Prospect: Information for the User

Propofol Lipuro 10mg/ml Injectable Emulsion and for Infusion

Propofol

Read this prospect thoroughly before starting to use this medication,because it contains important information for you.

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

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

2. What you need to knowbefore starting to use Propofol Lipuro

3. How to use Propofol Lipuro

4. Possible adverse effects

5. Storage of Propofol Lipuro

6. Contents of the package andadditional information

Propofol Lipuro belongs to a group of medicines 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 1 month,

• sedating patients over 16 years of age who are receiving artificial respiration in intensive care,

• sedating adults and children over 1 month 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, peanut, or any of the other components of this medication (listed in section6).

Do not use in patients 16years 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 your blood volume is too low (hypovolemia),
• if you have a low concentration of proteins in the blood (hypoproteinemia),
• if you are very weak or have any cardiac, renal, or hepatic problems,
• if you have high pressure in the skull,
• if you have any respiratory problems,
• if you have epilepsy,
• if you are undergoing some 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 doctor in anesthesia or intensive care.You will be constantly monitored during anesthesia and the recovery period.

If you experience signs of the so-called "propofol infusion syndrome" (see section4, "Possible adverse effects", "Call a doctor immediatelyif any of the following effects") your doctor will stopimmediatelythe 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 newborns.

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

Other medications andPropofol 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 required.

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 simultaneously - you may develop a deep drop in blood pressure.

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

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

Propofol Lipuro 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 your baby, you should interrupt it and discard the breast milk for 24hours after receiving Propofol Lipuro. Studies in lactating women have shown that propofol passes in small amounts to breast milk.

Driving and operating machines

Do not drive or operate tools or 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 Lipurocontains sodium and soy oil

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

Propofol Lipuro contains soy oil.Do not use this medication in case of allergyto peanut 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 monitor 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. If administered by infusion, it may be diluted beforehand.

Since Propofol Lipuro does not contain preservatives, the infusion of a Propofol Lipuro vial will not last more than 12 hours. An infusion from a diluted Propofol Lipuro vial will not last more than 6 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 cardiac and respiratory depression. 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 10mg/ml, may cause side effects, although not everyone will experience them.

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 have been reported, presenting as a combination of the following symptoms: muscle tissue degradation, accumulation of acidic substances in the blood, abnormally high potassium levels in the blood, high levels of fats 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 exceeding 4mg of propofol per kilogram 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 hepatic sensitivity, indicated by pain under the front part of the chest in 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 propofol administration
• Cases of fever after surgery

• Tissue damage after accidental injection of the medication outside the vein

Not known (cannot be estimated from available data):

• Involuntary movements
• Abnormally good mood
• Drug abuse and 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 medication outside the vein

• There have been rare cases of muscle tissue degradation in cases where propofol was administered in doses exceeding the recommended amounts for sedation in intensive care units.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

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

Do not store at a temperature above 25°C. Do not freeze.

Propofol Lipuro must be used immediately after opening the ampule or vial.

The dilutions of Propofol Lipuro must be used immediately after preparation.

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 principle is propofol.

Each milliliter of Propofol Lipuro 10mg/ml contains 10mg of propofol.

1 vial of 10ml contains 100mg of propofol

1 vial or ampoule of 20ml contains 200mg of propofol.

1 vial of 50ml contains 500mg of propofol.

1 vial of 100ml 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 content

It is an injectable and perfusion emulsion.

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

It is presented in:

• 10ml glass ampoules, available in packs of 10ampoules

• 20ml glass ampoules, available in packs of 5ampoules,
• 20ml vials, available in packs of 10vials
• 50ml or 100ml glass vials, available in packs of 1or 10vials.

Only some packaging 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

Phone: +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 Lipuro 1% (10mg/ml):Czech Republic, Ireland, Malta, Poland, Portugal, Slovakia, United Kingdom (Northern Ireland)

PropofolB.Braun 1%:Italy

Propofol “B.Braun” 10mg/ml: Denmark

Propofol Lipuro 10mg/ml: Austria, Estonia, Finland, France, Germany, Hungary, Latvia, Lithuania, Luxembourg, Netherlands, Slovenia, Spain, Sweden, Norway

Propofol Lipuro 1%:Cyprus, Greece

Last review date of thisleaflet:07/2024

For detailed 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 healthcare professionals:

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

The packaging must be shaken before use.

Before use, the neck of the ampoule or the surface of the rubber stopper of the vial must be cleaned with medicinal alcohol (in a spray or with a cotton swab soaked in it).

The perfusion route and the packaging containing Propofol Lipuro must be discarded and replaced with others at most after 12hours.

Any unused emulsion must be discarded at the end of administration.The elimination 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 summary.