Propofol-lipuro

Package Leaflet: Information for the User

Propofol-Lipuro, 5 mg/ml, Emulsion for Injection or Infusion

propofol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 pack 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 medicines can also be used for sedation (reducing the level of consciousness without complete sleep). Propofol-Lipuro is used for:

• induction of general anesthesia in adults and children over 1 month of age;
• sedation of adult patients during diagnostic and surgical procedures, alone or in combination with other local or regional anesthetics;
• induction of sedation in adults and children over 1 month of age during diagnostic and surgical procedures.

2. Important information before using Propofol-Lipuro

When not to use Propofol-Lipuro:

• if the patient is allergic to propofol, soy, peanuts, or any other component of this medicine (listed in section 6);
• for maintenance of general anesthesia or sedation during diagnostic and surgical procedures in children;
• for sedation during intensive care.

Warnings and precautions

Before receiving Propofol-Lipuro, discuss it with your 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 extra 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 severely weakened (cachectic) patients or those with 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, e.g., eye surgery. If the patient has any of these conditions or states, they should inform their doctor.

In case of concurrent administration of other fats in intravenous infusion, the doctor will pay attention to the total amount of fats received during the 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. In case of symptoms of so-called "propofol syndrome" (detailed list of symptoms, see section 4 "Possible side effects", subsection "If any of the following side effects occur, seek medical attention immediately"), the doctor will immediately stop the administration of the medicine. In the section "Driving and operating machinery", precautions are given that should be taken after using propofol.

Children and adolescents

Propofol-Lipuro is not recommended for newborns.

Propofol-Lipuro and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Propofol has been used successfully in various local anesthesia techniques that cause numbness only in a 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,
• anesthetics given by inhalation,
• painkillers. 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 depressant effect on the central nervous system may enhance the effect of propofol when given concurrently. Particular caution should be exercised when using antibiotics containing rifampicin concurrently - 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 5 mg/ml.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Propofol-Lipuro should not be used during pregnancy unless absolutely necessary. The medicine passes through the placenta and may depress the vital functions of the newborn. However, propofol can be used during abortion procedures. In the case of breastfeeding women, breastfeeding should be interrupted, 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 operating machinery

After receiving an injection or infusion of Propofol-Lipuro, do 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 20 ml, which means the medicine is considered "sodium-free". Propofol-Lipuro contains soybean oil. Do not use if you are allergic 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 adequately equipped day-care unit.

Dosage

The dose administered will vary depending on age, body weight, and physical condition. The doctor will give the correct dose to induce anesthesia or achieve the desired level of sedation, carefully observing the patient's reaction and vital signs (heart rate, blood pressure, breathing, etc.). The doctor will decide on the duration of administration. Propofol-Lipuro can be administered for a maximum of 1 hour.

Method of administration

Propofol-Lipuro will be administered by injection or intravenous infusion through a needle or a small venflon inserted into one of the patient's veins. In the case of infusion, the medicine can be diluted first. 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 carefully controlled. Nevertheless, if an overdose occurs, it may lead to disturbances in heart and respiratory function. In such a case, the doctor will immediately initiate the necessary treatment. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, seek medical attention immediately.

Frequent (may occur in up to 1 in 10 patients):

• Low blood pressure, which in rare cases may require fluid infusion and reduction of propofol administration rate.
• Slow heart rate, which in rare cases may be severe. Rare (may occur in up to 1 in 1,000 patients):
• Seizures resembling epilepsy. Very rare (may occur in up to 1 in 10,000 patients):
• 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 the recovery period.
• Pulmonary edema (fluid in the lungs) after propofol administration.
• Pancreatitis.

Frequency not known (frequency cannot be estimated from 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 potassium levels, high fat levels in the blood, EKG abnormalities (Brugada-type EKG), liver enlargement, irregular heartbeat, kidney failure, and heart failure. This has been referred to as "propofol syndrome". In some patients, this syndrome has ultimately led to death. These side 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 rib cage, on the right side of the body), sometimes with loss of appetite].

Additional side effects

Very common (may occur in more than 1 in 10 patients):

• 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. Frequent (may occur in up to 1 in 10 patients):
• Transient apnea.
• Headache during recovery from the medicine.
• Nausea or vomiting during recovery from the medicine. Uncommon (may occur in up to 1 in 100 patients):
• Blood clots in veins or vein inflammation at the injection site Very rare (may occur in up to 1 in 10,000 patients):
• Loss of sexual control during recovery from the medicine.
• Abnormal urine color after prolonged propofol administration.
• Postoperative fever.
• Tissue damage in case the medicine is accidentally injected outside a vein.

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

• Involuntary movements.
• Abnormal mood.
• Abuse and dependence on the medicine.
• 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 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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, you can help provide more information on the safety of this medicine.

5. How to store Propofol-Lipuro

Keep the medicine 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 ampoule. The diluted medicine should be used immediately after preparation. Do not use Propofol-Lipuro if, after shaking, two distinct layers are visible or if the emulsion is not milky white.

6. Contents of the pack and other information

What Propofol-Lipuro contains

• The active substance is propofol. Each milliliter of Propofol-Lipuro 5 mg/ml contains 5 mg of propofol. One ampoule of 20 ml contains 100 mg of propofol.
• The other ingredients are: soybean oil, purified; medium-chain triglycerides; glycerol; egg phospholipids for injection; 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 has a milky white appearance. Propofol-Lipuro is available in 20 ml ampoules, in packs of 5 ampoules.

Marketing authorization holder and manufacturer

• B. Braun Melsungen AG, Carl-Braun-Strasse 1, 34212 Melsungen, Postal address: 34209 Melsungen, Germany

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

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

Austria: Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion, Czech Republic: Propofol-Lipuro 0.5 % (5 mg/ml), Denmark: Propofol "B.Braun" 5 mg/ml, Finland: Propofol-Lipuro 5 mg/ml, France: Propofol-Lipuro 5 mg/ml, Spain: Propofol-Lipuro 0.5 % (5 mg/ml), Ireland: Propofol-Lipuro 0.5 % (5 mg/ml), Luxembourg: Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion, Germany: Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion, Norway: Propofol-Lipuro 5 mg/ml, Poland: Propofol-Lipuro 5 mg/ml, Portugal: Propofol-Lipuro 0.5 % (5 mg/ml), Slovakia: Propofol-Lipuro 0.5 % (5 mg/ml), Sweden: Propofol-Lipuro 5 mg/ml, Hungary: Propofol-Lipuro 5 mg/ml, United Kingdom (Northern Ireland): Propofol-Lipuro 0.5 % (5 mg/ml), Italy: Propofol B.Braun 0.5 %

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

Information intended for healthcare professionals only: The containers are for single use only in one patient. The containers should be shaken before use. Before use, the neck of the ampoule should be disinfected with medicinal spirit (aerosol or swab). Any unused emulsion should be discarded after 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.