PROPOFOL LIPOVEN FRESENIUS 20 mg/ml Injectable Emulsion for Infusion

2. What you need to know before you are given Propofol Lipoven Fresenius

Do not use Propofol Lipoven Fresenius

• If you are allergic to propofol or any of the other ingredients of this medicine (listed in section 6).
• In patients 16 years or younger for sedation in intensive care.
• This medicine contains soybean oil. It must not be used if you are allergic to peanuts or soybeans.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Propofol Lipoven Fresenius.

You should not be given Propofol Lipoven Fresenius, or only under extreme caution and with intensive monitoring, if you:

• have advanced heart failure
• have any other severe heart disease
• are receiving electroconvulsive therapy (ECT, a treatment for psychiatric problems)

Propofol Lipoven Fresenius should generally be used with caution in weak or elderly patients.

Before you are given Propofol Lipoven Fresenius, tell your anesthetist or intensive care doctor if you have:

• heart disease
• lung disease
• kidney disease
• liver disease
• seizures (epilepsy)
• high pressure inside the skull (elevated intracranial pressure). In combination with low blood pressure, this may reduce the amount of blood that reaches the brain
• altered lipid levels in the blood. If you are receiving total parenteral nutrition (nutrition through a vein), your lipid levels in the blood should be monitored
• your body has lost a large amount of water (hypovolemia)

If you have any of the following conditions, they should be treated before you are given Propofol Lipoven Fresenius:

• heart failure
• when not enough blood is reaching the tissues (circulatory failure)
• severe breathing problems (respiratory failure)
• dehydration (hypovolemia)
• seizures (epilepsy)

Propofol Lipoven Fresenius may increase the risk of:

• seizures
• a nervous reflex that slows down your heart rate (vagotonia, bradycardia)
• changes in blood flow to the organs of the body (hemodynamic effects on 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. Your doctor will take this into account and take necessary precautions for surgical procedures performed under sedation.

Very occasionally, after anesthesia, a period of unconsciousness associated with muscle numbness may occur. This only requires observation by the medical team, without the need for further treatment. It will resolve on its own.

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

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

If you can go home shortly after receiving Propofol, you should not return home without an escort.

Children and adolescents

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

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

Using Propofol Lipoven Fresenius with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines.

In particular, tell your doctor, anesthetist, or nurse if you are taking any of the following medicines:

• Rifampicin (for tuberculosis - TB).
• Midazolam (used to induce sedation and relieve anxiety and muscle tension).

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

• premedicines (your anesthetist will know which medicines may interact with Propofol Lipoven Fresenius)
• other anesthetics, including general, regional, local, and inhalational anesthetics (lower doses of Propofol Lipoven Fresenius 20 mg/ml may be required. Your anesthetist will know)
• analgesics (pain relievers)
• strong pain relievers (fentanyl or opioids)
• parasympatholytic agents (medicines used to treat, for example, painful cramps, asthma, or Parkinson's disease)
• benzodiazepines (medicines for treating anxiety)
• suxamethonium (muscle relaxant)
• medicines that affect many of the body's internal functions, such as heart rate, e.g., atropine
• medicines that contain alcohol or drinks
• neostigmine (a medicine used to treat a disease called myasthenia gravis)
• cyclosporin (a medicine used to prevent rejection in transplants)
• valproate (a medicine used to treat epilepsy or mental disorders)

Using Propofol Lipoven Fresenius with food, drinks, and alcohol

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

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 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 using machines

Do not drive or use tools or machines after you have been given Propofol Lipoven Fresenius, as this medicine may affect your ability to react. Your doctor will tell you when you can start driving or using machines again.

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

Do not drive or use tools or 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 home without an escort.

Ask your doctor when you can start 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 rarely cause severe hypersensitivity reactions (allergic reactions) (see "Do not use Propofol Lipoven Fresenius"). Tell your doctor if you know you are allergic to soybean oil.

This medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, and is therefore considered essentially "sodium-free".

3. How Propofol Lipoven Fresenius is given

Propofol Lipoven Fresenius will only be given to you in hospitals or in suitable therapy units by or under the direct supervision of your anesthetist or intensive care doctor.

Dose

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

You may need different types of medicines to keep you asleep or sedated, pain-free, breathing properly, and maintaining stable blood pressure. Your doctor will decide which medicines you need and when you need them.

Adults

Most people need 1.5 - 2.5 mg of propofol per kg of body weight to fall asleep (induction of anesthesia), and then 4 - 12 mg of propofol per kg of body weight per hour to stay asleep (maintenance of anesthesia). For sedation, a dose of 0.3 - 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 - 5 minutes for the start of sedation. Maintenance of sedation should be carried out by adjusting the infusion of Propofol Lipoven Fresenius to the desired level of sedation. Most patients require 1.5 - 4.5 mg of propofol/kg body weight/h. The infusion can be supplemented by administering a bolus of 10 - 20 mg of propofol (0.5 - 1 ml of Propofol Lipoven Fresenius 20 mg/ml injectable emulsion and for infusion) if a rapid increase in the intensity of sedation is required.

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

Elderly and weak patients

Elderly and weak 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 infusion 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 body weight of Propofol Lipoven Fresenius to fall asleep (induction of anesthesia). In younger children, the requirements may be higher (2.5 - 4 mg/kg body weight).

Doses in the range of 9 - 15 mg/kg/h usually achieve satisfactory anesthesia to maintain sleep (maintenance of anesthesia). In younger children, the 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 infusion, most pediatric patients require 1 - 2 mg/kg body weight of propofol for the start of sedation. Maintenance of sedation can be carried out by adjusting the infusion of Propofol Lipoven Fresenius to 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 infusion should not be given to children and adolescents under 16 years of age for sedation in the intensive care unit, as safety has not been demonstrated in this patient group for this indication.

Method of administration

Propofol Lipoven Fresenius is given by injection into a vein, usually in the back of the hand or in the forearm. Your anesthetist may use a needle or a cannula (a thin plastic tube). Propofol Lipoven Fresenius will be injected into the vein manually or using 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 two layers are observed after shaking, the emulsion should not be used. Only use homogeneous preparations and undamaged containers. Before use, the rubber stopper should be cleaned with an alcohol spray or a cotton swab moistened with alcohol.

Duration of treatment

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

If you are given too much Propofol Lipoven Fresenius

Your doctor will make sure 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 anesthetist may need to take measures to ensure your heart and breathing are adequate. This is why anesthetic medicines are only given by doctors specialized in anesthesia or intensive care.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects that may occur during anesthesia

The following side effects may occur during anesthesia (while you are being given the injection or when you are drowsy or asleep). Your doctor will be monitoring you. If they occur, your doctor will give you the necessary treatment.

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

• local pain during injection (while you are being given the injection, before you fall asleep)

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

• slow or fast heart rate
• low blood pressure
• changes in your breathing pattern (low breathing rate, respiratory arrest)
• hiccups
• coughing (may also occur when you wake up)

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

• swelling and redness or blood clots in the vein at the injection site

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

• muscle spasms and contractions, or convulsions (may also occur when you wake up)

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

• severe allergic reactions that can cause difficulty breathing, swelling, and redness of the skin, flushing
• fluid accumulation in the lungs that can make you feel very tired (may also occur when you wake up)

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

• Involuntary movements
• Severe skin and tissue reaction after accidental application outside the vein
• Prolonged and often painful erection (priapism)

Side effects that may occur after anesthesia

• The following side effects may occur after anesthesia (when you wake up or after you have woken up).

Common (may affect up to 1 in 10 people)

• headache
• feeling sick (nausea), being sick (vomiting)
• coughing

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

• dizziness, shivering, and feeling cold
• excitement

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

• being unconscious after the operation (when this has occurred, patients have recovered without problems)
• inflammation of the pancreas (pancreatitis) that causes severe stomach pain (causal relationship cannot be demonstrated)
• fever after surgery

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

• Feeling euphoric
• Feeling sexually excited
• Irregular heartbeat
• Changes in the ECG (Brugada-type ECG)
• Enlargement of the liver
• Kidney failure
• Destruction of muscle cells (rhabdomyolysis), increased blood acidity, elevated potassium and fat levels in the blood, heart failure
• Drug abuse, usually by healthcare professionals
• Prolonged and often painful erection (priapism)
• 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 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 adverse effects may rarely occur:

• dizziness
• vomiting
• drowsiness
• seizures
• a decrease in heart rate (bradycardia)
• irregular heartbeat (cardiac arrhythmias)
• shock

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Propofol Lipoven Fresenius

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

Do not use this medicine after the expiration date shown on the vial and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Do not freeze.

Once opened, the product must be used immediately.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

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

• The active ingredient is propofol.

Each ml of emulsion contains 20 mg of propofol.

Each 20 ml vial contains 400 mg of propofol.

Each 50 ml vial contains 1000 mg of propofol.

Each 100 ml vial contains 2000 mg of propofol.

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

Appearance of the product and package contents

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

Propofol Lipoven Fresenius is available in colorless 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

Marketing authorization holder:

Fresenius Kabi Deutschland GmbH

61346 Bad Homburg v.d.H.

Germany

Manufacturer:

Fresenius Kabi AB

S-75174 Uppsala, Rapsgatan 7

Sweden

or

Fresenius Kabi Austria GmbH

A-8055 Hafnerstrase 36

Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: July 2024.

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This information is intended only for healthcare professionals:

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

Shake before use.

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

Only use homogeneous preparations in intact containers.

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

Propofol must be administered by specialist doctors in anesthesia (or, when appropriate, by a doctor specializing in intensive care).

The patient and equipment must be constantly monitored for 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 on propofol have been reported, mostly by healthcare professionals. As with other general anesthetics, administration of propofol without control of the 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. A 5 mg/ml (5%) glucose injectable solution, a 9 mg/ml (0.9%) sodium chloride injectable solution, or a 1.8 mg/ml (0.18%) sodium chloride and 40 mg/ml (4%) glucose injectable solution may be administered through the same infusion equipment.

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

Propofol Lipomed Fresenius 20 mg/ml is not recommended for general anesthesia 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 Lipomed Fresenius 10 mg/ml should be considered in children between 1 month and 3 years of age if a dose 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 seal is broken, the emulsion must be transferred aseptically to a sterile syringe or used immediately. Administration must begin without delay.

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

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

As is usual for fat emulsions, the infusion of Propofol Lipoven Fresenius via an infusion system must not exceed 12 hours. The Propofol Lipoven Fresenius 20 mg/ml infusion equipment must be changed at least every 12 hours.

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

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