Propofol 2% mct/lct fresenius

Package leaflet: Information for the user

Propofol 2% MCT/LCT Fresenius, 20 mg/ml, emulsion for injection / for infusion
in prefilled syringe
Propofolum
Please read all of this leaflet carefully before using this medicine, because it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

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 anaesthetics.
General anaesthetics are used to induce loss of consciousness (sleep) to allow surgery or other procedures to be performed.
These medicines may also be used to achieve sedation (a state in which the patient is sleepy but not fully unconscious).
Propofol 2% MCT/LCT Fresenius is used for:

• induction and maintenance of general anaesthesia in adults, adolescents, and children over 3 years of age;
• sedation of ventilated patients over 16 years of age requiring intensive medical care;
• sedation of adults, adolescents, and children over 3 years of age during diagnostic and surgical procedures, either as a single agent or in combination with other medicines used to induce local or regional anaesthesia.

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 aged 16 years or younger requiring intensive medical care.

Warnings and precautions
Consult a doctor, pharmacist, or nurse before administering Propofol 2% MCT/LCT Fresenius, and inform them if any of the following conditions apply or have previously applied to the patient.
Propofol 2% MCT/LCT Fresenius should not be used or should be used with special caution and intensive monitoring in patients:

• with advanced heart failure;
• with other severe heart diseases;
• undergoing electroconvulsive therapy (electroconvulsive therapy used in psychiatric treatment).

Propofol 2% MCT/LCT Fresenius should be used with caution in elderly and debilitated patients.
Before administering Propofol 2% MCT/LCT Fresenius, inform the anesthesiologist or intensive care physician if the patient has:

• heart disease;
• lung disease;
• kidney disease;
• liver disease;
• seizures (epilepsy);
• increased intracranial pressure; when combined with low blood pressure, cerebral blood flow may be reduced;
• altered blood lipid levels; if the patient is receiving total parenteral nutrition (nutrition via a vein), blood lipid levels should be monitored;
• significant fluid loss from the body (dehydration).

The following conditions must be treated before administering Propofol 2% MCT/LCT Fresenius:

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

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

• seizures;
• vagal reflex causing slowed heart rate (vagotonia, bradycardia);
• hemodynamic effects on the cardiovascular system (changes in organ perfusion), especially in overweight patients receiving high doses of Propofol 2% MCT/LCT Fresenius.

Involuntary movements may occur during sedation with Propofol 2% MCT/LCT Fresenius. The physician will consider how this may affect the surgical procedure performed under sedation and take necessary precautions.
Very rarely, after anesthesia, a period of postoperative unconsciousness with associated increased muscle tone may occur. The patient should be observed, but no additional treatment is required. Recovery of consciousness occurs spontaneously.
Injection of Propofol 2% MCT/LCT Fresenius may be painful. To reduce pain, a local anesthetic may be used, but its use may cause adverse reactions.
The patient may leave the hospital once full consciousness has been regained.
If the patient is discharged soon after receiving propofol, another person should accompany them.

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

Propofol 2% MCT/LCT Fresenius and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
In particular, inform your attending physician, anesthesiologist, or nurse if the patient is taking any of the following medicines:

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

Exercise particular caution if the patient is taking and/or simultaneously receiving any of the following medicines:

• medicines used for premedication (the anesthesiologist will know which medicines may interact with Propofol 2% MCT/LCT Fresenius);
• other anesthetics, including general, regional, and local anesthetics, and inhalational anesthetics (the anesthesiologist may decide to reduce the dose of Propofol 2% MCT/LCT Fresenius);
• painkillers (analgesics);
• strong painkillers (fentanyl or opioids);
• parasympatholytic medicines (used for painful spasms, asthma, and Parkinson's disease);
• benzodiazepines (sedatives);
• suxamethonium (a muscle relaxant);
• medicines and beverages containing alcohol;
• neostigmine (a medicine used to treat muscle weakness);
• cyclosporine (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 administration of Propofol 2% MCT/LCT Fresenius, the patient should not eat, drink, or consume alcohol until full consciousness has been regained.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Propofol 2% MCT/LCT Fresenius should not be administered to pregnant women unless absolutely necessary. Breastfeeding mothers should discontinue breastfeeding and discard milk for 24 hours after receiving Propofol 2% MCT/LCT Fresenius.

Driving and operating machinery
Drowsiness may occur for some time after receiving propofol. Do not drive or operate machinery until you are certain that the effects of the medicine have completely worn off.
If the patient is discharged soon after receiving propofol, they should not drive or return home unaccompanied.
Ask your doctor when it is safe to 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 the patient is allergic to peanuts or soy, this medicine should not be used.
This medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, meaning the medicine is considered "sodium-free".

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

Propofol 2% MCT/LCT Fresenius will be administered to the patient only in a hospital or on an appropriate therapeutic ward by an anaesthesiologist or a physician specialized in intensive care medicine, or under their direct supervision.
Dosage
The dose administered will depend on the patient's age, body weight, and condition. The physician will administer the appropriate dose to induce and maintain anaesthesia or achieve the required level of sedation, carefully monitoring the patient's responses and vital signs (pulse, blood pressure, respiration, etc.).
It may be necessary to use other medications to achieve calming or complete sleep, relieve pain perception, ensure proper breathing, and maintain stable blood pressure. The physician will decide which medications should be used and when they should be administered to the patient.
Adults
Most patients require 1.5 to 2.5 mg of propofol/kg body weight to induce sleep (induction of anaesthesia), followed by 4 to 12 mg of propofol/kg body weight/hour to maintain anaesthesia. To achieve the required level of sedation, doses of 0.3 to 4.0 mg of propofol/kg body weight/hour are usually sufficient.
To achieve the required level of sedation during surgical and diagnostic procedures in adults, most patients will require an initial dose of 0.5 to 1 mg of propofol/kg body weight administered over 1 to 5 minutes. Maintenance of the required level of sedation can be achieved by appropriately adjusting the infusion rate of Propofol 2% MCT/LCT Fresenius.
Most patients will require an infusion rate of 1.5 to 4.5 mg of propofol/kg body weight/hour. If a rapid increase in the level of sedation is required, the infusion may be supplemented by a bolus injection of propofol at a dose of 10 to 20 mg of propofol (0.5 to 1 ml of Propofol 2% MCT/LCT Fresenius).
For sedation of mechanically ventilated patients aged over 16 years receiving intensive care, the dose should be adjusted according to the required level of sedation. A satisfactory level of sedation is usually achieved with an infusion rate between 0.3 and 4.0 mg of propofol/kg body weight/hour. Infusion of the drug at a rate exceeding 4.0 mg of propofol/kg body weight/hour is not recommended.
Elderly and debilitated patients
Lower doses may be required in elderly and debilitated patients.
Children and adolescents above the age of 3
The use of Propofol 2% MCT/LCT Fresenius is not recommended in children under 3 years of age.
The dose should be adjusted according to age and/or body weight.
In most children above 8 years of age, the dose required for induction of anaesthesia is approximately 2.5 mg/kg body weight of Propofol 2% MCT/LCT Fresenius. In younger children, a higher dose may be required (2.5 to 4 mg/kg body weight).
Doses ranging from 9 to 15 mg/kg body weight/hour usually allow the required level of anaesthesia (maintenance) to be achieved. Higher doses may be required in younger children.
To induce sedation with Propofol 2% MCT/LCT Fresenius during surgical and diagnostic procedures in children above 3 years of age, an initial dose of 1 to 2 mg/kg body weight of propofol is usually required in most patients. Maintenance of the required level of sedation is achieved by appropriately adjusting the infusion rate of Propofol 2% MCT/LCT Fresenius. Most patients will require an infusion rate of 1.5 to 9 mg of propofol/kg body weight/hour.
Propofol 2% MCT/LCT Fresenius must not be used for sedation in intensive care units in children and adolescents under 16 years of age, as the safety of propofol use for this indication has not been confirmed in this age group.
Method of administration
Propofol 2% MCT/LCT Fresenius is intended for intravenous administration, usually into the back of the hand or forearm. The anaesthesiologist may use a needle or cannula (a thin plastic tube).
Propofol 2% MCT/LCT Fresenius may be injected into the vein manually or using an electric pump. The physician will ensure compatibility of the pump with the prefilled syringe.
Propofol 2% MCT/LCT Fresenius is for single use only. Any unused portions of the emulsion must be discarded. The prefilled syringe should be shaken before use. If two layers are visible in the emulsion after shaking, it must not be used.
Use only medication with a uniform consistency and from an undamaged prefilled syringe.
Use of prefilled syringes:
Use only under aseptic conditions. The outer surface of the syringe and plunger are not sterile.

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

Duration of treatment
When Propofol 2% MCT/LCT Fresenius is used for sedation, it must not be administered for longer than 7 days.
Administration of a higher than recommended dose of Propofol 2% MCT/LCT Fresenius
The physician will ensure that the patient receives the appropriate dose of propofol according to the procedure being performed. However, different patients may require different doses. If a patient receives too high a dose of the drug, the anaesthesiologist will initiate appropriate measures to ensure proper cardiac and respiratory function. Therefore, anaesthetic agents are administered exclusively by physicians specialized in anaesthesiology or intensive care medicine.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects occurring during anaesthesia
The adverse effects listed below may occur during anaesthesia (during injection and while the patient is drowsy or fully unconscious). Your doctor will monitor for these effects. If any of these adverse effects occur, your 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 up to 1 in 10 patients):

• slow or fast heartbeat;
• low blood pressure;
• changes in breathing pattern (shallow breathing, apnoea);
• hiccups;
• cough (may also occur during emergence from anaesthesia).

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

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

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

• body tremors, shaking or convulsions (may also occur during emergence from anaesthesia).

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

• severe allergic reaction causing breathing difficulties, skin swelling and redness, hot flushes;
• fluid accumulation in the lungs, causing severe breathing difficulties (may also occur during emergence from anaesthesia);
• change in urine colour (may also occur during emergence from anaesthesia).

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

• involuntary movements;
• severe skin and tissue reactions following accidental extravascular administration;
• prolonged, often painful erection (priapism).

Adverse effects that may occur after emergence from anaesthesia
The following adverse effects may occur after emergence from anaesthesia (during waking up or after the patient has woken up):
Common (may affect up to 1 in 10 patients):

• headache;
• nausea, vomiting;
• cough.

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

• dizziness, chills and feeling cold;
• agitation.

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

• postoperative unconsciousness (in such cases, patients regained consciousness without difficulty);
• pancreatitis, causing severe abdominal pain (causal relationship not established);
• postoperative fever.

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

• euphoria;
• sexual arousal;
• irregular heartbeat;
• changes in ECG recording (corresponding to Brugada syndrome);
• liver enlargement;
• kidney failure;
• muscle damage (rhabdomyolysis), increased blood acidity, high blood potassium levels, high blood lipid levels, heart failure;
• misuse of the medicine, primarily by medical professionals;
• 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 on palpation (indicated as pain under the front part of the rib cage 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 anaesthetic used to reduce injection site pain), the following adverse effects may rarely occur:

• dizziness;
• vomiting;
• drowsiness;
• convulsions;
• slow heartbeat (bradycardia);
• irregular heartbeat (arrhythmia);
• shock.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps 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 prefilled syringe and outer packaging following: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Do not freeze.
After first opening, the medicine should be used immediately.
Administration sets with Propofol 2% MCT/LCT Fresenius should be replaced 12 hours after opening the prefilled syringe.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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 50 ml pre-filled syringe contains 1000 mg of propofol.

• Other ingredients are: purified soybean oil, medium-chain triglycerides, purified egg phospholipids, 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/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 with 50 ml of emulsion.

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

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36, 8055 Graz
Austria

For further information, please contact the representative of the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. +48 22 345 67 89

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

Information intended exclusively for medical professionals:

For single use only. Any unused portions of the emulsion must be discarded.
The pre-filled syringe should be shaken before use.
If two layers are visible in the emulsion after shaking, the product must not be used.
Only use the product if it is homogeneous in appearance and comes from an undamaged pre-filled syringe.
After use, punctured pre-filled syringes must be discarded.
Propofol should be administered only by physicians specialized in anesthesiology (or, if indicated, in intensive care medicine).
Patients must be continuously monitored, and equipment for maintaining airway patency, artificial ventilation, administration of oxygen at increased concentration, and other resuscitation equipment must be immediately available at all times. Propofol must not be administered by the same person who is performing the diagnostic or surgical procedure.
Cases of propofol abuse and dependence have been reported, particularly among medical professionals. As with other general anesthetics, administration of propofol without maintaining respiratory function may lead to respiratory complications resulting in death.
When propofol is used to achieve sedation in conscious patients during surgical and diagnostic procedures, early signs of arterial hypotension, airway obstruction, and desaturation must be continuously monitored.
Propofol 2% MCT/LCT Fresenius must be administered as a continuous infusion in its undiluted form.
Propofol 2% MCT/LCT Fresenius must not be mixed with other injectable solutions or infusions.
Propofol 2% MCT/LCT Fresenius may be administered via the same infusion set as 50 mg/ml (5%) glucose injection solution, 9 mg/ml (0.9%) sodium chloride injection solution, or 1.8 mg/ml (0.18%) sodium chloride injection solution with 40 mg/ml (4%) glucose injection solution.
Other drugs or fluids administered concomitantly with Propofol 2% MCT/LCT Fresenius using the same infusion line should be given close to the cannula insertion site using a Y-connector or a three-way stopcock.
The use of Propofol 2% MCT/LCT Fresenius for general anesthesia is not recommended in children under 3 years of age, as the 20 mg/ml concentration makes it difficult to accurately administer the very small doses required in young children. Consider using Propofol 1% MCT/LCT Fresenius in children between 1 month and 3 years of age when the expected dose is less than, for example, 100 mg/hour.
Propofol 2% MCT/LCT Fresenius is a lipid-containing emulsion without antimicrobial preservatives and may support rapid microbial growth.
The emulsion must be aseptically transferred into a sterile infusion set immediately after opening the pre-filled syringe. Infusion must be started promptly.
Propofol 2% MCT/LCT Fresenius and any infusion equipment containing this medication must be handled under strict aseptic conditions throughout the duration of the infusion. Propofol 2% MCT/LCT Fresenius must not be administered through a microbiological filter.
To control infusion rate, infusion pumps (e.g., burettes, drop counters, syringe pumps, or volumetric infusion pumps) are recommended.
As is generally the case with lipid emulsions, Propofol 2% MCT/LCT Fresenius infusion must not be administered for longer than 12 hours using the same infusion set. Infusion sets for Propofol 2% MCT/LCT Fresenius must be replaced at least every 12 hours.
To reduce 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 must not be used in patients with inherited acute porphyria.
Muscle relaxants such as atracurium and mivacurium may be administered via the same infusion line as Propofol 2% MCT/LCT Fresenius only after the line has been flushed.