PROPOFOL LIPURO 10 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, soy, peanut, or any of the other ingredients of this medicine (listed in section 6).

It must not be used in patients 16 years of age or younger for sedation in intensive care.

Safety and efficacy have not been demonstrated in these age groups.

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 immediately call a doctor if any of the following effects occur") your doctor will immediately stop the administration of propofol.

Also, see the "Driving and using machines" section for precautions to take after using propofol.

Children and adolescents

The use of Propofol Lipuro is not recommended in newborns.

This medicine 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 medicines and Propofol Lipuro

Tell your doctor or pharmacist if you are taking or have recently taken or may 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 - 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 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 plan to become pregnant, consult your doctor or pharmacist 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 interrupt it 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 indicate

• 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 100 ml; i.e., it is essentially "sodium-free".

Propofol Lipuro contains soybean oil. Do not use this medicine in case of peanut or soy allergy.

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 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 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.).

Your 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, 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.

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

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

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

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

4. Possible side effects

Like all medicines, Propofol Lipuro 10 mg/ml can cause side effects, although not everybody gets them.

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

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

• 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 between 1 and 10 in every 10,000 patients):

Seizures as in epilepsy.

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

• 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 propofol administration.
• Pancreatitis (inflammation of the pancreas).

Unknown (cannot be estimated from 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, abnormalities in the electrocardiogram (ECG type Brugada), 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 intensive care patients, 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 as follows:

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

• 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. The simultaneous injection of lidocaine (a local anesthetic) and propofol also helps to reduce pain at the injection site.

Common (may affect between 1 and 10 in every 100 patients):

• Brief interruption of breathing.

• Headache during the recovery period.

• Nausea or vomiting during the recovery period.

Uncommon (may affect between 1 and 10 in every 1,000 patients):

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

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

• 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.

Unknown (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 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, pharmacist, or nurse, even if it is 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 expiration date stated on the label and carton. The expiration 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 the ampoule or vial.

Dilutions of Propofol Lipuro should be used immediately after preparation.

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 other information

Composition of Propofol Lipuro

• The active substance is propofol.

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

1 ampoule of 10 ml contains 100 mg of propofol.

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

1 vial of 50 ml contains 500 mg of propofol.

1 vial of 100 ml contains 1,000 mg of propofol.

• The other ingredients (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 emulsion and for infusion.

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

It is available in:

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

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

Not all pack sizes may be marketed.

Marketing authorization holder, manufacturer, and local representative

Marketing authorization holder and manufacturer

• Braun Melsungen AG.

Carl-Braun-Straße 1, 34212 Melsungen, Germany.

Phone: +49/5661/71-0.

Fax: +49/5661/71-4567.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

• 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:

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

Propofol B.Braun 1%: Italy.

Propofol "B.Braun" 10 mg/ml: Denmark.

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

Propofol Lipuro 1%: Cyprus, Greece.

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 must be shaken before use.

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

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

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.