to coughing, wheezing or shortness of breath).
• The patient is a child under two years of age.

AErrane can cause malignant hyperthermia
(when you suddenly develop a dangerously high
body temperature during or shortly after surgery).
Fatal outcome of malignant hyperthermia has been
reported with AErrane.

Your doctor will monitor your breathing
during treatment, especially if you are given
any other medicines which can affect your
breathing, like:

If children are given AErrane to bring
on (induce) anaesthesia this can cause
unwanted side effects such as:

Your doctor may give you less AErrane if:
– you have a low blood volume (hypovolaemia)
– you have low blood pressure (hypotension)
– you are weakened (debilitated)

– increased saliva flow
– increased secretions in the windpipe and upper
airways

AErrane can cause irritation of the lining of the
mouth and the airways, which may result in
an increased saliva flow and increased slime
production from the windpipe and upper airways.
In children this may make it harder for them to
breathe in or can cause a muscle spasm of the
vocal chords (voicebox) called a laryngospasm.

These can cause a muscle spasm of the vocal
chords (voicebox) called a laryngospasm.
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.

If you are having an abortion you may suffer
increased loss of blood if you are given AErrane.

Other medicines and AErrane:
Tell your doctor, nurse or pharmacist if you are
taking, have recently taken or might take any other
medicines. This includes medicines that you have
obtained yourself, without a prescription, including
herbal medicines and natural products.

If you are given AErrane, you may have
brief:
– changes in liver function
– increases in blood sugar (glucose) levels
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Children Rarely, inhaled anaesthetics 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 succinylcholine was given at the
same time.

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– sedatives (e.g. diazepam, nitrazepam)
– strong pain killers (e.g. opioids such as
fentanyl, morphine and remifentanil)

AErrane with food and drink

You must take special care if you are also taking
any of the following medicines:
• non selective MAOIs (monoamine oxidase
inhibitor such as phenelzine, isocarboxazid –
these medicines are used to treat depression):
Your doctor will instruct you to stop taking
such medicines 15 days before you have your
operation.
• heart medicines called beta-sympathomimetics
(e.g. isoprenaline) and alpha- and betasympathomimetics (e.g. adrenaline). These may
increase your heart rate and cause a serious
irregular heartbeat.
• beta-blockers (e.g. atenolol, metoprolol): These
are heart medicines often given to treat a high
blood pressure.
• isoniazid: A medicine used to treat tuberculosis
(TB). Your doctor will instruct you to stop using
isoniazid one week before your operation.
Do not start taking isoniazid again until 15 days
after your operation.
• indirect sympathomimetic drugs e.g.:
– amphetamines, amphetamine derivatives
(used to treat attention-deficit hyperactivity
disorder (ADHD))
– drugs which reduce your appetite
– ephedrine and ephedrine derivatives
(commonly found in cough and cold
medicines)
These medicines may cause an Increased risk
of high blood pressure when given together with
AErrane. Your doctor will instruct you if and when
to stop these medicines.
• muscle relaxants (e.g. suxamethonium,
pancuronium, atracurium, vecuronium). These
medicines are used during general anaesthesia
to relax your muscles. Your anaesthetist may
need to reduce the dose of these medicines.
• opioids (e.g. morphine, fentanyl, remifentanil):
These medicines are strong pain killers and are
often used during general anaesthesia.
• calcium antagonists: Used for treating high
blood pressure (e.g. felodipine, nicardipine)

AErrane 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.
You should not drink alcohol. Your doctor will tell
you when you can resume drinking alcohol.

Pregnancy and breast-feeding

Driving and using machines
Do not drive or operate tools or machines for at
least 24 hours after your operation if you were
given AErrane. Receiving an anaesthetic may
influence your alertness and behaviour which may
affect your ability to carry out normal tasks for
up to 6 days. Make sure that someone takes you
home after your operation.

3. How you will be given AErrane
AErrane 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.
Your child should be monitored closely during the
administration of Isoflurane.
Inducing sleep at the start of anaesthesia
Isoflurane is not recommended in infants and
children for inducing sleep at the start of
anaesthesia.
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Consult your doctor, surgeon or anaesthetist if
you are pregnant, might be pregnant, or if you are
breast-feeding.

Date:
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You will only be given AErrane whilst you are
pregnant if the benefit outweighs the risk, as
there is limited data of use in pregnant women.
However, lower doses of AErrane can be used
during Caesarean section.
As it is not known if AErrane is excreted in human
milk, you should avoid breast feeding after an
operation if you were given AErrane as the general
anaesthetic.

Tell your doctor, nurse or pharmacist
straight away if you notice any of the
following side effects, which can be serious.

Medication before anaesthesia
The anaesthetist may decide to give your child
medication to counteract the possible reduction in
breathing and heart rate effects which may occur
with the use of Isoflurane.

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

If you have too much AErrane
If you are given too much AErrane 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. What will happen after receiving
AErrane?
Like all medicines, this medicine can cause side
effects, although not everybody gets them Most
side effects are mild to moderate in their severity
and are brief but there may be some serious side
effects.
If you or your child suffer from any unusual or
unexpected symptoms after an operation tell your
doctor or anaesthetist IMMEDIATELY.
The most commonly reported side effects are:
• A tightening of your lungs and airways causing
a difficulty in breathing
• Increases in blood sugar levels or potassium
levels. There have been rare reports of
abnormal heartbeat (arrhythmias) and death
associated with the use of inhaled anaesthetics
in children shortly after surgery
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• Presence of carboxyhaemoglobin in the blood
• Allergic reaction
• Hypersensitivity
• Agitation, alterations in mood, sometimes
extreme
• Confusion, convulsions, mental impairment
• Irregular heart beat or palpitations
• Abnormal electrocardiogram (ECG), change in
heart rate or rhythm
• Cardiac arrest
• Low blood pressure
• Haemorrhage (uncontrolled bleeding)
• Slow shallow breathing
• Shortness of breath, wheezing
• A muscle spasm of the vocal chords (voice box)
called a laryngospasm
• Swelling of the face
• Contact dermatitis
• Skin rash
• Increased blood levels of an enzyme called
creatinine
• Decreased blood levels of a substance called
urea
• Muscles of your intestine may stop working
temporarily, causing discomfort, bloating and
vomiting
• Nausea and vomiting
• Inability of the liver to function properly,
including liver injury, liver cell death
• Increased blood levels of a substance called
bilirubin
• Shivering, chills
• Raised body temperature due to malignant
hyperthermia
• Chest discomfort
• Abnormal levels of certain cells or products
found in your blood
• Increases in blood fluoride levels (due to your
body breaking down isoflurane) Abnormal
results from a EEG (electroencephalogram) test
• Presence of myoglobin (material from the
muscles) in the urine
• Muscle destruction
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AErrane is produced from liquid isoflurane in a
vaporiser. You may receive AErrane in one of two
ways:
• you may be given an injection of another
anaesthetic to make you sleep before being
given AErrane through a mask. This is the most
common way that you may receive AErrane.
or
• you may be asked to breathe the isoflurane
vapour through a mask to make you sleep.
You will fall asleep quickly and very easily.
This is a less common way to receive AErrane.

Date:
Date:

Not known (the number of people affected is
unknown)

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

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme: www.mhra.gov.uk/yellowcard

This leaflet was last revised in September 2015

By reporting side effects you can help provide
more information on the safety of this medicine.

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

5. How AErrane is stored
Keep out of sight and reach of children.
This medicine requires no special storage
conditions.

Baxter and AErrane are trademarks of Baxter
International Inc.

Date:
Date:

Do not use AErrane after the expiry date that is
printed on the label. The expiry date refers to the
last day of that month.
Do not throw any medicines via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use.
These measures will help protect the environment.

6. Contents of the pack and other
information
What AErrane contains

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The active substance is isoflurane.
There are no other ingredients.

What AErrane looks like and contents of the
pack
AErrane is a liquid.
It is supplied in 100 ml and 250 ml bottles with
screw cap closures.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER
Baxter Healthcare Limited
Caxton Way, Thetford
Norfolk IP24 3SE, UK

MANUFACTURER
Baxter S.A.
Lessines, Belgium
Baxter Manufacturing Sp. z o.o.
Lublin, Poland
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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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