Prospecto: information for the user

Etomidate-Lipuro 2mg/ml, injectable emulsion

Etomidate

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• See section 4 if you experience adverse effects, even if they are not listed in this prospect.

1.What Etomidate-Lipuro is and for what it is used

2.What you need to know before starting to use Etomidate-Lipuro

3.How to use Etomidate-Lipuro

4.Possible adverse effects

5.Storage of Etomidate-Lipuro

6.Contents of the package and additional information

Etomidato-Lipuro belongs to a group of medications known as general anesthetics. It is used to induce general anesthesia, that is, to put patients to sleep before operations and other procedures, so that they do not feel anything.It is injected into a vein.

Etomidato-Lipuro is used in adults, adolescents, and children over 6 months old.

No use Etomidato-Lipuro:

Advertencias y precauciones

Consult your doctor or pharmacist before starting to use Etomidato-Lipuro.

Only medical professionals who have been trained in the placement of tracheal tubes in patients should use Etomidato-Lipuro. During the use of this product, there should always be available equipment for respiratory support.

Your doctor may administer analgesics initially to avoid pain during the etomidate injection. To minimize the risk of local pain, your doctor should use the largest caliber veins for the injection.

In most cases, your doctor will give you some medications that help prevent uncontrolled muscle spasms.

Since etomidate does not have effects on pain, but only makes you sleep, your doctor will administer a potent analgesic along with etomidate during short operations.

Your doctor will administer lower doses of etomidate:

• If you have liver problems.

• If you received medications for the treatment of mental illnesses (neuroleptic medications).
• If you received potent analgesics (called opioids) or sedatives (see also section 3).

In elderly patients, etomidate may reduce cardiac output and therefore should be administered with caution (see also section 3).

The use of etomidate may lead to a decrease in blood pressure. Your doctor will take special precautions if you are very weak (debilitated), as low blood pressure can be dangerous in this case.

Doctors should not administer etomidate to patients with congenital disorders of red blood cell pigment production (hemo) unless a safer anesthetic is not available.

Etomidate should not be used to maintain people under anesthesia because it can cause a decrease in a hormone called cortisol, especially when administered for a prolonged period.To avoid a cortisol level below normal values, your doctor may need to administer cortisol to some patients (especially those undergoing intense stress) before administering etomidate.

Single doses of etomidate induction may lead to transient adrenal insufficiency and decreased serum cortisol levels.

Etomidate should be used with caution in critically ill patients, including those with sepsis, as it has been associated with a higher risk of mortality in some studies of these patient groups.

Children and adolescents

Etomidato-Lipuro should not be used in children under 6 months unless the doctor considers it necessary (see also «Do not use Etomidato-Lipuro»).

Children under 15 years of age may need higher doses of Etomidato-Lipuro to achieve the same depth and duration of sleep as in adults (see also section 3).

Use of Etomidato-Lipuro with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications for the treatment of mental illnesses (neuroleptic medications), some potent analgesics (called opioids), and sedatives may make the anesthetic effect of etomidate more potent.

Your doctor will take into account that the necessary dose of etomidate may change if fentanil and alfentanilo opioids are administered in combination with etomidate.

Alpha-blockers and other medications used to lower blood pressure

Etomidato-Lipuro may potentiate the effect of alpha-blockers and other medications that reduce your blood pressure.

Calcium channel blockers (e.g., verapamil, diltiazem; used to treat high blood pressure and heart disease)

When taking verapamil in combination with etomidate, your blood pressure may decrease. Additionally, heart function may be affected.

Monamine oxidase inhibitors (MAOIs, substances used to treat mental depression or Parkinson's disease)

You should not take MAOIs for at least two weeks before a treatment with etomidate, otherwise this may harm your health.

Use of Etomidato-Lipuro and alcohol

You should not take any alcoholic beverages before receiving etomidate as this may increase the effect of etomidate.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

There is no evidence that the use of etomidate during pregnancy is safe, so doctors will only use it in exceptional cases if no other alternative is available.

Like other anesthetics used during delivery, etomidate may cross the placental barrier.

Etomidate passes into breast milk. Do not breastfeed your baby for 24 hours after receiving etomidate. Discard any milk you express during this time.

Driving and operating machinery

Do not drive or operate machinery for at least 24 hours after receiving etomidate.Your doctor will indicate when you can drive and use machinery again.

Etomidato-Lipuro contains soy oil and sodium

Etomidato-Lipurocontains soy oil. If you are allergic to peanuts or soy, do not use this medication.

This medication contains less than 1mmol (23mg) of sodium per ampoule, which is essentially “sodium-free”.

The doctor will decide on the appropriate dose of Etomidato-Lipuro based on how you respond.

Adults and adolescents

The usual dose is 0.3mg per kilogram (kg) of body weight, for both adults and adolescents.This is equivalent to 0.15ml per kg of body weight.You will not be given more than 3 ampoules (30ml) of Etomidato-Lipuro.

Use in children

Children usually receive the same dose as adults.However, there may be cases where children do not achieve a deep enough sleep with this dose.Therefore, a higher amount of etomidate may need to be administered, up to 0.4mg per kg of body weight, once the doctor has ensured that this will not put the patient at a higher risk.

Elderly patients

Elderly patients usually respond to doses of between 0.15and 0.2mg per kg of body weight.

This dose is lower in patients with a liver disease called cirrhosis and in patients who have received special medications for the treatment of mental illnesses (neuroleptics), powerful analgesics (called opioids) or sedatives before receiving etomidate.

Generally, the doctor will apply the injection slowly over 30seconds, or as a series of small injections in the vein.The doctor will avoid injecting the medication into an artery.

Before administering etomidate, the doctor usually gives the patient a medication such as diazepam, which depresses the central nervous system and reduces uncontrolled muscle spasms.

If you use more Etomidato-Lipuro than you should

In this case, the sleep period may be prolonged and breathing may stop for a short time.Your blood pressure may also be decreased.

The treatment of such events depends on the severity of the symptoms.Generally, for treating these events, all the necessary equipment and medications will be available, as usual in general anesthesia procedures (especially respiratory support equipment).

Overdose may also affect the function of the adrenal glands.In these cases, your doctor may administer a medication called hydrocortisone.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most likely effect of etomidate is on breathing and circulation. Uncontrolled muscle movements may also occur. In addition, etomidate may also affect the function of the adrenal glands.

The following side effects may be serious and require immediate treatment:

Frequent(may affect up to 1 in 10 people):

• Respiratory arrest or stoppage for a short time. Your anesthesiologist may easily control these situations.

Rare(may affect up to 1 in 100 people):

• Slow or irregular heart rhythm.

Rare(may affect up to 1 in 1,000 people):

• Laryngeal spasm.

Unknown frequency(frequency cannot be estimated from available data):

• Allergic reactions have been observed. A special type of hypersensitivity reaction, anaphylactoid reaction, has also been observed.
• Shock.
• Life-threatening breathing difficulty.

Other side effects include

Very frequent(may affect more than 1 in 10 people):

• Spasmodic movements.
• Cortisol decrease.

Frequent(may affect up to 1 in 10 people):

• Muscle spasms.
• Low blood pressure.
• Wheezing.
• Hyperventilation.
• Unpleasant sensation, vomiting.
• Skin rashes.

Rare(may affect up to 1 in 100 people):

• Unusual muscle stiffness and involuntary muscle contractions.
• Involuntary eye movements (nystagmus).
• Chills.
• High blood pressure.
• Hypovenilation.
• Coughing.
• Hiccup.
• Excessive salivation.
• Skin redness.
• Pain around the injection site.
• Complications related to general anesthesia (delayed recovery from anesthesia, pain due to insufficient analgesic effect, unpleasant sensation).

Unknown frequency(frequency cannot be estimated from available data):

• Problems with your adrenal glands (glands adjacent to the kidneys).
• Seizures.
• Heart attack.
• Severe heart problems.
• Hives.
• Severe allergic reactions in the skin and mucous membranes accompanied by blisters and skin redness (erythema), which could, in very severe cases, affect internal organs and be potentially fatal (Stevens-Johnson syndrome).
• Trismus.

If any of the side effects are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use.Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the ampule label and the box. The expiration date is the last day of the month indicated.

The ampules must be shaken before use. This medication should only be used if the emulsion is homogeneous and off-white in color after shaking it.The product should not be used if two separate layers are observed after shaking the ampule. The doctor or nurse will check that the ampule is not damaged.

Store the ampules in the outer packaging to protect them from light.Do not freeze.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need.By doing so, you will help protect the environment.

Composition of Etomidate-Lipuro

• The active principle is Etomidate

Each milliliter of the emulsion contains 2mg of etomidate.

Each ampule (10milliliters) contains 20mg of etomidate.

• The other components are:

Soybean oil

Medium-chain triglycerides

Glycerol

Egg phospholipids for injectable preparations

Sodium oleate

Water for injectable preparations

• pH: 6.0‑8.5

Appearance of the product and contents of the container

Etomidate-Lipuro is a white, milky oil-in-water emulsion.

It is presented in colorless glass ampules containing 10ml of sterile emulsion.

It is available in containers of 10 ampules.

Marketing authorization holder and responsible manufacturer

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Postal address:

34209 Melsungen

Germany

Phone: +49-5661-71-0

Fax: +49-5661-71-4567

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Netherlands:Etomidaat-Lipuro 2mg/ml, emulsion for injection

Portugal:Etomidate-Lipuro 2mg/ml, emulsion injectable

Spain:Etomidate-Lipuro 2mg/ml, injectable emulsion

United Kingdom (Northern Ireland):Etomidate-Lipuro 2mg/ml, emulsion for injection

Last review date of this leaflet:11/2023.