Propofol 2% Mct/lct Fresenius

Package Leaflet: Information for the User

Propofol 2% MCT/LCT Fresenius, 20 mg/ml, Emulsion for Injection/Infusion

Propofol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What Propofol 2% MCT/LCT Fresenius is and what it is used for
• 2. Important information before using Propofol 2% MCT/LCT Fresenius
• 3. How to use Propofol 2% MCT/LCT Fresenius
• 4. Possible side effects
• 5. How to store Propofol 2% MCT/LCT Fresenius
• 6. Contents of the pack and other information

1. What Propofol 2% MCT/LCT Fresenius is and what it is used for

Propofol 2% MCT/LCT Fresenius belongs to a group of medicines called general anesthetics.
General anesthetics are used to cause unconsciousness (sleep) so that surgery or other procedures can be performed.
These medicines can also be used to produce sedation (a state where the patient is drowsy but not completely asleep).

Propofol 2% MCT/LCT Fresenius 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 who are mechanically ventilated and require intensive care;
• sedation of adults, adolescents, and children over 3 years of age during diagnostic and surgical procedures, as a single agent or in combination with other medicines used to induce local or regional anesthesia.

2. Important information before using Propofol 2% MCT/LCT Fresenius

When not to use Propofol 2% MCT/LCT Fresenius

• if the patient is allergic to propofol, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6);
• for sedation of patients under 16 years of age who require intensive care.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before using Propofol 2% MCT/LCT Fresenius and if any of the following apply to you now or have ever applied in the past.
Propofol 2% MCT/LCT Fresenius should not be used or should be used with caution and with close monitoring in patients:

• with severe heart failure;
• with other severe heart diseases;
• being treated with electroconvulsive therapy (a treatment used in psychiatry).

In elderly and weak patients, Propofol 2% MCT/LCT Fresenius should be used with caution.
Before using Propofol 2% MCT/LCT Fresenius, tell your anesthesiologist or intensive care doctor if you have:

• heart disease;
• lung disease;
• kidney disease;
• liver disease;
• epilepsy (seizures);
• increased intracranial pressure (increased pressure inside the skull), combined with decreased blood pressure, the amount of blood reaching the brain may decrease;
• changed fat levels in the blood, if the patient is completely fed intravenously (fed through a vein), the fat levels in the blood should be monitored;
• severe loss of body fluids (dehydration).

Before using Propofol 2% MCT/LCT Fresenius, the following conditions must be treated in the patient:

• heart failure;
• insufficient blood supply to tissues (circulatory failure);
• severe breathing difficulties (respiratory failure);
• dehydration (hypovolemia);
• epilepsy (seizures).

Propofol 2% MCT/LCT Fresenius may increase the risk of:

• seizures;
• nerve reflex slowing down heart rate (vagotonia, bradycardia);
• changes in blood supply to the patient's organs (hemodynamic effects on the cardiovascular system), if the patient is overweight and receives large doses of Propofol 2% MCT/LCT Fresenius.

During sedation with Propofol 2% MCT/LCT Fresenius, involuntary movements may occur in the patient.
The doctor will consider how this may affect the surgical procedure being performed under sedation and take necessary precautions.
Very rarely, after anesthesia, a postoperative loss of consciousness may occur with increased muscle tension.
The patient should be monitored, but this does not require additional treatment.
Recovery of consciousness occurs spontaneously.
The injection of Propofol 2% MCT/LCT Fresenius can be painful.
To reduce pain, a locally acting anesthetic can be used, but its use may cause side effects.
The patient will be able to leave the hospital when they have fully recovered consciousness.
If the patient is to return home soon after using propofol, they should be accompanied by another person.

Children and Adolescents

Propofol 2% MCT/LCT Fresenius should not be used in children under 3 years of age.
Propofol 2% MCT/LCT Fresenius should not be used in children and adolescents under 16 years of age for sedation in intensive care units, as the safety of propofol in this indication has not been established in this age group.

Propofol 2% MCT/LCT Fresenius with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about any medicines you plan to take.
In particular, tell your doctor, anesthesiologist, or nurse if you are taking any of the following medicines:

• rifampicin (a medicine used to treat tuberculosis);
• midazolam [a medicine used to induce sedation (a deep state of relaxation, drowsiness, or sleep) and to relieve anxiety and reduce muscle tension].

Special caution is required if you are taking and/or receiving any of the following medicines:

• premedication medicines (the anesthesiologist will know which medicines may interact with Propofol 2% MCT/LCT Fresenius);
• other anesthetics, including general, regional, and local anesthetics, as well as inhalation anesthetics (the anesthesiologist may decide to reduce the dose of Propofol 2% MCT/LCT Fresenius);
• analgesics (painkillers);
• strong analgesics (fentanyl or opioids);
• parasympatholytic medicines (used for painful spasms, asthma, and Parkinson's disease);
• benzodiazepines (sedatives);
• suxamethonium (a muscle relaxant);
• medicines that can affect the body's internal functions, such as heart rate, e.g., atropine;
• medicines and drinks containing alcohol;
• neostigmine (a medicine used to treat muscle weakness);
• cyclosporin (a medicine used to prevent transplant rejection);
• valproate (a medicine used to treat epilepsy and psychiatric disorders).

Propofol 2% MCT/LCT Fresenius with food, drink, and alcohol

After using Propofol 2% MCT/LCT Fresenius, the patient should not eat, drink, or consume alcohol until they have fully recovered consciousness.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Propofol 2% MCT/LCT Fresenius should not be used in pregnant women unless absolutely necessary.
Mothers should stop breastfeeding and discard breast milk for 24 hours after receiving Propofol 2% MCT/LCT Fresenius.

Driving and Using Machines

For some time after using propofol, drowsiness may occur.
Do not drive, operate machinery, or use appliances until you are sure that the effect of the medicine has worn off.
If you are to return home soon after using propofol, do not drive or return home unaccompanied.
Ask your doctor when you can resume these activities and return to work.

Propofol 2% MCT/LCT Fresenius contains soybean oil and sodium

Propofol 2% MCT/LCT Fresenius contains soybean oil.
If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, which means that it is essentially 'sodium-free'.

3. How to use Propofol 2% MCT/LCT Fresenius

Propofol 2% MCT/LCT Fresenius will be given to you by a doctor or nurse in a hospital or a specialized treatment unit, under the supervision of an anesthesiologist or a doctor specializing in intensive care.

Dosage

The dose given will depend on your age, weight, and condition.
The doctor will give you the correct dose to induce and maintain anesthesia or to achieve the required level of sedation, carefully monitoring your reactions and vital signs (pulse, blood pressure, breathing, etc.).
Other medicines may be needed to induce relaxation or deep sleep, relieve pain, ensure proper breathing, and maintain blood pressure at a stable level.
The doctor will decide which medicines to use and when to give them to you.

Adults

Most patients need 1.5 to 2.5 mg of propofol per kilogram of body weight to induce anesthesia (induction of anesthesia), and then 4 to 12 mg of propofol per kilogram of body weight per hour to maintain anesthesia (maintenance of anesthesia).
To achieve the required level of sedation, doses of 0.3 to 4.0 mg of propofol per kilogram of body weight per hour are usually sufficient.
To achieve the required level of sedation during surgical and diagnostic procedures in adults, most patients require a dose of 0.5 to 1 mg of propofol per kilogram of body weight over 1 to 5 minutes.
Maintenance of the required level of sedation can be achieved by adjusting the infusion rate of Propofol 2% MCT/LCT Fresenius.
Most patients require a dose of 1.5 to 4.5 mg of propofol per kilogram of body weight per hour.
If rapid increase in sedation level is necessary, the infusion can be supplemented by administering propofol in a bolus dose of 10 to 20 mg (0.5 to 1 ml of Propofol 2% MCT/LCT Fresenius).
For sedation of patients over 16 years of age who are mechanically ventilated in intensive care, the dose of the medicine should be adjusted to achieve the required level of sedation.
A satisfactory level of sedation is usually achieved with an infusion rate of 0.3 to 4.0 mg of propofol per kilogram of body weight per hour.
It is not recommended to use the medicine with an infusion rate greater than 4.0 mg of propofol per kilogram of body weight per hour.

Elderly and Weak Patients

Older and weaker patients may require smaller doses.

Children and Adolescents over 3 years of age

Propofol 2% MCT/LCT Fresenius should not be used in children under 3 years of age.
The dose should be adjusted according to age and/or weight.
Most children over 8 years of age require a dose of approximately 2.5 mg/kg of Propofol 2% MCT/LCT Fresenius to induce anesthesia.
Younger children may require a higher dose (2.5 to 4 mg/kg).
Doses of 9 to 15 mg/kg/h usually allow for the required level of anesthesia to be achieved (maintenance of anesthesia).
Younger children may require a higher dose.
To induce sedation using Propofol 2% MCT/LCT Fresenius during surgical and diagnostic procedures in children over 3 years of age, most patients require an initial dose of 1 to 2 mg/kg of propofol.
Maintenance of the required level of sedation can be achieved by adjusting the infusion rate of Propofol 2% MCT/LCT Fresenius.
Most patients require a dose of 1.5 to 9 mg of propofol per kilogram of body weight per hour.
Propofol 2% MCT/LCT Fresenius should not be used in children and adolescents under 16 years of age for sedation in intensive care units, as the safety of propofol in this indication has not been established in this age group.

Method of Administration

Propofol 2% MCT/LCT Fresenius is intended for intravenous administration, usually on the back of the hand or forearm.
The anesthesiologist may use a needle or cannula (a thin plastic tube).
Propofol 2% MCT/LCT Fresenius will be injected into a vein manually or using an electric pump.
Propofol 2% MCT/LCT Fresenius is for single use only.
Any unused emulsion should be discarded.
The packaging should be shaken before use.
If, after shaking, two layers are visible in the emulsion, it should not be used.
Only use the medicine if it has a uniform consistency and the packaging is undamaged.
Before use, the rubber membrane should be cleaned with alcohol spray or an alcohol swab.

Duration of Treatment

When using Propofol 2% MCT/LCT Fresenius for sedation, it should not be used for more than 7 days.

Using more than the recommended dose of Propofol 2% MCT/LCT Fresenius

The doctor will ensure that you receive the correct dose of propofol, depending on the procedure being performed.
However, different patients require different doses of the medicine.
If you receive too much of the medicine, the anesthesiologist will take appropriate action to ensure proper heart and respiratory function.
This is why anesthetics are only administered by doctors specializing in anesthesiology or intensive care.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Propofol 2% MCT/LCT Fresenius can cause side effects, although not everybody gets them.

Side effects during anesthesia

The following side effects may occur during anesthesia (during injection and when the patient is sleepy or completely asleep).
The doctor will be aware of these.
If such side effects occur, the doctor will provide appropriate treatment.

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

• pain at the injection site (during injection, before the patient falls asleep).

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

• slow or fast heart rate;
• low blood pressure;
• change in breathing pattern (low breathing rate, breathing stop);
• hiccups;
• cough (may also occur during recovery from anesthesia).

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

• swelling and redness along the vein into which the medicine was administered or blood clots.

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

• shivering and trembling of the body or seizures (may also occur during recovery from anesthesia).

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

• severe allergic reaction causing breathing difficulties, swelling, and redness of the skin, hot flushes;
• fluid accumulation in the lungs, making breathing very difficult (may also occur during recovery from anesthesia);
• change in urine color (may also occur during recovery from anesthesia).

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

• involuntary movements;
• severe skin and tissue reactions after accidental administration of the medicine outside a vein;
• prolonged, often painful erection (priapism).

Side effects that may occur after recovery from anesthesia

The following side effects may occur after recovery from anesthesia (during recovery or when the patient is already awake):

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

• headache;
• nausea, vomiting;
• cough.

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

• dizziness, shivering, and feeling cold;
• agitation.

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

• postoperative loss of consciousness (in such cases, patients recovered consciousness without problems);
• pancreatitis, which causes severe abdominal pain (no causal relationship has been established);
• postoperative fever.

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

• euphoria;
• sexual arousal;
• irregular heartbeat;
• changes in ECG recording (corresponding to Brugada syndrome);
• enlargement of the liver;
• kidney failure;
• muscle damage (rhabdomyolysis), increased acidity of the blood, high potassium levels in the blood, high fat levels in the blood, heart failure;
• misuse of the medicine, mainly by medical personnel;
• prolonged, often painful erection (priapism);
• hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain, and liver tenderness

(indicated as pain under the front part of the chest, on the right side of the body),
sometimes with loss of appetite].
When Propofol 2% MCT/LCT Fresenius is administered in combination with lidocaine (a local anesthetic used to reduce pain at the injection site), the following side effects may rarely occur:

• dizziness;
• vomiting;
• drowsiness;
• seizures;
• slow heart rate (bradycardia);
• irregular heartbeat (arrhythmia);
• shock.

Reporting side effects

If you experience any side effects, including any not listed in the package leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Propofol 2% MCT/LCT Fresenius

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and outer packaging after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
After first opening, the medicine should be used immediately.
Administration sets used with Propofol 2% MCT/LCT Fresenius should 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 medicines no longer required.
These measures will help protect the environment.

6. Contents of the pack and other information

What Propofol 2% MCT/LCT Fresenius contains

• The active substance is propofol.

Each milliliter 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 ingredients are purified soybean oil, medium-chain triglycerides, purified egg phosphatides, glycerol, oleic acid, sodium hydroxide, water for injections.

What Propofol 2% MCT/LCT Fresenius looks like and contents of the pack

Propofol 2% MCT/LCT Fresenius is a white oil-in-water emulsion for injection or infusion.
Propofol 2% MCT/LCT Fresenius is available in colorless glass vials.
The glass vials are closed with rubber stoppers.
Pack sizes:
10 glass vials of 20 ml emulsion.
1 glass vial of 50 ml emulsion.
10 glass vials of 50 ml emulsion.
10 glass vials of 100 ml emulsion.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi Deutschland GmbH
Else-Kroener Strasse 1
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
Fresenius Kabi AB
Rapsgatan 7
S-75174 Uppsala
Sweden
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Jerozolimskie Avenue 134
02-305 Warsaw
phone: +48 22 345 67 89

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

Date of last revision of the package leaflet:17.01.2025
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Information intended for healthcare professionals only:

For single use only.
Any unused emulsion should be discarded.
The packaging should be shaken before use.
If, after shaking, two layers are visible in the emulsion, it should not be used.
Only use the medicine if it has a uniform consistency and the packaging is undamaged.
Before use, the rubber membrane should be cleaned with alcohol spray or an alcohol swab.
After use, punctured packaging should be discarded.
Propofol should be administered by doctors specializing in anesthesiology (or, if necessary, doctors specializing in intensive care).
Patients should be continuously monitored and have access to equipment for maintaining airway patency, artificial ventilation, oxygen administration, and other resuscitation equipment at all times.
Propofol should not be administered by the same person who is performing the diagnostic or surgical procedure.
There have been reports of abuse and dependence on propofol, particularly among medical personnel.
As with other general anesthetics, the use of propofol without maintaining respiratory function may lead to respiratory complications resulting in death.
If propofol is used to induce sedation in conscious patients during surgical and diagnostic procedures, it is necessary to constantly monitor for early signs of hypotension, airway obstruction, and desaturation.
Propofol 2% MCT/LCT Fresenius should be used in continuous infusion in an undiluted form.
Propofol 2% MCT/LCT Fresenius should not be mixed with other solutions for injection or infusion.
Propofol 2% MCT/LCT Fresenius can be administered through the same infusion line as 50 mg/ml (5%) glucose solution for injection, 9 mg/ml (0.9%) sodium chloride solution for injection, or 1.8 mg/ml (0.18%) sodium chloride solution for injection with 40 mg/ml (4%) glucose solution for injection.
Other medicines or fluids administered simultaneously with Propofol 2% MCT/LCT Fresenius using the same infusion line should be administered close to the infusion site using a Y-connector or a three-way valve.
It is not recommended to use Propofol 2% MCT/LCT Fresenius for general anesthesia in children under 3 years of age, as the 20 mg/ml dose is difficult to adjust in small children due to the need for very small amounts of the medicine.
Consider using Propofol 1% MCT/LCT Fresenius in children between 1 month and 3 years of age if the expected dose is less than, for example, 100 mg/h.
Propofol 2% MCT/LCT Fresenius is an emulsion containing fats without antibacterial preservatives and may promote rapid growth of microorganisms.
The emulsion should be drawn up in aseptic conditions into a sterile syringe and infusion set immediately after the vial seal has been pierced.
Infusion should be started immediately.
Propofol 2% MCT/LCT Fresenius and any infusion equipment containing this medicine should be used in accordance with aseptic principles throughout the infusion period.
Propofol 2% MCT/LCT Fresenius should not be administered through a microbiological filter.
To control the infusion rate, it is recommended to use burettes, drop counters, syringe pumps, or volumetric infusion pumps.
As with other fat emulsions, infusions of Propofol 2% MCT/LCT Fresenius should not be administered for more than 12 hours through the same infusion set.
Infusion sets for Propofol 2% MCT/LCT Fresenius should be replaced at least every 12 hours.
To alleviate pain at the injection site, Propofol 2% MCT/LCT Fresenius can be administered into a larger vein and/or lidocaine can be injected immediately before its administration.
Lidocaine should not be used in patients with hereditary acute porphyria.
Muscle relaxants like atracurium and mivacurium can be administered through the same infusion line as Propofol 2% MCT/LCT Fresenius, but only after the line has been flushed beforehand.