PROPOFOL LIPOVEN FRESENIUS 10 mg/ml Injectable Emulsion and Perfusion Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Propofol Lipoven Fresenius 10 mg/ml injectable emulsion and infusion in pre-filled syringe EFG

Propofol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Propofol Lipoven Fresenius is and what it is used for
2. What you need to know before you use 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 anaesthetics. General anaesthetics are used to produce unconsciousness (sleep) so that surgery or other procedures can be performed. They can 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 anaesthesia in adults, adolescents, and children over 1 month of age
• sedation of patients over 16 years of age with assisted ventilation in the Intensive Care Unit
• sedation in adults, adolescents, and children over 1 month of age during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia

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

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Propofol Lipoven Fresenius and if you have or have had any of the following conditions.

You should not receive Propofol Lipoven Fresenius, or only under extreme precautions and with intensive monitoring, if:

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

Propofol Lipoven Fresenius should generally be administered with caution in elderly or debilitated 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)
• high pressure inside the skull (elevated intracranial pressure). In combination with low blood pressure, this may decrease the amount of blood that reaches the brain.
• altered fat levels in the blood. If you are receiving total parenteral nutrition (nutrition through a vein), your blood fat levels should be monitored
• if your body has lost a large amount of water (you are hypovolaemic).

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

• heart failure
• when not enough blood reaches the tissues (circulatory failure)
• severe breathing problems (respiratory failure)
• dehydration (hypovolaemia)
• seizures (epilepsy)

Propofol Lipoven Fresenius may increase the risk of

• seizures
• a nervous reflex that slows down the heart rate (vagotonia, bradycardia)
• changes in blood flow to the body's organs (haemodynamic effects on the cardiovascular system) if you are overweight and receive high doses of Propofol Lipoven Fresenius.

During sedation with Propofol Lipoven Fresenius, involuntary movements can occur. Your doctor will take into account how this may affect surgical procedures performed under sedation and will take necessary precautions.

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

The injection of Propofol Lipoven Fresenius can be painful. A local anaesthetic 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 go without an escort.

Children and adolescents

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

Due to limited data available, the use of a controlled infusion system (TCI) in the paediatric population 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 the intensive care unit, as safety has not been demonstrated for this patient group in this indication.

Use of Propofol Lipoven Fresenius with other medicines

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

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

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

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

• Pre-medication (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 may be required. Your anaesthetist will know)
• Painkillers (analgesics)
• Strong painkillers (fentanyl or opioids)
• Parasympatholytic agents (medicines used to treat, for example, painful cramps of organs, asthma, or Parkinson's disease)
• Benzodiazepines (medicines for treating anxiety)
• Suxamethonium (muscle relaxants)
• Medicines that affect many of the body's internal functions, such as heart rate, e.g. atropine
• Alcohol contained in medicines or drinks
• Neostigmine (a medicine used to treat a disease called myasthenia gravis)
• Ciclosporin (a medicine used to prevent rejection in transplants)
• Valproate (a medicine used to treat epilepsy or mental disorders)

Use of 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. Mothers should 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 machines after receiving Propofol Lipoven Fresenius, as this medicine may affect your ability to react. 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 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 go home accompanied.

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

Propofol Lipoven Fresenius contains sodium

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

3. How to use Propofol Lipoven Fresenius

Propofol Lipoven Fresenius will only be administered in hospitals or in suitable therapy units by, or under the direct supervision of, an anaesthetist or an 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 anaesthesia 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 medicines to keep you asleep or sedated, pain-free, breathing properly, and maintaining stable blood pressure. The 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 anaesthesia) and then 4-12 mg of propofol per kg of body weight per hour to stay asleep (maintenance of anaesthesia). 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 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 can be supplemented by administering a bolus of 10-20 mg of propofol (1-2 ml of Propofol Lipoven Fresenius 10 mg/ml) if a rapid increase in the intensity of sedation is required.

To provide sedation in ventilated patients 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 and 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 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 10 mg/ml is not recommended in children under 1 month of age.

Special care should be taken when administering Propofol Lipoven Fresenius 10 mg/ml to children under 3 years of age. However, available data do not suggest that it is less safe than in children over 3 years of age.

The dose should be adjusted based on 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 fall asleep (induction of anaesthesia). In younger children, especially between 1 month and 3 years, 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 anaesthesia for maintaining sleep (maintenance of anaesthesia). In younger children, especially between 1 month and 3 years, the 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, most paediatric patients require 1-2 mg/kg of body weight of propofol for the start of sedation. Maintenance of sedation can be carried out by titrating the infusion of Propofol Lipoven Fresenius to the desired level of sedation. Most patients require 1.5-9 mg/kg/h of propofol. The infusion can be supplemented by administering a bolus of up to 1 mg/kg of body weight if a rapid increase in the intensity of sedation is required.

Propofol Lipoven Fresenius 10 mg/ml 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.

Method of administration

Propofol Lipoven Fresenius is administered by intravenous injection, usually into the back of the hand or into the forearm. Your anaesthetist may use a needle or cannula (a thin plastic tube). Propofol Lipoven Fresenius will be injected into a vein either manually or using an electric pump. Your doctor will ensure that the pump is compatible with the pre-filled syringes. The 10 ml and 20 ml glass syringes and the 10 ml plastic syringes are suitable for manual use and should not be used with a pump.

Propofol Lipoven Fresenius is for single use. Any unused emulsion should be discarded. Pre-filled syringes should be shaken before use. If two layers can still be seen after shaking, the emulsion should not be used. Only use homogeneous preparations and intact pre-filled syringes.

Use of pre-filled syringes (for pre-assembled syringes, step 2 may be omitted)

Ensure sterility. The outer surface of the syringe and the plunger rod are not sterile.

1. Remove the syringe from the packaging and shake it.
2. Insert the plunger rod by screwing it into the syringe in a clockwise direction.
3. Remove the syringe cap and connect the infusion line, needle, or cannula to the syringe. Remove air bubbles (small bubbles may remain) and the syringe will be installed in the pump ready for use or for manual administration.

Duration of treatment

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 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 anaesthetist may need to take measures to ensure your heart and breathing are adequate. This is why anaesthetic medicines are only administered by doctors specialising in anaesthesia 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 anaesthesia

The following side effects may occur during anaesthesia (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 appropriate treatment.

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

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

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

• slow or fast heartbeat
• 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 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 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 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 anaesthesia

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

Common (may affect up to 1 in 10 patients)

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

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

• dizziness, shivering, 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)
• 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-colored urine, stomach pain, and liver sensitivity (indicated by pain below the front of the rib cage 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 prospectus. 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 medication.

5. Storage of Propofol Lipoven Fresenius

Keep this medication out of sight and reach of children.

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

Do not store at a temperature above 25°C.

Do not freeze.

Once opened, the medication must be used immediately.

The administration systems with Propofol Lipoven Fresenius 10 mg/ml without dilution must be replaced 12 hours after opening the syringe. Dilutions with injectable glucose solution 50 mg/ml (5%) or injectable sodium chloride solution 9 mg/ml (0.9%) or a mixture of preservative-free injectable lidocaine solution 10 mg/ml (1%) (at least 2 mg of propofol per ml) should be prepared aseptically (under controlled and validated conditions) immediately before administration and must be administered within 6 hours after preparation.

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

6. Container Contents and Additional Information

Composition of Propofol Lipoven Fresenius

• The active ingredient is propofol.

Each ml of emulsion contains 10 mg of propofol.

Each 10 ml syringe contains 100 mg of propofol.

Each 20 ml syringe contains 200 mg of propofol.

Each 50 ml syringe contains 500 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.

Product Appearance and Container Contents

Propofol Lipoven Fresenius is a white oil-in-water injectable or infusion emulsion in a pre-filled syringe.

Propofol Lipoven Fresenius is available in pre-filled glass or plastic syringes.

Container sizes:

Container containing 5 pre-filled glass syringes with 10 ml of emulsion.

Container containing 6 pre-filled plastic syringes with 10 ml of emulsion.

Container containing 5 pre-filled glass syringes with 20 ml of emulsion.

Container containing 6 pre-filled plastic syringes with 20 ml of emulsion.

Container containing 1 pre-filled plastic syringe with 50 ml of emulsion.

Only some container 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 Austria GmbH

Hafnerstrase 36, 08055 Graz

Austria

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

Date of last revision of this leaflet: July 2024.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es

-----------------------------------------------------------------------------------------------------------------------

This information is intended exclusively for healthcare professionals:

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

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

Shake the pre-filled syringes before use.

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

Only homogeneous preparations in intact pre-filled syringes should be used.

After use, the capped pre-filled syringes should be discarded.

Propofol should only be administered by an anesthesiology specialist (or, when appropriate, by an intensive care specialist).

Patient monitoring should be continuous, and facilities and equipment for maintaining a clear airway, providing artificial ventilation, oxygen supply, and other resuscitation equipment should be readily available. Propofol should not be administered by the same person performing the surgical or diagnostic procedure.

Cases of abuse and dependence on propofol have been reported, mostly in healthcare professionals. As with other general anesthetics, administration of propofol without control of the respiratory tract can lead to fatal respiratory complications.

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

Propofol Lipoven Fresenius 10 mg/ml can be administered undiluted or diluted in glucose 50 mg/ml (5%) or sodium chloride 9 mg/ml (0.9%) injectable solutions.

Propofol Lipoven Fresenius 10 mg/ml should not be mixed with any other injectable or infusion solution 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 solutions can be administered through the same infusion equipment.

Co-administration of other medicinal products or fluids added to the Propofol Lipoven Fresenius infusion line should be performed near the cannula using a Y-connector or a three-way valve.

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

The emulsion should be transferred aseptically to an administration set immediately after opening the syringe. Administration should begin without delay.

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

Infusion of undiluted Propofol Lipoven Fresenius 10 mg/ml:

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

As is usual for fat emulsions, infusion of Propofol Lipoven Fresenius using an infusion system should not exceed 12 hours. The Propofol Lipoven Fresenius infusion equipment should be changed at least every 12 hours.

Infusion of diluted Propofol Lipoven Fresenius 10 mg/ml:

Burettes, drips, or volumetric infusion pumps should always be used to control the infusion rate. The maximum dilution should not exceed 1 part of Propofol Lipoven Fresenius 10 mg/ml 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 should be prepared aseptically (under controlled and validated conditions) immediately before administration and should be administered within 6 hours after preparation.

To reduce pain at the injection site, Propofol Lipoven Fresenius can be administered in a larger vein or lidocaine injectable solution can be administered before induction of anesthesia with Propofol Lipoven Fresenius. Alternatively, lidocaine can be added to the solution (20 parts of Propofol Lipoven Fresenius 10 mg/ml to 1 part of lidocaine 1% injectable solution without preservatives) to reduce pain at the injection site.

Lidocaine should not be used intravenously in patients with acute porphyrias.

Muscle relaxants such as atracurium and mivacurium should only be administered after the same infusion system used for Propofol Lipoven Fresenius has been cleared.

Composition of Propofol Lipoven Fresenius

• The active ingredient is propofol.

Each ml of emulsion contains 10 mg of propofol.

Each 10 ml syringe contains 100 mg of propofol.

Each 20 ml syringe contains 200 mg of propofol.

Each 50 ml syringe contains 500 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.

Product Appearance and Container Contents

Propofol Lipoven Fresenius is a white oil-in-water injectable or infusion emulsion in a pre-filled syringe.

Propofol Lipoven Fresenius is available in pre-filled glass or plastic syringes.

Container sizes:

Container containing 5 pre-filled glass syringes with 10 ml of emulsion.

Container containing 6 pre-filled plastic syringes with 10 ml of emulsion.

Container containing 5 pre-filled glass syringes with 20 ml of emulsion.

Container containing 6 pre-filled plastic syringes with 20 ml of emulsion.

Container containing 1 pre-filled plastic syringe with 50 ml of emulsion.

Only some container 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 Austria GmbH

Hafnerstrase 36, 08055 Graz

Austria

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

Date of last revision of this leaflet: June 2021.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es

-----------------------------------------------------------------------------------------------------------------------

This information is intended exclusively for healthcare professionals:

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

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

Shake the pre-filled syringes before use.

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

Only homogeneous preparations in intact pre-filled syringes should be used.

After use, the capped pre-filled syringes should be discarded.

Propofol should only be administered by an anesthesiology specialist (or, when appropriate, by an intensive care specialist).

Patient monitoring should be continuous, and facilities and equipment for maintaining a clear airway, providing artificial ventilation, oxygen supply, and other resuscitation equipment should be readily available. Propofol should not be administered by the same person performing the surgical or diagnostic procedure.

Cases of abuse and dependence on propofol have been reported, mostly in healthcare professionals. As with other general anesthetics, administration of propofol without control of the respiratory tract can lead to fatal respiratory complications.

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

Propofol Lipoven Fresenius 10 mg/ml can be administered undiluted or diluted in glucose 50 mg/ml (5%) or sodium chloride 9 mg/ml (0.9%) injectable solutions.

Propofol Lipoven Fresenius 10 mg/ml should not be mixed with any other injectable or infusion solution 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 solutions can be administered through the same infusion equipment.

Co-administration of other medicinal products or fluids added to the Propofol Lipoven Fresenius infusion line should be performed near the cannula using a Y-connector or a three-way valve.

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

The emulsion should be transferred aseptically to an administration set immediately after opening the syringe. Administration should begin without delay.

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

Infusion of undiluted Propofol Lipoven Fresenius 10 mg/ml:

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

As is usual for fat emulsions, infusion of Propofol Lipoven Fresenius using an infusion system should not exceed 12 hours. The Propofol Lipoven Fresenius infusion equipment should be changed at least every 12 hours.

Infusion of diluted Propofol Lipoven Fresenius 10 mg/ml:

Burettes, drips, or volumetric infusion pumps should always be used to control the infusion rate. The maximum dilution should not exceed 1 part of Propofol Lipoven Fresenius 10 mg/ml 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 should be prepared aseptically (under controlled and validated conditions) immediately before administration and should be administered within 6 hours after preparation.

To reduce pain at the injection site, Propofol Lipoven Fresenius can be administered in a larger vein or lidocaine injectable solution can be administered before induction of anesthesia with Propofol Lipoven Fresenius. Alternatively, lidocaine can be added to the solution (20 parts of Propofol Lipoven Fresenius 10 mg/ml to 1 part of lidocaine 1% injectable solution without preservatives) to reduce pain at the injection site.

Lidocaine should not be used intravenously in patients with acute porphyrias.

Muscle relaxants such as atracurium and mivacurium should only be administered after the same infusion system used for Propofol Lipoven Fresenius has been cleared.

n.

Lidocaine must not be used intravenously in patients with acute porphyrias.

Muscle relaxants such as atracurium and mivacurium should only be administered after it has been clarified that the same perfusion system used for Propofol Lipoven Fresenius is cleared.