Propofol Lipuro 5 mg/ml emulsion for injection and for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Propofol Lipuro 5mg/ml injectable and perfusion emulsion

Propofol

Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet Contents

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

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

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

Propofol Lipuro is used for:

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

2. What you need to know before using Propofol Lipuro

What you need to know before using Propofol Lipuro

Do not use Propofol Lipuro

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

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, or a disorder in which your body does not properly process fats,
• if you have any other health condition requiring particular caution with the use of fat emulsions,
• if your blood volume is too low (hypovolemia),
• if you have low levels of protein in the blood (hypoproteinemia),
• if you are very weak or suffer from heart, kidney, or liver problems,
• if you have high pressure in the skull,
• if you have respiratory problems,
• if you have epilepsy,
• if you are undergoing procedures where spontaneous movements are especially undesirable.

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

If you are simultaneously receiving other lipids via intravenous infusion, 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 continuously monitored during anesthesia and the recovery period.

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

See also the section "Driving and use of machines" for precautions to take after using propofol.

Children and adolescents

The use of Propofol Lipuro is not recommended in newborns.

Other medicines and Propofol Lipuro

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Propofol has been effectively used in combination with various regional anesthesia techniques, which numb only part of the body (epidural and spinal anesthesia).

Its safe use has also been demonstrated in combination with:

• drugs administered before surgery,
• other medications such as muscle relaxants,
• inhaled anesthetic agents,
• analgesics.

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

Your doctor should be aware that administering propofol together with other medicines that have a central nervous system depressant effect may increase the effects of propofol. Special attention should be paid if you are concurrently receiving an antibiotic containing rifampicin—you may develop a severe 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 advise you regarding 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 absolutely necessary. It crosses the placenta and may depress vital functions in the baby.

However, propofol may be used during induced abortion.

If you are breastfeeding, you must stop and discard breast milk for 24 hours after receiving Propofol Lipuro. Studies in lactating women have shown that propofol passes into breast milk in small amounts.

Driving and use of machines

Do not drive or operate tools or machinery for some time after receiving an injection or infusion of Propofol Lipuro.

Your doctor will advise you

• whether you should be accompanied when leaving,
• when you may resume driving and using machines,
• about the use of other sedative drugs (e.g., tranquilizers, strong analgesics, alcohol).

Propofol Lipuro contains sodium and soybean oil

This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml; therefore, it is essentially “sodium-free”.

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

3. How to use Propofol Lipuro

Propofol Lipuro will only be administered by individuals who have been trained in anaesthesia administration or by specially qualified physicians in a properly equipped hospital or day-care treatment unit.

Posology

The dose you receive will vary depending on your age, body weight, and physical condition. Your doctor will administer the appropriate dose to induce anaesthesia or achieve the desired level of sedation, carefully observing your responses and vital signs (pulse, blood pressure, respiration, 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 into one of your veins. If administered by infusion, it may be diluted beforehand.

Your circulation and respiration will be continuously monitored while you receive the injection or infusion.

If you have been given more Propofol Lipuro than you should have

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

However, if you accidentally receive an overdose, this could lead to depression of cardiac and respiratory function. In such a case, your doctor will immediately initiate the necessary treatment.

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

4. Possible adverse effects

Like all medicines, Propofol Lipuro 5 mg/ml may produce adverse effects, although not everyone experiences them.

Call a doctor immediately if any of the following effects occur

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

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

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

• Seizures resembling epilepsy.

Rare (may affect up to 1 in every 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.

• Cases of postoperative loss of consciousness have been reported. Therefore, you will be carefully monitored during the recovery period.

• Fluid in the lungs (pulmonary edema) after administration of propofol.

• Inflammation of the pancreas.

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

• Isolated cases of adverse reactions have been reported, presenting as a combination of the following symptoms: breakdown of muscle tissue, accumulation of acidic substances in the blood, abnormally high potassium levels in the blood, high levels of fats in the blood, abnormalities in the electrocardiogram (Brugada-type ECG), enlarged liver, irregular heartbeats, kidney failure and heart failure. This has been termed the “propofol infusion syndrome”. Some of the reported cases have been fatal. 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 exceeding 4 mg of propofol per kg of body weight 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 tenderness (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 every 10 people):

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

Common (may affect up to 1 in every 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 every 100 people):

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

Rare (may affect up to 1 in every 10,000 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 medicine outside the vein.

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

• Involuntary movements.
• Abnormally elevated 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.
• Muscle tissue breakdown has been very rarely reported in cases where propofol was administered at doses higher than recommended for sedation in intensive care units.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the label and packaging. The expiry date refers to the last day of the month indicated.

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

Propofol Lipuro should be used immediately after opening/dilution.

Do not use Propofol Lipuro if two separate layers are observed after shaking the product, or if it does not have a white milky appearance.

6. Package contents and other information

Composition of Propofol Lipuro

• The active substance is propofol.

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

One 20-ml ampoule contains 100 mg propofol.

• The other components are:

Refined soya bean oil,

Medium-chain triglycerides,

Egg phospholipids for injectable preparations,

Glycerol,

Sodium oleate,

Water for injectable preparations.

Appearance of Propofol Lipuro and contents of the container

It is an injectable and infusion emulsion.

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

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

Marketing Authorisation Holder and Manufacturer, and Local Representative

Marketing Authorisation Holder and Manufacturer

• B. Braun Melsungen AG

Carl-Braun-Straße 1
Postal address:
34212 Melsungen
34209 Melsungen, Germany

Telephone: +49/5661/71-0
Fax: +49/5661/71-4567

Local Representative

B. Braun Medical, S.A.
Ctra Terrassa, 121.
08191 Rubí (Spain)

This medicinal product is authorised 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 the most recent review of this leaflet: 07/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended for healthcare professionals only:

Containers are for single use in a single patient only.

Containers must be shaken before use.

Before use, the ampoule neck must be cleaned with medicinal alcohol (using a spray or a swab soaked in alcohol).

Any unused emulsion must be discarded at the end of administration. Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.

For complete information on this medicinal product, consult the Summary of Product Characteristics.