ETOMIDATE-LIPURO 2 mg /Ml Emulsion

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
2. What is Etomidate-Lipuro and what is it used for
3. Important information before using Etomidate-Lipuro
   1. When not to use Etomidate-Lipuro
   2. Warnings and precautions
   3. Pregnancy
   4. Breastfeeding
   5. Driving and using machines
   6. Etomidate-Lipuro and other medicines
   7. Etomidate-Lipuro with alcohol
4. How to use Etomidate-Lipuro
   1. Recommended dose
   2. Children over 6 months of age and adolescents up to 15 years of age, as well as elderly patients
   3. In case of administration of a higher dose of Etomidate-Lipuro than recommended
5. Possible side effects
   1. Reporting side effects
6. How to store Etomidate-Lipuro
   1. Expiry date
7. Contents of the packaging and other information
   1. What Etomidate-Lipuro contains
   2. What Etomidate-Lipuro looks like and what the pack contains
   3. Marketing authorization holder Manufacturer
   4. Date of last update of the leaflet: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   5. Information intended for healthcare professionals only:
   6. Dosing
   7. Incompatibilities
   8. Instructions for use and handling of the product

Leaflet accompanying the packaging: patient information

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

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Etomidate-Lipuro and what is it used for
• 2. Important information before using Etomidate-Lipuro
• 3. How to use Etomidate-Lipuro
• 4. Possible side effects
• 5. How to store Etomidate-Lipuro
• 6. Contents of the packaging and other information

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

The active substance of Etomidate-Lipuro, etomidate, has a sedative effect and is used in general anesthesia. The effect of the medicine appears very quickly, and the sedative effect is short
Note:
In the case of short-term anesthesia, Etomidate-Lipuro should be administered together with an appropriate analgesic.

2. Important information before using Etomidate-Lipuro

When not to use Etomidate-Lipuro

• in newborns and infants up to six months of age,

Warnings and precautions

Before starting Etomidate-Lipuro, discuss it with your doctor or nurse.
Single inducing doses of etomidate may lead to transient adrenal insufficiency and decreased cortisol levels in the serum.
Etomidate should be used with caution in critically ill patients, including those with sepsis, as it has been associated with an increased risk of death in some studies in this patient group.
Tell your doctor if any of the following apply to you:

to patients with hereditary disorders of hemoglobin synthesis, unless there is a clear indication for administration after careful consideration of the risks and benefits.

Etomidate-Lipuro does not have analgesic effects. In the case of short-term anesthesia, a strong analgesic, such as fentanyl, should be administered simultaneously or before Etomidate-Lipuro.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor before using this medicine.
The safety of using Etomidate-Lipuro during pregnancy has not been established.
Therefore, Etomidate-Lipuro can only be administered to pregnant women in exceptional cases, when there is no other option.

Breastfeeding

Before using any medicine, consult your doctor
Etomidate passes into breast milk. If Etomidate-Lipuro needs to be administered during lactation, breastfeeding should be interrupted for at least 24 hours after administration of the medicine; the milk obtained during this time should be discarded.

Driving and using machines

Etomidate-Lipuro impairs psychomotor performance. Do not drive vehicles, operate any machines, or use hazardous tools for 24 hours after receiving Etomidate-Lipuro.

Etomidate-Lipuro and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The sedative effect of Etomidate-Lipuro is enhanced by: neuroleptics (used to treat mental disorders, mainly schizophrenia and other psychoses), opioids (strong painkillers), sedatives.

Etomidate-Lipuro with alcohol

Alcohol enhances the sedative effect of Etomidate-Lipuro.
Etomidate-Lipuro contains soybean oil and sodium.
The medicine contains soybean oil. Do not use if you are hypersensitive to peanuts or soybeans.
This medicine contains less than 1 mmol (23 mg) of sodium (as sodium oleate) per ampoule, which means the medicine is considered "sodium-free".

3. How to use Etomidate-Lipuro

Etomidate-Lipuro may only be administered by a doctor who is able to perform endotracheal intubation and has access to resuscitation equipment.
Etomidate-Lipuro is administered intravenously in a slow injection. If necessary, the dose can be divided into several parts.
Before using Etomidate-Lipuro, the doctor may administer a benzodiazepine to the patient intramuscularly or intravenously to avoid uncontrolled muscle movements.
Etomidate-Lipuro does not have analgesic effects. The doctor may administer a painkiller (e.g., fentanyl) to the patient simultaneously or before using Etomidate-Lipuro.
In case of adrenal cortex dysfunction or during very long surgical procedures, the doctor may administer cortisol, an adrenal cortex hormone.

Recommended dose

The dose will be adjusted by the doctor according to the patient's body weight, age, health status, individual reactions, and clinical effect of the medicine.
Generally: the safe sedative dose is in the range of 0.15 to 0.3 mg of etomidate/kg of body weight, which corresponds to 0.075 to 0.15 ml of Etomidate-Lipuro/kg of body weight.

Children over 6 months of age and adolescents up to 15 years of age, as well as elderly patients

Single dose: 0.15 to 0.2 mg of etomidate/kg of body weight, which corresponds to 0.075 to 0.1 ml of Etomidate-Lipuro/kg of body weight. The dose should be adjusted according to the clinical effects of the medicine.
Patients with liver cirrhosis and those previously treated with neuroleptic drugsThe dose should be reduced.
In the case of using the medicine to interrupt a seizure or a series of seizures, the doctor will quickly, i.e., within 10 seconds, inject the appropriate dose of etomidate (0.3 mg/kg of body weight, corresponding to 0.15 ml of Etomidate-Lipuro). If necessary, this dose can be administered several times.
In case of doubts, consult a doctor or nurse.

In case of administration of a higher dose of Etomidate-Lipuro than recommended

In cases of overdose, especially when etomidate is used in combination with inhaled anesthetics, the sleep period may be prolonged, and a short period of apnea may occur. When using Etomidate-Lipuro, the doctor will have access to equipment and medicines required during general anesthesia (including respiratory support).

4. Possible side effects

Like all medicines, Etomidate-Lipuro can cause side effects, although not everybody gets them.
Similar to most general anesthetics, etomidate affects the functions of the respiratory and cardiovascular systems. Also, like most other general anesthetics, etomidate can cause uncontrolled muscle movements. Additionally, etomidate often affects adrenal cortex function.
The following side effects of etomidate have been observed:
Very common (occurs in at least 1 in 10 patients):
Etomidate inhibits steroid synthesis in the adrenal cortex. After a single dose of etomidate, the adrenal response to stressors is significantly reduced for about 3-6 hours. See "Warnings and precautions" in section 2
After a single dose of etomidate, patients sometimes observe uncontrolled muscle movements (myoclonus). They can be prevented by administering opioids or benzodiazepines to the patients before anesthesia.
Decreased cortisol levels.
Common (occurs in 1 to 10 in 100 patients)
Mild, transient decrease in blood pressure may occur as a reaction to decreased peripheral vascular resistance.
Respiratory arrest and apnea may occur, especially after administration of high doses of etomidate in combination with central nervous system depressants.
Nausea and vomiting may occur, which are mainly caused by opioids administered simultaneously or before Etomidate-Lipuro.
Mild pain during injection, which occurs mainly when the undiluted product is administered into small veins without prior administration of fentanyl. To minimize the risk of pain, the product should be administered into larger veins.
Rare (occurs in 1 to 10 in 10,000 patients):shivering,
arrhythmia, cough, laryngospasm, hiccups
Very rare (occurs in less than 1 in 10,000 patients):
Allergic reactions and rare cases of bronchospasm and anaphylactic reactions have been reported.
Release of histamine after etomidate administration has been observed. Seizures have been reported.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail:
[email protected] .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Etomidate-Lipuro

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C.
Do not freeze.
Ampoules should be stored in the outer packaging to protect from light.

Expiry date

Do not use this medicine after the expiry date stated on the label after the word EXP (the abbreviation "EXP" is used to indicate the expiry date). The expiry date refers to the last day of the month.
The batch number is indicated by the abbreviation "Lot".

6. Contents of the packaging and other information

What Etomidate-Lipuro contains

• The active substance of Etomidate-Lipuro is etomidate. 1 ml of the emulsion for injection contains 2 mg of etomidate. 1 ampoule contains 20 mg in 10 ml of the emulsion for injection
• The excipients are: soybean oil, medium-chain triglycerides, glycerol, egg phospholipids for injection, sodium oleate, water for injection

What Etomidate-Lipuro looks like and what the pack contains

Etomidate-Lipuro is a milky white emulsion of the "oil in water" type.
The carton contains 10 ampoules of clear glass with 10 ml of the emulsion for injection.

Marketing authorization holder Manufacturer

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany
• B. Braun Melsungen AG Carl-Braun-Str. 1 34212 Melsungen P.O. BOX 11 20 34209 Melsungen Germany

Date of last update of the leaflet: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Etomidate-Lipuro may only be administered by a doctor who is able to perform endotracheal intubation and has access to resuscitation equipment.

Dosing

Doses must be adjusted according to individual patient reactions and the clinical effect of the medicine.
Follow the instructions below for dosing:
Generally: the safe sedative dose is in the range of 0.15 to 0.3 mg of etomidate/kg of body weight, which corresponds to 0.075 to 0.15 ml of Etomidate-Lipuro/kg of body weight.
Children over 6 months of age and adolescents up to 15 years of age, as well as elderly patients, receive a single dose of 0.15 to 0.2 mg of etomidate/kg of body weight, which corresponds to 0.075 to 0.1 ml of Etomidate-Lipuro/kg of body weight. In these age groups, the exact dose should be adjusted according to the clinical effects of the medicine.
In patients with liver cirrhosis and those previously treated with neuroleptic drugs, the dose should be reduced.
To avoid too slow diffusion of Etomidate-Lipuro in the brain in patients with overt epilepsy or increased tendency to seizures, Etomidate-Lipuro should be injected quickly, i.e., within a few seconds. Good bioavailability and rapid distribution of etomidate in the brain prevent the occurrence of seizures.
In the case of using the medicine to interrupt a seizure or a series of seizures, the appropriate dose of etomidate (0.3 mg/kg of body weight, corresponding to 0.15 ml of Etomidate-Lipuro) should be injected quickly, i.e., within 10 seconds. If necessary, this dose can be administered several times.
Method and route of administration

• Etomidate-Lipuro should only be administered intravenously, usually slowly (a single dose over approximately 30 seconds), and if necessary, the dose can be divided into several parts.

If
the patient has not been administered fentanyl beforehand, mild pain may occur during injection of the undiluted Etomidate-Lipuro into small veins. Therefore, the product should be administered into larger veins.

• Injection outside the vein can cause severe pain.
• Arterial injections should be avoided, as there is a risk of causing necrosis by etomidate administered arterially.
• Before administering Etomidate-Lipuro, premedication should be used to prevent myoclonus. It is recommended to administer benzodiazepines, such as diazepam, which can be injected intramuscularly about 1 hour or intravenously 10 minutes before administering Etomidate-Lipuro.
• In case of adrenal cortex dysfunction and during very long surgical procedures, it may be necessary to administer cortisol, such as 50-100 mg of hydrocortisone.
• Etomidate-Lipuro does not have analgesic effects. In the case of short-term anesthesia, a strong analgesic, such as fentanyl, should be administered simultaneously or before Etomidate-Lipuro.

Incompatibilities

Etomidate-Lipuro should not be mixed with other solutions for injection without prior verification of their compatibility.
Furthermore, Etomidate-Lipuro should not be administered simultaneously with other solutions for injection through the same line, unless their compatibility has been verified. Concomitantly administered medicines, such as analgesics, must be administered through the same injection site in the next sequence or simultaneously through a different injection site. Etomidate-Lipuro can be injected during infusion of isotonic sodium chloride solution during a short break in its administration.

Instructions for use and handling of the product

Before use, shake the ampoule to ensure uniform distribution.
Do not use if the emulsion is discolored and/or non-uniform after shaking.
The product does not contain antibacterial preservatives. Since fat emulsions can promote bacterial growth, the emulsion should be drawn up immediately after opening the ampoule using a syringe under aseptic conditions and then injected.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.