Propofol 1% mct/lct fresenius

Package leaflet: Information for the user

Propofol 1% MCT/LCT Fresenius, 10 mg/ml, emulsion for injection / for infusion
Propofolum
Please read all of this leaflet before use, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any 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 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 drowsy but not fully unconscious).
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 medical 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
Consult a doctor, pharmacist, or nurse before administering Propofol 1% MCT/LCT Fresenius, and inform them if any of the following conditions apply or have applied to the patient in the past.
Propofol 1% MCT/LCT Fresenius should not be used or should only be used with special 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 intensive care physician if the patient has:

• heart disease;
• lung disease;
• kidney disease;
• liver disease;
• seizures (epilepsy);
• increased intracranial pressure (increased intracranial pressure); when combined with low blood pressure, blood flow to the brain may be reduced;
• altered blood lipid levels; if the patient is fully parenterally fed (nutrition via a vein), blood lipid levels should be monitored;
• significant fluid loss (dehydration).

The following conditions must be treated prior to administration of Propofol 1% MCT/LCT Fresenius:

• 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:

• seizures;
• vagal reflex causing slowed heart rate (vagotonia, bradycardia);
• changes in organ perfusion (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, postoperative unconsciousness with associated increased muscle tone may occur after anesthesia. The patient should be monitored, but no additional treatment is required. Recovery occurs 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 effects.
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 Fresenius using a TCI system (Target Controlled Infusion) 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 safety has not been established for this indication in this age group.

Propofol 1% MCT/LCT Fresenius and other medicines
Inform the 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], relieve anxiety, and reduce muscle tension).

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

• 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 inhaled anesthetic agents (the anesthesiologist may decide to reduce the dose of Propofol 1% MCT/LCT Fresenius);
• painkillers (analgesics);
• strong painkillers (fentanyl or opioids);
• parasympatholytic agents (used for painful spasms, asthma, and Parkinson's disease);
• benzodiazepines (sedatives);
• 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, 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 plans 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 nursing and discard expressed milk for 24 hours after receiving Propofol 1% MCT/LCT Fresenius.

Driving and using machines
Drowsiness may occur for some time after receiving propofol. Do not drive, operate machinery, or perform tasks requiring alertness until 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 the doctor when it is safe to 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, this medicine should not be used.
This medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, meaning it is considered "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 on an appropriate therapeutic ward by an anaesthesiologist or a physician specialized in intensive medical care, 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 arterial blood pressure. The physician will decide which medications should be used and when to administer them to the patient.
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, a dose of 0.5 to 1 mg of propofol/kg body weight administered over 1 to 5 minutes is typically required in most patients. The required level of sedation can be maintained by adjusting the infusion rate of Propofol 1% MCT/LCT Fresenius appropriately. In most patients, a rate of 1.5 to 4.5 mg of propofol/kg body weight/hour will be required.
If a rapid increase in the level of sedation is needed, the infusion may be supplemented by bolus administration 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 medical care, the drug dosage should be adjusted according to the required level of sedation. A satisfactory level of sedation is usually achieved by administering at a rate of 0.3 to 4.0 mg of propofol/kg body weight/hour. Administration by infusion 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 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 usually allow achieving the required level of anaesthesia (maintenance). In younger children, particularly those between 1 month and 3 years of age, a higher dose may be required.
To achieve 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 typically required in most patients. The required level of sedation is maintained by adjusting the infusion rate of Propofol 1% MCT/LCT Fresenius appropriately. In most patients, a rate of 1.5 to 9 mg of propofol/kg body weight/hour is required. If a rapid increase in the level of sedation is necessary, the infusion may be supplemented by bolus administration 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 will be injected into the vein either manually or using an electric pump.
Propofol 1% MCT/LCT Fresenius is for single use only. Any unused portions of the emulsion must be discarded. The container should be shaken before use.
If two layers are visible in the emulsion after shaking, it must not be used. Only use the product if it has a uniform consistency and is from an undamaged container.
Before use, the rubber stopper should be cleaned with alcohol spray or an alcohol-impregnated swab.
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 drugs are administered exclusively by physicians specialized in anaesthesiology or intensive medical care.
If you have any further questions regarding the use of this medicine, 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 following adverse reactions 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 heart rate;
• Low blood pressure;
• Changes in breathing pattern (reduced respiratory rate, apnoea);
• Hiccups;
• Coughing (may also occur during emergence from anaesthesia).

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

• Swelling, redness along the vein used for administration, or blood clots.

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

• Tremors, body jerks, 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 extravasation (injection outside the vein);
• 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 awakening or once the patient is 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, chills, and feeling cold;
• Agitation.

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

• Postoperative unconsciousness (in such cases, patients returned to consciousness without complications);
• 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 (corresponding to Brugada syndrome);
• Liver enlargement;
• Kidney failure;
• Muscle damage (rhabdomyolysis), increased blood acidity, high potassium levels in blood, high blood lipid levels, heart failure;
• Misuse of the medicine, primarily by healthcare 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 (felt as pain under the front of the ribcage 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 heart rate (bradycardia);
• Irregular heartbeat (arrhythmia);
• Shock.

Reporting of adverse reactions
If any adverse reactions occur, including those 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
Phone: +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 provide 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 specified 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 or vial.
Dilutions of 50 mg/ml (5%) with glucose injection solution or 9 mg/ml (0.9%) sodium chloride injection solution or addition of 10 mg/ml (1%) lidocaine injection solution without preservatives (at least 2 mg of 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. Such measures 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 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 yolk 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 or infusion.
Propofol 1% MCT/LCT Fresenius is available in colourless glass ampoules or vials.
The glass vials are sealed 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 Authorisation 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

For further information, contact the local 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:

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.
Shake the container before use.
If, after shaking, two layers are visible in the emulsion, the product must not be used.
Use only the product with homogeneous consistency and from undamaged packaging.
Before use, clean the ampoule neck or rubber stopper with alcohol in aerosol form or with an alcohol-impregnated swab. After use, punctured containers must be discarded.
Propofol should be administered only by physicians specialized in anesthesiology (or, when appropriate, in intensive care medicine).
Patients must be continuously monitored, and equipment for maintaining airway patency, artificial ventilation, administration of oxygen with increased concentration, and other resuscitation equipment must be immediately available at all times. Propofol must not be administered by the same person performing the diagnostic or surgical procedure.
Cases of misuse and dependence on propofol have been reported, particularly among medical professionals. 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 during surgical and diagnostic procedures, early signs of arterial hypotension, airway obstruction, and desaturation must be continuously monitored.
Propofol 1% MCT/LCT Fresenius may be administered as an infusion in undiluted form 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 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 medications or fluids administered simultaneously with Propofol 1% MCT/LCT Fresenius using the same infusion line should be administered close to the cannula insertion site using a Y-connector or three-way stopcock.
Propofol 1% MCT/LCT Fresenius is a lipid emulsion without antibacterial preservatives and may support rapid microbial growth.
The emulsion must be aseptically drawn into a sterile syringe and infusion set immediately after opening the ampoule or piercing the vial stopper. Infusion must be started immediately.
Propofol 1% MCT/LCT Fresenius and any infusion equipment containing this medication must be handled under aseptic conditions throughout the entire infusion period. 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 as an undiluted infusion, burettes, drop 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, drop counters, or volumetric infusion pumps must always be used to control the infusion rate. 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 reduce injection site pain, Propofol 1% MCT/LCT Fresenius may be administered into a larger vein and/or lidocaine may be injected immediately before 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.

Muscle relaxants 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 flushed.