Etomidate-Lipuro 2 mg/ml injectable emulsion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Etomidate-Lipuro 2mg/ml, injectable emulsion

Etomidate

Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet Contents

1. What Etomidate-Lipuro is and what it is used for
2. What you need to know before using 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 anesthetics. It is used to induce general anesthesia, that is, to render patients unconscious before surgery and other procedures so that they do not feel anything. It is injected into a vein.

Etomidate-Lipuro is used in adults, adolescents, and children over 6 months of age.

2. What you need to know before using Etomidate-Lipuro

Do not use Etomidate-Lipuro:

• If you are allergic to etomidate, soybeans, peanuts, or any of the other components of this medicine (listed in section 6).
• It should not be used in children under 6 months of age, unless in a hospital emergency situation.

Warnings and precautions

Talk to your doctor or pharmacist before using Etomidate-Lipuro.

Only healthcare professionals trained in endotracheal intubation should administer Etomidate-Lipuro. Life-supporting respiratory equipment must always be available during the use of this product.

Your doctor may give you analgesics beforehand to prevent pain during etomidate injection. To minimize the risk of local pain, your doctor should use large-caliber veins for the injection.

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

Because etomidate does not provide pain relief but only induces sleep, your doctor will administer a potent analgesic along with etomidate during short surgical procedures.

Your doctor will administer lower doses of etomidate:

• If you have liver problems.
• If you have received medications for mental illnesses (neuroleptic drugs).
• If you have 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 exercise special caution if you are severely debilitated, as low blood pressure may be dangerous in such cases.

Etomidate should not be administered to patients with congenital disorders of the production of the red pigment in blood (heme), unless no safer anesthetic is available.

Etomidate should not be used for maintenance of anesthesia because it may cause a reduction in cortisol, a hormone, especially when administered for prolonged periods. To prevent cortisol levels from dropping below normal, the doctor may need to administer cortisol to some patients (particularly those under significant stress) before giving etomidate.

Single induction doses of etomidate 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 an increased risk of mortality has been observed in some studies involving these patient groups.

Children and adolescents

Etomidate-Lipuro should not be used in children under 6 months of age unless the doctor considers it necessary (see also "Do not use Etomidate-Lipuro").

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

Using Etomidate-Lipuro with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medications used to treat mental illnesses (neuroleptic drugs), certain potent analgesics (called opioids), and sedatives may enhance the anesthetic effect of etomidate.

Your doctor will take into account that the required dose of etomidate may change when potent analgesics such as fentanyl and alfentanil are administered in combination with etomidate.

Alpha-blockers and other medicines used to lower blood pressure

Etomidate-Lipuro may enhance 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 conditions)

When verapamil is taken in combination with etomidate, your blood pressure may decrease. In addition, heart function may be affected.

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

You should not take MAOIs for at least two weeks before receiving etomidate treatment, as this could harm your health.

Alcohol and Etomidate-Lipuro

Do not consume any alcoholic beverages before receiving etomidate, as this may increase the effect of etomidate.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

There are no data demonstrating that the use of etomidate during pregnancy is safe; therefore, doctors will use it only in exceptional cases when no alternative is available.

Like other anesthetics used during childbirth, etomidate can cross the placental barrier.

Etomidate passes into breast milk. You must not breastfeed your baby for 24 hours after receiving etomidate. Discard any milk expressed during this period.

Driving and using machines

Do not drive or operate machinery for at least 24 hours after receiving etomidate. Your doctor will advise you when you can resume driving and using machinery.

Etomidate-Lipuro contains soybean oil and sodium

Etomidate-Lipuro contains soybean oil. If you are allergic to peanuts or soybeans, do not use this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, i.e., it is essentially "sodium-free".

3. How to use Etomidate-Lipuro

The doctor will decide the appropriate dose of Etomidate-Lipuro depending on how you respond.

Adults and adolescents

Generally, the dose is 0.3 mg per kilogram (kg) of body weight, for both adults and adolescents. This corresponds to 0.15 ml per kg of body weight. You will not be given more than 3 vials (30 ml) of Etomidate-Lipuro.

Use in children

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

Elderly patients

Elderly patients usually respond to doses between 0.15 and 0.2 mg 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), strong painkillers (called opioids), or sedatives before receiving etomidate.

Generally, the doctor will administer the injection slowly over approximately 30 seconds, or as a series of small injections into the vein. Your 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 Etomidate-Lipuro than you should

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

Treatment of such events depends on the severity of the symptoms. Generally, all necessary equipment and medications usually required during general anesthesia procedures (especially respiratory support) will be available.

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

4. Possible adverse effects

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

Etomidate is most likely to affect breathing and circulation. Uncontrolled muscle movements may occur. In addition, etomidate can also affect the function of the adrenal glands.

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 temporarily. Your anaesthetist can easily manage these situations.

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

• Slow or irregular heartbeat.

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

• Laryngospasm.

Frequency not known (frequency cannot be estimated from the available data):

• Allergic reactions have been observed. A special type of hypersensitivity reaction, known as an anaphylactoid reaction, has also been observed.
• Shock.
• Difficulty breathing, which may be fatal.

Other adverse effects include

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

• Spasmodic movements.
• Decreased cortisol levels.

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

• Muscle spasms.
• Low blood pressure.
• Wheezing.
• Hyperventilation.
• Feeling unwell, vomiting.
• Skin rashes.

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

• Unusual muscle rigidity and involuntary muscle contractions.
• Involuntary eye movements (nystagmus).
• Chills.
• High blood pressure.
• Hypoventilation.
• Cough.
• Hiccups.
• Excessive salivation.
• Reddening of the skin.
• Pain around the injection site.
• Complications related to general anaesthesia (delayed recovery from anaesthesia, sensation of pain due to insufficient analgesic effect, feeling unwell).

Frequency not known (frequency cannot be estimated from the available data):

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Etomidate-Lipuro

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

Do not use this medicine after the expiry date stated on the ampoule label and the outer carton. The expiry date refers to the last day of the month indicated.

Ampoules must be shaken before use. This medicine should only be used if, after shaking, the emulsion is homogeneous and milky white in appearance. The product must not be used if two separate layers are observed after shaking the ampoule. The doctor or nurse will check that the ampoule is not damaged.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Etomidato-Lipuro

• 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 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

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

It is supplied in colourless glass ampoules containing 10 ml of sterile emulsion.

It is available in packs of 10 ampoules.

Marketing Authorisation Holder and Manufacturer

• Braun Melsungen AG
  Carl-Braun-Strasse 1
  34212 Melsungen
  Germany

Postal address:
34209 Melsungen
Germany
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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

Date of the most recent review of this leaflet: 11/2023