Propofol 1% Mct/lct Fresenius

Leaflet attached to the packaging: information for the user

Propofol 1% MCT/LCT Fresenius, 10 mg/ml, emulsion for injection/infusion

In a pre-filled syringe
Propofol

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Propofol 1% MCT/LCT Fresenius belongs to a group of medicines called general anesthetics.
General anesthetics are used to induce unconsciousness (sleep) to enable surgery or other procedures to be performed. These medicines can also be used to produce sedation (a state in which the patient is drowsy but not completely asleep).

Propofol 1% MCT/LCT Fresenius 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 who are mechanically ventilated and require intensive medical care;
• sedation of adults, adolescents, and children over 1 month 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 1% MCT/LCT Fresenius

When not to use Propofol 1% 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 medical care.

Warnings and precautions

You should consult a doctor, pharmacist, or nurse before using Propofol 1% MCT/LCT Fresenius and if any of the following situations apply or have applied to the patient in the past.
Propofol 1% MCT/LCT Fresenius should not be used or should be used with caution and with close monitoring in patients:

• with advanced heart failure;
• with other severe heart diseases;
• being treated with electroshock therapy (electroconvulsive therapy, used in psychiatric treatment).

In elderly and weakened patients, Propofol 1% MCT/LCT Fresenius should be used with caution.
Before using Propofol 1% MCT/LCT Fresenius, you should tell the anesthesiologist or intensive care doctor if the patient has:

• heart disease;
• lung disease;
• kidney disease;
• liver disease;
• seizures (epilepsy);
• 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 being fed entirely intravenously (through a vein), the fat levels in the blood should be monitored;
• severe fluid loss from the body (dehydration).

Before using Propofol 1% MCT/LCT Fresenius, the following conditions should be treated in the patient:

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

Propofol 1% MCT/LCT Fresenius may increase the risk of:

• seizures;
• nerve reflex slowing down the 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 1% MCT/LCT Fresenius.

During sedation with Propofol 1% 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 will 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 1% 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 if they have fully regained consciousness.
If the patient is to return home soon after using propofol, they should be accompanied by another person.

Children and adolescents

Propofol 1% MCT/LCT Fresenius is not recommended for use in newborns and children under 1 month of age.
Due to limited data, it is not recommended to administer Propofol 1% MCT/LCT using a Target Controlled Infusion (TCI) system in children under 2 years of age.
Propofol 1% 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 confirmed in this age group.

Propofol 1% MCT/LCT Fresenius and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should tell your doctor 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 drugs (the anesthesiologist will know which drugs may interact with Propofol 1% MCT/LCT Fresenius);
• other anesthetics, including general, regional, and local anesthetics, as well as inhaled anesthetics (the anesthesiologist may decide to reduce the dose of Propofol 1% MCT/LCT Fresenius);
• analgesics (pain relievers);
• strong analgesics (fentanyl or opioids);
• parasympatholytic drugs (used for painful spasms, asthma, and Parkinson's disease);
• benzodiazepines (sedatives);
• suxamethonium (a muscle relaxant);
• drugs that may affect the body's internal functions, such as heart rate, e.g., atropine;
• drugs and beverages 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 1% MCT/LCT Fresenius with food, drink, and alcohol

After using Propofol 1% MCT/LCT Fresenius, the patient should not eat, drink, or consume alcohol until they have fully regained consciousness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.
Propofol 1% 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 1% MCT/LCT Fresenius.

Driving and using machines

For some time after using propofol, drowsiness may occur. You should not drive, operate machinery, or use appliances until you are sure that the effects of the medicine have worn off.
If you are to return home soon after using propofol, you should not drive or return home without someone accompanying you.
You should ask your doctor when you can resume these activities and return to work.

Propofol 1% MCT/LCT Fresenius contains soybean oil and sodium

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

3. How to use Propofol 1% MCT/LCT Fresenius

Propofol 1% MCT/LCT Fresenius will be administered to you only in a hospital or in an appropriate therapeutic department by an anesthesiologist or a doctor specializing in intensive care medicine or under their direct supervision.

Dosage

The dose administered will depend on the patient's age, weight, and condition. The doctor will administer the appropriate dose to induce and maintain anesthesia or to achieve the required level of sedation, carefully monitoring the patient's reactions and vital signs (pulse, blood pressure, breathing, etc.).
It may be necessary to use other medicines to induce relaxation or deep sleep, to relieve pain, to ensure proper breathing, and to maintain blood pressure at a stable level. The doctor will decide which medicines to use and when to administer them to the patient.

Adults

Most patients require 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 a period of 1 to 5 minutes. Maintaining the required level of sedation can be achieved by adjusting the infusion rate of Propofol 1% MCT/LCT Fresenius.
Most patients require 1.5 to 4.5 mg of propofol per kilogram of body weight per hour.
If it is necessary to quickly increase the level of sedation, the infusion can be supplemented by administering a bolus of propofol at a dose of 10 to 20 mg of propofol (1 to 2 ml of Propofol 1% MCT/LCT Fresenius).
For sedation of patients over 16 years of age who are mechanically ventilated during 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 by administering at a rate of 0.3 to 4.0 mg of propofol per kilogram of body weight per hour. It is not recommended to administer the medicine by infusion at a rate greater than 4.0 mg of propofol per kilogram of body weight per hour.

Elderly and weakened patients

Lower doses may be required in elderly and weakened patients.

Children and adolescents over 1 month of age

Propofol 1% MCT/LCT Fresenius is not recommended for use in children under 1 month of age.
Special caution is also required when administering Propofol 1% MCT/LCT Fresenius to children under 3 years of age, although currently available data do not indicate that the use of the medicine is less safe in children over 3 years of age.
The dose should be adjusted based on the patient's age and/or weight. In most children over 8 years of age, the dose required to induce anesthesia (induction of anesthesia) is approximately 2.5 mg of Propofol 1% MCT/LCT Fresenius per kilogram of body weight. In younger children, particularly those between 1 month and 3 years of age, the required dose may be higher (2.5 to 4 mg per kilogram of body weight).
Doses of 9 to 15 mg of propofol per kilogram of body weight per hour usually allow for the required level of anesthesia (maintenance of anesthesia) to be achieved. In younger children, particularly those between 1 month and 3 years of age, a higher dose may be required.
To induce sedation using Propofol 1% MCT/LCT Fresenius during surgical and diagnostic procedures in children over 1 month of age, most patients require an initial sedation dose of 1 to 2 mg of propofol per kilogram of body weight.
Maintaining the required level of sedation can be achieved by adjusting the infusion rate of Propofol 1% MCT/LCT Fresenius. Most patients require 1.5 to 9 mg of propofol per kilogram of body weight per hour. If it is necessary to quickly increase the level of sedation, the infusion can be supplemented by administering a bolus of propofol at a dose of up to 1 mg of propofol per kilogram of body weight.
Propofol 1% 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 confirmed in this age group.

Method of administration

Propofol 1% 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 1% MCT/LCT Fresenius will be injected into a vein manually or using an electric pump.
The doctor will ensure that the pump is compatible with the pre-filled syringe.
Glass pre-filled syringes of 10 ml and 20 ml and plastic pre-filled syringes of 10 ml are suitable only for manual injection and should not be used with a pump.
Propofol 1% MCT/LCT Fresenius is for single use only. Any unused emulsion should be discarded.
The pre-filled syringe should be shaken before use. If, after shaking, the emulsion has two layers, it should not be used.
Only use the medicine if it has a uniform consistency and the pre-filled syringe is undamaged.
Using pre-filled syringes (for pre-filled syringes ready for use, point 2 can be skipped):
Use only with aseptic precautions. The outer surface of the pre-filled syringe and the plunger are not sterile.

• 1. Remove the pre-filled syringe from the packaging and shake it.
• 2. Connect the plunger to the pre-filled syringe by screwing it clockwise.
• 3. Remove the cap from the pre-filled syringe and connect the infusion line, needle, or cannula to the pre-filled syringe. Remove the air bubble (a small bubble may remain) and place the ready-to-use pre-filled syringe in the pump or use it manually.

Duration of treatment

When using Propofol 1% MCT/LCT Fresenius for sedation, it should not be used for more than 7 days.

Overdose of Propofol 1% MCT/LCT Fresenius

The doctor will ensure that the patient receives the appropriate dose of propofol depending on the procedure being performed. However, different patients require different doses of the medicine. If the patient receives too much of the medicine, the anesthesiologist will take appropriate action to ensure proper heart and respiratory function. That's why anesthetics are only administered by doctors specializing in anesthesiology or intensive care medicine.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Propofol 1% MCT/LCT Fresenius can cause side effects, although not everybody gets them.

Side effects during anesthesia

During anesthesia (during injection and when the patient is drowsy or completely asleep), the following side effects may occur. The doctor will monitor them.
If such side effects occur, the doctor will provide appropriate treatment.

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

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

Common (may affect less than 1 in 10 patients):

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

Uncommon (may affect less than 1 in 100 patients):

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

Rare (may affect less than 1 in 1,000 patients):

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

Very rare (may affect less than 1 in 10,000 patients):

• severe allergic reaction causing breathing difficulties, swelling, and redness of the skin, hot flashes;
• fluid accumulation in the lungs, making breathing very difficult (may also occur during awakening from anesthesia);
• change in urine color (may also occur during awakening 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 the vein;
• prolonged, often painful erection (priapism).

Side effects that may occur after awakening from anesthesia

The following side effects may occur after awakening from anesthesia (during or after the patient has awakened):

Common (may affect less than 1 in 10 patients):

• headache;
• nausea, vomiting;
• cough.

Rare (may affect less than 1 in 1,000 patients):

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

Very rare (may affect less than 1 in 10,000 patients):

• 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;
• abuse 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 of the chest, on the right side of the body), sometimes with loss of appetite]. When Propofol 1% 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 side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Propofol 1% MCT/LCT Fresenius

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pre-filled syringe and outer packaging after EXP. The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Do not freeze.
The medicine should be used immediately after opening.
Administration sets for undiluted Propofol 1% MCT/LCT Fresenius should be changed 12 hours after opening the pre-filled syringe.
Dilutions of 50 mg/ml (5%) glucose solution for injection or 9 mg/ml (0.9%) sodium chloride solution for injection or 10 mg/ml (1%) lidocaine solution for injection without preservatives should be prepared under aseptic conditions (controlled and validated) immediately before administration and administered within 6 hours of preparation.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Propofol 1% MCT/LCT Fresenius contains

• The active substance of the medicine is propofol.

Each milliliter of emulsion contains 10 mg of propofol.
Each 10 ml pre-filled syringe contains 100 mg of propofol.
Each 20 ml pre-filled syringe contains 200 mg of propofol.
Each 50 ml pre-filled syringe contains 500 mg of propofol.

• The other ingredients are: soybean oil, purified, medium-chain triglycerides, purified egg lecithin, glycerol, oleic acid, sodium hydroxide, water for injections.

What Propofol 1% MCT/LCT Fresenius looks like and contents of the packaging

Propofol 1% MCT/LCT Fresenius is a white emulsion for injection/infusion in a pre-filled syringe.
Propofol 1% MCT/LCT Fresenius is available in plastic and glass pre-filled syringes.
Pack sizes:
The pack contains 5 glass pre-filled syringes of 10 ml of emulsion, in a cardboard box.
The pack contains 6 plastic pre-filled syringes of 10 ml of emulsion, in a cardboard box.
The pack contains 5 glass pre-filled syringes of 20 ml of emulsion, in a cardboard box.
The pack contains 1 plastic pre-filled syringe of 50 ml of emulsion, in a cardboard box.
Not all pack 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
Hafnerstraße 36
8055 Graz
Austria
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. +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 leaflet:08.08.2024

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Information intended for healthcare professionals only:

Propofol 1% MCT/LCT Fresenius should not be mixed before administration with solutions for injection or infusion, except for 50 mg/ml (5%) glucose solution for injection or 9 mg/ml (0.9%) sodium chloride solution for injection or 10 mg/ml (1%) lidocaine solution for injection without preservatives. The final concentration of propofol should not be less than 2 mg/ml.
For single use only. Any unused emulsion should be discarded.
The pre-filled syringe should be shaken before use. If, after shaking, the emulsion has two layers, it should not be used.
Only use the medicine if it has a uniform consistency and the pre-filled syringe is undamaged.
After use, the punctured pre-filled syringe should be discarded.
Propofol should be administered by doctors specializing in anesthesiology (or, if necessary, doctors specializing in intensive care medicine).
Patients should be continuously monitored and ensured access to equipment for maintaining airway patency, artificial ventilation, administration of oxygen at increased concentrations, and other resuscitation equipment at all times. Propofol should not be administered by the same person performing the diagnostic or surgical procedure.
There have been reports of abuse and dependence on propofol, particularly among medical personnel. Like other general anesthetics, the use of propofol without maintaining respiratory function may cause respiratory complications leading to death.
If propofol is used to induce sedation in conscious patients during surgical and diagnostic procedures, early signs of hypotension, airway obstruction, and desaturation should be constantly monitored.
Propofol 1% MCT/LCT Fresenius may be administered by infusion undiluted or diluted with 50 mg/ml (5%) glucose solution for injection or 9 mg/ml (0.9%) sodium chloride solution for injection.
Propofol 1% MCT/LCT Fresenius should not be mixed with other solutions for injection or infusion than those mentioned above.
Propofol 1% MCT/LCT Fresenius can be administered through the same infusion set with 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 1% MCT/LCT Fresenius using the same infusion line should be administered near the infusion site using a Y-connector or a three-way valve.
Propofol 1% MCT/LCT Fresenius is an emulsion containing fats without antibacterial preservatives and may promote rapid growth of microorganisms.
The emulsion should be drawn up into a sterile infusion set under aseptic conditions immediately after opening the pre-filled syringe. Infusion should be started immediately.
Propofol 1% MCT/LCT Fresenius and any infusion equipment containing this medicine should be used with aseptic precautions throughout the infusion period. Propofol 1% MCT/LCT Fresenius should not be administered through a microbiological filter.
Infusion of undiluted Propofol 1% MCT/LCT Fresenius
When Propofol 1% MCT/LCT Fresenius is administered by infusion undiluted, to control the infusion rate, it is recommended to use burettes, drop counters, syringe pumps, or volumetric infusion pumps.
As is usually the case with fat emulsions, infusion of Propofol 1% MCT/LCT Fresenius should not be administered for more than 12 hours through one infusion set. Infusion sets for Propofol 1% MCT/LCT Fresenius should be changed at least every 12 hours.
Infusion of diluted Propofol 1% MCT/LCT Fresenius:
To administer Propofol 1% MCT/LCT Fresenius by infusion diluted, biurettes, drop counters, or volumetric infusion pumps should always be used to control the infusion rate. The maximum dilution should not exceed 1 part of Propofol 1% MCT/LCT Fresenius in 4 parts of 50 mg/ml (5%) glucose solution for injection or 9 mg/ml (0.9%) sodium chloride solution for injection (minimum concentration 2 mg of propofol per ml). The diluted medicine should be prepared under aseptic conditions (controlled and validated) immediately before administration and administered within 6 hours of preparation.
To reduce pain at the injection site, Propofol 1% MCT/LCT Fresenius can be administered into a larger vein and/or lidocaine can be injected immediately before its administration. Alternatively, a lidocaine solution (20 parts of Propofol 1% MCT/LCT Fresenius and 1 part of preservative-free 1% lidocaine solution for injection) can be added. Lidocaine should not be used in patients with acute porphyria.
Muscle relaxants, such as atracurium and mivacurium, can be administered through the same infusion line as Propofol 1% MCT/LCT Fresenius, provided that the line is flushed first.