PROPOFOL-LIPURO 20 mg /Ml Emulsion

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Propofol-Lipuro 2% (20 mg/ml) emulsion for injection or infusion
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Propofol-Lipuro and what is it used for
4. Important information before using Propofol-Lipuro
   1. When not to use Propofol-Lipuro:
   2. Warnings and precautions
   3. Children and adolescents
   4. Propofol-Lipuro and other medicines
   5. Propofol-Lipuro with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Propofol-Lipuro contains sodium and soybean oil
5. How to use Propofol-Lipuro
   1. Dosage
   2. Method of administration
   3. Use of a higher than recommended dose of Propofol-Lipuro
6. Possible side effects
   1. If any of the following occur, the patient should immediately contact their doctor
   2. Additional side effects
   3. Reporting side effects
7. How to store Propofol-Lipuro
8. Contents of the packaging and other information
   1. What Propofol-Lipuro contains
   2. What Propofol-Lipuro looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine has been authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   5. Date of last revision of the leaflet: 26-07-2024
   6. Information intended for healthcare professionals only:

Leaflet attached to the packaging: information for the user

Propofol-Lipuro 2% (20 mg/ml) emulsion for injection or infusion

propofol

Read the leaflet carefully before taking 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 pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Propofol-Lipuro belongs to a group of medicines called general anesthetics. General anesthetics are used to induce anesthesia (cause sleep) for surgical procedures or other interventions. These agents can also be used for sedation (reducing the level of patient consciousness without complete sleep). Propofol-Lipuro is used for:

• induction of general anesthesia in adults and children over 3 years of age
• sedation of patients over 16 years of age who are mechanically ventilated in intensive care units
• sedation in adults and children over 3 years of age during diagnostic and surgical procedures, alone or in combination with other local or regional anesthetics

2. Important information before using Propofol-Lipuro

When not to use Propofol-Lipuro:

• if the patient has a known hypersensitivity to propofol, soy, or peanuts, or any of the other ingredients of Propofol-Lipuro 2% (20 mg/ml) listed in section 6.

The medicine must not be given to patients under 16 years of age for sedation in intensive care. There is no data on the safety and efficacy of Propofol-Lipuro 2% (20 mg/ml) in these age groups.

Warnings and precautions

Before receiving Propofol-Lipuro, the patient should discuss it with their doctor or pharmacist. Particular caution should be exercised

• if the patient has a severe head injury,
• if the patient has a mitochondrial disease,
• if the patient has a disease that affects the body's ability to process fat,
• if the patient has any other health problems that require greater caution when using fat emulsions,
• if the patient has low blood volume (hypovolemia),
• if the patient has low protein levels in the blood (hypoproteinemia),
• in patients who are severely weakened (cachectic) or have heart, kidney, or liver problems,
• in patients with high intracranial pressure,
• if the patient has breathing difficulties,
• if the patient has epilepsy,
• in patients undergoing procedures where spontaneous movements are particularly undesirable.

If the patient has any of these diseases or conditions, they should inform their doctor. If other fats are administered simultaneously in intravenous infusion, the doctor will pay attention to the total amount of fat received per day. Propofol is administered to the patient by a doctor trained in anesthesiology and intensive care. During anesthesia and recovery, the patient is constantly monitored.

Children and adolescents

Propofol-Lipuro is not recommended for children under 3 years of age. This medicine must not be used in patients 16 years of age or younger for sedation in intensive care due to the lack of data on safety and efficacy in these age groups (see "When not to use Propofol-Lipuro").

Propofol-Lipuro and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Propofol has been used successfully in various local anesthesia techniques that cause numbness in only part of the body (epidural and spinal anesthesia). In addition, safety has been demonstrated when used in combination with

• medicines given before surgery,
• other medicines, such as muscle relaxants,
• anesthetic gases,
• analgesics. However, the doctor may give lower doses of propofol if general anesthesia or sedation is needed as a supplement to local anesthesia.

The doctor will consider that other medicines with a central nervous system depressant effect may enhance the effect of propofol when administered simultaneously. Particular caution should be exercised when using antibiotics containing rifampicin simultaneously - the patient may experience a decrease in blood pressure. The doctor may reduce the dose if the patient is also taking valproate (an antiepileptic drug).

Propofol-Lipuro with alcohol

The doctor will advise the patient on alcohol consumption before and after using Propofol-Lipuro.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Propofol-Lipuro should not be used during pregnancy unless absolutely necessary. The medicine crosses the placenta and may inhibit the vital functions of the newborn. However, propofol can be used during abortion procedures. In the case of breastfeeding women, breastfeeding should be discontinued, and milk discarded for 24 hours after receiving Propofol-Lipuro. Studies in breastfeeding women have shown that propofol passes into breast milk in small amounts.

Driving and using machines

After receiving an injection or infusion of Propofol-Lipuro, the patient should not drive or operate machinery. The doctor will advise the patient

• whether they should be accompanied by another person when leaving the medical facility;
• when they can drive and operate machinery again;
• whether they can take other sedative medicines (e.g., sedatives, strong painkillers, alcohol).

Propofol-Lipuro contains sodium and soybean oil

The medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, which means it is considered "sodium-free". Propofol-Lipuro contains soybean oil. It should not be used in case of known hypersensitivity to peanuts or soy.

3. How to use Propofol-Lipuro

Propofol-Lipuro can only be administered by persons trained in the administration of anesthesia or specially trained doctors in a hospital or suitably equipped day-care unit.

Dosage

The dose administered will vary depending on age, body weight, and physical condition. The doctor will give the appropriate dose to induce and maintain anesthesia or to achieve the desired level of sedation, observing the patient's reaction and vital signs (pulse, blood pressure, breathing, etc.). If necessary, the doctor will monitor the duration of use. Propofol-Lipuro can be administered for a maximum of 7 days.

Method of administration

The medicine will be administered by injection or intravenous infusion through a needle or a small tube inserted into one of the patient's veins. Since Propofol-Lipuro does not contain preservatives, an infusion prepared from one vial of Propofol-Lipuro must not last longer than 12 hours. During the injection or infusion, the patient's circulation and breathing will be constantly monitored.

Use of a higher than recommended dose of Propofol-Lipuro

Overdose is unlikely because the dose administered is very closely controlled. Nevertheless, if an overdose occurs, it may lead to disturbances in heart function, circulation, and breathing. In such cases, the doctor will immediately initiate the necessary treatment. If there are any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Propofol-Lipuro can cause side effects, although not everybody gets them.

If any of the following occur, the patient should immediately contact their doctor

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

• Low blood pressure, which in rare cases may require fluid infusion and a reduction in the rate of propofol administration.
• Slow heart rate, which in rare cases may be severe.

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

• Seizures resembling epilepsy.

Rare (may affect up to 1 in 10,000 people):

• Allergic reactions, including anaphylactic shock, with symptoms such as facial swelling, tongue or throat swelling, wheezing, skin rash, and low blood pressure.
• Reports of loss of consciousness after operations. For this reason, the patient will be closely monitored during recovery.
• Pulmonary edema (fluid in the lungs) after propofol administration.
• Pancreatitis.

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

• There have been reports of individual cases of severe side effects, which are a combination of the following symptoms: muscle breakdown, accumulation of acidic substances in the blood, high levels of potassium, high levels of fat in the blood, abnormal electrocardiogram (Brugada-type ECG), liver enlargement, irregular heartbeat, kidney failure, and heart failure. This has been referred to as "propofol infusion syndrome". In some patients, this syndrome has ultimately led to death. These effects have only occurred in patients in intensive care units, mainly in patients with severe head injuries and children with respiratory infections, who received propofol doses greater than 4 mg/kg/hour. See also section 2 "Warnings and precautions".
• Hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain, and liver tenderness (indicated as pain under the front of the chest, on the right side of the body), sometimes with loss of appetite].

Additional side effects

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

• Pain at the injection site during the first injection. Pain can be reduced by injecting propofol into larger veins in the forearm. Concurrent injection of lidocaine (a local anesthetic) and propofol also reduces pain at the injection site.

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

• Transient apnea.
• Headache during recovery.
• Nausea or vomiting during recovery.

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

• Blood clots in veins or vein inflammation at the injection site.

Rare (may affect up to 1 in 10,000 people):

• Loss of sexual urge control during recovery.
• Abnormal urine color after prolonged propofol administration.
• Postoperative fever.
• Tissue damage in case the medicine is accidentally injected outside a vein.

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

• Involuntary movements.
• Abnormal mood.
• Drug abuse and dependence.
• Heart failure.
• Cardiac arrest.
• Shallow breathing.
• Prolonged and painful erection.
• Pain and/or swelling at the injection site in case the medicine is accidentally injected outside a vein.
• Muscle tissue breakdown, which has been reported very rarely in cases where propofol was administered in doses higher than recommended as a sedative in intensive care units.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Propofol-Lipuro

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month. Do not store above 25°C. Do not freeze. Propofol-Lipuro should be used immediately after opening the vial. Do not use Propofol-Lipuro if, after shaking, two separate layers are visible or if the emulsion is not milky white.

6. Contents of the packaging and other information

What Propofol-Lipuro contains

• The active substance is propofol. Each milliliter of Propofol-Lipuro 2% (20 mg/ml) contains 20 mg of propofol. One vial of 50 ml contains 1000 mg of propofol.

The other ingredients are: soybean oil, purified, medium-chain triglycerides, egg phospholipids for injection, glycerol, sodium oleate, water for injection.

What Propofol-Lipuro looks like and contents of the pack

The medicine is an emulsion for injection or infusion. It appears as a milky white oil-in-water emulsion. The medicine is available in glass vials of 50 milliliters, available in packs containing 1 vial or 10 vials. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Tel.: +49/5661/71-0, Fax: +49/5661/71-4567

This medicine has been authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Propofol-Lipuro 2% (20 mg/ml): Czech Republic, Ireland, Latvia, Portugal, Spain, United Kingdom (Northern Ireland), Poland, Slovakia. Propofol "B.Braun" 20 mg/ml: Denmark. Propofol B.Braun 2%: Italy. Propofol-Lipuro 20 mg/ml: Austria, Estonia, Finland, France, Germany, Hungary, Lithuania, Luxembourg, Netherlands, Norway, Slovenia, Sweden. Propofol-Lipuro 2%: Greece

Date of last revision of the leaflet: 26-07-2024

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Information intended for healthcare professionals only:

Containers are for single use only in one patient. Containers should be shaken before use. Before use, the surface of the rubber stopper of the vial should be disinfected with medicinal spirit (aerosol or swab). After use, opened containers should be discarded. The infusion line and Propofol-Lipuro container should be discarded and replaced at the latest after 12 hours. Any unused emulsion should be discarded after the end of the administration. Any unused medicinal product or waste should be disposed of in accordance with local requirements. Detailed information on this product is given in the summary of product characteristics.