PROPOFOL LIPURO 20 mg/ml INJECTABLE EMULSION AND INFUSION SOLUTION

2. What you need to know before you use Propofol Lipuro

Do not use Propofol Lipuro:

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

It must not be used in patients 16 years or younger for sedation in intensive care. It has not been shown to be safe and effective in these age groups.

Warnings and precautions

Tell your doctor or pharmacist before you start receiving Propofol Lipuro

Special care should be taken

• if you have severe head injuries,
• if you have mitochondrial disease
• if you have any disorder in which your body does not handle fats properly,
• if you have any other health problem that requires great caution when using fat emulsions,
• if you are severely overweight,
• if your blood volume is too low (hypovolaemia),
• if you have low protein levels in your blood (hypoproteinaemia),
• if you are very weak or if you have heart, circulatory, kidney or liver problems,
• if you have high pressure in the skull and low blood pressure,
• if you have any respiratory problems,
• if you have epilepsy,
• if you are undergoing procedures where spontaneous movements are especially undesirable.

Tell your doctor if you have any of these diseases or disorders.

If you are receiving other lipids by infusion in your vein at the same time, your doctor will pay special attention to your total daily fat intake.

Propofol will be given to you by a doctor who is specialised in anaesthesia or intensive care. You will be constantly monitored during anaesthesia and the recovery period.

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

Also, see section "Driving and using machines" for precautions to be taken 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 16 years or younger for sedation in intensive care (see section "Do not use Propofol Lipuro").

Other medicines and Propofol Lipuro

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Propofol has been used effectively for different regional anaesthesia techniques, which numb only a part of the body (epidural and spinal anaesthesia).

It has also been shown to be safe when used in combination with

• medicines you receive before an operation,
• other medicines, such as muscle relaxants,
• anaesthetic medicines that can be inhaled,
• analgesics.

However, your doctor may give you lower doses of propofol if general anaesthesia or sedation is needed to supplement regional anaesthesia techniques.

Your doctor should be aware that the administration of propofol together with other medicines that have an inhibitory effect on the central nervous system may increase the effects of propofol. Special care should be taken if you receive an antibiotic containing rifampicin at the same time - you may develop a deep drop in blood pressure.

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

Using Propofol Lipuro and alcohol

Your doctor will inform you about alcohol consumption before and after using Propofol Lipuro.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Propofol should not be used during pregnancy unless absolutely necessary.

It crosses the placenta and may depress the vital functions of the baby.

However, propofol may be used during an induced abortion.

If you are breast-feeding, you should stop breast-feeding and discard the breast milk for 24 hours after you have received Propofol Lipuro. Studies in breast-feeding women have shown that propofol passes into breast milk in small amounts.

Driving and using machines

Do not drive or use tools or machines for a time after you have received an injection or infusion of Propofol Lipuro.

Your doctor will tell you

• if you should be accompanied when you leave,
• when you can drive and use machines again,
• the use of other sedative medicines (e.g. sedatives, strong painkillers, alcohol).

Propofol Lipuro contains sodium and soya oil

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

Propofol Lipuro contains soya oil. Do not use this medicine if you are allergic to peanut or soya.

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3. How to use Propofol Lipuro

Propofol Lipuro will only be given to you by people who have been trained in the administration of anaesthesia or by specially trained doctors in a hospital or a day treatment unit that is properly equipped.

Dosage

The dose you receive will vary, depending on your age, body weight and physical condition. Your doctor will give you the correct dose to start and maintain anaesthesia or to achieve the desired level of sedation, by carefully observing your responses and vital signs (pulse, blood pressure, breathing, etc.).

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

Propofol Lipuro will only be given to you for a maximum of seven days.

Method of administration

You will receive Propofol Lipuro by injection or infusion, i.e. through a small needle or a small tube placed in one of your veins.

Since Propofol Lipuro does not contain preservatives, the infusion of a vial of Propofol Lipuro will not last more than 12 hours.

Your circulation and breathing will be constantly monitored while you receive the injection or infusion.

If you have received more Propofol Lipuro than you should

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

However, if you accidentally receive an overdose, this may lead to depression of heart function, circulation and breathing. In this case, your doctor will immediately use any necessary treatment.

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

4. Possible side effects

Like all medicines, Propofol Lipuro 20 mg/ml can cause side effects, although not everybody gets them.

You should see a doctor immediately if you experience any of the following effects

Frequent (may affect up to 1 in 10 people):

• Drop in blood pressure that may occasionally require the administration of fluids and a reduction in the rate of propofol administration.
• Very slow heartbeats, which may be severe in rare cases.

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

Seizures as in epilepsy

Very rare (may affect less than 1 in 10,000 people):

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

• There have been cases of postoperative loss of consciousness. Therefore, you will be carefully observed during the recovery period.
• Fluid in the lungs (pulmonary oedema) after administration of propofol.
• Inflammation of the pancreas.

Not known (cannot be estimated from the available data):

• There have been reports of isolated cases of adverse reactions that present as a combination of the following symptoms: muscle tissue breakdown, accumulation of acidic substances in the blood, abnormally high potassium levels in the blood, abnormalities in the electrocardiogram (ECG type Brugada), liver enlargement, irregular heartbeats, kidney failure and heart failure. This has been called the "propofol infusion syndrome". Some of the reported cases have had a fatal outcome. These effects have only been observed in patients in intensive care, mainly in patients with severe head injuries and in children with respiratory tract infections who received doses higher than 4 mg of propofol per kg body weight and per hour. See also section 2 "Warnings and precautions".
• Hepatitis (inflammation of the liver), acute liver failure (symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain and liver sensitivity (indicated by pain below the front of the rib cage on the right side), sometimes with loss of appetite).

Other side effects are as follows:

Very common (may affect more than 1 in 10 people):

• Pain at the injection site, occurring during the first injection. The pain can be reduced by injecting propofol into the large veins of the forearm. The simultaneous injection of lidocaine (a local anaesthetic) and propofol also helps to reduce the pain at the injection site.

Frequent (may affect up to 1 in 100 people):

• Brief interruption of breathing.

• Headache during the recovery period

• Nausea or vomiting during the recovery period

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

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

Very rare (may affect less than 1 in 10,000 people):

• Loss of sexual control during recovery
• Abnormal urine colour after prolonged administration of propofol
• Cases of fever after an operation
• Tissue damage after accidental injection of the medicine outside the vein

Not known (cannot be estimated from the available data):

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es.

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

5. Storing Propofol Lipuro

Keep out of the sight and reach of children.

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

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 you observe two separate layers after shaking the product or if it does not have a white milky colour.

6. Contents of the pack 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. 1 vial of 50 ml contains 1,000 mg propofol.

• The other ingredients (excipients) are:

Refined soya 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 emulsion and for infusion.

It is an oil-in-water emulsion, white milky in colour.

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

Not all pack sizes may be marketed.

Marketing authorisation holder, manufacturer and local representative

Marketing authorisation holder and manufacturer

• Braun Melsungen AG

Carl-Braun-Straße 1 Postal address:

34212 Melsungen 34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

You can obtain more information on this medicine by contacting the local representative of the marketing authorisation holder

• Braun Medical, SA

Ctra. Terrasa, 121

08191 Rubí (Spain)

This medicine is authorised 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 last revision of this leaflet: 07/2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

The containers are for single use, in a single patient.

The containers should be shaken before use

Before use, the rubber stopper surface of the vial should be cleaned with medicinal alcohol (in a spray or with a swab). Once used, the containers should be discarded.

The infusion line and the container holding Propofol Lipuro should be discarded and replaced with new ones after a maximum of 12 hours.

Any unused emulsion should be discarded at the end of the administration. The disposal of the unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations.

For complete information on this medicinal product, consult the summary of product characteristics.