PROPOFOL-LIPURO 10 mg /Ml Emulsion

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Propofol-Lipuro, 10 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. Other medicines and Propofol-Lipuro
   5. Propofol-Lipuro with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
   8. Propofol-Lipuro contains sodium and soybean oil
5. How to use Propofol-Lipuro
   1. Dosage
   2. Method of administration
   3. Overdose of Propofol-Lipuro
6. Possible side effects
   1. Reporting side effects
7. How to store Propofol-Lipuro
8. Contents of the pack 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 approved 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:

Package Leaflet: Information for the User

Propofol-Lipuro, 10 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.
• Ask your doctor or pharmacist if you need more information or advice.
• 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 (induce sleep) for surgical procedures or other interventions.
These agents can also be used for sedation (reducing the level of patient consciousness without complete sedation).
Propofol-Lipuro is used for:

• induction of general anesthesia in adults and children over 1 month of age
• sedation in patients over 16 years of age who are mechanically ventilated in intensive care units
• sedation in adults and children over 1 month 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, peanuts, or any other component of this medicine (listed in section 6),

The medicine should not be used in children under 16 years of age as a sedative during intensive medical care. There is no data on the safety and efficacy of this medicine for these age groups.

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 results in the body not processing fat properly
• if the patient has any other health problems that require greater caution when using fat emulsions,
• if the patient has a low blood volume (hypovolemia),
• if the patient has a low protein level in the blood (hypoproteinemia),
• in patients who are very weak (exhausted) 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 one of these diseases or conditions, they should inform their doctor.
In the case of concurrent administration of other fats in intravenous infusion, the doctor should pay attention to the total daily intake of fats.
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 the event of symptoms of so-called "propofol syndrome" (a detailed list of symptoms
see section 4 "Possible side effects", subsection "If any of the following occur, seek medical attention immediately") the doctor will immediately stop the administration of the medicine.
In the section "Driving and operating machinery" measures are indicated that should be taken after using propofol.

Children and adolescents

Propofol-Lipuro should not be given to newborns.
This medicine should not be used in patients under 16 years of age for sedation in intensive care units (see section "When not to use Propofol-Lipuro").

Other medicines and Propofol-Lipuro

Tell your doctor about all medicines you are currently 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 of 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 medicines that are 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 take into account that other medicines with a central nervous system depressant effect 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 drop 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 10 mg/ml.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, consult a doctor or pharmacist before using this medicine.
Propofol-Lipuro 10 mg/ml should not be used during pregnancy unless absolutely necessary. This medicine passes through the placenta and may cause depression of vital functions in the newborn.
However, propofol can be used for 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 injection or infusion of Propofol-Lipuro, do not drive vehicles or operate mechanical devices.
The doctor will advise the patient

• whether they should be accompanied by another person when leaving the medical facility
• when they can drive vehicles 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, i.e. the medicine is considered "sodium-free".
Propofol-Lipuro 10 mg/ml contains soybean oil. Do not use if you are hypersensitive 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 appropriately equipped day care unit.

Dosage

The dose administered will vary depending on the patient's age, 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 limit the duration of treatment.
Propofol-Lipuro can be administered for a maximum of 7 days.

Method of administration

The medicine will be given by injection or intravenous infusion, which means that the medicine will be given through a needle or a small tube inserted into one of the patient's veins. In the case of infusion, the medicine can be diluted first.
Since Propofol-Lipuro does not contain preservatives, the medicine should not be administered from the same vial for more than 12 hours. Administration of diluted Propofol-Lipuro from one container should not last more than 6 hours.
During injection or infusion, the patient's circulation and breathing will be constantly monitored.

Overdose of Propofol-Lipuro

Overdose is unlikely because the dose administered is very closely controlled.
However, if an overdose of the medicine occurs, it may lead to disturbances in heart function, circulation, and breathing. In such a case, the doctor will immediately initiate the necessary treatment.
In case of doubts about the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Propofol-Lipuro 10 mg/ml can cause side effects, although they may not occur in everyone.
If you experience any of the following, seek medical attention immediately
Frequent (may occur in up to 1 in 10 people):

• 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 people):

• Seizures resembling epilepsy.

Very rare (may occur in up to 1 in 10,000 people):

• Allergic reactions including anaphylactic shock, including 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 isolated cases of severe side effects consisting of a combination of the following symptoms: muscle breakdown, accumulation of acidic substances in the blood, high potassium levels, high fat levels in the blood, ECG abnormalities (Brugada-type ECG), liver enlargement, irregular heartbeat, kidney failure, and heart failure. This has been called "propofol 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 in 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].

Other side effects include:
Very common (occurs in 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 occur in up to 1 in 10 people):

• Short-term apnea
• Headache during recovery from the medicine.
• Nausea or vomiting during recovery from the medicine.

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

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

Very rare (may occur in up to 1 in 10,000 people):

• Loss of sexual drive control during recovery from the medicine.
• Abnormal urine color after prolonged administration of propofol.
• 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
• 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Propofol-Lipuro

Keep the medicine out of the reach and sight 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 that month.
Do not store above 25°C. Do not freeze.
Use Propofol-Lipuro immediately after opening the ampoule or vial.
Diluted Propofol-Lipuro 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 10 mg/ml contains 10 mg of propofol. 1 ampoule or vial of 20 ml contains 200 mg of propofol. 1 vial of 50 ml contains 500 mg of propofol. 1 vial of 100 ml contains 1,000 mg of propofol.
• Other ingredients of the medicine are: soybean oil, purified, triglycerides of saturated fatty acids of medium chain length, egg yolk 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 has the appearance of a milky white emulsion of the oil-in-water type.
The medicine is in

• glass ampoules of 20 milliliters, available in packs of 5 ampoules,
• glass vials of 20 milliliters, available in packs of 10 vials
• glass vials of 50 or 100 ml, available in packs of 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Phone: +49/5661/71-0
Fax: +49/5661/71-4567

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

Propofol-Lipuro 1% (10 mg/ml):
Czech Republic, Ireland, Malta, Poland, Portugal, Slovakia,
United Kingdom (Northern Ireland)
Propofol B.Braun 1%:
Italy
Propofol "B.Braun" 10 mg/ml:
Denmark
Propofol-Lipuro 10 mg/ml:
Austria, Estonia, Finland, France, Germany, Hungary,
Latvia, Lithuania, Luxembourg, Netherlands, Slovenia,
Spain, Sweden, Norway
Propofol-Lipuro 1%:
Cyprus, Greece

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

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Information intended for healthcare professionals only:

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