PROPOFOL LIPOVEN FRESENIUS 20 mg/ml Injectable Emulsion for Infusion in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Propofol Lipoven Fresenius 20 mg/ml injectable emulsion and infusion in pre-filled syringe EFG

Propofol

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 anesthetics. General anesthetics are used to produce unconsciousness (sleep) and thus enable surgical operations or other procedures to be carried out. They can also be used to sedate you (to make you feel drowsy but not completely asleep).

Propofol Lipoven Fresenius 20 mg/ml is used for:

• induction and maintenance of general anesthesia in adults, adolescents, and children over 3 years of age
• sedation of patients over 16 years of age with assisted ventilation in the Intensive Care Unit
• sedation in adults, adolescents, and children over 3 years of age during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.

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

Do not use Propofol Lipoven Fresenius

• This medicine contains soybean oil. It must not be used in case of peanut or soy allergy.
• In patients 16 years or younger for sedation in intensive care.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Propofol Lipoven Fresenius and if you suffer, or have ever suffered, from any of the following conditions.

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

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

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

Before administration of Propofol Lipoven Fresenius, inform your anesthetist or intensive care doctor if you suffer from:

• heart disease
• lung disease
• kidney disease
• liver disease
• seizures (epilepsy)
• high pressure inside the skull (elevated intracranial pressure). In combination with low blood pressure, it 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), blood fat levels should be monitored.
  • if your body has lost a large amount of water (you are hypovolemic).

If you suffer from any of the following problems, they must 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 (hypovolemia)
• 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 (hemodynamic 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 may occur. Your doctor will take into account how this may affect surgical procedures performed under sedation and will take necessary precautions.

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

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 go without an escort.

Children and adolescents

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

Propofol Lipoven Fresenius 20 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 demonstrated for this group of patients 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, anesthetist, 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).

Tell your doctor or pharmacist if you are taking or receiving any of the following medicines:

• Premedication (your anesthetist will know which medicines may be affected by Propofol Lipoven Fresenius)
• Other anesthetics, including general, regional, local, and inhalational anesthetics (lower doses of Propofol Lipoven Fresenius may be required. Your anesthetist 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 must 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 must 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 use 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 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 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 supervision of an anesthetist or an intensive care doctor.

Dose

The dose that you will be given 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. The doctor will decide which medicines 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 fall asleep (induction of anesthesia), and then 4 to 12 mg of propofol per kg of body weight per hour to stay asleep (maintenance of anesthesia). 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 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 (0.5 – 1 ml of Propofol Lipoven Fresenius 20 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 to 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 3 years of age and adolescents

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

The dose should be adjusted according to age and/or body weight. Most patients over 8 years of age require approximately 2.5 mg/kg of body weight of Propofol Lipoven Fresenius to induce sleep (induction of anesthesia). In younger children, requirements may be higher (2.5 – 4 mg/kg of body weight).

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

For sedation during surgical and diagnostic procedures in children over 3 years of age with Propofol Lipoven Fresenius 20 mg/ml, most pediatric 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.

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

Method of administration

Propofol Lipoven Fresenius is administered intravenously, usually into the back of the hand or into the forearm. Your anesthetist may use a needle or cannula (a thin plastic tube). Propofol Lipoven Fresenius will be injected into the vein either manually or using an electric pump. Your doctor will ensure that the pump is compatible with the pre-filled syringes.

Propofol Lipoven Fresenius is for single use. Any unused emulsion must be discarded. The pre-filled syringes must 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

Sterility must be ensured. 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 the direction of the clock hands.
3. Remove the syringe cap and connect the infusion line, needle, or cannula to the syringe. Eliminate 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 too much propofol

Your doctor will make sure you receive the correct amount of propofol for the procedures being carried out.

However, different people need different doses, and if you receive too much, your anesthetist may need to take measures to ensure that your heart and breathing are adequate. This is why anesthetic medicines are only administered by doctors specialized in anesthesia or intensive care.

If you have any further questions on the use of this product, 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 appropriate 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):

• 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 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 below 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 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 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 syringe 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 medicine must be used immediately.

Administration systems with Propofol Lipoven Fresenius must be replaced 12 hours after opening the syringe.

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

• The active ingredient is propofol.

Each ml of emulsion contains 20 mg of propofol.

Each 50 ml syringe 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 injectable preparations.

Appearance of the product and package 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 plastic syringes.

Package size:

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

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, 8055 Graz

Austria

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

Date of last revision of this prospectus: July 2024.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

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

The pre-filled syringes must be shaken before use.

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

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

After use, the sealed pre-filled syringes must be discarded.

Propofol should be administered by persons specialized in anesthesia (or, when appropriate, physicians specialized in the care of patients in intensive care).

Patients must be constantly monitored and must have fully available facilities and equipment to maintain a clear airway, provide artificial ventilation, oxygen supply, and other resuscitation equipment. Propofol must not be administered by the person performing the diagnostic or surgical procedure.

Cases of abuse and dependence on propofol have been reported, mostly by healthcare professionals. As with other general anesthetics, the 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 by intravenous infusion.

Propofol Lipoven Fresenius 20 mg/ml must not be mixed with any other injectable or infusion solution.

A 50 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 added to the Propofol Lipoven Fresenius infusion line must be performed near the cannula using a Y-connector or a three-way valve.

The use of Propofol Lipoven Fresenius 20 mg/ml for general anesthesia in children under 3 years is not recommended, as the 20 mg/ml dose is difficult to titrate in small children due to the extremely small volumes required. The use of Propofol Lipoven Fresenius 10 mg/ml should be considered in children between 1 month and 3 years if the expected dose is less than 100 mg/h, for example.

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

The emulsion must be transferred aseptically to an administration system immediately after opening the syringe. 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 drip, burette, 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 through an infusion system must not exceed 12 hours. The Propofol Lipoven Fresenius infusion system must be changed at least every 12 hours.

To reduce pain at the injection site, it can be administered in a larger vein and/or lidocaine injectable solution can be administered before induction of anesthesia with Propofol Lipoven Fresenius.

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

The infusion system must be flushed before administering atracurium or mivacurium-type muscle relaxants when using the same infusion system as for Propofol Lipoven Fresenius.