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

Package leaflet: Information for the user

Propofol-Lipuro 2% (20 mg/ml) emulsion for injection or infusion
propofol
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

• induction of general anaesthesia in adults and children over 3 years of age
• sedation in 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 or surgical procedures, either alone or in combination with local or regional anaesthesia

2. Important information before using Propofol-Lipuro
When not to use Propofol-Lipuro:

• if the patient is allergic to propofol, soybeans, peanuts, or any of the other ingredients of Propofol-Lipuro 2% (20 mg/ml) listed in section 6.

This medicine must not be administered to patients under 16 years of age for sedation during intensive care. There are 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, discuss this with your doctor or pharmacist.
Exercise particular caution:

• if the patient has suffered severe head injury,
• if the patient has a mitochondrial disease,
• if the patient has a condition in which the body does not properly metabolize fat,
• if the patient has any other health problems requiring special caution when using fat emulsions,
• if the patient has too low circulating blood volume (hypovolemia),
• if the patient has low protein levels in the blood (hypoproteinemia),
• in very weak (debilitated) patients or those with heart, kidney, or liver problems,
• in patients with increased 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 conditions, inform the doctor.
If other fat-containing intravenous infusions are administered simultaneously, the doctor will monitor the total daily fat intake.
Propofol is administered by a doctor trained in anaesthesia and intensive care. The patient is continuously monitored during anaesthesia and recovery.
If symptoms of so-called "propofol syndrome" occur (see detailed list of symptoms in section 4, "Possible side effects", under "If any of the following occur, call your doctor immediately"), the doctor will immediately stop administering the medicine.
Precautions regarding driving and operating machinery after propofol administration are described in the section "Driving and using machines".
Children and adolescents
Propofol-Lipuro is not recommended for children under 3 years of age.
This medicine must not be used in patients aged 16 years or younger for sedation in intensive care due to lack of data on safety and efficacy of propofol in these age groups (see section "When not to use Propofol-Lipuro").
Propofol-Lipuro and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Propofol has been successfully used in various regional anaesthesia techniques that anaesthetize only part of the body (epidural and spinal anaesthesia).
In addition, it has been shown safe to use in combination with:

• medicines given before surgery,
• other medicines such as muscle relaxants,
• inhalational anaesthetics,
• painkillers. However, the doctor may use lower doses of propofol if general anaesthesia or sedation is needed as an adjunct to regional anaesthesia.

The doctor will take into account that other medicines with central nervous system depressant effects may enhance the action of propofol when administered concomitantly. Particular caution is required when using antibiotics containing rifampicin – the patient may experience low blood pressure.
The doctor may reduce the dose if the patient is also receiving treatment with valproate (an anticonvulsant).
Propofol-Lipuro and alcohol
The doctor will advise the patient on alcohol consumption before and after administration of Propofol-Lipuro.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Propofol-Lipuro should not be used during pregnancy unless absolutely necessary. This medicine crosses the placenta and may depress vital functions in the newborn. However, propofol may be used during procedures for termination of pregnancy.
In breastfeeding women, breastfeeding must be discontinued and milk expressed and 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 must not drive or operate machinery.
The doctor will advise the patient:

• whether another person should accompany the patient when leaving the medical facility,
• when the patient can resume driving and operating machinery,
• whether the patient may use other sedative medicines (e.g. sedatives, strong painkillers, alcohol).

Propofol-Lipuro contains sodium and soya oil
This medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, meaning the medicine is considered "sodium-free".
Propofol-Lipuro contains soya oil. Do not use if hypersensitivity to peanuts or soya has been diagnosed.

3. How to use Propofol-Lipuro

Propofol-Lipuro must be administered only by personnel trained in anaesthesia or by specially trained physicians in a hospital or appropriately equipped day-care unit.
Dosage
The dose administered will vary depending on age, body weight, and physical condition. The physician will determine the appropriate dose for induction and maintenance of anaesthesia, or for achieving the desired level of sedation, while continuously monitoring the patient's response and vital signs (pulse, blood pressure, respiration, etc.).
If necessary, the physician will monitor the duration of administration.
Propofol-Lipuro may be administered for up to a maximum of 7 days.
Method of administration
The medicine will be given by intravenous injection or infusion through a needle or a small tube placed in one of the patient's veins.
Since Propofol-Lipuro does not contain preservatives, an infusion prepared from a single vial of Propofol-Lipuro must not last longer than 12 hours.
During injection or infusion, the patient's circulation and respiration will be continuously monitored.
Administration of a higher than recommended dose of Propofol-Lipuro
Overdose is unlikely to occur, as the administered dose is very precisely controlled.
Nevertheless, if an overdose occurs accidentally, it may lead to disturbances in heart, circulation, and respiration. In such a case, the physician will immediately initiate necessary treatment.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If any of the following effects occur, call a doctor immediately
Common (may affect up to 1 in 10 patients):

• Low blood pressure, which in rare cases may require fluid infusion and reduction of the propofol infusion rate.
• Abnormally slow heart rate, which in rare cases may be serious.

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

• Seizures resembling epilepsy.

Very rare (may affect up to 1 in 10,000 patients):

• Allergic reactions including anaphylactic shock, such as swelling of the face, tongue or throat, wheezing, skin redness and low blood pressure.
• Cases of loss of consciousness after surgery have been reported. For this reason, the patient will be closely monitored during the recovery period.
• Fluid in the lungs (pulmonary oedema) after administration of propofol.
• Pancreatitis.

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

• There have been reports of isolated cases of severe adverse effects combining the following symptoms: muscle breakdown, accumulation of acidic substances in the blood, abnormally high potassium levels, high levels of fats in the blood, abnormalities in the electrocardiogram (Brugada-type ECG), liver enlargement, irregular heartbeat, kidney failure and heart failure. This has been termed "propofol infusion syndrome". In some patients, this syndrome ultimately led to death. These effects occurred only in intensive care unit patients, mainly in patients with severe head injuries and in children with respiratory tract infections who received propofol doses exceeding 4 mg per kg body weight per 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 on palpation (indicated as pain under the front part of the rib cage on the right side of the body), sometimes with loss of appetite].

Additional adverse effects
Very common (may affect more than 1 in 10 patients):

• Pain at the injection site occurring during the initial injection. Pain can be reduced by administering propofol simultaneously into larger forearm veins. Simultaneous injection of lidocaine (a local anaesthetic) with propofol also reduces pain at the injection site.

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

• Transient apnoea.
• Headache during recovery from the effect of the medicine.
• Nausea or vomiting during recovery from the effect of the medicine.

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

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

Very rare (may affect up to 1 in 10,000 patients):

• Loss of control of sexual urges during recovery from the effect of the medicine.
• Abnormal urine colour after prolonged administration of propofol.
• Cases of postoperative fever.
• Tissue damage if the medicine is accidentally injected outside the vein.

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

• Involuntary movements.
• Abnormally elevated mood.
• Misuse and dependence on the medicine.
• Heart failure.
• Cardiac arrest.
• Shallow breathing.
• Prolonged and painful erection.
• Pain and (or) swelling at the injection site when the medicine is accidentally injected outside the vein.
• Muscle tissue breakdown, which has been very rarely reported when propofol was administered at doses higher than recommended as a sedative in intensive care units.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Propofol-Lipuro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton. The expiry date refers to the last day of the specified month.
Do not store above 25°C. Do not freeze.
Propofol-Lipuro must 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 pack and other information

What Propofol-Lipuro contains

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

The other components 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
Propofol-Lipuro is an emulsion for injection or infusion.
It is a white, milky oil-in-water emulsion.
The medicine is contained in 50 ml glass vials, available in packs containing 1 vial or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
Postal address:
34212 Melsungen, Germany
34209 Melsungen, Germany
Tel.: +49/5661/71-0
Fax: +49/5661/71-4567

This medicinal product has been authorised in the European Economic Area countries
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

Information intended exclusively for healthcare professionals:

Containers are for single use only in one patient.
Shake containers before use.
Disinfect the surface of the rubber stopper of the vial with medical spirit (aerosol or swab) before use.
Partially used containers must be discarded.
The infusion line and the container with Propofol-Lipuro product must be removed and replaced no later than after 12 hours.
Any unused remnants of the emulsion must be discarded after administration is complete. Any unused portions of the medicinal product or waste must be disposed of in accordance with local regulations.
Detailed information on this product is provided in the product's summary of characteristics.