Propofol 2% Mct/lct Fresenius

Package Leaflet: Information for the User

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

In a pre-filled syringe
Propofolum

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, talk to your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

• 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 of calm or sleepiness) in patients.

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 produce 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, soybeans, 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 or have applied to the patient in the past.
Propofol 2% 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;
• 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 the anesthesiologist or intensive care doctor if the patient has:

• heart disease;
• lung disease;
• kidney disease;
• liver disease;
• seizures (epilepsy);
• increased pressure inside the skull (increased intracranial pressure), 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 (through a vein), the fat levels in the blood should be monitored;
• severe loss of body water (dehydration).

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

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

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, the patient may experience involuntary movements.
The doctor will consider how this may affect the surgical procedure being performed under sedation and take necessary precautions.
Very rarely, after anesthesia, a post-operative loss of consciousness may occur, with increased muscle tension.
The patient should be monitored, but this does not require additional treatment.
Recovery from anesthesia 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 or have recently taken, and any medicines you plan to take.
In particular, tell your doctor if you are taking any of the following medicines:

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

Special caution is required if you are taking or are given any of the following medicines:

• medicines used in premedication (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 (pain-relieving medicines);
• strong analgesics (fentanyl or opioids);
• parasympatholytic medicines (used for painful spasms, asthma, and Parkinson's disease);
• benzodiazepines (sedative medicines);
• suxamethonium (a muscle relaxant);
• medicines that may 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 are planning to have a baby, 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 or operate machinery or machines until you are sure that the effects of the medicine have 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 soybeans, do 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 2% MCT/LCT Fresenius

Propofol 2% MCT/LCT Fresenius will be given to you by a doctor or nurse in a hospital or clinic setting.
It will be given by injection into a vein, usually on the back of the hand or forearm.

Dosage

The dose will depend on your age, weight, and condition.
Your doctor will give you the right dose to produce the desired level of anesthesia or sedation, carefully watching your reactions and vital signs (pulse, blood pressure, breathing, etc.).
Other medicines may be given to produce relaxation, sleep, pain relief, ensure proper breathing, and maintain blood pressure at a stable level.
Your doctor will decide which medicines to give 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 4 to 12 mg per kilogram of body weight to maintain anesthesia (maintenance of anesthesia).
To produce the desired level of sedation, doses of 0.3 to 4.0 mg per kilogram of body weight per hour are usually sufficient.
To produce the desired level of sedation during surgical and diagnostic procedures in adults, most patients require a dose of 0.5 to 1 mg per kilogram of body weight over 1 to 5 minutes.
Maintenance of the desired 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 per kilogram of body weight per hour.
If rapid increase in sedation is necessary, the infusion can be supplemented by giving a bolus dose of propofol at 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 should be adjusted to produce the desired level of sedation.
A satisfactory level of sedation is usually achieved with an infusion rate of 0.3 to 4.0 mg per kilogram of body weight per hour.
It is not recommended to use the medicine at an infusion rate greater than 4.0 mg per kilogram of body weight per hour.

Elderly and weak patients

Lower doses may be required in elderly and weak patients.

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 body weight.
Most children over 8 years of age require a dose of about 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 produce the desired level of anesthesia (maintenance of anesthesia).
Younger children may require a higher dose.
To produce 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 desired 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 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 for intravenous injection, usually into a vein on the back of the hand or forearm.
The doctor or nurse may use a needle or cannula (a thin plastic tube).
Propofol 2% MCT/LCT Fresenius will be injected into the vein manually or using an electric pump.
The doctor will ensure the pump is compatible with the pre-filled syringe.
Propofol 2% MCT/LCT Fresenius is for single use only.
Any unused emulsion should be discarded.
The pre-filled syringe should be shaken before use.
If the emulsion is separated into two layers after shaking, it should not be used.
Only use the medicine if it is of uniform consistency and the pre-filled syringe is undamaged.

• 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 any air bubbles (a small bubble may remain) and place the pre-filled syringe in the pump or use it manually.

Duration of treatment

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

Overdose of Propofol 2% MCT/LCT Fresenius

Your doctor will ensure you receive the right 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 the necessary actions to ensure your heart and lungs are working properly.
This is why anesthetics are only given by doctors who are specialized in anesthesiology or intensive care.

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 asleep or unconscious).
Your doctor will be aware of these.
If these side effects occur, your doctor will give you the necessary 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;
• changes in breathing (low breathing rate, breathing stop);
• hiccups;
• coughing (may also occur when waking up from anesthesia).

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

• swelling and redness along the vein where the medicine was given or blood clots.

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

• shaking or trembling of the body or seizures (may also occur when waking up from anesthesia).

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

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

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

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

Side effects that may occur after waking up from anesthesia

The following side effects may occur after waking up from anesthesia (while the patient is waking up or when they are already awake):

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

• headache;
• nausea, vomiting;
• coughing.

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):

• post-operative loss of consciousness (in these cases, patients recovered consciousness without problems);
• pancreatitis, which causes severe abdominal pain (no causal relationship has been established);
• post-operative 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 staff;
• 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 2% MCT/LCT Fresenius is given 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, talk to your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, 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.
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 the medicine out of the sight and reach of children.
Do not use Propofol 2% MCT/LCT Fresenius 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.
Use immediately after opening.
Infusion sets with Propofol 2% MCT/LCT Fresenius should be replaced 12 hours after opening the pre-filled syringe.
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 ml of emulsion contains 20 mg of propofol.
Each pre-filled syringe of 50 ml contains 1000 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 2% MCT/LCT Fresenius looks like and contents of the pack

Propofol 2% MCT/LCT Fresenius is a white emulsion for injection/infusion in a pre-filled syringe.
Propofol 2% MCT/LCT Fresenius is available in plastic pre-filled syringes.
Pack sizes:
The pack contains 1 pre-filled syringe of 50 ml emulsion.

Marketing authorization holder

Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H.
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstraße 36, 8055 Graz
Austria
For more detailed information, please 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:08.08.2024
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Information intended for healthcare professionals only:

For single use only.
Any unused emulsion should be discarded.
The pre-filled syringe should be shaken before use.
If the emulsion is separated into two layers after shaking, it should not be used.
Only use the medicine if it is of 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 who are specialized in anesthesiology (or, if necessary, doctors who are specialized in intensive care).
Patients should be continuously monitored and should always have access to equipment to maintain airway patency, artificial ventilation, oxygen supply, and other resuscitation equipment.
Propofol should not be administered by the same person who is performing the diagnostic or surgical procedure.
There have been reports of abuse of and dependence on propofol, particularly in medical staff.
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 produce sedation in awake patients during surgical and diagnostic procedures, the patient should be constantly monitored for early signs of hypotension, airway obstruction, and desaturation.
Propofol 2% MCT/LCT Fresenius should be used in continuous infusion undiluted.
Propofol 2% MCT/LCT Fresenius should not be mixed with other solutions for injection or infusion.
Propofol 2% MCT/LCT Fresenius can be used in 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 2% MCT/LCT Fresenius using the same infusion line should be given close to the injection site using a Y-connector or a three-way tap.
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 very small amounts of medicine required.
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 support the rapid growth of microorganisms.
The emulsion should be drawn up into a sterile infusion set immediately after opening the pre-filled syringe.
Infusion should be started immediately.
Propofol 2% MCT/LCT Fresenius and any infusion equipment containing this medicine should be used with aseptic precautions throughout the infusion period.
Propofol 2% MCT/LCT Fresenius should not be administered through a microbiological filter.
Burettes, drop counters, syringe pumps, or volumetric infusion pumps are recommended to control the infusion rate.
As with other fat emulsions, infusion of Propofol 2% MCT/LCT Fresenius should not be continued for more than 12 hours using 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 should be administered into a larger vein and/or lidocaine should be injected immediately before 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.