PROPOFOL LIPURO 5 mg/ml INJECTABLE EMULSION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Propofol Lipuro 5mg/ml injectable emulsion and for infusion

Propofol

Read all of this leaflet carefully before you start usingthismedicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Propofol Lipuro and what is it used for
2. What you need to know before you start using Propofol Lipuro
3. How to use Propofol Lipuro
4. Possible side effects
5. Storage of Propofol Lipuro
6. Contents of the pack and further information

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

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 (to make you drowsy but not completely asleep).

Propofol Lipuro is used for:

• inducing general anesthesia in adults and children over 1 month of age,
• sedating adult patients during diagnostic and surgical procedures for a short period of time, alone or in combination with local or regional anesthesia,

inducing sedation in adults and children over 1 month of age during diagnostic and surgical procedures

2. What you need to know before you start using Propofol Lipuro

What you need to know before you start using Propofol Lipuro

Do not use Propofol Lipuro

• If you are allergic to propofol, soy, peanut or any of the other components of this medicine (listed in section 6).
• For maintenance of general anesthesia or sedation in diagnostic and surgical procedures in children
• For sedation in intensive care.

Warnings and precautions

Talk to 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 a disorder in which your body does not handle fats properly,
• if you have any other health problem that requires great caution in the use of fat emulsions,
• if your blood volume is too low (hypovolemia),
• if you have low protein levels in your blood (hypoproteinemia),
• if you are very weak or if you have heart, kidney, or liver problems,
• if you have high pressure in the skull,
• 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 administered to you by a doctor specializing 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 section 4, "Possible side effects", "You should 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 using machines" the precautions you should take after using propofol.

Children and adolescents

The use of Propofol Lipuro is not recommended in newborns.

Other medicines and Propofol Lipuro

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

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

It has also been shown to be safe in combination with

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

However, your doctor may give you lower doses of propofol if general anesthesia or sedation is needed as a supplement to regional anesthesia 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 attention should be paid if you are receiving 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).

Use ofPropofol 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Propofol Lipuro should not be used during pregnancy unless it is absolutely necessary. It crosses the placenta and can depress the baby's vital functions.

However, propofol can be used during an induced abortion.

If you are breastfeeding, you should stop 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 using machines

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

Your doctor will tell you

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

Propofol Lipuro contains sodium and soybean oil

This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml; i.e. it is essentially "sodium-free".

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

3. How to use Propofol Lipuro

Propofol Lipuro will only be administered by persons who have received training in the administration of anesthesia or by specially trained doctors in a hospital or a properly equipped day treatment unit.

Posology

The dose you receive will vary, depending on your age, body weight, and physical condition. Your doctor will administer the correct dose to start anesthesia 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 administered for a maximum of 1 hour.

Method of administration

You will receive Propofol Lipuro by intravenous injection or infusion, i.e. through a small needle or a small tube placed in one of your veins. If administered by infusion, it can be diluted beforehand.

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 could lead to depression of cardiac and respiratory function. In this case, your doctor will immediately use the necessary treatment.

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

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4. Possible side effects

Like all medicines, Propofol Lipuro 5 mg/ml can cause side effects, although not everybody gets them.

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

Frequent (may affect between 1 and 10 in 100 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 can be severe in rare cases.

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

• Seizures as in epilepsy

Very rare: (may affect up to 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 edema) after administration of propofol.
• Pancreatitis.

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

• Isolated cases of adverse reactions have been reported, which 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, high fat levels in the blood, abnormal ECG (Brugada-type ECG), liver enlargement, irregular heartbeat, 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 of 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 the following:

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

• Pain at the injection site, which occurs 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 anesthetic) and propofol also helps to reduce pain at the injection site.

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

• Brief interruption of breathing.

• Headache during the recovery period

• Nausea or vomiting during the recovery period

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

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

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

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

Not known (frequency cannot be estimated from the 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 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, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Propofol Lipuro

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

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

Do not store above 25°C. Do not freeze.

Propofol Lipuro should be used immediately after opening/dilution.

Do not use Propofol Lipuro if you observe two separate layers after shaking the product or if it does not have a white milky color.

6. Contents of the pack and further information

Composition of Propofol Lipuro

• The active substance is propofol.

Each milliliter of Propofol Lipuro 5 mg/ml contains 5 mg of propofol.

1 ampoule of 20 ml contains 100 mg propofol.

• The other ingredients 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 emulsion and for infusion.

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

It is available in 20 ml glass ampoules, in packs of 5 ampoules.

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

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

Local representative

B Braun Medical, SA

Ctra Terrasa, 121.

08191 Rubí (Spain)

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

Germany Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion

Austria Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion

Denmark Propofol "B.Braun" 5 mg/ml

Slovakia Propofol Lipuro 0.5% (5 mg/ml)

Spain Propofol Lipuro 5 mg/ml

Finland Propofol Lipuro 5 mg/ml

France Propofol Lipuro 5 mg/ml

Hungary Propofol Lipuro 5 mg/ml

Ireland Propofol Lipuro 0.5% (5 mg/ml)

Italy Propofol B.Braun 0.5%

Luxembourg Propofol-Lipuro 5 mg/ml Emulsion zur Injektion oder Infusion

Norway Propofol Lipuro 5 mg/ml

Poland Propofol Lipuro 5 mg/ml

Portugal Propofol Lipuro 0.5% (5 mg/ml)

United Kingdom (Northern Ireland) Propofol Lipuro 0.5% (5 mg/ml)

Czech Republic Propofol Lipuro 0.5% (5 mg/ml)

Sweden Propofol Lipuro 5 mg/ml

Date of last revision of this leaflet:07/2024

Detailed 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 neck of the ampoule should be cleaned with medicinal alcohol (in a spray or with a cotton swab).

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

To obtain complete information on this medicine, consult the summary of product characteristics.