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HALOTHANE 100% INHALATION VAPOUR LIQUID

Active substance(s): HALOTHANE

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DNH 4065/1

TECHNICAL LEAFLET

DNH 4065/1

HALOTHANE

HALOTHANE

100% INHALATION VAPOUR, LIQUID

100% Inhalation Vapour, Liquid
Please read this information carefully before using Halothane
100% Inhalation Vapour, Liquid. Further information is contained
in the Summary of Product Characteristics.
Presentation
Halothane 100% Inhalation Vapour, Liquid is a clear liquid used in a
vapouriser to produce an inhalation gas.
The active ingredient is Halothane 100% v/v supplied in 250ml amber
glass bottles
Indications
Halothane 100% Inhalation Vapour, Liquid is a general anaesthetic
used in inhalation anaesthesia.
Use of halothane in paediatric dental anaesthesia should be restricted
to hospitals only.
Posology and Method of Administration
Adults
Induction: Anaesthesia may be induced with 2 to 4% v/v of halothane in
oxygen or mixtures of nitrous oxide and oxygen. Induction may also be
started at a concentration of 0.5% v/v and increased gradually to the
required level.
Maintenance: Anaesthesia is maintained with concentrations of 0.5 to
2% depending on the flow rate used; the lower concentration is usually
suitable for the elderly.
Children:
For induction in children a concentration of 1.5 to 2% v/v has been
used.
Elderly:
Elderly patients tend to require less halothane than adults but the
actual dose is dependent on the patient's physical state
Contraindications
Hypersensitive to halothane or to other halogenated agents
History of unexplained jaundice or pyrexia after a previous exposure to
halothane is an absolute contraindication to its future use in that
patient.
Halothane is contraindicated in patients with known, or suspected,
genetic predisposition to malignant hyperpyrexia.
Children under 18 years undergoing dental procedures outside
hospital
Special warnings and precautions for use
Halothane can induce liver damage. Minor changes in serum aminotransferase activity have been reported to occur in up to 30% of
patients. The incidence of severe liver damage (jaundice, which may
lead to hepatic failure as a consequence of massive hepatic cell
necrosis) is much rarer but cases requiring liver transplants and
fatalities have been reported. The risk of developing hepatic failure
appears to be greatly increased by repeated exposure to halothane.
Although short intervals of time between exposures are likely to
increase the risk of hepatotoxicity, even long intervals between
exposure may not reduce the risks, since some patients have
developed severe reactions to halothane given many years after the
previous exposure. Other risk factors for hepatotoxicity include female
gender, obesity, middle age and a history of drug allergy. On the
information presently available, the following precautions should be

INFORMATION FOR THE PATIENT

taken:
• A careful anaesthetic history is to be taken from patients due to
undergo anaesthesia in order to determine whether exposure to
halothane took place and the nature of any adverse reaction to this
agent.
• History of unexplained jaundice or pyrexia after a previous
exposure to halothane is an absolute contraindication to its future
use in that patient.
• Further exposure to halothane within three months is to be avoided
unless there are overriding reasons for its re-use.
• Patients who have exhibited adverse reactions to halothane should
be informed and strictly instructed to alert their physician. Details of
the reaction should be entered on the patient's medical records.

Read all of this leaflet carefully before you are
taking 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 or
nurse.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.

A rise in CSF and/or intracranial pressure might occur during
neurosurgery, the effects of which may be mitigated by the use
moderate hyperventilation.

What is in this leaflet:
1. What Halothane is and what it is used for
2. What you need to know before you are given
halothane
3. How halothane will be given
4. Possible side effects
5. How to store halothane
6. Contents of the pack and further information

Halothane reduces uterine muscle tone during pregnancy and
generally its use is not recommended in obstetrics because of the
increased risk of postpartum haemorrhage.
As with other agents of this type, halothane anaesthesia has been
shown to trigger a skeletal muscle hypermetabolic state leading to
high oxygen demand and the clinical syndrome known as malignant
hyperpyrexia. This is more common when halothane is coadministered with suxamethonium. The syndrome includes nonspecific features such as hypercapnia, muscle rigidity, tachycardia,
tachypnoea, cyanosis, arrhythmias and unstable blood pressure. An
increase in overall metabolism may be reflected in an elevated
temperature. Treatment includes discontinuation of triggering agents,
administration of dantrolene sodium and application of supportive
therapy.
During the induction of halothane anaesthesia, a moderate fall in
blood pressure commonly occurs. (Halothane lowers arterial blood
pressure in a dose-dependent manner). The pressure tends to rise
when the vapour concentration is reduced to maintenance levels, but
it usually remains steady below the preoperative level. This
hypotensive effect is useful in providing a clear operating field and a
reduction in haemorrhage. However, if necessary, intravenous doses
of methoxamine (5 mg are usually adequate) can be given to
counteract the fall in blood pressure.
Anaesthesia with halothane may be associated with bradycardia,
which may augment its hypotensive effect. The intravenous
administration of an anticholinergic agent before induction or during
maintenance of anaesthesia should be considered, especially in
situations where vagal tone is likely to be predominant or when
halothane is used in conjunction with other agents likely to cause a
bradycardia.
Halothane should be used with caution in patients with:
• Phaeochromocytoma
• Renal failure
• Pre-existing liver disease
• Myasthenia gravis
• Porphyria

1. What Halothane is and what it is used for
Halothane is an inhaled, general anaesthetic. It acts
on the brain and causes unconsciousness.
Halothane is used to put you to sleep and maintain
your level of unconsciousness during an operation.
It stops you knowing what is going on during surgical
operations and other procedure. Normally you will
receive another medicine to sedate you and to dry
your mouth. You will be given halothane as a gas in
the air you breathe to keep you asleep during the
operation.
2. What you need to know before you take
Halothane
Do not take Halothane
· If you are hypersensitive to halothane or to other
similar anaesthetics.
· If you are under 18 years of age and are having
dental treatment outside hospital.
· If you or any member of your family suffered from a
condition known as malignant hyperpyrexia (a
sudden severe fever), when having an anaesthetic
during a previous operation.
· If you have reacted badly to halothane or other
similar anaesthetic following a previous operation
e.g. you developed jaundice (yellowing of the skin
and eyes), fever, liver or blood problems.
Exposure to halothane within three months is to be
avoided unless there are overriding reasons for its re –
use

Warnings and precautions
Talk to your doctor before taking Halothane
· If you have ever been given halothane before.
· If you have had an allergic reaction to a medicine or
food.
· If you have suffered a head injury in the last few
days.
· If you are, or think you might be, pregnant.
· If you are breastfeeding.
· If you have a disease of your liver or kidneys.
· If you suffer from phaeochromocytoma (high blood
pressure due to a tumour near the kidneys).
· If you suffer from myasthenia gravis (Chronic
fatigue and muscle weakness, especially in the face
and throat).
· If you suffer from porphyria.
Other medicines and Halothane
Tell your doctor or nurse if you taking,have recently
taken or might take any other medicines:
· Any Medicines used to treat high blood Pressure
(Hypertension)
· Medicines such as methylphenidate, used to treat
ADHD
· Medicines such as levodopa, used to treat
Parkinson's disease
· Muscle relaxants such as gallamine and dtubocurarine.
· Drug that lower blood pressure such as pentolonium
and trimetaphan.
· A medicine called suxamethonium (a muscle
relaxant used in operations). There is an increased
risk of hyperpyrexia.
· Theophylline, used to treat asthma
· Morphine, used for pain relief
· Chlorpromazine, used to treat mental illness
· Ergometrine or oxiytocin, used to control bleeding in
the uterus or to induce labour
· Antipsychotic medicines
· Monoamine oxidase inhibitors (MAOIS), used to
treat depression. There should be stopped 2 weeks
before surgery
· Antibiotics
Pregnancy and breast-feeding and fertility
Halothane can weaken the muscles of the uterus and
might increase the risk of severe bleeding after
delivery.
If you are pregnant or think you may be pregnant or are
planning to have a baby, ask your doctor for advice
before taking this medicine. You should not receive
Halothane if you are pregnant unless it is essential.
Continued overleaf

Pantone Black C

Traces of halothane have been found in breast milk, if
you have been breastfeeding, tell your doctors, you
will be advised to stop for at least 24 hours after being
given Halothane.
Driving and using machines
You should not drive or use machines for at least 24
hours after you have had a general anaesthetic. Even
then, you should not drive or operate machinery if you
think you have not fully recovered from the effects of
the anaesthetic.
3. How to take Halothane
Halothane will be given by a trained anaesthetist in a
surgery or hospital. A special piece of equipment is
used to deliver halothane as a gas in the air, which you
will breathe in.
· Your anaesthetist will determine the amount you
receive as the effect of halothane varies between
people. The anaesthetist will constantly monitor
your condition.
· If your child is given halothane, hospital staff will
check the electrical pattern of their heart, their blood
pressure and their blood gases throughout the
operation. The anaesthetist will consider factors
which could affect these measures, such as the
level of oxygen or carbon dioxide in their blood and
other medicines being used.
Emergency use of Halothane
In an emergency you may have been given halothane
and received this leaflet afterwards.
If you have any further questions on the use of this
product, ask doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately if you develop any
symptoms of jaundice.
· Damage to the liver. This may show itself as
jaundice with a yellowing of the skin or whites of the
eyes. The number of white blood cell may also be
increased. Very rarely the damage may be severe
or even fatal. The risk of liver damage increases
with repeated use of halothane or if you have had a
bad reaction to anaesthetics in the post.
· A condition known as malignant hyperpyrexia.
Halothane, like other general anaesthetics, can
cause a sudden severe increase in body
temperature, which could be fatal. This condition
tends to run in families,
· Disturbances of the heart rhythm are very common.
· Feeling sick, being sick or feeling shivery after the
operations are common, mild side effects.
· Cardiac arrest.
· Kidney failure, sometimes with liver failure. If you
experience these or any other side effect not listed
in this leaflet tell you doctor or nurse.

Like other general anaesthetics, halothane might
occasionally cause some unwanted effects during
your operation. These include breathing difficulties,
low blood pressure, irregular or slow heartbeat or
too mush muscle relaxation. These are rarely
serious, as your anaesthetist will quickly deal with
any problems that arise during your operation.
Reporting of side effects
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 at:
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 Halothane
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 'EXP'. The expiry date refers to the
last day of that month.
Halothane will be stored by the hospital in a dark place
below 250 C.
6. Contents of the pack and other information
What Halothane contains
- The active substance is Halothane. There are no
other ingredients.
What Halothane looks like and contents of the
pack
· Halothane is a clear liquid available in 250ml amber
glass bottles
Marketing Authorisation Holder and Manufacturer
Piramal Healthcare UK Limited
Whalton Road, Morpeth,
Northumberland, NE61 3YA,
United Kingdom
This leaflet was last approved in : 12/2015

Paediatric population
Arrhythmias are very common in children anaesthetised with
halothane. Children anaesthetised with halothane should have ECG,
blood pressure, oxygen saturation and end tidal C02 monitoring in a
setting where full resuscitative equipment is available and with staff
fully trained in the resuscitation of children. The presence of additional
arrhythmogenic factors especially hypoxia and CO2 retention, use of
sympathomimetics (see 'Interactions'), and other factors which may
stimulate the sympathetic nervous system should also be taken into
account. Thus, to prevent hypoxia, inhalational anaesthetics are given
with concentrations of oxygen greater than 21%.
Use of inhaled anaesthetic agents has been associated with very rare
increases in serum potassium levels that have resulted in cardiac
arrhythmias and death in children during the postoperative period. The
condition has been described in patients with latent as well as overt
neuromuscular disease, particularly Duchenne muscular dystrophy.
Use of suxamethonium has been associated with most, but not all of
these cases. These patients showed evidence of muscle damage with
increased serum creatine kinase concentration and myoglobinuria.
These patients did NOT have classical signs of malignant
hyperthermia such as muscle rigidity, rapid increase in body
temperature, or increased oxygen uptake and carbon dioxide
production. Prompt and vigorous treatment for hyperkalaemia and
arrhythmias is recommended. Subsequent evaluation for latent
neuromuscular disease is indicated.
Fertility, pregnancy and lactation :
Pregnacy:
There is no clear evidence in animals that halothane is safe in early
pregnancy. Avoid, unless its use is essential.
Halothane reduces uterine muscle tone during pregnancy and
generally its use is not recommended in obstetrics because of the
increased risk of postpartum haemorrhage.
Breastfeeding:
Traces of halothane have been detected in breast milk. Breast-feeding
should be withheld for 24 hours after halothane anaesthesia.
Effects on ability to drive and use machines
Patients should not drive, or operate machinery, until fully recovered;
i.e. for at least 24 hours after receiving halothane.
Interactions with other medicinal products and other forms of
interaction
The incidence of cardiac arrhythmias may be increased when
adrenaline, most other sympathomimetics (e.g. methylphenidate),
and theophylline are used concurrently with halothane. There is also
an increased risk of hypertension when volatile liquid anaesthetics are
given with methylphenidate. The use of beta-adrenoceptor
antagonists during halothane anaesthesia is at the discretion of the
anaesthetist. The risk of arrhythmias is also increased if halothane is
used in patients receiving dopaminergics (e.g. levodopa).
Muscle relaxants: All commonly used muscle relaxants may be used in
conjunction with halothane, but, as halothane potentiates the actions
of gallamine and d-tubocurarine, the doses of these muscle relaxants
must be reduced. The association of d-tubocurarine with halothane
may lead to a marked fall in blood pressure.
Ganglion blocking agents: Potentiation occurs between halothane and
hypotensive agents such as pentolonium and trimetaphan. These

drugs must be used in reduced dosage when administered in
conjunction with halothane.
Aminoglycoside antibiotics: Halothane, along with all other general
anaesthetics, may interact with aminoglycoside antibiotics resulting
in respiratory depression. This effect may be potentiated by the
concurrent use of a neuromuscular blocker.
Suxamethonium: The concurrent use of suxamethonium with
halothane is not advisable due to the increased possibility of
hyperpyrexia.
Morphine and chlorpromazine increase the depressant effects of
halothane on respiration.
The effects of both ergometrine and oxytocin on the parturient
uterus are diminished by halothane.
An enhanced hypotensive effect may be seen when general
anaesthetics are given with adrenergic neurone blockers, alphablockers, antipsychotics or calcium channel blockers.
Monoamine oxidase inhibitors (MAOIs) should normally be
stopped 2 weeks before surgery because of hazardous
interactions between general anaesthetics and MAOIs.
Pharmaceutical Information
Excipients
None
Incompatibilities
Vaporiser: Halothane must not be used in the EMO ether vaporiser
as it attacks the metal; a vaporiser specially constructed for
halothane should be used.
Shelf-life
60 months
Storage Precautions
Store in a dark place below 25°C. Keep well closed.
Nature of Container
Amber glass bottle with red collar and an aluminium gold lacquered
cap fitted with a polythene wad. Pack size: 250 ml
Special precautions for disposal and other handling :
Please refer to 'Posology and Method of Administration'.
This leaflet was last approved: 12/2015

MA Holder :
Piramal Healthcare UK Limited
Whalton Road, Morpeth,
Northumberland, NE61 3YA
United Kingdom

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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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