Label: Information for the User

Propofol Lipuro 20mg/ml injectable emulsion and for perfusion

Propofol

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1. What is Propofol Lipuro and how is it used

2. What you need to knowbeforestarting to use Propofol Lipuro

3. How to use Propofol Lipuro

4. Possible adverse effects

5. Storage of Propofol Lipuro

6. Contents of the package and additional information

Propofol Lipuro belongs to a group of medications called general anesthetics. General anesthetics are used to produce unconsciousness (sleep) so that surgical operations or other procedures can be performed. They can also be used to sedate you (so that you are drowsy but not completely asleep).

Propofol Lipuro is used for:

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

No use Propofol Lipuro:

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

Do not use in patients 16 years or younger for sedation in intensive care. The safety and efficacy have not been demonstrated in these age groups.

Warnings and precautions:

Consult your doctor or pharmacist before starting to receive 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 careful use of fatty emulsions,
• if you are significantly overweight,
• if your blood volume is too low (hypovolemia),
• if you have low blood protein levels (hypoproteinemia),
• if you are very weak or have any heart, circulatory, renal, or hepatic problems,
• if you have high pressure in the skull and low blood pressure in the arteries,
• if you have any respiratory problems,
• if you have epilepsy,
• if you are undergoing procedures in which spontaneous movements are undesirable.

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

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

Propofol will be administered by a specialist in anesthesia or intensive care. It will be constantly monitored during anesthesia and the recovery period.

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

See also in the section "Driving and operating machines" the precautions you should take after using propofol.

Children and adolescents:

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

This medication should not be used in patients 16 years of age or younger for sedation in intensive care (see section "Do not use Propofol-Lipuro").

Other medications and Propofol-Lipuro:

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

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

It has also been demonstrated to be safe in combination with:

• medications you receive before surgery,
• other medications, such as muscle relaxants,
• inhaled anesthetics,
• analgesics.

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

Your doctor should take into account that the administration of propofol with other medications that have an inhibitory effect on the central nervous system may increase the effects of propofol. Special attention should be paid if you are receiving rifampicin-containing antibiotics - you may develop a deep drop in blood pressure.

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

Use of Propofol Lipuro and alcohol:

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

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Propofol should not be used during pregnancy unless absolutely necessary.

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

However, propofol may be used during induced abortion.

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

Driving and operating machines:

Do not drive or operate machines for a time after receiving an injection or infusion of Propofol Lipuro.

Your doctor will indicate:

• if you should be accompanied when leaving,
• when you can drive and use machines again,
• the use of other tranquilizing medications (e.g., tranquilizers, potent analgesics, alcohol).

Propofol Lipuro contains sodium and soy oil:

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

Propofol Lipuro contains soy oil. Do not use this medication in case of allergy to peanuts or soy.

Propofol Lipuro will only be administered by individuals who have received training in anesthesia administration or by specially trained doctors in a hospital or day treatment unit equipped with the necessary facilities.

Dosage

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

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

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

Administration Form

You will receive Propofol Lipuro by injection or infusion, that is, 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 Propofol Lipuro vial 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 have

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

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

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

Like all medicines, Propofol Lipuro 20mg/ml may cause side effects, although not everyone will experience them.

You should call a doctor immediately if any of the following side effects occur

Frequent (may affect between 1 and 10 in every 100patients/people):

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

Rare (may affect between 1 and 10 in every 10,000patients/people):

Seizures like those in epilepsy

Very rare (may affect fewer than 1 in every 10,000patients/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 closely monitored during the recovery period.
• Pulmonary edema after propofol administration.
• Pancreatitis inflammation.

Not known (cannot be estimated from available data):

• Isolated cases of adverse reactions that present as a combination of the following symptoms: muscle tissue degradation, accumulation of acidic substances in the blood, high potassium levels in the blood, high levels of lipids in the blood, abnormal electrocardiogram (ECG type Brugada), liver enlargement, irregular heartbeats, renal insufficiency, 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 intensive care patients, mainly in patients with severe head injuries and children with respiratory tract infections who received doses above 4mg of propofol per kg of body weight and per hour. See also section2 "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 under the front part of the chest on the right side), sometimes with loss of appetite).

Other side effects are as follows:

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

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

Frequent (may affect between 1 and 10 in every 100patients/people):

• Brief interruption of breathing.

• Headache during the recovery period

• Nausea or vomiting during the recovery period

Occasional (may affect between 1 and 10 in every 1,000patients/people)):

• Thrombosis in veins or inflammation of veins at the injection site

Very rare (may affect fewer than 1 in every 10,000patients/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 drug outside the vein

Not known (cannot be estimated from 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 siteafter accidental injection of the drug outside the vein
• Very rarely, muscle tissue degradation has been reported in cases where propofol was administered in doses higher than those recommended for sedation in intensive care units.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date shown on the label and packaging. The expiration date is the last day of the month indicated.

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

Composition of Propofol Lipuro

• The active ingredient is propofol.

Each milliliter of Propofol Lipuro 20mg/ml contains 20mg of propofol.1vial of 50ml contains 1,000mg 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 packaging contents

It is an injectable and perfusion emulsion.

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

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

Only some pack sizes may be marketed.

Marketing authorization holder, manufacturer, and local representative

Marketing authorization holder and manufacturer

B. Braun Melsungen AG

Carl-Braun-Straße 1Postal address:

34212 Melsungen34209 Melsungen, Germany

Telephone: +49/5661/71-0

Fax: +49/5661/71-4567

For more information about this medication, please contact the local representative of the marketing authorization holder

B. Braun Medical, SA

Ctra. Terrasa, 121

08191 Rubí (Spain)

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Propofol Lipuro2% (20mg/ml):Czech Republic, Ireland, Latvia, Portugal,United Kingdom (Northern Ireland), Poland, Slovakia

Propofol “B.Braun” 20mg/ml:Denmark

Propofol B.Braun 2 %:Italy

Propofol Lipuro20mg/ml:Austria, Estonia, Finland, France,Germany,Hungary, Lithuania, Luxembourg, Netherlands, Norway, Slovenia,Spain, Sweden

Propofol Lipuro2%:Greece

Last review date of this leaflet: 07/2024

For detailed and up-to-date information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”

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This information is intended solely for medical professionals or healthcare professionals:

The packaging is for single use, in a single patient.

The packaging must be shaken before use.

Before use, the rubber stopper of the vial must be cleaned with medicinal alcohol (in a spray or with a cotton swab soaked in it). Once used, the packaging must be disposed of.

The perfusion route and the packaging containing Propofol Lipuro must be discarded and replaced with others within a maximum of 12hours.

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

For complete information about this medication, please consult the product characteristics summary.