Propofol Lipuro 20 mg/ml emulsion for injection and for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Propofol Lipuro 20mg/ml emulsion for injection and infusion

Propofol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Propofol Lipuro is and what it is used for
2. What you need to know before using Propofol Lipuro
3. How to use Propofol Lipuro
4. Possible adverse 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 produce unconsciousness (sleep) so that surgical operations or other procedures can be performed. They may also be used to sedate you (make you drowsy but not completely asleep).

Propofol Lipuro is used for:

• inducing and maintaining general anaesthesia in adults and children over 3 years of age.
• sedating patients over 16 years of age who are receiving mechanical ventilation in intensive care.
• sedating adults and children over 3 years of age during diagnostic and surgical procedures, either alone or in combination with local or regional anaesthesia.

2. What you need to know before using Propofol Lipuro

Do not use Propofol Lipuro:

• If you are allergic to propofol, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).

It must not be used in patients aged 16 years or younger for sedation in intensive care. Safety and efficacy have not been established in these age groups.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Propofol Lipuro.

Special care is needed:

• if you have severe head injuries,
• if you have a mitochondrial disease,
• if you have a disorder in which your body cannot properly process fats,
• if you have any other medical condition requiring particular caution when using fat emulsions,
• if you are significantly overweight,
• if your blood volume is too low (hypovolemia),
• if you have low levels of protein in your blood (hypoproteinemia),
• if you are very weak or have heart, circulatory, kidney, or liver problems,
• if you have high pressure in the skull and low arterial pressure,
• if you have any respiratory problems,
• if you suffer from epilepsy,
• if you are undergoing certain procedures where spontaneous movements are especially undesirable.

Inform your doctor if you have any of these diseases or conditions.

If you are simultaneously receiving other lipids intravenously, your doctor will pay special attention to your total daily fat intake.

Propofol will be administered by a specialist doctor in anaesthesia or intensive care. You will be continuously monitored during anaesthesia and the recovery period.

If you experience signs of the so-called "propofol infusion syndrome" (see section 4, "Possible side effects", "Call a doctor immediately if any of the following effects occur"), your doctor will immediately stop the administration of propofol.

See also section "Driving and use of machines" for precautions to take after using propofol.

Children and adolescents

The use of Propofol Lipuro is not recommended in children under 3 years of age.

This medicine must not be used in patients aged 16 years or younger for sedation in intensive care (see section "Do not use Propofol-Lipuro").

Other medicines and Propofol-Lipuro

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Propofol has been effectively used in combination with various regional anaesthesia techniques, which numb only a part of the body (epidural and spinal anaesthesia).

Its safe use has also been demonstrated in combination with:

• drugs administered before surgery,
• other medicines such as muscle relaxants,
• inhaled anaesthetic agents,
• analgesics.

However, your doctor may administer lower doses of propofol if general anaesthesia or sedation is required as a supplement to regional anaesthesia techniques.

Your doctor should be aware that administering propofol together with other medicines that have a central nervous system depressant effect may enhance the effects of propofol. Special attention is required if you are concurrently receiving a rifampicin-containing antibiotic—you may develop a profound drop in blood pressure.

Your doctor may reduce the dose if you are also receiving treatment with valproate (an anticonvulsant).

Use of Propofol Lipuro and alcohol

Your doctor will advise you on alcohol consumption before and after using Propofol-Lipuro.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Propofol should not be used during pregnancy unless absolutely necessary.

It crosses the placenta and may depress vital functions in the newborn.

However, propofol may be used during induced abortion.

If you are breastfeeding, you should interrupt breastfeeding and discard breast milk for 24 hours after receiving Propofol Lipuro. Studies in breastfeeding women have shown that propofol passes into breast milk in small amounts.

Driving and use of machines

Do not drive or operate tools or machinery for some time after receiving an injection or infusion of Propofol Lipuro.

Your doctor will advise you:

• whether you should be accompanied when leaving,
• when you can drive or use machinery again,
• about the use of other sedative medicines (e.g., tranquilizers, strong analgesics, alcohol).

Propofol Lipuro contains sodium and soybean oil

This medicine contains less than 1 mmol of sodium (23 mg) per 100 ml; hence, essentially "sodium-free".

Propofol Lipuro contains soybean oil. Do not use this medicine if you are allergic to peanuts or soy.

3. How to use Propofol Lipuro

Propofol Lipuro will only be administered by individuals trained in the administration of anaesthesia or by specially qualified doctors in a hospital or a properly equipped day treatment unit.

Dosage

Your dose will vary depending on your age, body weight, and physical condition. The doctor will administer the appropriate dose to induce and maintain anaesthesia or to achieve the desired level of sedation, carefully observing your responses and vital signs (pulse, blood pressure, respiration, etc.).

The doctor will observe the maximum administration time, if necessary.

Propofol Lipuro will only be administered for a maximum of seven days.

Method of administration

You will receive Propofol Lipuro by injection or infusion, that is, through a small needle or a small tube inserted into one of your veins.

Since Propofol Lipuro does not contain preservatives, the infusion from a single vial of Propofol Lipuro must not last longer than 12 hours.

Your circulation and respiration will be continuously monitored while you receive the injection or infusion.

If you have been given more Propofol Lipuro than you should have

This is unlikely to happen, as the doses you receive are very carefully controlled.

However, if you accidentally receive an overdose, it may lead to depression of cardiac function, circulation, and respiration. In such a case, your doctor will immediately initiate any necessary treatment.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Propofol Lipuro 20 mg/ml can cause adverse effects, although not everyone experiences them.

Call a doctor immediately if any of the following effects occur

Frequent (may affect between 1 and 10 out of 100 patients/people):

• Decrease in blood pressure, which may occasionally require administration of fluids and reduction of the propofol infusion rate.
• Very slow heartbeats, which could rarely be serious.

Rare (may affect between 1 and 10 out of 10,000 patients/people):

Seizures resembling epilepsy

Very rare (may affect less than 1 out of 10,000 patients/people):

• Allergic reactions up to anaphylactic shock, such as swelling of the face, tongue or throat, wheezing, skin redness, and low blood pressure.

• Cases of postoperative loss of consciousness have been reported. Therefore, you will be carefully monitored during the recovery period.

• Fluid in the lungs (pulmonary edema) after administration of propofol.

• Inflammation of the pancreas.

Not known (cannot be estimated from available data):

• Isolated cases of adverse reactions have been reported, presenting as a combination of the following symptoms: breakdown of muscle tissue, accumulation of acidic substances in the blood, abnormally high potassium levels in the blood, high levels of fats in the blood, abnormalities in the electrocardiogram (Brugada-type ECG), enlarged liver, irregular heartbeats, kidney failure, and heart failure. This has been termed the "propofol infusion syndrome". Some of the reported cases have been fatal. These effects have only been observed in intensive care patients, mainly in patients with severe head injuries and in children with respiratory tract infections who received doses exceeding 4 mg of propofol per kg of body weight per hour. See also section 2 "Warnings and precautions".

• Hepatitis (liver inflammation), acute liver failure (symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and liver tenderness (indicated by pain below the front part of the rib cage on the right side)), sometimes accompanied by loss of appetite).

Other side effects are as follows:

Very frequent (may affect more than 1 out of 10 patients/people):

• Pain at the injection site, occurring during the first injection. Pain can be reduced by injecting propofol into large veins of the forearm. Simultaneous injection of lidocaine (a local anesthetic) with propofol also helps reduce pain at the injection site.

Frequent (may affect between 1 and 10 out of 100 patients/people):

• Brief interruption of breathing.

• Headache during the recovery period.

• Nausea or vomiting during the recovery period.

Uncommon (may affect between 1 and 10 out of 1,000 patients/people):

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

Very rare (may affect less than 1 out of 10,000 patients/people):

• Loss of sexual control during recovery.
• Abnormal urine color after prolonged administration of propofol.
• Cases of fever after surgery.
• Tissue damage after accidental injection of the medicine outside the vein.

Not known (cannot be estimated from available data):

• Involuntary movements.
• Abnormally elevated mood.
• Drug abuse and drug dependence.
• Heart failure.
• Cardiac arrest.
• Shallow breathing.
• Prolonged and painful penile erection.
• Pain and/or swelling at the injection site after accidental injection of the medicine outside the vein.
• Muscle tissue breakdown has been very rarely reported in cases where propofol was administered at doses higher than those recommended for sedation in intensive care units.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Propofol Lipuro

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and packaging. The expiry date refers to the last day of the month indicated.

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 two separate layers are observed after shaking the product, or if it does not have a white milky appearance.

6. Package contents and other information

Composition of Propofol Lipuro

• The active substance is propofol.

Each millilitre of Propofol Lipuro 20 mg/mL contains 20 mg of propofol. One 50 mL vial contains 1,000 mg of propofol.

• The other components (excipients) are:

Refined soybean oil,
Medium-chain triglycerides,
Egg phospholipids for injectable preparations,
Glycerol,
Sodium oleate,
Water for injectable preparations.

Appearance of Propofol Lipuro and contents of the pack

It is an injectable and infusion emulsion.

It is a white, milky, oil-in-water emulsion.

It is supplied in 50 mL glass vials, available in packs of 1 or 10 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder, Manufacturer, and Local Representative

Marketing Authorization Holder and Manufacturer

• Braun Melsungen AG
  Carl-Braun-Straße 1
  Postal address:
  34212 Melsungen
  34209 Melsungen, Germany
  Telephone: +49/5661/71-0
  Fax: +49/5661/71-4567

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder.

• Braun Medical, S.A.
  Ctra. Terrasa, 121
  08191 Rubí (Spain)

This medicinal product is 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, 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, Spain, Sweden
Propofol Lipuro 2%: Greece

Date of the most recent review of this leaflet: 07/2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

The containers are for single use in one patient only.

The containers must be shaken before use.

Before use, the surface of the vial’s rubber stopper must be cleaned with medicinal alcohol (spray or soaked cotton swab). After use, the containers must be discarded.

The infusion line and the container containing Propofol Lipuro must be discarded and replaced with new ones within a maximum of 12 hours.

Any unused emulsion must be discarded at the end of administration. Disposal of unused medicinal product and all materials that have been in contact with it must be carried out in accordance with local regulations.

For complete information on this medicinal product, consult the Summary of Product Characteristics.