Propofol 1% mct/lct fresenius

Package leaflet: Information for the user

Propofol 1% MCT/LCT Fresenius, 10 mg/ml, emulsion for injection / infusion
in prefilled syringe
Propofolum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If any side effects occur in the patient, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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 pack 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 anaesthetics.
General anaesthetics are used to cause loss of consciousness (sleep) to allow surgical procedures or other interventions to be performed. These medicines may also be used to achieve sedation (a state in which the patient is drowsy but not fully asleep).
Propofol 1% MCT/LCT Fresenius is used for:

• induction and maintenance of general anaesthesia in adults, adolescents, and children over 1 month of age;
• sedation of mechanically ventilated patients over 16 years of age requiring intensive care;
• sedation of adults, adolescents, and children over 1 month 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 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 aged 16 years or younger requiring intensive medical care.

Warnings and precautions
Please consult a doctor, pharmacist, or nurse before administering Propofol 1% MCT/LCT Fresenius, and if any of the situations listed below apply or have previously applied to the patient.
Propofol 1% MCT/LCT Fresenius should not be used or should be used only with extreme caution and under intensive monitoring in patients:

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

Propofol 1% MCT/LCT Fresenius should be used with caution in elderly and debilitated patients.
Before administering Propofol 1% MCT/LCT Fresenius, inform the anesthesiologist or physician in the intensive care unit if the patient has:

• heart disease;
• lung disease;
• kidney disease;
• liver disease;
• seizures (epilepsy);
• increased intracranial pressure; in combination with low blood pressure, blood flow to the brain may be reduced;
• altered blood fat levels; if the patient is receiving total parenteral nutrition (nutrition via a vein), blood fat levels should be monitored;
• significant fluid loss (dehydration).

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

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

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

• occurrence of seizures;
• vagal reflex causing slowing of the heart (vagotonia, bradycardia);
• changes in blood flow to the patient's body organs (hemodynamic effects on the cardiovascular system), particularly in overweight patients receiving high doses of Propofol 1% MCT/LCT Fresenius.

During sedation with Propofol 1% MCT/LCT Fresenius, involuntary movements may occur. The physician will consider how this may affect the surgical procedure performed under sedation and take necessary precautions.
Very rarely, after anesthesia, a postoperative period of unconsciousness may occur, accompanied by increased muscle tone. The patient should be observed, but no additional treatment is required. Consciousness returns spontaneously.
Injection of Propofol 1% MCT/LCT Fresenius may be painful. To reduce pain, a local anesthetic may be used, but this 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 1% MCT/LCT Fresenius is not recommended in newborns and children under 1 month of age.
Due to limited data, administration of Propofol 1% MCT/LCT using the TCI (Target Controlled Infusion) system is not recommended in children under 2 years of age.
Propofol 1% 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 has not been established in this age group.

Propofol 1% 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 the 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) and to relieve anxiety symptoms and reduce muscle tension].

Extreme caution is required 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 1% MCT/LCT Fresenius);
• other anesthetics, including general, regional, and local anesthetics, and inhalational anesthetic agents (the anesthesiologist may decide to reduce the dose of Propofol 1% MCT/LCT Fresenius);
• pain-relieving medicines (analgesics);
• strong painkillers (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 internal body functions such as heart rhythm, e.g., atropine;
• medicines and drinks 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 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 fully conscious.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Propofol 1% MCT/LCT Fresenius should not be administered to pregnant women unless absolutely necessary. Breastfeeding mothers should discontinue breastfeeding and discard breast milk collected for 24 hours after receiving Propofol 1% MCT/LCT Fresenius.

Driving and operating machinery
Drowsiness may occur for some time after receiving propofol. Do not drive, operate equipment, or 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 you can resume these activities and return to work.

Propofol 1% MCT/LCT Fresenius contains soy oil and sodium
Propofol 1% MCT/LCT Fresenius contains soy 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, meaning the medicine is considered "sodium-free."

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

Propofol 1% MCT/LCT Fresenius will be administered to the patient exclusively in a hospital or in an appropriate therapeutic unit by an anaesthesiologist or a physician specialized in intensive care medicine, or under their direct supervision.
Dosage
The dose given will depend on the patient's age, body weight, and clinical 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 provide calming effects or complete sleep, relieve pain perception, ensure proper breathing, and maintain stable arterial blood pressure. The physician will decide which medications are required and when they should be administered.
Adults
Most patients require 1.5 to 2.5 mg of propofol/kg body weight to induce anaesthesia (induction), followed by 4 to 12 mg of propofol/kg body weight/hour to maintain anaesthesia (maintenance). For achieving the required level of sedation, doses ranging from 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 adjusting the infusion rate of Propofol 1% 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 (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 treatment, 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 rates exceeding 4.0 mg of propofol/kg body weight/hour are not recommended.
Elderly and debilitated patients
Lower doses may be required in elderly and debilitated patients.
Children and adolescents above 1 month of age
Propofol 1% MCT/LCT Fresenius is not recommended for use in children under 1 month of age.
Particular caution should also be exercised when administering Propofol 1% MCT/LCT Fresenius to children under 3 years of age, although current data do not indicate that its use is less safe than in children over 3 years of age.
The dose should be adjusted according to age and/or body weight. In most children over 8 years of age, the dose required for induction of anaesthesia is approximately 2.5 mg/kg body weight of Propofol 1% MCT/LCT Fresenius. In younger children, particularly those between 1 month and 3 years of age, a higher dose may be required (2.5 to 4 mg/kg body weight).
Doses in the range of 9 to 15 mg/kg body weight/hour generally allow maintenance of the required level of anaesthesia. Higher doses may be required in younger children, especially those between 1 month and 3 years of age.
For sedation with Propofol 1% MCT/LCT Fresenius during surgical and diagnostic procedures in children over 1 month of age, an initial dose of 1 to 2 mg/kg body weight of propofol is usually required in most patients to achieve initial sedation. Maintenance of the required level of sedation is achieved by adjusting the infusion rate of Propofol 1% MCT/LCT Fresenius. Most patients will require an infusion rate of 1.5 to 9 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 up to 1 mg/kg body weight.
Propofol 1% 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 has not been established in this age group.
Method of administration
Propofol 1% 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 1% MCT/LCT Fresenius may be administered manually or by an electric pump. The physician must ensure compatibility between the pump and the prefilled syringe. Glass prefilled syringes of 10 ml and 20 ml and plastic 10 ml prefilled syringes are suitable only for manual injection and must not be used with a pump.
Propofol 1% 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, after shaking, two layers are visible in the emulsion, it must not be used. Use only the preparation with a homogeneous consistency and from an undamaged prefilled syringe.
Use of prefilled syringes (for ready-to-use prefilled syringes, point 2. may be omitted):
Use only under aseptic conditions. The outer surface of the prefilled syringe and the plunger are not sterile.

1. Remove the prefilled syringe from its 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 the infusion line, needle, or cannula to the prefilled syringe. Remove air bubbles (a small bubble may remain), and place the ready-to-use prefilled syringe in the pump or use it manually.

Duration of treatment
When Propofol 1% 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 1% MCT/LCT Fresenius
The physician 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 drug. If a patient receives too high a dose, the anaesthesiologist will initiate appropriate measures to ensure adequate cardiac and respiratory function. Therefore, anaesthetic agents are administered exclusively by physicians specialized in anaesthesiology or intensive care medicine.
If you have any further questions regarding the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions occurring during anaesthesia
The adverse reactions listed below may occur during anaesthesia (during injection and when the patient is drowsy or fully unconscious). The doctor will monitor for these. If such adverse reactions 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 heartbeat;
• low blood pressure;
• changes in breathing pattern (shallow breathing, apnoea);
• hiccups;
• coughing (may also occur during emergence from anaesthesia).

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

• swelling and redness along the vein used for administration or blood clots.

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

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

Very rare (may affect less than 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 reactions that may occur after emergence from anaesthesia
The following adverse reactions may occur after emergence from anaesthesia (during waking up or when the patient is already awake):
Common (may affect less than 1 in 10 patients):

• headache;
• nausea, vomiting;
• coughing.

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 regained consciousness without problems);
• 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;
• drug abuse, primarily by medical personnel;
• prolonged, often painful erection (priapism);
• hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain and liver tenderness (indicated as pain under the front part of the rib cage 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 anaesthetic used to reduce injection site pain), the following adverse reactions may rarely occur:
• dizziness;
• vomiting;
• drowsiness;
• convulsions;
• slow heartbeat (bradycardia);
• irregular heartbeat (arrhythmia);
• shock.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the 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-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 containing undiluted Propofol 1% MCT/LCT Fresenius must be replaced 12 hours after opening the ampoule-syringe.
Dilutions of 50 mg/ml (5%) glucose injection solution or 9 mg/ml (0.9%) sodium chloride injection solution or admixture of 10 mg/ml (1%) lidocaine injection solution without preservatives (at least 2 mg propofol per ml) must be prepared under aseptic conditions (controlled and validated) immediately before administration and administered within 6 hours after preparation.
Medicines must not be disposed of via wastewater or household waste. Ask your 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 ml of emulsion contains 10 mg of propofol.
Each 10 ml ampoule-syringe contains 100 mg of propofol.
Each 20 ml ampoule-syringe contains 200 mg of propofol.
Each 50 ml ampoule-syringe contains 500 mg of propofol.

• Other components 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 oil-in-water emulsion for injection/infusion in an ampoule-syringe.
Propofol 1% MCT/LCT Fresenius is available in plastic and glass ampoule-syringes.
Pack sizes:
Pack containing 5 glass ampoule-syringes with 10 ml emulsion each, in a cardboard box.
Pack containing 6 plastic ampoule-syringes with 10 ml emulsion each, in a cardboard box.
Pack containing 5 glass ampoule-syringes with 20 ml emulsion each, in a cardboard box.
Pack containing 1 plastic ampoule-syringe with 50 ml emulsion, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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 Marketing Authorisation Holder's representative:
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 European Economic Area countries under the following names:

Information intended exclusively for medical professionals:

Propofol 1% MCT/LCT Fresenius must not be mixed prior to administration with injection or infusion solutions except with 50 mg/ml (5%) glucose injection solution, 9 mg/ml (0.9%) sodium chloride injection solution, or 10 mg/ml (1%) preservative-free lidocaine injection solution. The final concentration of propofol must not be less than 2 mg/ml.
For single use only. Any unused portions of the emulsion must be discarded.
The ampoule-syringe must be shaken before use.
If, after shaking, two layers are visible in the emulsion, the product must not be used.
Only use the product if it has a homogeneous appearance and the ampoule-syringe is undamaged.
After use, punctured ampoule-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 abuse and dependence on propofol, particularly among medical professionals, have been reported. As with other general anesthetic agents, 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 undergoing surgical or diagnostic procedures, early signs of arterial hypotension, airway obstruction, and desaturation must be continuously monitored.
Propofol 1% MCT/LCT Fresenius may be administered by infusion either undiluted or diluted with 50 mg/ml (5%) glucose injection solution or 9 mg/ml (0.9%) sodium chloride injection solution.
Propofol 1% MCT/LCT Fresenius must not be mixed with any other injection or infusion solutions than those listed above.
Propofol 1% MCT/LCT Fresenius may be administered through 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 simultaneously with Propofol 1% MCT/LCT Fresenius using the same infusion line should be given close to the cannula insertion site using a Y-connector or three-way stopcock.
Propofol 1% MCT/LCT Fresenius is a lipid emulsion containing no antibacterial preservatives and may support rapid microbial growth.
The emulsion must be aseptically transferred into a sterile infusion set immediately after opening the ampoule-syringe. Administration should be started promptly.
Propofol 1% MCT/LCT Fresenius and all infusion equipment containing this drug must be handled under aseptic conditions throughout the duration of the infusion. Propofol 1% MCT/LCT Fresenius must not be administered through a microbiological filter.

Infusion of undiluted Propofol 1% MCT/LCT Fresenius
When Propofol 1% MCT/LCT Fresenius is administered by undiluted infusion, burettes, drip counters, syringe pumps, or volumetric infusion pumps are recommended to control the infusion rate.
As is generally the case with lipid emulsions, infusion of Propofol 1% MCT/LCT Fresenius must not be continued for longer than 12 hours using a single infusion set. Infusion sets for Propofol 1% MCT/LCT Fresenius must be replaced at least every 12 hours.

Infusion of diluted Propofol 1% MCT/LCT Fresenius
For infusion of diluted Propofol 1% MCT/LCT Fresenius, burettes, drip counters, or volumetric infusion pumps must always be used to control the infusion rate. The maximum dilution must not exceed 1 part of Propofol 1% MCT/LCT Fresenius to 4 parts of 50 mg/ml (5%) glucose injection solution or 9 mg/ml (0.9%) sodium chloride injection solution (minimum concentration 2 mg propofol per ml). The diluted solution must be prepared aseptically (under controlled and validated conditions) immediately before administration and must be administered within 6 hours of preparation.

To alleviate injection site pain, Propofol 1% MCT/LCT Fresenius may be administered into a larger vein and/or lidocaine may be injected immediately before propofol administration. Alternatively, lidocaine solution may be added (20 parts of Propofol 1% MCT/LCT Fresenius and 1 part of preservative-free 1% lidocaine injection solution). Lidocaine must not be used in patients with inherited acute porphyria.
Neuromuscular blocking agents such as atracurium and mivacurium may be administered through the same infusion line as Propofol 1% MCT/LCT Fresenius only after the line has been previously flushed.