Prospecto: information for the user

Propofol Lipoven Fresenius 10 mg/ml injectable emulsion and for perfusion
Propofol

1. What is Propofol Lipoven Fresenius and for what it is used

2. What you need to know before starting to use Propofol Lipoven Fresenius

3. How to use Propofol Lipoven Fresenius

4. Possible adverse effects

5. Storage of Propofol 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, allow surgical interventions or other procedures to be performed. They can also be used to sedate you (so you feel drowsy but not completely asleep).

Propofol Lipoven Fresenius 10 mg/ml is used for:

• induction and maintenance of general anesthesia in adults, adolescents, and children over 1 month of age
• sedation of patients over 16 years of age with assisted respiration in the Intensive Care Unit
• sedation in adults, adolescents, and children over 1 month 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), lipid levels in the blood should be monitored

-Significant loss of body water (hypovolemia)

If you have any of the following conditions, they should 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, 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 10 mg/ml injectable emulsion or for perfusion is not recommended in newborns or children under 1 month of age.

Due to the limited available data, the use of a controlled infusion system (TCI) in children under 2 years of age is not recommended.

Propofol Lipoven Fresenius 10 mg/ml should not be administered to children and adolescents under 16 years of age for sedation in intensive care, as safety has not been demonstrated in this patient group 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 calmness, drowsiness, 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 inhalation anesthetics (may require lower doses of Propofol Lipoven Fresenius 10 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 (medication used to treat a disease called myasthenia gravis)

-Ciclosporin (medication used to prevent rejection in transplants)

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

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

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

Pregnancy and breastfeeding

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

Propofol Lipoven Fresenius should not be used in pregnant women unless 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 worn off.

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 considered 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 by an 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 kg of body weight to put them to sleep (anesthesia induction), and then 4 to 12 mg of propofol per kg 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 kg 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 (1 – 2 ml of Propofol Lipoven Fresenius 10 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 mechanically ventilated patients 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 kg of body weight per hour. Perfusion rates greater than 4.0 mg of propofol per kg of body weight per hour are not recommended.

Elderly patients and debilitated patients

Elderly patients and debilitated patients may require lower doses.

Use in children over 1 month of age and adolescents

The use of Propofol Lipoven Fresenius is not recommended in children under 1 month of age.

Special care should be taken when administering Propofol Lipoven Fresenius 10 mg / ml injectable emulsion or for perfusion in children under 3 years. However, the available evidence does not suggest that its use is less safe than for children over 3 years.

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 younger children, especially between 1 month and 3 years of age, the 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 sleep maintenance (anesthesia maintenance). In younger children, especially between 1 month and 3 years of age, the dose requirements may be higher.

To provide sedation during surgical and diagnostic procedures in children over 1 month of age with Propofol Lipoven Fresenius 10 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. If a rapid increase in the depth of sedation is required, the perfusion can be supplemented with a bolus administration of up to 1 mg/kg body weight.

Propofol Lipoven Fresenius 10 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 its safety has not been demonstrated in this patient group for this indication.

Administration form

Propofol Lipoven Fresenius is administered intravenously, usually on the back of the hand or on the 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. The 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 moistened cotton swab.

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 may 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 your 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):

-Spasms and muscle contractions, or seizures (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 spasms
• 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), feeling sick (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 the 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
• Seizures
• 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 ampoule/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 undiluted administration systems must be replaced 12 hours after opening the ampoule or vial. Dilutions with injectable glucose solution 50 mg/ml (5%) or injectable sodium chloride solution 9 mg/ml (0.9%) or a mixture of injectable lidocaine without preservatives 10 mg/ml (1%) (at least 2 mg of propofol per ml) must be prepared aseptically (maintaining controlled and validated conditions) immediately before administration and must be administered within 6 hours after preparation.

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

Composition of Propofol Lipoven Fresenius 10 mg/ml

-The active ingredient is propofol.

Each ml of emulsion contains 10 mg of propofol.

Each ampoule of 20 ml contains 200 mg of propofol.

Each vial of 20 ml contains 200 mg of propofol.

Each vial of 50 ml contains 500 mg of propofol.

Each vial of 100 ml contains 1000 mg of propofol.

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

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 glass ampoules or vials that are colorless. The glass vials are sealed with rubber stoppers.

Package size:

Packages of 5 glass ampoules with 20 ml of emulsion

Packages of 10 glass ampoules with 20 ml of emulsion

Packages of 1 glass vial with 20, 50, or 100 ml of emulsion

Packages of 5 glass vials with 20 ml of emulsion

Packages of 10 glass vials with 20, 50, or 100 ml of emulsion

Packages of 15 glass vials with 50 or 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:

Fresenius Kabi Austria GmbH

A-8055 Hafnerstrasse 36

Austria

or

Fresenius Kabi AB

S-75174 Uppsala, Rapsgatan 7

Sweden

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.--------------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

Propofol Lipoven Fresenius 10 mg/ml emulsion for injection or infusion should not be mixed before administration with other injectable or infusion solutions. However, it can be mixed with glucose solution 50 mg/ml (5%), sodium chloride solution 9 mg/ml (0.9%), or lidocaine solution without preservatives 10 mg/ml (1%). The final concentration of propofol cannot be less than 2 mg/ml.

For single use only. Any part of the emulsion not used must be discarded.

Shake before use.

If two layers are observed after shaking the emulsion, it should not be used. Only use preparations that are homogeneous in intact containers.

Before use, the neck of the ampoule or the rubber stopper must be cleaned using an alcohol spray or an alcohol-impregnated swab. Once used, the containers must be discarded.

Propofol should be administered by specialist anesthesiologists (or, when appropriate, by a specialist in intensive care). Patients must be constantly monitored and must have the facilities and equipment available to maintain a clear airway, provide artificial respiration, oxygen supply, and other resuscitation equipment. Propofol should not be administered by the person performing the diagnostic or surgical procedure.

There have been reports of abuse and dependence on propofol, mainly by healthcare professionals. Like other general anesthetics, the administration of propofol without control of the airways can 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 10 mg/ml emulsion for injection or infusion can be administered undiluted or diluted in glucose solution 50 mg/ml (5%) or sodium chloride solution 9 mg/ml (0.9%).

Propofol Lipoven Fresenius 10 mg/ml emulsion for injection or infusion should not be mixed with other injectable or infusion solutions except those mentioned above.

Glucose solution 50 mg/ml (5%), sodium chloride solution 9 mg/ml (0.9%), or sodium chloride solution 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) can be administered through the same infusion set.

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

Propofol Lipoven Fresenius 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 placed immediately. Administration should start without delay.

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

Perfusion of Propofol Lipoven 10 mg/ml without dilution:

The use of a burette, dropper, syringe pump, or volumetric infusion pump is recommended to control the perfusion rate when Propofol Lipoven Fresenius 10 mg/ml is perfused.

As is usual for fatty emulsions, perfusion of Propofol Lipoven Fresenius 10 mg/ml through a perfusion system should not exceed 12 hours. The Propofol Lipoven Fresenius 10 mg/ml perfusion set must be changed at least every 12 hours.

Perfusion of Propofol Lipoven Fresenius 10 mg/ml diluted:

Burettes, droppers, or volumetric infusion pumps must always be used to control the perfusion rate. The maximum dilution should not exceed 1 part of Propofol Lipoven Fresenius 10 mg/ml emulsion for injection or infusion with 4 parts of glucose solution 50 mg/ml (5%) or sodium chloride solution 9 mg/ml (0.9%) (minimum concentration of 2 mg propofol/ml). The mixture must be prepared aseptically (controlled and validated conditions) and administered within 6 hours after preparation.

To reduce pain at the injection site, it may be administered in a larger vein or lidocaine solution may be administered before the induction of anesthesia with Propofol Lipoven Fresenius. Alternatively, lidocaine may be added to the diluted solution (20 parts of Propofol Lipoven Fresenius 10 mg/ml per 1 part of lidocaine solution without preservatives 1%). Lidocaine should 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 (e.g., atracurium and mivacurium), the infusion set must be washed first.