PROPOFOL 10 mg /Ml Emulsion

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Propofol 1% MCT/LCT Fresenius, 10 mg/ml, Emulsion for Injection/Infusion
   1. Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What is Propofol 1% MCT/LCT Fresenius and what is it used for
   1. Propofol 1% MCT/LCT Fresenius is used for:
4. Important information before using Propofol 1% MCT/LCT Fresenius
   1. When not to use Propofol 1% MCT/LCT Fresenius:
   2. Warnings and precautions
   3. Children and Adolescents
   4. Propofol 1% MCT/LCT Fresenius and other medicines
   5. Propofol 1% MCT/LCT Fresenius with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Propofol 1% MCT/LCT Fresenius contains soybean oil and sodium
5. How to use Propofol 1% MCT/LCT Fresenius
   1. Dosage
   2. Adults
   3. Elderly and debilitated patients
   4. Children and adolescents over 1 month of age
   5. Method of administration
   6. Duration of treatment
   7. Overdose of Propofol 1% MCT/LCT Fresenius
6. Possible side effects
   1. Side effects during anesthesia
   2. Very common (may affect more than 1 in 10 people):
   3. Common (may affect up to 1 in 10 people):
   4. Uncommon (may affect up to 1 in 100 people):
   5. Rare (may affect up to 1 in 1,000 people):
   6. Very rare (may affect up to 1 in 10,000 people):
   7. Frequency not known (frequency cannot be estimated from the available data):
   8. Side effects that may occur after recovery from anesthesia
   9. Common (may affect up to 1 in 10 people):
   10. Rare (may affect up to 1 in 1,000 people):
   11. Very rare (may affect up to 1 in 10,000 people):
   12. Frequency not known (frequency cannot be estimated from the available data):
   13. Reporting side effects
7. How to store Propofol 1% MCT/LCT Fresenius
8. Contents of the pack and other information
   1. What Propofol 1% MCT/LCT Fresenius contains
   2. What Propofol 1% MCT/LCT Fresenius looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Information intended for healthcare professionals only:

Package Leaflet: Information for the User

Propofol 1% MCT/LCT Fresenius, 10 mg/ml, Emulsion for Injection/Infusion

Propofol

Read the Package Leaflet Carefully Before Using the Medication, 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, including any not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Propofol 1% MCT/LCT Fresenius and what is it 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 pack and other information

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

Propofol 1% 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 of calm, sleepiness, or drowsiness).

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 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 agents used to produce local or regional anesthesia.

2. Important information before using Propofol 1% MCT/LCT Fresenius

When not to use Propofol 1% MCT/LCT Fresenius:

• for sedation of patients under 16 years of age who require intensive care.

Warnings and precautions

Before using Propofol 1% MCT/LCT Fresenius, the patient should inform their doctor, pharmacist, or nurse about any of the following conditions that apply to them or have applied in the past.
Propofol 1% MCT/LCT Fresenius should not be used or should be used with caution and close monitoring in patients with:

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

In elderly and debilitated patients, Propofol 1% MCT/LCT Fresenius should be used with caution.
Before using Propofol 1% MCT/LCT Fresenius, the patient should inform the anesthesiologist or intensive care doctor if they have:

• heart disease;
• lung disease;
• kidney disease;
• liver disease;
• seizures (epilepsy);
• increased intracranial pressure (increased pressure inside the skull), combined with decreased blood pressure, which may lead to decreased blood flow to the brain;
• altered blood fat levels, if the patient is receiving total parenteral nutrition (nutrition through a vein), blood fat levels should be monitored;
• severe fluid loss (dehydration).

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

• heart failure;
• insufficient tissue perfusion (circulatory failure);
• severe respiratory difficulties (respiratory failure);
• dehydration (hypovolemia);
• seizures (epilepsy).

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

• seizures;
• nerve reflex slowing heart rate (vagotonia, bradycardia);
• changes in blood flow to organs (hemodynamic effects on the cardiovascular system), if the patient is overweight and receives high 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 take necessary precautions.
Very rarely, after anesthesia, a postoperative loss of consciousness may occur, accompanied by 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 can be discharged from the hospital if they have fully recovered consciousness.
If the patient is to return home soon after receiving 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 Fresenius 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 and age group has not been established.

Propofol 1% MCT/LCT Fresenius and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor about the following medicines:

• rifampicin (a medicine used to treat tuberculosis);
• midazolam (a medicine used to produce sedation and relieve anxiety).

Special caution is required if the patient is taking 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 inhalational 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 to treat 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 myasthenia gravis);
• 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 receiving Propofol 1% MCT/LCT Fresenius, the patient should not eat, drink, or consume alcohol until they have fully recovered consciousness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 receiving propofol, drowsiness may occur.
The patient should not drive, operate machinery, or use tools until they are sure that the effects of the medicine have worn off.
If the patient is to return home soon after receiving propofol, they should not drive or return home unaccompanied.
The patient should ask their doctor when they 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 the patient is allergic to peanuts or soy, they should not use this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, which means it is essentially "sodium-free".

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

Propofol 1% MCT/LCT Fresenius will be administered to the patient only in a hospital or a suitable therapeutic unit by an anesthesiologist or a doctor specialized 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 achieve the required level of sedation, carefully monitoring the patient's reactions and vital signs (pulse, blood pressure, breathing, etc.).
Other medicines may be used to produce relaxation, deep sleep, pain relief, ensure proper breathing, and maintain stable blood pressure.
The doctor will decide which medicines to use and when to administer them.

Adults

Most patients require 1.5 to 2.5 mg of propofol per kilogram of body weight to induce anesthesia (induction of anesthesia), and 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 1% MCT/LCT Fresenius.
Most patients require 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 with a bolus 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 in intensive care, the dose of Propofol 1% MCT/LCT Fresenius 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.
Doses greater than 4.0 mg of propofol per kilogram of body weight per hour are not recommended.

Elderly and debilitated patients

Lower doses may be required in elderly and debilitated patients.

Children and adolescents over 1 month of age

Propofol 1% MCT/LCT Fresenius should not be used in children under 1 month of age.
Caution is also required when administering Propofol 1% MCT/LCT Fresenius to children under 3 years of age, although 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 age and/or weight.
In most children over 8 years of age, the dose required to induce anesthesia is approximately 2.5 mg of propofol 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 to be achieved (maintenance of anesthesia).
In younger children, particularly those between 1 month and 3 years of age, a higher dose may be required.
To produce 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.
Maintenance of 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 rapid increase in sedation level is necessary, the infusion can be supplemented with a bolus 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 and age group has not been established.

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 manually or using an electric pump.
Propofol 1% MCT/LCT Fresenius is for single use only.
Any unused emulsion should be discarded.
The packaging should be shaken before use.
If, after shaking, the emulsion shows two distinct layers, it should not be used.
Only use the medicine if it has a uniform consistency and the packaging is intact.
Before use, the rubber membrane should be cleaned with alcohol spray or an alcohol swab.

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.
This is why anesthetics are only administered by doctors specialized in anesthesiology or intensive care medicine.
In case of any further questions about the use of this medicine, the patient should consult their 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 sleepy or fully unconscious), the following side effects may occur.
The doctor will monitor these side effects and provide appropriate treatment if they occur.

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;
• changes in breathing (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 where the medicine was administered or blood clots.

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

• shaking or tremors 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, flushing;
• 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 or after the patient has regained consciousness):

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 these 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 blood acidity, 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 by pain in the upper right abdomen), 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 side effects occur, including any not listed in this package leaflet, the patient should inform their 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
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 this medicine.

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

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule/vial 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.
After first opening, the medicine should be used immediately.
Administration sets with undiluted Propofol 1% MCT/LCT Fresenius should be replaced 12 hours after opening the ampoule or vial.
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 infused within 6 hours of preparation.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What Propofol 1% MCT/LCT Fresenius contains

• The active substance is propofol.

Each milliliter of emulsion contains 10 mg of propofol.
Each 20 ml ampoule contains 200 mg of propofol.
Each 20 ml vial contains 200 mg of propofol.
Each 50 ml vial contains 500 mg of propofol.
Each 100 ml vial contains 1000 mg of propofol.

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

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

Propofol 1% MCT/LCT Fresenius is a white emulsion for injection or infusion.
Propofol 1% MCT/LCT Fresenius is available in colorless glass ampoules or vials.
The glass vials are closed with rubber stoppers.
Pack sizes:
5 glass ampoules containing 20 ml of emulsion each.
1 glass vial containing 50 or 100 ml of emulsion.
5 glass vials containing 20 ml of emulsion each.
10 glass ampoules containing 20 ml of emulsion each.
10 glass vials containing 50 or 100 ml of emulsion each.
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, the patient 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 package leaflet:17.01.2025
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Information intended for healthcare professionals only:

Propofol 1% MCT/LCT Fresenius should not be mixed with other solutions for injection or infusion before administration, 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 packaging should be shaken before use.
If, after shaking, the emulsion shows two distinct layers, it should not be used.
Only use the medicine if it has a uniform consistency and the packaging is intact.
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 specialized in anesthesiology (or, if necessary, doctors specialized in intensive care medicine).
Patients should be continuously monitored and have access to equipment to maintain airway patency, artificial ventilation, oxygen supply, 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 of and dependence on propofol, particularly in medical personnel.
As with other general anesthetics, the use of propofol without maintaining respiratory function may lead to respiratory complications resulting in death.
When propofol is used for sedation in conscious patients during surgical and diagnostic procedures, the doctor should constantly monitor for early signs of hypotension, airway obstruction, and desaturation.
Propofol 1% MCT/LCT Fresenius can be administered 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 except 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 given close to the infusion site using a Y-connector or a three-way tap.
Propofol 1% MCT/LCT Fresenius is an emulsion containing fats without antibacterial preservatives and may support the rapid growth of microorganisms.
The emulsion should be drawn into a sterile syringe or infusion set under aseptic conditions (controlled and validated) immediately after opening the ampoule or vial.
Administration should be started immediately.
Propofol 1% MCT/LCT Fresenius and any infusion equipment containing this medicine should be used under aseptic conditions 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 undiluted, it is recommended to use burettes, drop counters, syringe pumps, or volumetric infusion pumps to control the infusion rate.
As with other fat emulsions, infusion of Propofol 1% MCT/LCT Fresenius should not be administered for more than 12 hours through the same infusion set.
Infusion sets for Propofol 1% MCT/LCT Fresenius should be replaced at least every 12 hours.
Infusion of diluted Propofol 1% MCT/LCT Fresenius:
To administer diluted Propofol 1% MCT/LCT Fresenius, burettes, 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 infused 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 before 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 hereditary acute porphyria.
Muscle relaxants like atracurium and mivacurium can be administered through the same infusion line as Propofol 1% MCT/LCT Fresenius, but only after the line has been flushed.