Prospecto: information for the user

Propofol Lipoven Fresenius 20 mg/ml injectable emulsion and for perfusion
Propofol

1. What it isPropofol Lipoven Freseniusand how it is used

2. What you need to know before starting to usePropofol Lipoven Fresenius

3. How to usePropofol Lipoven Fresenius

4. Possible adverse effects

5. Conservation ofPropofol Lipoven Fresenius

6. Contents of the package and additional information

Propofol Lipoven Fresenius belongs to a group of medicines called general anesthetics. General anesthetics are used to produce unconsciousness (sleep) and thus, enable surgical operations or other procedures to be performed. They can also be used to sedate you (so that you feel drowsy but not completely asleep).

Propofol Lipoven Fresenius 20 mg/ml is used for:

• Induction and maintenance of general anesthesia in adults, adolescents, and children over 3 years of age
• Sedation of patients over 16 years of age with assisted respiration in intensive care
• Sedation in adults, adolescents, and children over 3 years of age for diagnostic and surgical procedures, alone or in combination with local or regional anesthesia

Do not use Propofol Lipoven Fresenius

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

-In patients 16 years of age or younger for sedation in intensive care.

-This medication contains soybean oil. Do not use in case of allergy to peanuts or soy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Propofol Lipoven Fresenius.

Do not use Propofol Lipoven Fresenius, or only under extreme precautions and with intensive monitoring, if you:

-Have advanced heart failure

-Have any other serious heart disease

-Are receiving electroconvulsive therapy (ECT, a treatment for psychiatric problems)

Generally, Propofol Lipoven Fresenius should be administered with caution in weak patients or elderly patients.

Before administration of Propofol Lipoven Fresenius, inform your anesthesiologist or intensive care physician if you have:

-Heart disease

-Lung disease

-Kidney disease

-Liver disease

-Seizures (epilepsy)

-Increased intracranial pressure. In combination with low blood pressure, it may decrease the amount of blood reaching the brain

-Altered lipid levels in the blood. If you receive total parenteral nutrition (nutrition through a vein), monitor lipid levels in the blood

-Significant loss of body water (hypovolemia)

If you have any of the following conditions, they must be treated before administration of Propofol Lipoven Fresenius:

-Heart failure

-Insufficient blood flow to tissues (circulatory insufficiency)

-Severe respiratory problems (respiratory insufficiency)

-Dehydration (hypovolemia)

-Seizures (epilepsy)

Propofol Lipoven Fresenius may increase the risk of:

-Seizures

-A reflex that decreases heart rate (vagotonia, bradycardia)

-Changes in blood flow to organs (hemodynamic effects in the cardiovascular system) if you are overweight and receive high doses of Propofol Lipoven Fresenius

During sedation with Propofol Lipoven Fresenius 20 mg/ml, involuntary movements may occur. The doctor should take into account how this may affect surgical procedures performed under sedation and take necessary precautions.

Occasionally, after anesthesia, a period of unconsciousness associated with muscle numbness may occur. This only requires observation by the medical team, without administration of additional treatment. It will resolve spontaneously.

The injection of Propofol Lipoven Fresenius may be painful. A local anesthetic may be used to reduce this pain, but it may produce its own adverse effects.

You will not be allowed to leave the hospital until you are fully awake.

If you can go home in a short period of time after receiving Propofol, do not return without a companion.

Children and adolescents

The use of Propofol Lipoven Fresenius 20 mg/ml emulsion and for infusion is not recommended in children under 3 years of age.

Propofol Lipoven Fresenius 20 mg/ml should not be administered to children and adolescents under 16 years of age for sedation in intensive care, as its safety has not been demonstrated in this group of patients for this indication.

Use of Propofol Lipoven Fresenius with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications.

Particularly, inform your doctor, anesthesiologist, or nurse if you are taking any of the following medications:

• Rifampicin (for tuberculosis-TB).
• Midazolam (used to induce sedation (a very relaxed state of calm, somnolence, or sleep) and relieve anxiety and muscle tension).

Be especially careful if you are also taking/receiving any of the following medications:

-Premedication (your anesthesiologist will know which medications may interact with Propofol Lipoven Fresenius)

-Other anesthetics, including general, regional, local, and inhalational anesthetics (may require lower doses of Propofol Lipoven Fresenius 20 mg/ml. Your anesthesiologist will know)

-Analgesics (pain relievers)

-Strong pain relievers (fentanyl or opioids)

-Parasympatholytic agents (medications used to treat, for example, muscle cramps, asthma, or Parkinson's disease)

-Benzodiazepines (medications for anxiety)

-Suxamethonium (muscle relaxant)

-Medications that affect many of the body's internal functions, such as heart rate, e.g. Atropine

-Medications that contain alcohol or beverages

-Neostigmine (a medication used to treat a disease called myasthenia gravis)

-Ciclosporin (a medication used to prevent rejection in transplants)

-Valproate (a medication used to treat epilepsy or mental disorders)

Use of Propofol Lipoven Fresenius with food, drinks, and alcohol

After you have been administered Propofol Lipoven Fresenius, do not eat, drink, or consume alcohol until you are fully recovered.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Propofol Lipoven Fresenius should not be used in pregnant women unless it is clearly necessary. You should stop breastfeeding and discard breast milk for 24 hours after receiving Propofol Lipoven Fresenius.

Driving and operating machines

Do not drive or operate machines after receiving Propofol Lipoven Fresenius, as this medication may affect your reaction time. Your doctor will indicate how long you should wait before driving or operating machines.

After receiving propofol, you may feel drowsiness for some time.

Do not drive or operate machines until you are sure the effects have disappeared.

If you can go home shortly after receiving propofol, do not drive a car and do not return to your home without a companion.

Ask your doctor when you can return to these activities again and when you can return to work.

Propofol Lipoven Fresenius contains soybean oil and sodium

Propofol Lipoven Fresenius contains soybean oil. This may cause rare severe hypersensitivity reactions (allergic reactions) (see "Do not use Propofol Lipoven Fresenius"). Inform your doctor if you know you are allergic to soybean oil.

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

Propofol Lipoven Fresenius will only be administered in hospitals or in suitable intensive care units under the direct supervision of your anesthesiologist or intensive care physician.

Dose

The dose administered to you will depend on your age, body weight, and physical condition. Your doctor will administer the correct dose to initiate and maintain anesthesia or to achieve the required level of sedation, carefully monitoring your response and vital signs (pulse, blood pressure, breathing, etc.).

You may need different types of medications to keep you asleep or sedated, without pain, breathing properly, and maintaining stable blood pressure. Your doctor will decide which medications you need and when you need them.

Adults

Most people need between 1.5 – 2.5 mg of propofol per kilogram of body weight to fall asleep (anesthesia induction), and then 4 to 12 mg of propofol per kilogram of body weight per hour afterwards to keep them asleep (anesthesia maintenance). For sedation, a dose of 0.3 to 4.0 mg of propofol per kilogram of body weight per hour is usually sufficient.

To provide sedation during surgical and diagnostic procedures in adults, most patients require 0.5 – 1 mg of propofol/kg body weight during 1 to 5 minutes for the initiation of sedation. Sedation maintenance should be carried out by evaluating the perfusion of Propofol Lipoven Fresenius to the desired level of sedation. Most patients require 1.5 - 4.5 mg of propofol/kg body weight/h. A bolus of 10 – 20 mg of propofol (0.5 – 1 ml of Propofol Lipoven Fresenius 20 mg/ml injectable emulsion and for perfusion) can be supplemented if a rapid increase in the intensity of sedation is required.

To provide sedation in patients with assisted breathing over 16 years of age in intensive care, the dose should be adjusted according to the required level of sedation. Generally, satisfactory sedation is achieved by continuous perfusion with a rate of administration between 0.3 to 4.0 mg of propofol per kilogram of body weight per hour. Perfusions rates greater than 4.0 mg of propofol per kilogram of body weight per hour are not recommended.

Older patients and debilitated patients

Older patients and debilitated patients may require lower doses.

Use in children over 3 years of age and adolescents

The use of Propofol Lipoven Fresenius 20 mg/ml injectable emulsion and for perfusion is not recommended in children under 3 years of age.

The dose should be adjusted according to age and/or body weight.

Most patients over 8 years of age require approximately 2.5 mg/kg of body weight of Propofol Lipoven Fresenius to initiate sleep (anesthesia induction). In smaller children, requirements may be higher (2.5 – 4 mg/kg of body weight).

Doses in the range of 9 – 15 mg/kg/h usually achieve satisfactory anesthesia for maintaining sleep (anesthesia maintenance). In smaller children, dose requirements may be higher.

For sedation during surgical and diagnostic procedures in children over 3 years of age with Propofol Lipoven Fresenius 20 mg/ml injectable emulsion or for perfusion, most pediatric patients require 1 – 2 mg/kg of body weight of propofol for the initiation of sedation. Sedation maintenance can be carried out by adjusting the perfusion of Propofol Lipoven Fresenius to achieve the desired level of sedation. Most patients require 1.5 – 9 mg/kg/h of propofol.

Propofol Lipoven Fresenius 20 mg/ml injectable emulsion or for perfusion should not be administered to children and adolescents under 16 years of age for sedation in the intensive care unit, as safety has not been demonstrated for this patient group in this indication.

Administration form

Propofol Lipoven Fresenius is administered intravenously, usually on the back of the hand or forearm. Your anesthesiologist may use a needle or cannula (a thin plastic tube). Propofol Lipoven Fresenius will be injected into the vein manually or by an electric pump.

Propofol Lipoven Fresenius is for single use only. Any unused emulsion should be discarded. Containers should be shaken before use. If, after shaking, two layers are observed, the emulsion should not be used. Use only homogeneous preparations and undamaged containers. Before use, the rubber stopper should be cleaned with an alcohol spray or a cotton swab moistened with alcohol.

Treatment duration

When used for sedation, Propofol Lipoven Fresenius should not be administered for more than 7 days.

If you are given more Propofol Lipoven Fresenius than you should

Your doctor will ensure that you receive the correct amount of propofol for the procedures being performed.

However, different people need different doses, and if you receive too much, your anesthesiologist may need to take measures to ensure that your heart and breathing are adequate. This is why anesthetic medications are administered only by specialized anesthesiologists or intensive care physicians.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects that may occur during anesthesia

During anesthesia, the following side effects may occur (while the injection is being administered or when you are drowsy or asleep). Your doctor will be monitoring you. If they occur, your doctor will give you the appropriate treatment.

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

-Local pain during injection (while the injection is being administered, before falling asleep)

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

-Slow or rapid heart rate

-Low blood pressure

-Changes in breathing pattern (low respiratory rate, respiratory arrest)

-Hypoxia

-Cough (may also occur when waking up)

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

-Swelling and redness or blood clots in the vein at the injection site

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

-Muscle spasms and contractions, or convulsions (may also occur when waking up)

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

-Severe allergic reactions that may cause difficulty breathing, swelling and redness of the skin, flushing

-Pulmonary edema that may make you feel very tired (may also occur when waking up)

Frequency not known (cannot be estimated from available data)

• Muscle twitching
• Severe skin and tissue reaction after accidental application to the side of the vein
• Prolonged and often painful erection (priapism)

Side effects that may occur after anesthesia

• The following side effects may occur after anesthesia (when waking up or after waking up).

Common (may affect up to 1 in 10 patients)

• Headache
• Feeling unwell (nausea), vomiting
• Cough

Rare (may affect up to 1 in 1,000 patients)

• Dizziness, chills, and feeling cold
• Excitement

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

• Being unconscious after the operation (when this has occurred, patients have recovered without problems)
• Pancreatitis (inflammation of the pancreas) that causes severe abdominal pain (cannot be demonstrated as causal)
• Fever after surgery

Frequency not known (cannot be estimated from available data)

• Feeling euphoric
• Feeling sexually excited
• Irregular heart rate
• Changes in ECG (ECG type Brugada)
• Enlargement of the liver
• Renal failure
• Cellular muscle destruction (rhabdomyolysis), increased blood acidity, elevated potassium and fat levels in the blood, heart failure
• Abuse of the medication, usually by healthcare professionals
• Prolonged and often painful erection (priapism)
• Hepatitis (inflammation of the liver), acute liver insufficiency (symptoms may include yellow skin and eyes, itching, dark urine, abdominal pain, and sensitivity to the liver (indicated by pain under the front of the ribcage on the right side), sometimes with loss of appetite).

When Propofol Lipoven Fresenius is administered in combination with lidocaine (a local anesthetic used to reduce pain at the injection site), certain side effects may rarely occur:

• Dizziness
• Vomiting
• Somnolence
• Convulsions
• Decreased heart rate (bradycardia)
• Irregular heartbeat (cardiac arrhythmias)
• Shock

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es.By reporting side 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 vial and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Do not freeze.

Once opened, the product must be used immediately.

Propofol Lipoven Fresenius 20 mg/ml administration systems must be replaced 12 hours after opening the vial.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Composition of Propofol Lipoven Fresenius 20 mg/ml injectable emulsion and for infusion

-The active ingredient is propofol.

Each ml of emulsion contains 20 mg of propofol.

Each vial of 20 ml contains 400 mg of propofol.

Each vial of 50 ml contains 1000 mg of propofol.

Each vial of 100 ml contains 2000 mg of propofol.

• The other components are refined soybean oil, medium-chain triglycerides, purified egg phospholipids, glycerol, oleic acid, sodium hydroxide, and water for injection preparations.

Appearance of the product and contents of the package

Propofol Lipoven Fresenius is a white oil-in-water emulsion for injection or infusion.

Propofol Lipoven Fresenius is available in colourless glass vials. The glass vials are sealed with rubber stoppers.

Package size:

Packages of 10 glass vials with 20 ml of emulsion

Packages of 1 glass vial with 50 ml of emulsion

Packages of 10 glass vials with 50 ml of emulsion

Packages of 15 glass vials with 50 ml of emulsion

Packages of 10 glass vials with 100 ml of emulsion

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg v.d.H.

Germany

Manufacturer responsible:

Fresenius Kabi AB

S-75174 Uppsala, Rapsgatan 7

Sweden

or

Fresenius Kabi Austria GmbH

A-8055 Hafnerstrasse 36

Austria

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: July 2024.

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This information is intended solely for healthcare professionals:

For single use only. Any unused portion of the emulsion must be discarded.

Shake before use.

If two layers are observed after shaking the emulsion, it must not be used.

Use only homogeneous preparations in intact containers.

Before use, the rubber stopper must be cleaned using an alcohol spray or an alcohol-soaked cotton swab. Once used, the containers must be discarded.

Propofol must be administered by specialist anaesthetists (or, when appropriate, by a specialist in intensive care).

The patient and equipment must be constantly monitored, and the maintenance of the patient's airways, artificial ventilation, oxygen supply, and other resuscitation equipment must be available at all times. Propofol must not be administered by the same person performing the surgical or diagnostic procedure.

Cases of abuse and dependence of propofol have been reported, mainly among healthcare professionals. As with other general anaesthetics, the administration of propofol without control of the patient's airways may lead to fatal respiratory complications.

When propofol is administered for conscious sedation in diagnostic and surgical procedures, patients must be continuously monitored to detect the first signs of hypotension, respiratory obstruction, and oxygen desaturation.

Propofol Lipoven Fresenius 20 mg/ml is administered undiluted intravenously by continuous infusion.

Propofol Lipoven Fresenius 20 mg/ml must not be mixed with any other injectable or infusion solution. Glucose solution 5 mg/ml (5%), sodium chloride solution 9 mg/ml (0.9%), or sodium chloride solution 1.8 mg/ml (0.18%) and glucose solution 40 mg/ml (4%) may be administered through the same infusion set.

The co-administration of other medications or fluids with Propofol Lipoven Fresenius must be performed near the catheter using a Y-connector or a three-way valve.

Propofol Lipoven Fresenius 20 mg/ml is not recommended for general anaesthesia in children under 3 years of age, as the concentration of 20 mg/ml is difficult to adjust adequately in small children due to the small volumes required. The use of Propofol Lipoven Fresenius 10 mg/ml in children between 1 month and 3 years of age may be considered if a dose of less than 100 mg/h is required.

Propofol Lipoven Fresenius 20 mg/ml is a lipid emulsion without antimicrobial preservatives and may facilitate the rapid growth of microorganisms.

Once the ampoule is opened or the vial stopper is broken, the emulsion must be transferred aseptically to a sterile syringe or administered immediately. Administration must begin without delay.

During the infusion period, the asepsis of both Propofol Lipoven Fresenius and the infusion set must be maintained. Propofol Lipoven Fresenius must not be administered through a microbiological filter.

The use of a burette, dropper, syringe pump, or volumetric infusion pump is recommended to control the infusion rate when Propofol Lipoven Fresenius is infused.

As is customary for fat emulsions, the infusion of Propofol Lipoven Fresenius through a perfusion system must not exceed 12 hours. The Propofol Lipoven Fresenius 20 mg/ml infusion set must be changed at least every 12 hours.

To reduce pain at the injection site, Propofol Lipoven Fresenius 20 mg/ml must be administered in a major vein or lidocaine solution may be administered before the induction of anaesthesia with Propofol Lipoven Fresenius 20 mg/ml. Lidocaine must not be used in patients with acute porphyria.

If the same infusion set used for Propofol Lipoven Fresenius is used for the injection of muscle relaxants (such as atracurium and mivacurium), the infusion set must be washed first.