Propofol Lipoven Fresenius 10 mg/ml emulsion for injection and infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Propofol Lipoven Fresenius 0.1% Injectable Emulsion and Perfusion Solution Propofol

Read the entire leaflet carefully before you are given 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, pharmacist, or nurse. If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Propofol Lipoven Fresenius belongs to a group of medicines called general anesthetics. General anesthetics are used to cause unconsciousness (sleep) so that surgical operations or other procedures can be performed. They may also be used to sedate you (make 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 receiving assisted ventilation in the Intensive Care Unit
• sedation in adults, adolescents, and children over 1 month of age for diagnostic and surgical procedures, either alone or in combination with local or regional anesthesia

2. What you need to know before using Propofol Lipoven Fresenius

Do not use Propofol Lipoven Fresenius

• If you are allergic to propofol or to any of the other ingredients of this medicine (listed in section 6).
• In patients aged 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 soy.

Warnings and precautions

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

You must not use Propofol Lipoven Fresenius, or use it only under extreme caution 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 conditions)

In general, Propofol Lipoven Fresenius should be administered with caution in frail patients or elderly patients.

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

• Heart disease
• Lung disease
• Kidney disease
• Liver disease
• Seizures (epilepsy)
• Increased pressure inside the skull (elevated intracranial pressure). In combination with low blood pressure, this may reduce blood flow to the brain
• Abnormal blood lipid levels. If you are receiving total parenteral nutrition (feeding through a vein), blood lipid levels should be monitored
• Severe fluid loss from your body (hypovolemia)

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

• Heart failure
• Inadequate blood supply to tissues (circulatory insufficiency)
• Severe breathing problems (respiratory failure)
• Dehydration (hypovolemia)
• Seizures (epilepsy)

Propofol Lipoven Fresenius may increase the risk of:

• Epileptic seizures
• A nervous reflex that slows the heart rate (vagotonia, bradycardia)
• Changes in blood flow to body organs (haemodynamic effects on the cardiovascular system), especially if you are overweight and receive high doses of Propofol Lipoven Fresenius

Involuntary movements may occur during sedation with Propofol Lipoven Fresenius. Your doctor will take into account how this might affect surgical procedures performed under sedation and will take necessary precautions.

Very rarely, after anaesthesia, a period of unconsciousness associated with muscle numbness may occur. This requires only medical observation and no additional treatment. It resolves spontaneously.

Injection of Propofol Lipoven Fresenius may be painful. A local anaesthetic may be used to reduce this pain, but it may cause its own adverse effects.

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

If you are discharged soon after receiving Propofol, you must not return home unaccompanied.

Children and adolescents

The use of Propofol Lipoven Fresenius 10 mg/ml injectable or infusion emulsion is not recommended in newborns or children under 1 month of age.

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

Propofol Lipoven Fresenius 10 mg/ml must not be administered to children and adolescents under 16 years of age for sedation in the intensive care unit, as safety has not been established in this patient group for this indication.

Use of Propofol Lipoven Fresenius with other medicines

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

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

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

Take special care if you are also taking/receiving any of the following medicines:

• Premedications (your anaesthetist will know which medicines may interact with Propofol Lipoven Fresenius)
• Other anaesthetics, including general, regional, local, and inhalational anaesthetics (lower doses of Propofol Lipoven Fresenius 10 mg/ml may be required. Your anaesthetist will know this)
• Analgesics (pain relievers)
• Strong sedatives (fentanyl or opioids)
• Parasympatholytic agents (medicines used to treat, for example, painful cramps, asthma, or Parkinson's disease)
• Benzodiazepines (medicines used to treat anxiety)
• Suxamethonium (muscle relaxant)
• Medicines affecting many internal body functions such as heart rate, e.g. Atropine
• Medicines containing alcohol or beverages
• Neostigmine (a medicine used to treat a condition called myasthenia gravis)
• Cyclosporine (a medicine used to prevent transplant rejection)
• Valproate (a medicine used to treat epilepsy or mental disorders)

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

After receiving Propofol Lipoven Fresenius, you must not eat, drink, or consume alcohol until you have fully recovered.

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

Driving and using machines

Do not drive or operate tools or machinery after receiving Propofol Lipoven Fresenius, as this medicine may affect your reaction ability. Your doctor will tell you how long you should wait before driving or using machines.

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

Do not drive or operate tools or machinery until you are certain that the effects have worn off.

If you are discharged soon after receiving propofol, do not drive a car and must not return home unaccompanied.

Ask your doctor when you can resume these activities 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 (allergic) reactions (see "Do not use Propofol Lipoven Fresenius"). Inform 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 to use Propofol Lipoven Fresenius

Propofol Lipoven Fresenius will only be administered to you in hospitals or in appropriate intensive care units by, or under the direct supervision of, your anaesthetist or an intensive care physician.

Dosage

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

You may require different types of medications to keep you asleep or sedated, pain-free, breathing adequately, and with stable blood pressure. Your doctor will decide which medications you need and when they are required.

Adults

Most people require between 1.5 – 2.5 mg of propofol per kg of body weight to induce sleep (induction of anaesthesia), followed by 4 to 12 mg of propofol per kg of body weight per hour to maintain anaesthesia. 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 over 1 to 5 minutes to initiate sedation. Maintenance of sedation should be achieved by titrating 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 may be supplemented by administering a bolus dose of 10 – 20 mg of propofol (1 – 2 ml of Propofol Lipoven Fresenius 10 mg/ml injectable and infusion emulsion) if a rapid increase in the depth 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. Satisfactory sedation is generally achieved with continuous infusion at an administration rate between 0.3 and 4.0 mg of propofol per kg of body weight per hour. Infusion rates exceeding 4.0 mg of propofol per kg of body weight per hour are not recommended.

Elderly and debilitated patients

Elderly 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 caution should also be exercised when administering Propofol Lipoven Fresenius 10 mg/ml injectable or infusion emulsion to children under 3 years of age. However, currently available evidence does not suggest that its use is less safe than in children over 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 induce sleep (induction of anaesthesia). In younger children, especially between 1 month and 3 years of age, requirements may be higher (2.5 – 4 mg/kg body weight).

Doses in the range of 9 – 15 mg/kg/h usually achieve satisfactory anaesthesia to maintain sleep (maintenance of anaesthesia). In younger children, especially between 1 month and 3 years of age, dose requirements may be higher.

For sedation during surgical and diagnostic procedures in children over 1 month of age with Propofol Lipoven Fresenius 10 mg/ml injectable or infusion emulsion, most paediatric patients require 1 – 2 mg/kg body weight of propofol to initiate sedation. Maintenance of sedation can be achieved by adjusting the infusion rate 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 infusion may be supplemented with a bolus dose of up to 1 mg/kg body weight.

Propofol Lipoven Fresenius 10 mg/ml injectable or infusion emulsion must not be administered to children and adolescents under 16 years of age for sedation in the intensive care unit, as safety has not been established for this patient group in this indication.

Method of administration

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

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

Duration of treatment

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

If you are given more Propofol Lipoven Fresenius than you should

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

However, different individuals require different doses, and if you receive too much, your anaesthetist may need to take measures to ensure that your heart and breathing remain adequate. This is why anaesthetic medicines are administered only by physicians specialized in anaesthesia or in the care of intensive care patients.

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

4. Possible adverse effects

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

Adverse effects that may occur during anesthesia

The following adverse effects may occur during anesthesia (while the injection is being administered or while you are drowsy or unconscious). Your doctor will monitor you for these. If they occur, your doctor will provide 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 fast heartbeat
• low blood pressure
• changes in your breathing pattern (low respiratory rate, respiratory arrest)
• hiccups
• coughing (may also occur when you wake 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 1000 patients):

• spasms and contractions of your body, or seizures (may also occur when you wake up)

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

• severe allergic reactions which may cause difficulty breathing, skin swelling and redness, hot flushes
• fluid accumulation in the lungs, which may 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 reaction in the skin and tissues following accidental para-venous administration
• Prolonged and often painful erection (priapism)

Adverse effects that may occur after anesthesia

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

Frequent (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 surgery (when this has occurred, patients have recovered without complications)
• Inflammation of the pancreas (pancreatitis) causing severe stomach pain (causal relationship not proven)
• 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 levels of potassium and fat in the blood, heart failure
• Medication 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-colored urine, stomach pain, and liver tenderness (indicated by pain beneath the front of the ribs 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 injection site pain), certain adverse reactions may rarely occur:

• dizziness
• vomiting
• somnolence
• seizures
• decreased heart rate (bradycardia)
• irregular heartbeat (cardiac arrhythmias)
• shock

Reporting of adverse reactions

If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide 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 expiry date stated on the ampoule/vial and on the outer packaging after EXP. The expiry date refers to 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 containing undiluted Propofol Lipoven Fresenius must be replaced 12 hours after opening the ampoule or vial. Dilutions with glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection, or a mixture with preservative-free lidocaine 10 mg/ml (1%) solution for injection (containing 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Propofol Lipoven Fresenius 10 mg/ml

• The active substance is propofol.

Each ml of emulsion contains 10 mg of propofol.

Each 20 ml ampoule contains 200 mg of propofol.

Each 20 ml vial contains 200 mg of propofol.

Each 50 ml vial contains 500 mg of propofol.

Each 100 ml vial contains 1000 mg of propofol.

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

Appearance of the product and contents of the container

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

Propofol Lipoven Fresenius is available in colorless glass ampoules or vials. The glass vials are sealed with rubber stoppers.

Container sizes:

Packs of 5 glass ampoules with 20 ml of emulsion

Packs of 10 glass ampoules with 20 ml of emulsion

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

Packs of 5 glass vials with 20 ml of emulsion

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

Packs of 15 glass vials with 50 or 100 ml of emulsion

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

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 European Economic Area member states under the following names:

Member State	Medicinal Product Name
Germany	Propofol 1% (10 mg/1 ml) MCT Fresenius, Emulsion zur Injektion oder Infusion
Austria	Propofol “Fresenius” 1 % mit MCT - Emulsion zur Injektion oder Infusion
Belgium	Propolipid 1 %
Bulgaria	???????? MCT/LCT ????????? 10 mg/ml ???????????/?????????? ???????
Cyprus	Propofol 1% MCT/LCT Fresenius
Denmark	Propolipid
Slovakia	Propofol MCT/LCT Fresenius 10 mg/ml injekcná/infúzna emulzia
Slovenia	Propoven 10 mg/ml emulzija za injiciranje ali infundiranje
Spain	Propofol Lipoven Fresenius 10 mg/ml emulsión inyectable y para perfusión
Estonia	Propoven 1%
Finland	Propolipid 10 mg/ml
Greece	Propofol MCT/LCT 1%
Hungary	Propofol 1% MCT/LCT Fresenius
Ireland	Propofol 1% (10 mg/ml) emulsion for injection/infusion
Iceland	Propolipid 10 mg/ml
Italy	Propofol Kabi
Latvia	Propoven 1%
Lithuania	Propoven 1%
Luxembourg	Propofol 1% MCT Fresenius
Norway	Propolipid 10 mg/ml
Netherlands	Propofol 10mg/ml MCT/LCT Fresenius
Poland	Propofol 1% MCT/LCT Fresenius
Portugal	Propofol 1% MCT/LCT Fresenius
United Kingdom	Propofol 1% (10 mg/ml) emulsion for injection/infusion
Czech Republic	Propofol MCT/LCT Fresenius 10 mg/ml injekcní/infuzní emulze
Romania	Propofol MCT/LCT Fresenius 10 mg/ml emulsie injectabila/perfuzabila
Sweden	Propolipid 10 mg/ml

Date of the most recent review of this summary of product characteristics: July 2024.--------------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

Propofol Lipoven Fresenius 10 mg/ml injectable emulsion for infusion should not be mixed prior to administration with other injectable or infusion solutions. However, it may be mixed with glucose 50 mg/ml (5%) solution, sodium chloride 9 mg/ml (0.9%) solution, or preservative-free lidocaine 10 mg/ml (1%) injectable solution. The final concentration of propofol must not be less than 2 mg/ml.

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

Shake well 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 neck of the ampoule or rubber stopper must be cleaned using an alcohol spray or an alcohol-impregnated swab. After use, containers must be discarded.

Propofol must be administered by anaesthesia specialists (or, where appropriate, by an intensive care specialist).

Patients must be continuously monitored, and facilities and equipment for maintaining a patent airway, providing artificial ventilation, oxygen supply, and other resuscitation equipment must be fully available. Propofol must not be administered by the person performing the diagnostic or surgical procedure.

Cases of propofol abuse and dependence have been reported, mostly among healthcare professionals. As with other general anaesthetics, administration of propofol without airway monitoring may result in fatal respiratory complications.

When propofol is administered for conscious sedation during diagnostic and surgical procedures, patients must be continuously monitored for early signs of hypotension, airway obstruction, and oxygen desaturation.

Propofol Lipoven Fresenius 10 mg/ml injectable emulsion for infusion may be administered undiluted or diluted in glucose 50 mg/ml (5%) injectable solution or sodium chloride 9 mg/ml (0.9%) injectable solution.

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

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

Co-administration of other drugs or fluids into the Propofol Lipoven Fresenius infusion line should be performed close to the catheter using a Y-connector or a three-way stopcock.

Propofol Lipoven Fresenius is a lipid emulsion without antimicrobial preservatives and may support rapid microbial growth.

Once the ampoule is opened or the vial seal broken, the emulsion must be transferred aseptically into a sterile syringe or used immediately. Administration must begin without delay.

Aseptic technique must be maintained throughout the infusion period for both Propofol Lipoven Fresenius and the infusion equipment. Propofol Lipoven Fresenius must not be administered through a microbiological filter.

Infusion of undiluted Propofol Lipoven 10 mg/ml:

Use of a burette, drip set, syringe pump, or volumetric infusion pump is recommended to control the infusion rate when administering Propofol Lipoven Fresenius 10 mg/ml.

As is customary for fat emulsions, infusion of Propofol Lipoven Fresenius 10 mg/ml via an infusion system must not exceed 12 hours. The infusion set for Propofol Lipoven Fresenius 10 mg/ml must be changed at least every 12 hours.

Infusion of diluted Propofol Lipoven Fresenius 10 mg/ml:

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

To reduce injection site pain, administration may be performed into a larger vein or preservative-free lidocaine injectable solution may be administered prior to anaesthesia induction with Propofol Lipoven Fresenius. Alternatively, lidocaine may be added to the diluted solution (20 parts Propofol Lipoven Fresenius 10 mg/ml to 1 part preservative-free 1% lidocaine injectable solution). Lidocaine must not be used in patients with acute porphyria.

If the same infusion system used for Propofol Lipoven Fresenius 10 mg/ml is also used to administer muscle relaxants (e.g. atracurium and mivacurium), the infusion system must first be flushed.