Propofol-lipuro

Package leaflet: information for the user

Propofol-Lipuro, 10 mg/ml, emulsion for injection or infusion
propofol
Please read all of this leaflet carefully before use, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you need advice or any additional information.
• If you experience any adverse reactions, including those not listed in this leaflet, inform 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 (induce sleep) for the purpose of
surgical procedures or other interventions. These agents 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 > 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 > 1 month of age during diagnostic and surgical procedures, either alone or in combination with another agent for local or regional anaesthesia

2. Important information before using Propofol-Lipuro

When not to use Propofol-Lipuro:

• if the patient has hypersensitivity to propofol, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6),

This medicine must not be used in children under 16 years of age as a sedative during intensive care.
There are no data on the safety and efficacy of this medicine in these age groups.
Warnings and precautions
Before receiving Propofol-Lipuro, discuss this with your doctor or pharmacist.
Special caution is required
if the patient has suffered a severe head injury,
if the patient has a mitochondrial disease,

• if the patient has a condition due to which the body cannot properly metabolize fat,
• if the patient has any other health problems requiring extra caution when using fat emulsions,
• if the patient has too low circulating blood volume (hypovolemia),
• if the patient has low levels of protein in the blood (hypoproteinemia),
• in very weak (exhausted) 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 diseases or conditions, inform the doctor.
In case of concomitant administration of other intravenous fat emulsions, the doctor should monitor the total daily fat intake.
Propofol is administered by a doctor trained in anaesthesiology and intensive care. During anaesthesia and recovery, the patient is continuously monitored.
If symptoms of so-called "propofol infusion syndrome" occur (for a detailed list of symptoms, see section 4 "Possible side effects", subsection "If any of the following effects occur, call a doctor immediately"), the doctor will immediately stop administering the medicine.
Precautions to be taken after administration of propofol are described in the section "Driving and using machines".
Children and adolescents
Administration of Propofol-Lipuro to neonates is not recommended.
This medicine must not be used in patients aged 16 years and younger 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 currently used or recently used, as well as any medicines the patient plans to take.
Propofol has been successfully used in various regional anaesthesia techniques, which cause anaesthesia of only part of the body (epidural and spinal anaesthesia).
In addition, it has been shown to be safe when used in combination with

• medicines administered before surgery,
• other medicines such as muscle relaxants,
• anaesthetic medicines administered by inhalation,
• pain-relieving medicines. However, the doctor may administer lower doses of propofol if general anaesthesia or sedation is needed as a supplement 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 with propofol.
Particular caution is required when using antibiotics containing rifampicin simultaneously – the patient may experience low blood pressure.
The doctor may reduce the dose if the patient is simultaneously receiving valproate treatment (an anticonvulsant medicine).
Propofol-Lipuro and alcohol
The doctor will advise the patient on alcohol consumption before and after administration of Propofol-Lipuro 10 mg/ml.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or when planning pregnancy, 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 crosses the placenta and may cause depression of vital functions in the newborn.
However, propofol may be used during procedures terminating pregnancy.
In breastfeeding women, breastfeeding must be discontinued and milk expressed and discarded for 24 hours after administration of Propofol-Lipuro. Studies in breastfeeding women have shown that propofol passes into breast milk in small amounts.
Driving and using machines
After injection or infusion of Propofol-Lipuro, do not drive or operate machinery.
The doctor will advise the patient

• whether another person should accompany them when leaving the medical facility,
• when they will be able to drive and operate machinery again,
• whether they can use other sedative medicines (e.g. sedatives, strong painkillers, alcohol).

Propofol-Lipuro contains sodium and soybean oil
This medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, meaning the medicine is considered "sodium-free".
Propofol-Lipuro 10 mg/ml contains soybean oil. Do not use if hypersensitivity to peanuts or soy has been diagnosed.

3. How to use Propofol-Lipuro

Propofol-Lipuro must be administered only by personnel trained in anaesthesia or specially trained physicians in a hospital or appropriately equipped day-care unit.
Dosage
The dose administered will vary depending on the patient's age, body weight, and physical condition.
The physician will administer the appropriate dose to induce and maintain anaesthesia or to achieve the desired level of sedation, while continuously monitoring the patient's response and vital parameters (pulse, blood pressure, respiration, etc.). When necessary, the physician will limit the duration of treatment.
Propofol-Lipuro may be administered for a maximum of 7 days.
Method of administration
The medicine will be given by intravenous injection or infusion, meaning that the medicine will be delivered through a needle or a small tube placed in one of the patient's veins. When administered by infusion, the medicine may first be diluted.
Since Propofol-Lipuro does not contain preservatives, medication from a single vial must not be used for longer than 12 hours. Administration of diluted Propofol-Lipuro from a single container must not exceed 6 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 because the administered dose is very precisely controlled.
Nevertheless, if an overdose occurs accidentally, it may lead to disturbances in heart, circulation, and respiratory function. In such a case, the physician will immediately initiate necessary treatment.
If you have any doubts regarding the use of the medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Propofol-Lipuro 10 mg/ml may cause adverse reactions, although
not everyone will experience them.
If any of the following occur, call a doctor immediately
Common (may affect up to 1 in 10 people):

• 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.

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, 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 edema) 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 reactions characterized by a combination of the following symptoms: rhabdomyolysis, metabolic acidosis, hyperkalemia, hyperlipidemia, ECG abnormalities (Brugada-type ECG), hepatomegaly, arrhythmia, renal failure and cardiac failure. This has been termed the “propofol infusion syndrome”. In some patients, this syndrome ultimately led to death. These reactions 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].

Other adverse reactions include:
Very common (affects more than 1 in 10 people):

• Pain at the injection site occurring during the initial injection. This pain can be reduced by co-administering propofol into larger forearm veins.
  Concomitant
  administration of lidocaine (a local anesthetic) with propofol also reduces pain
  at the injection site.
  Common (may affect up to 1 in 10 people):

• Transient apnea

• 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 people):

• Blood clots in veins or phlebitis at the injection site

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

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

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, tell your doctor or nurse. Adverse reactions can be reported
directly to the Department of Monitoring 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

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 cardboard box. The expiry date refers to the last day of the specified month.
Do not store above 25 °C. Do not freeze.
Propofol-Lipuro should be used 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 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 10 mg/ml contains 10 mg of propofol. One 20 ml ampoule or vial contains 200 mg of propofol, one 50 ml vial contains 500 mg of propofol, and one 100 ml vial contains 1,000 mg of propofol.
• Other ingredients are: purified soybean oil, medium-chain triglycerides, egg phospholipids for injections, glycerol, sodium oleate, water for injections.

What Propofol-Lipuro looks like and contents of the pack
The medicine is an emulsion for injection or infusion.
It is a white, milky oil-in-water emulsion.
The medicine is contained in:

• 20 ml glass ampoules, available in packs containing 5 ampoules,
• 20 ml glass vials, available in packs containing 10 vials,
• 50 ml or 100 ml glass vials, available in packs containing 1 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 medicine has been authorised in the European Economic Area countries
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

Information intended exclusively for healthcare professionals:

Containers are for single use only in one patient.
Containers should be shaken before use.
The neck of the ampoule or the rubber stopper of the vial should be disinfected with medical spirit (spray or alcohol swab) before use.
The infusion line and the container with Propofol-Lipuro product must be removed and replaced no later than 12 hours after commencement.
Any unused remnants of the emulsion must be discarded after administration is completed. 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.