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ETOMIDATE-LIPURO 2 MG/ML EMULSION FOR INJECTION

Active substance(s): ETOMIDATE

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Summary of Product Characteristics
B. Braun Melsungen AG · 34209 Melsungen, Germany

1.  NAME OF THE MEDICINAL PRODUCT

Etomidate-Lipuro 2 mg/ml
emulsion for injection
2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of emulsion for injection contains
2 mg of etomidate
10 ml of emulsion for injection (= 1 ampoule) contain 20 mg of etomidate
Excipients with known effect:
One ampoule (10 ml) of emulsion for injection contains:
Soya-bean oil, refined
1.0 g
Sodium (as sodium oleate)
0.23 mg
For the full list of excipients, see section 6.1.
3.

PHARMACEUTICAL FORM

Emulsion for injection.
Milky-white oil-in-water emulsion
pH
4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

6.0 – 8.5

Etomidate-Lipuro 2 mg/ml is indicated for the induction of general anaesthesia in adults, infants and toddlers
older than 6 months, children and adolescents.
4.2

Posology and method of administration

Posology
In all patients, the dosage should be adjusted according to the individual response and the clinical effect.
The following dosage guidelines should be followed:
Adults and adolescents
As a rule, the effective hypnotic dose is 0.3 mg of etomidate per kg body weight, corresponding to 0.15 ml of
Etomidate-Lipuro 2 mg/ml per kg body weight.
Therefore, in an adult patient one ampoule usually suffices for a sleep duration of 4-5 min.
Hypnosis can be prolonged by additional injections of Etomidate-Lipuro 2 mg/ml.
Do not exceed the total amount of 3 ampoules (30 ml).
Paediatric population
In children under 15 years the dosage may need to be increased: a supplementary dose of up to 30% of the
normal dose for adults is sometimes necessary to obtain the same depth and duration of sleep as obtained in
adults.

4.5

Interactions with other medicinal products and other forms of interaction

The hypnotic effect of etomidate may be enhanced by:
• neuroleptic drugs
• opioids
• sedatives
• alcohol.
Induction with etomidate may be accompanied by a slight and transient reduction in peripheral resistance which
may enhance the effect of other drugs reducing blood pressure.
Alfentanil
Co-administration of etomidate with alfentanil has been reported to decrease the terminal half-life of etomidate
to approximately 29 minutes. Caution should be used when both drugs are administered together as the
concentrations of etomidate may drop below the hypnotic threshold.

Calcium channel blockers (Verapamil, Diltiazem)
Combination with general anaesthetics results in an enhancement of the hypotensive effect and also AV delay.
Monoamine oxidase inhibitors (MAOI)
Because of hazardous interactions between general anaesthetics and MAOIs, MAOIs should normally be stopped 2
weeks before surgery.
4.6

Pregnancy
Safety of the use of Etomidate-Lipuro 2 mg/ml during pregnancy has not yet been established. In animals
etomidate has no primary effect on fertility, nor primary embryotoxic nor teratogenic effects. At maternally toxic
doses in rats, decreased survival was noted.

Fontsize: 9,0 pt.

Etomidate-Lipuro 2 mg/ml should be used during pregnancy only if the potential benefit justifies the risks to the
foetus.

G 140853

During obstetric anaesthesia, etomidate may cross the placenta. The Apgar scores of the newborns whose mothers
have received etomidate are comparable with those of infants born after the use of other hypnotic agents.
A transient fall in cortisol levels lasting about 6 hours was observed in the neonate after the mother was given
etomidate. The decreased values remained within the normal range.
Etomidate is excreted into human milk. Caution should be exercised when Etomidate-Lipuro 2 mg/ml is
administered to a nursing mother.

Other special patient groups

If Etomidate-Lipuro 2 mg/ml must be given during the lactation period, nursing is to be interrupted and not to be
resumed 24 hours after administration; breast milk secreted during this period must be discarded.

Etomidate-Lipuro 2 mg/ml must be injected strictly intravenously and slowly, usually over approximately
30 seconds, in fractions if required.
Intra-arterial injection must be avoided. Paravenous injection causes severe local pain.
The use of narcotic analgesics or diazepam as premedication and during surgery will reduce the uncontrolled
spontaneous muscle movements (myoclonus) shown by some patients after Etomidate-Lipuro 2 mg/ml
administration (see section 4.4 and 5.1).
Since etomidate has no analgesic effect, it is recommended to administer a suitable opioid, e.g. fentanyl
intravenously 1-2 min before the injection of Etomidate-Lipuro 2 mg/ml (see section 4.4 and 5.1).
The product must only be used by physicians trained in endotracheal intubation. Equipment for artificial
respiration must be available (see section 4.4).
4.3

Contraindications

Hypersensitivity to etomidate, soya, peanut or to any of the excipients listed in section 6.1 (see also section 4.8).
Neonates and infants up to the age of 6 months should be excluded from treatment with Etomidate-Lipuro 2 mg/
ml except for imperative indications during in-patient treatment.
4.4

4.7

Effects on ability to drive and use machines

Etomidate has a major influence on the ability to drive and use machines.
It is not recommended to use potentially dangerous machines or to drive a car during the first 24 hours after
administration.
The return of normal alertness may vary according to the duration of the operation, the total dose of etomidate
administered and concomitant medication used. Hence, a decision to allow for driving or operating machinery
must be a judgment made by the post‑anaesthesiology treatment team.
4.8

Undesirable effects

Like most general anaesthetics, etomidate may affect respiratory and vascular functions. Like some other general
anaesthetics, etomidate may cause involuntary muscle movements. Besides this, etomidate frequently affects
adrenocortical functions.
Undesirable effects are listed according to their frequencies as follows:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Not known (frequency cannot be estimated from the available data)

Special warnings and precautions for use

Special warnings
An injection of Etomidate-Lipuro 2 mg/ml should only be administered intravenously.
Induction with Etomidate-Lipuro 2 mg/ml may be accompanied by a slight and transient drop in blood pressure
due to a reduction of the peripheral vascular resistance (especially after previous administration of droperidol). In
debilitated patients in whom hypotension may be hazardous, the following measures should be taken:
1. Before induction, intravenous access should be obtained for the management of circulatory blood volume.
2. Other inducing agents should be avoided to the extent possible.
3. The induction should be carried out with the patient supine.
4. The drug should be injected slowly (e.g. 10 ml in 1 min.).
Etomidate inhibits the adrenocortical biosynthesis of steroids. Induction doses of etomidate have been associated
with a reduction in plasma cortisol and aldosterone concentrations, unresponsive to ACTH administration. When
etomidate is used for induction, the postoperative rise of serum cortisol observed after thiopentone induction is
delayed for approximately 3 – 6 hours (see section 5.1).
Where concern exists for patients undergoing severe stress, particularly those with adrenocortical dysfunction,
supplementation with exogenous cortisol (e.g. 50 – 100 mg hydrocortisone) should be considered. In such
situations stimulation of the adrenal gland with ACTH is not useful.
Prolonged suppression of endogenous cortisol and aldosterone may occur as a direct consequence of etomidate
when given by continuous infusion or in repeated doses. Use of etomidate for maintenance of anaesthesia should
therefore be avoided. In such situations stimulation of the adrenal gland with ACTH is not useful.
Etomidate should be used with caution in patients with underlying cortico-adrenal insufficiency such as patients
with sepsis.
In patients with liver cirrhosis, or in those who have already received neuroleptic, opiate, or sedative agents, the
dose of etomidate should be reduced.
Spontaneous movements may occur in one or more groups of muscles, particularly when no premedication has
been administered (see also section 4.8). These movements have been ascribed to subcortical disinhibition (see
section 5.1). They can be largely prevented by the intravenous administration of small doses of fentanyl, with
droperidol or diazepam 1-2 min before induction with Etomidate-Lipuro 2 mg/ml (see also section 4.2).
Myoclonus and local pain on injection, which is usually mild, is observed during the administration of EtomidateLipuro 2 mg/ml especially when it is injected undiluted into a small vein. This can largely be avoided by
intravenous application of a small dose of suitable opioids, e.g. fentanyl, 1 to 2 minutes before induction. To
minimise the risk of local pain, larger veins should be used.
Etomidate-Lipuro 2 mg/ml should be used with caution in elderly patients, since the potential exists for decreases
in cardiac output, which have been reported with doses greater than recommended (see section 4.2).
In animal experiments, Etomidate-Lipuro 2 mg/ml has been shown to possess a porphyrogenic potential. Therefore
it should not be administered to patients with hereditary disorder of haem biosynthesis, unless there is no safer
alternative.
Precautions for use
Since Etomidate-Lipuro 2 mg/ml has no analgesic action, appropriate analgesics should be used during
surgical procedures. If used for short-term narcosis, a strong analgesic, e. g. fentanyl, must be given prior to or
simultaneously with Etomidate-Lipuro 2 mg/ml (see section 4.2). Attention should be paid also to instructions
given in sections 4.5 and 6.6.
Etomidate-Lipuro 2 mg/ml may be used only by a doctor skilled in endotracheal intubation.

System Organ
Class

Very Common
(≥1/10)

Common
(≥1/100 to
<1/10)

Adverse Drug Reactions
Frequency Category
Uncommon
Rare
(≥1/1,000 to
(≥1/10,000 to
<1/100)
<1/1,000)

Immune System
Disorders

Endocrine
Disorders

Nervous System
Disorders

Not Known
(cannot be estimated
from the available
data)
Hypersensitivity1
(such as
anaphylactic shock,
anaphylactic
reaction,
anaphylactoid
reaction)
Adrenal insufficiency

Dyskinesia

Hypertonia,
Muscle
contractions
involuntary,
Nystagmus,
Shivering
Bradycardia,
Extrasystoles,
Ventricular
extrasystoles

Myoclonus

Cardiac
Disorders
Vascular
Disorders

Hypotension

Convulsion
(including grand mal
convulsion)

Cardiac arrest,
Atrioventricular
block complete

Hypertension

Shock
Laryngospasm

Respiratory
depression2,
Bronchospasm
(including fatal
outcome)

Respiratory,
Thoracic and
Mediastinal
Disorders

Apnoea2,
Hypoventilation,
Hyperventilation,
Hiccups, Cough
Stridor

Gastrointestinal
Disorders

Vomiting, Nausea

Salivary
hypersecretion

Rash

Erythema

Stevens-Johnson
syndrome, Urticaria

Muscle rigidity

Trismus

Skin and
Subcutaneous
Tissue Disorders
Musculoskeletal
and Connective
Tissue Disorders
General
Disorders and
Administration
Site Conditions

Injection site
pain
Anaesthetic
complication,
Delayed
recovery from
anaesthesia,
Inadequate
analgesia,
Procedural
nausea

When Etomidate-Lipuro 2 mg/ml is used, resuscitation equipment should be readily available to manage
respiratory depression and the possibility of apnoea.
Etomidate-Lipuro 2 mg/ml contains less than 1 mmol (23 mg) sodium (as sodium oleate) per ampoule, i.e. it is
essentially sodium-free.

GB___401
401/12610220/0714
GIF (L11)
Standort Berlin

Fertility, pregnancy and lactation

Breast-feeding

Intravenous use

Lätus 99

Adrenergic neurone blockers, alpha blockers
Combination with general anaesthetics leads to an enhancement of the hypotensive effect of these substances.

Elderly patients should be given a single dose of 0.15 to 0.2 mg of etomidate per kg body weight and the dose
should be further adjusted according to effects (see section 4.4).

Method of administration

Format = 335 x 962 mm
2 Seiten

Ketamine
Co-administration of etomidate and ketamine appears to have no significant effect on the plasma concentrations
or pharmacokinetic parameters of ketamine or its principal metabolite, norketamine.

Elderly patients

In patients with liver cirrhosis or those who have already received neuroleptic, opiate or sedative medication, the
dose of etomidate should be reduced.

schwarz

Fentanyl
The total plasma clearance and volume of distribution of etomidate is decreased by a factor of 2 to 3 without
a change in half-life when administered with fentanyl intravenously. When etomidate is co-administered with
fentanyl intravenously, the dose may need to be reduced.

Injury, Poisoning
and Procedural
Complications

1) After administration of etomidate, release of histamine has been noted.
Etomidate-Lipuro 2 mg/ml contains soya-bean oil, which may very rarely cause severe allergic reactions.
2) Respiratory depression and apnoea may occur especially after administration of higher doses of etomidate in
combination with central depressant drugs. In patients of 55 years of age or older, respiratory depression and
apnoea may occur especially after doses exceeding the recommended maximum dose of 0.2 mg of etomidate
per kg body weight.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

B|BRAUN

B. Braun Melsungen AG
34209 Melsungen, Germany

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Etomidate-Lipuro 2 mg/ml Emulsion for Injection
Etomidate
Read all of this leaflet carefully before 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 or pharmacist.
• 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 pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:
1. What Etomidate-Lipuro is and what it is used for
2. What you need to know before you use Etomidate-Lipuro
3. How to use Etomidate-Lipuro
4. Possible side effects
5. How to store Etomidate-Lipuro
6. Contents of the pack and other information

1. What Etomidate-Lipuro is and what it is used for
Etomidate-Lipuro belongs to a group of medicines called general anaesthetics. It is used to induce a general anaesthesia, that is, to put patients to sleep before operations and other procedures, so they do not feel anything. It
is injected into a vein.
Etomidate-Lipuro is used in adults, adolescents and children older than 6 months.

2. What you need to know before you use Etomidate-Lipuro
Do not use Etomidate-Lipuro:
• if you are allergic to etomidate, soya, peanut or any of the other ingredients of this medicine (listed in section 6).
• It should not be used in children who are under 6 months old, unless the case is a hospital emergency.

Warnings and precautions
Talk to your doctor or pharmacist before using Etomidate-Lipuro.
Only doctors trained in putting tubes down into patients’ windpipes should use Etomidate-Lipuro. Life-saving
respiration equipment should always be available during the use of this product.
Your doctor may give you painkillers first, in order to prevent pain during injection of etomidate. To minimise the
risk of local pain, your doctor should use larger veins for injection.
In most cases your doctor will give you some medicines helping to prevent uncontrolled muscle spasms.
Because etomidate does not affect pain but only puts you to sleep, your doctor will give you a strong painkiller
with etomidate for short operations.
Your doctor will give you lower doses of etomidate:
• if you have problems with your liver
• if you received drugs for the treatment of mental illness (neuroleptic drugs)
• if you received strong painkillers (so-called opioids) or sedatives (see also section 3).
In elderly patients, etomidate may reduce cardiac output and therefore will be administered with caution (see also
section 3).
The use of etomidate may lead to a drop in blood pressure. Your doctor will take special care if you are very weak
(debilitated), because low blood pressure can be dangerous in this case.
Doctors should not administer etomidate to patients with an inborn disorder of production of the red blood pigment
(haem) unless there is no safer anaesthetic.
Etomidate should not be used for keeping people under anaesthesia because etomidate may cause a drop in a
hormone called cortisol, especially when administered over a longer time. To prevent a drop of the cortisol level
below normal values, the doctor may need to give cortisol to some patients (especially those undergoing severe
stress) before etomidate.
Your doctor will take special care if your adrenal glands (glands attached to the kidneys) are not working properly,
e.g. if you suffer from blood poisoning (sepsis).

Your doctor will take into account, that the required dose of etomidate may change if the strong pain killers
alfentanil and fentanyl are given in combination with etomidate.
Alpha-blockers and other agents used to lower the blood pressure
Etomidate-Lipuro may enhance the effect of alpha-blockers and other medicines that reduce your blood pressure.
Calcium channel blockers (e.g. Verapamil, Diltiazem; used to treat high blood pressure and heart diseases)
When you take Verapamil in combination with etomidate your blood pressure may decrease. Moreover your heart
function could be affected.
Monoamine oxidase inhibitors (MAOI, substances used to treat mental depression or Parkinson’s disease)
You should not take MAOI at least two weeks before a treatment with etomidate. Otherwise this could harm your
health.

Etomidate-Lipuro with alcohol
You should not drink any alcoholic beverages before you are given etomidate because this may increase the effect
of etomidate.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
There are no data demonstrating that it is safe to use etomidate during pregnancy, so doctors only use it in
exceptional cases if there is no safer alternative available.
Like other anaesthetics used in childbirth, etomidate may cross the placenta.
Etomidate passes into breast milk. Do not breast-feed your baby for 24 hours after you have had etomidate. Throw
away any milk you express during this time.

Driving and using machines
Do not drive or use machines for at least 24 hours after you received etomidate. Your doctor will tell you when you
can drive and use machinery again.

Etomidate-Lipuro contains soya-bean oil and sodium
This product contains soya-bean oil. In rare cases, soya-bean oil may cause severe allergic reactions.
Etomidate-Lipuro contains less than 1 mmol (23 mg) sodium (as sodium oleate) per ampoule, i.e. it is essentially
sodium-free.

3. How to use Etomidate-Lipuro
The doctor will decide on the right dose of Etomidate-Lipuro depending on how you respond.
Adults and adolescents
Normally the dose is 0.3 mg per kilogram (kg) of bodyweight for both adults and adolescents. This is the same as
0.15 ml per kg body weight. No more than 3 ampoules (30 ml) of Etomidate-Lipuro will be given to you.
Use in children
Usually children receive the same dose as adults. There may be cases, however, where children do not sleep
sufficiently deeply with this dose. Then more etomidate will have to be given, up to 0.4 mg per kg of body weight,
after the doctor is sure that this will not put the patient at a higher risk.
Elderly patients
Elderly patients usually respond to 0.15 to 0.2 mg per kg bodyweight.

Children and adolescents

401/12610220/0714

Etomidate-Lipuro should not be used in children younger than 6 months unless the doctor considers it necessary
(see also “Do not use Etomidate-Lipuro”).
Children under 15 years of age may need higher doses of Etomidate-Lipuro to obtain the same depth and duration
of sleep as in adults (see also section 3).

Etomidate-Lipuro 2 mg/ml
Emulsion for Injection

Other medicines and Etomidate-Lipuro
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some drugs for treatment of mental illness (neuroleptic drugs), some strong painkillers (so-called opioids) and
sedatives can make the anaesthetic effect of etomidate stronger.

Etomidate

B|BRAUN

12610220_Etomidate-Lipuro2_GIF-L11__GB.indd 1

B. Braun Melsungen AG
34209 Melsungen, Germany

04.07.14 06:01

4.9

Overdose

Symptoms
An overdose of etomidate, administered as a bolus, deepens sleep and may cause respiratory depression and even
respiratory arrest, in which case adequate respiratory support is mandatory.
Hypotension has also been observed in such cases.
Overdosage may depress cortical secretion. This may be associated with disorientation and delayed awakening.
Treatment
Treatment depends on the nature and severity of the symptoms, including, if necessary, respiratory support.
In addition to supportive measures (e.g. of respiration) administration of 50‑100 mg hydrocortisone (not ACTH)
may be required.
All equipment and medication usually required in general anaesthetic procedures should be available.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Soya-bean oil, refined,
Medium-chain triglycerides,
Glycerol,
Egg lecithin,
Sodium oleate,
Water for injections
6.2

6.3
5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Other general anaesthetics,
ATC code: N01AX07.
Mechanism of action, pharmacodynamic effects
The effect of etomidate starts at short notice and the duration of the hypnotic effect is short as a result of
redistribution and metabolic inactivation. A single dose of 0.3 mg/kg body weight leads to loss of consciousness in
30-60 seconds and to narcosis of 3 – 5 minutes duration, followed by sleep.
Other pharmacological effects

Incompatibilities

Etomidate-Lipuro 2 mg/ml must not be mixed with any other product.
Shelf Life

Unopened
2 years
After first opening
To be used immediately, see section 6.6.
After reconstitution / dilution
not applicable
6.4

Special precautions for storage

Do not freeze.
Keep ampoules in the outer carton in order to protect from light.

Etomidate suppresses the function of the adrenal cortex. Etomidate inhibits adrenal cell cortisol production
by reversibly blocking the steroid synthesis enzyme 11-β-hydroxylase. The cortisol suppression is unresponsive
to ACTH and lasts up to 8 h after a single 0.3 mg/kg dose of etomidate. The inhibition of cortisol synthesis is
reversible and depends on the etomidate concentration in plasma.

6.5

Involuntary muscle movements observed after administration of etomidate result from disinhibition of
physiological diencephalic excitations, similar to myoclonus during physiological sleep.

6.6

Etomidate has been reported to possess anticonvulsive properties and a protective effect on brain cells against
hypoxic damage.

Ampoules should be shaken prior to use to ensure homogenous distribution. Only to be used if the emulsion is
homogenous and milky-white after shaking. If two layers can be seen after shaking the ampoule should not be
used.

Since etomidate has no analgesic effect, concurrent administration of an analgesic is required for all surgical
procedures.
5.2

Pharmacokinetic properties

Absorption
Since Etomidate-Lipuro 2 mg/ml is administered intravenously, its bioavailability is 100 %.
Distribution

Nature and contents of container

The product is supplied in colourless glass ampoules (type I glass, Ph. Eur.) containing 10 ml
Pack sizes:
packs of 10 ampoules
Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Not to be used if ampoule shows signs of damage.
Etomidate-Lipuro 2 mg/ml does not contain antimicrobial preservatives. Immediately after opening of the
ampoule, the emulsion has to be drawn up in a syringe under aseptic conditions and injected, because fat
emulsions promote microbial growth. Unused portions must be discarded.
Drugs to be given concurrently with Etomidate-Lipuro 2 mg/ml, e.g. an analgesic, should be administered
consecutively through the same line or through separate venous cannulae.

Etomidate rapidly separates from the oil particles upon injection. This is reflected by the etomidate plasma
concentration, which is comparable with that of the aqueous formulation.

Etomidate-Lipuro 2 mg/ml may be injected into the tubing of an infusion of isotonic sodium chloride having
temporarily been stopped.

The plasma protein binding of etomidate (primarily to albumin) is about 75 %, it is reduced in renal dysfunction or
chronic liver damage.

7.

Etomidate is rapidly distributed to the brain and other tissues.
The total volume of distribution is about 4.5 l/kg.
Rapid distribution from the central compartment to a peripheral and a deeper peripheral compartment as well
as a high elimination rate cause the plasma concentration to fall rapidly for about 30 minutes after a single
administration. Then, the plasma concentration declines more slowly.
Biotransformation and elimination
The primary step of biotransformation is the hydrolysis of the ethyl ester in the liver. A small proportion is also
subject to oxidative N-dealkylation. All metabolites discovered are pharmacologically inactive.
The elimination half-life is relatively long (terminal elimination half-life 2 – 5 h) despite a high rate of hepatic
extraction due to slow redistribution of etomidate from the deeper peripheral compartment.
About 75 % of the administered dose of etomidate appear in the urine within 24 hours, primarily as metabolites.
Other routes of excretion play a minor role.
The major metabolite in the urine (about 80 %) is the hydrolysis product of etomidate, namely R-(+)-1-(amethylbenzyl)-5-imidazolecarboxylic acid. Only 2 % of etomidate are excreted unchanged via the urine.

MARKETING AUTHORISATION HOLDER

B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
8.

MARKETING AUTHORISATION NUMBER(s)

PL 03551/0041
9.

DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

11.03.2002 / 31.05.2006
10.

DATE OF REVISION OF THE TEXT

July 2014

The half-life of the lipid particles is short.
Accumulation has not been observed.
5.3

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber that are additional to those already stated in other
sections of the SmPC.

B|BRAUN

B. Braun Melsungen AG
34209 Melsungen, Germany

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The dose is less in patients with a liver disease called cirrhosis and in patients who have had special drugs for
treatment of mental illness (neuroleptics), strong painkillers (so-called opioids) or sedatives just before etomidate.
Your doctor will usually give the injection slowly over about 30 seconds, or as a number of very small injections,
into the vein. Your doctor will avoid to inject this medicine into an artery.
Before giving etomidate, the doctor will usually give the patient a drug such as diazepam, which depresses the
central nervous system and reduces uncontrolled muscle spasms.

If you have received more Etomidate-Lipuro than you should
In such a case the sleeping period may be extended and breathing may stop for a short time. Your blood pressure
may also be lowered.
The treatment of such events depends on the severity of symptoms. In general, to manage such occurrences, all
equipment and medicines usually required in general anaesthetic procedures (especially breathing support) will be
available.
Overdosage may also affect the function of your adrenal glands. In such cases your doctor may give you a medicine
called hydrocortisone.

Not known (frequency cannot be estimated from the available data):
• Problems with your adrenal glands (glands attached to the kidneys)
• Convulsions
• Heart attack
• Severe problems with your heart
• Hives
• Severe allergic reaction of the skin and mucous membranes accompanied by blistering and reddening of the skin
(Erythema), which might in very severe cases affect inner organs and might be life threatening (Stevens-Johnson
syndrome)
• Lockjaw
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 the package 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.

4. Possible side effects

5. How to store Etomidate-Lipuro

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most likely, etomidate may affect breathing and circulation. Uncontrolled muscle movements may occur. Besides
this, etomidate may also affect the function of the adrenal glands.

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule label and the carton. The expiry date
refers to the last day of that month.
Ampoules should be shaken before use. This medicine must only be used if it is homogenous and milky-white after
shaking. The product must not be used if two separate layers can be seen after shaking the ampoule. The doctor or
nurse will check that the ampoule is not damaged.
Keep ampoules in the outer carton in order to protect from light. Do not freeze.
Do not throw away 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.

The following side effects may be serious and, therefore, require immediate treatment:
Common (may affect up to 1 in 10 people):
• Breathing may slow down or stop for a short time. This can be easily managed by your anaesthetist.
Uncommon (may affect up to 1 in 100 people):
• Slow or irregular heartbeat
Rare (may affect up to 1 in 1,000 people):
• Spasm of the voice box
Not known (frequency cannot be estimated from the available data):
• Allergic reactions have been observed. A special type of hypersensitivity reaction, the so-called anaphylactoid
reaction, has been observed, too.
• Shock
• Difficulty in breathing that may be fatal

Other side effects include
Very common (may affect more than 1 in 10 people):
• Jerky movements
Common (may affect up to 1 in 10 people):
• Muscle twitching
• Low blood pressure
• Wheezing
• Hyperventilation
• Feeling sick, vomiting
• Rash
Uncommon (may affect up to 1 in 100 people):
• Unusual muscle stiffness and involuntary muscle contractions
• Involuntary eye movements (nystagmus)
• Shivering
• High blood pressure
• Hypoventilation
• Coughing
• Hiccups
• Too much saliva
• Redness of the skin
• Pain around the injection site
• Complications associated with general anaesthesia (delayed wake-up, sensation of pain due to insufficient
painkilling effect, feeling sick)

6. Contents of the pack and other information
What Etomidate-Lipuro contains
– The active substance is Etomidate
Each millilitre of the emulsion contains 2 mg of Etomidate.
Each ampoule (10 millilitres) contains 20 mg of Etomidate.
– The other ingredients are:
Soya-bean oil
Medium-chain triglycerides
Glycerol
Egg lecithin
Sodium oleate
Water for injections
– pH: 6.0 – 8.5

What Etomidate-Lipuro looks like and contents of the pack
Etomidate-Lipuro is a milky-white emulsion of oil in water.
It comes in colourless glass ampoules containing 10 ml of sterile emulsion.
It is available in packs of 10 ampoules.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567

Postal address:
34209 Melsungen, Germany

This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands: Etomidaat-Lipuro 2 mg/ml, emulsie voor injectie
Portugal:
Etomidato-Lipuro 2 mg/ml, emulsão injectável
Spain:
Etomidato-Lipuro 2 mg/ml, emulsión inyectable
United Kingdom: Etomidate-Lipuro 2 mg/ml, emulsion for injection

This leaflet was last revised in July 2014.

B|BRAUN

12610220_Etomidate-Lipuro2_GIF-L11__GB.indd 2

B. Braun Melsungen AG
34209 Melsungen, Germany

04.07.14 06:01

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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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