PROPOFOL 10 mg /Ml Emulsion

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
2. What Propofol 1% Fresenius is and what it is used for
   1. Propofol 1% Fresenius is used for:
3. Important information before using Propofol 1% Fresenius
   1. When not to use Propofol 1% Fresenius
   2. Warnings and precautions
   3. Children and adolescents
   4. Propofol 1% Fresenius with other medicines
   5. Propofol 1% Fresenius with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Propofol 1% Fresenius contains soybean oil and sodium
4. How to use Propofol 1% Fresenius
   1. Dosage
   2. Adult patients
   3. Elderly and debilitated patients
   4. Children and adolescents over 1 month of age
   5. Method of administration
   6. Duration of treatment
   7. Using a higher dose of Propofol 1% Fresenius than recommended
5. Possible side effects
   1. Side effects during anesthesia
   2. Very common (may affect more than 1 in 10 people):
   3. Common (may affect less than 1 in 10 people):
   4. Uncommon (may affect less than 1 in 100 people):
   5. Rare (may affect less than 1 in 1,000 people):
   6. Very rare (may affect less than 1 in 10,000 people):
   7. Frequency not known (cannot be estimated from the available data):
   8. Side effects that may occur after awakening from anesthesia
   9. Common (may affect less than 1 in 10 people):
   10. Rare (may affect less than 1 in 1,000 people):
   11. Very rare (may affect less than 1 in 10,000 people):
   12. Frequency not known (cannot be estimated from the available data):
   13. Reporting side effects
6. How to store Propofol 1% Fresenius
7. Contents of the pack and other information
   1. What Propofol 1% Fresenius contains
   2. What Propofol 1% Fresenius looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:
   6. Information intended for healthcare professionals only:

Package Leaflet: Information for the User

PROPOFOL 1% FRESENIUS, 10 mg/ml, emulsion for injection or infusion

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, tell the doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What Propofol 1% Fresenius is and what it is used for
• 2. Important information before using Propofol 1% Fresenius
• 3. How to use Propofol 1% Fresenius
• 4. Possible side effects
• 5. How to store Propofol 1% Fresenius
• 6. Contents of the pack and other information

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

Propofol 1% Fresenius belongs to a group of medicines called general anesthetics. General anesthetics are used to induce unconsciousness (sleep) to enable surgery or other procedures to be performed. These medicines can also be used to induce sedation (a state in which the patient is drowsy but not completely asleep).

Propofol 1% Fresenius is used for:

• induction and maintenance of general anesthesia in adult patients, adolescents, and children over 1 month of age;
• sedation of patients over 16 years of age who are mechanically ventilated and require intensive medical care;
• sedation of adult patients, adolescents, and children over 1 month of age during diagnostic and surgical procedures, as a single agent or in combination with other medicines used to induce local or regional anesthesia.

2. Important information before using Propofol 1% Fresenius

When not to use Propofol 1% Fresenius

• if the patient is allergic (hypersensitive) to propofol or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic (hypersensitive) to soy or peanuts (see "Propofol 1% Fresenius contains soybean oil and sodium" at the end of section 2 of the leaflet);
• for sedation of patients under 16 years of age who require intensive medical care.

Warnings and precautions

Consult a doctor, pharmacist, or nurse before using Propofol 1% Fresenius, and if any of the following conditions apply or have applied to the patient in the past.

Propofol 1% Fresenius should not be used or should be used with caution and with close monitoring in patients:

• with advanced heart failure;
• with other severe heart diseases;
• being treated with electroshock therapy (electroconvulsive therapy, used in psychiatric treatment).

In elderly and debilitated patients, Propofol 1% Fresenius should be used with caution.

Before using Propofol 1% Fresenius, tell the anesthesiologist or intensive care doctor if the patient has:

• heart disease;
• lung disease;
• kidney disease;
• liver disease;
• seizures (epilepsy);
• increased intracranial pressure (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), blood fat levels should be monitored;
• significant water loss from the body (dehydration).

Before administering Propofol 1% 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% Fresenius may increase the risk of:

• seizures;
• nerve reflex slowing heart rate (vagotonia, bradycardia);
• changes in blood flow to the patient's organs (hemodynamic effects on the cardiovascular system), if the patient is overweight and has received large doses of Propofol 1% Fresenius.

During sedation with Propofol 1% 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.

Rarely, after general anesthesia, a postoperative loss of consciousness may occur, accompanied by increased muscle tension. The patient should be monitored, but no additional treatment is required. Consciousness returns spontaneously.

The injection of Propofol 1% 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 if they have fully regained consciousness.

If the patient is to return home soon after using propofol, they should be accompanied by another person.

Children and adolescents

Propofol 1% Fresenius is not recommended for use in newborns and children under 1 month of age.

Propofol 1% 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 1% Fresenius with other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

In particular, tell the attending doctor, 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 relaxation, drowsiness, or sleep) and to relieve anxiety symptoms and reduce muscle tension].

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

• premedication medicines (the anesthesiologist will know which medicines may interact with Propofol 1% Fresenius);
• other anesthetics, including general, regional, and local anesthetics, as well as inhalation anesthetics (the anesthesiologist may decide to reduce the dose of Propofol 1% Fresenius);
• analgesics (pain relievers);
• strong pain relievers (fentanyl or opioids);
• parasympatholytic medicines (used for painful spasms, asthma, and Parkinson's disease);
• benzodiazepines (sedatives);
• suxamethonium (a muscle relaxant);
• medicines that can affect the body's internal functions, such as heart rate, e.g., atropine;
• medicines or 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 mental illnesses).

Propofol 1% Fresenius with food, drink, and alcohol

After using Propofol 1% Fresenius, the patient should not eat, drink, or consume alcohol until they have fully regained consciousness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Propofol 1% Fresenius should not be given to pregnant women unless absolutely necessary.

Mothers should stop breastfeeding and discard breast milk for 24 hours after using Propofol 1% Fresenius.

Driving and using machines

For some time after using Propofol 1% Fresenius, drowsiness may occur. Do not drive vehicles, operate equipment, or use machines until you are sure that the effect of the medicine has worn off.

If the patient is to return home soon after using propofol, they should not drive vehicles or leave the hospital without an accompanying person.

Ask the doctor when you can resume these activities and return to work.

Propofol 1% Fresenius contains soybean oil and sodium

Propofol 1% Fresenius contains soybean oil. If the patient is allergic to soy or peanuts, they should not use this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per 100 ml, i.e., the medicine is considered "sodium-free".

3. How to use Propofol 1% Fresenius

Propofol 1% Fresenius will be administered to the patient only in a hospital or in an appropriate therapeutic department by an anesthesiologist or a doctor specializing in intensive care medicine, or under their direct supervision.

Dosage

The administered dose will depend on the patient's age, weight, and condition, as well as on the premedication used (preparation of the patient for anesthesia). The doctor will administer the appropriate dose to induce and maintain anesthesia or achieve the required level of sedation, carefully monitoring the patient's reactions and vital signs (pulse, blood pressure, breathing, etc.).

Other medicines may be used to induce sedation or deep sleep, relieve pain, ensure proper breathing, and maintain blood pressure at a stable level. The doctor will decide which medicines to use and when to administer them to the patient.

Adult patients

Most patients require 1.5 to 2.5 mg of propofol per kilogram of body weight to induce sleep (induction of anesthesia), and then 4 to 12 mg of propofol per kilogram of body weight per hour to maintain sleep (maintenance of anesthesia). To ensure the required level of sedation, doses of 0.3 to 4.0 mg of propofol per kilogram of body weight per hour are usually sufficient.

To ensure the required level of sedation during surgical and diagnostic procedures in adult patients, most patients will require administration of a dose of 0.5 to 1 mg of propofol per kilogram of body weight over a period of 1 to 5 minutes. Maintenance of the required level of sedation can be achieved by adjusting the infusion rate of Propofol 1% Fresenius.

Most patients will require the use of 1.5 to 4.5 mg of propofol per kilogram of body weight per hour.

If it is necessary to quickly increase the level of sedation, the infusion can be supplemented by administering a bolus of propofol at a dose of 10 to 20 mg of propofol (1 to 2 ml of Propofol 1% Fresenius).

For sedation of patients over 16 years of age who are mechanically ventilated during intensive care, the dose of the medicine should be adjusted to achieve the required level of sedation.

A satisfactory level of sedation is usually achieved using an infusion rate of 0.3 to 4.0 mg of propofol per kilogram of body weight per hour. It is not recommended to use the medicine at an infusion rate higher than 4.0 mg of propofol per kilogram of body weight per hour.

Elderly and debilitated patients

Smaller doses may be required for elderly and debilitated patients.

Children and adolescents over 1 month of age

Propofol 1% Fresenius should not be used in children under 1 month of age.

Particular caution should also be exercised when administering Propofol 1% Fresenius to children under 3 years of age, although currently available data do not indicate that the use of the medicine is less safe in children over 3 years of age than in children under 3 years of age.

The dose should be adjusted taking into account the patient's age and/or weight.

For most children over 8 years of age, the dose required to induce sleep (induction of anesthesia) is approximately 2.5 mg of Propofol 1% Fresenius per kilogram of body weight.

In younger children, particularly those between 1 month and 3 years of age, a higher dose may be required (2.5 to 4 mg per kilogram of body weight).

Doses of 9 to 15 mg per kilogram of body weight per hour usually allow for the required level of sleep (maintenance of anesthesia) to be achieved.

In younger children, particularly those between 1 month and 3 years of age, a higher dose may be required.

To induce sedation during surgical and diagnostic procedures in children over 1 month of age, most patients will require administration of Propofol 1% Fresenius at a dose of 1 to 2 mg per kilogram of body weight.

Maintenance of the required level of sedation is achieved by adjusting the infusion rate of Propofol 1% Fresenius.

Most patients will require the use of 1.5 to 9 mg of propofol per kilogram of body weight per hour.

If it is necessary to quickly increase the level of sedation, the infusion can be supplemented by administering a bolus of propofol at a dose of up to 1 mg per kilogram of body weight.

Propofol 1% 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 1% Fresenius is intended for intravenous administration, usually on the back of the hand or forearm.

The anesthesiologist may use a needle or cannula (a thin plastic tube).

Propofol 1% Fresenius will be injected into a vein manually or using an electric pump.

During long operations and in intensive care, an electric pump may be used.

Duration of treatment

When using Propofol 1% Fresenius for sedation, it should not be used for more than 7 days.

Using a higher dose of Propofol 1% Fresenius than recommended

The doctor will ensure that the patient receives the appropriate dose of Propofol 1% Fresenius, depending on the procedure being performed.

However, different patients require different doses of the medicine.

If the patient receives too high a dose of the medicine, the anesthesiologist will take appropriate action to ensure proper heart and respiratory function.

Therefore, anesthetic medicines are administered only by doctors specializing in anesthesiology or intensive care medicine.

In case of any further doubts regarding the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects during anesthesia

During anesthesia (during injection and when the patient is drowsy or completely asleep), the following side effects may occur.

The doctor will be aware of this.

If such side effects occur, the doctor will provide appropriate 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 less than 1 in 10 people):

• slow or fast heart rate;
• low blood pressure;
• change in breathing pattern (low breathing rate, breathing stop);
• hiccups;
• cough (may also occur during awakening from anesthesia).

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

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

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

• shaking and trembling of the body or seizures (may also occur during awakening from anesthesia).

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

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

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

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

Side effects that may occur after awakening from anesthesia

The following side effects may occur after awakening from anesthesia (during awakening of the patient or when they are already awake):

Common (may affect less than 1 in 10 people):

• headache;
• nausea, vomiting;
• cough.

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

• dizziness, shivering, and feeling cold;
• agitation.

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

• postoperative loss of consciousness (in such cases, patients recovered consciousness without problems);
• pancreatitis, which causes severe abdominal pain (no causal relationship has been established);
• postoperative fever.

Frequency not known (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 (metabolic acidosis), high potassium levels in the blood, high fat levels in the blood, heart failure;
• misuse of the medicine, mainly by medical personnel;
• prolonged, often painful erection (priapism).

When Propofol 1% Fresenius is administered in combination with lidocaine (a local anesthetic used to reduce pain at the injection site), the following side effects may rarely occur:

• dizziness;
• vomiting;
• drowsiness;
• seizures;
• slow heart rate (bradycardia);
• irregular heartbeat (arrhythmia);
• shock.

Reporting side effects

If side effects occur, including any not listed in the leaflet, tell the doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

tel.: +48 22 49 21 301

fax: +48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Propofol 1% 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/bottle 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 the medicine immediately after opening.

Administration sets with undiluted Propofol 1% Fresenius should be replaced 12 hours after opening the ampoule or bottle.

Dilutions of 50 mg/ml (5%) glucose solution or 9 mg/ml (0.9%) sodium chloride solution or 10 mg/ml (1%) lidocaine solution without preservatives for injection should be prepared under aseptic conditions (controlled and validated) and administered within 6 hours of preparation.

Shake the container before use.

If, after shaking the container, two layers are visible in the emulsion, do not use it.

Use only the medicine with a uniform consistency and from undamaged packaging.

For single use only. Any unused emulsion residue should be discarded.

Medicines should 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% Fresenius contains

• The active substance is propofol.

1 ml of emulsion contains 10 mg of propofol.

Each 20 ml ampoule contains 200 mg of propofol.

Each 50 ml bottle contains 500 mg of propofol.

Each 100 ml bottle contains 1000 mg of propofol.

• The other ingredients are: soybean oil, egg lecithin, glycerol, oleic acid, sodium hydroxide, water for injections.

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

Propofol 1% Fresenius is a white emulsion for injection or infusion.

Propofol 1% Fresenius is available in colorless glass ampoules or bottles.

The glass bottles are closed with rubber stoppers.

Pack sizes:

5 glass ampoules containing 20 ml of emulsion in a cardboard box.

10 glass ampoules containing 20 ml of emulsion in a cardboard box.

1 glass bottle containing 50 or 100 ml of emulsion in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Germany

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

A-8055 Graz

Austria

To obtain more detailed information, 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

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Read the Summary of Product Characteristics.

Propofol 1% Fresenius should not be mixed before administration with solutions for injection or infusion, except for 50 mg/ml (5%) glucose solution or 9 mg/ml (0.9%) sodium chloride solution, or 10 mg/ml (1%) lidocaine solution without preservatives for injection.

The final concentration of propofol should not be less than 2 mg/ml.

For single use only. Any unused emulsion residue should be discarded.

Shake the container before use.

If, after shaking the container, two layers are visible in the emulsion, do not use it.

Use only the medicine with a uniform consistency and from undamaged packaging.

Before use, the neck of the ampoule or the rubber stopper should be cleaned with alcohol spray or an alcohol swab.

After use, punctured containers should be discarded.

Propofol should be administered by doctors specializing in anesthesiology (or, if necessary, doctors specializing in intensive care medicine).

Patients should be continuously monitored, and access to equipment for maintaining airway patency, artificial ventilation, oxygen administration, and other resuscitation equipment should be ensured at all times.

Propofol should not be administered by the same person performing the diagnostic or surgical procedure.

There have been reports of misuse and dependence on propofol, especially among healthcare professionals.

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 induce sedation in conscious patients during surgical and diagnostic procedures, the patient should be constantly monitored for early signs of hypotension, airway obstruction, and hypoxia.

Propofol 1% Fresenius can be administered by infusion in an undiluted or diluted form with 50 mg/ml (5%) glucose solution or 9 mg/ml (0.9%) sodium chloride solution for injection.

Propofol 1% Fresenius can be administered through the same infusion set with 50 mg/ml (5%) glucose solution, 9 mg/ml (0.9%) sodium chloride solution, or 1.8 mg/ml (0.18%) sodium chloride solution with 40 mg/ml (4%) glucose solution.

Propofol 1% Fresenius should not be mixed with other solutions for injection or infusion than those mentioned above.

Other medicines or fluids administered simultaneously with Propofol 1% Fresenius using the same infusion line should be administered near the infusion site using a Y-connector or a three-way valve.

Propofol 1% Fresenius is an emulsion containing fats without antibacterial preservatives and may promote rapid growth of microorganisms.

The emulsion should be drawn up into a sterile syringe and infusion set under aseptic conditions (controlled and validated) immediately after opening the ampoule or piercing the bottle cap.

Administration should be started immediately.

Propofol 1% Fresenius and any infusion equipment containing this medicine should be used under aseptic conditions throughout the infusion period.

Propofol 1% Fresenius should not be administered through a microbiological filter.

Infusion of undiluted Propofol 1% Fresenius

When Propofol 1% Fresenius is administered by infusion in an undiluted form, it is recommended to use burettes, drop counters, syringe pumps, or volumetric infusion pumps to control the infusion rate.

As is usually the case with fat emulsions, the infusion of Propofol 1% Fresenius should not be administered for more than 12 hours through a single infusion set.

Infusion sets for Propofol 1% Fresenius should be replaced at least every 12 hours.

Infusion of diluted Propofol 1% Fresenius

When administering Propofol 1% Fresenius by infusion, biurettes, drop counters, or volumetric infusion pumps should always be used to control the infusion rate.

The maximum dilutions should not exceed 1 part of Propofol 1% Fresenius in 4 parts of 50 mg/ml (5%) glucose solution or 9 mg/ml (0.9%) sodium chloride solution (minimum concentration 2 mg of propofol per ml).

The diluted medicine should be prepared under aseptic conditions (controlled and validated) and administered within 6 hours of preparation.

To reduce pain at the injection site, lidocaine solution can be added to Propofol 1% Fresenius (20 parts of Propofol 1% Fresenius and 1 part of preservative-free 1% lidocaine solution for injection).

Lidocaine should not be used in patients with hereditary acute porphyria.

Muscle relaxants, such as atracurium and mivacurium, can be administered through the same infusion line as Propofol 1% Fresenius, provided that the line is first flushed.