Propofol Baxter

Leaflet accompanying the packaging: information for the user

Propofol Baxter, 10 mg/ml, emulsion for injection/infusion

Propofol

Read the leaflet carefully before receiving 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, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What Propofol Baxter is and what it is used for
• 2. Important information before receiving Propofol Baxter
• 3. How to receive Propofol Baxter
• 4. Possible side effects
• 5. How to store Propofol Baxter
• 6. Contents of the packaging and other information

1. What Propofol Baxter is and what it is used for

Propofol Baxter contains the active substance propofol. Propofol Baxter belongs to a group of general anesthetics. It is used to induce loss of consciousness (deep sleep) to perform surgical procedures or other interventions. It can also be used to achieve sedation (a state in which the patient is drowsy but not completely asleep).

Propofol Baxter is used for:

• induction and maintenance of general anesthesia in adults and children over 1 month of age,
• 1 month of age,
• sedation (calming) of mechanically ventilated patients over 16 years of age in intensive care units,
• sedation in adults and children over 1 month of age during surgical and diagnostic procedures, separately or in combination with local or regional anesthesia (local anesthetics).

2. Important information before receiving Propofol Baxter

When not to use Propofol Baxter

• if the patient is allergic to propofol, soy, peanuts, or any other component of this medicine (listed in section 6),
• for sedation of patients under 16 years of age in intensive care units.

Warnings and precautions

Before starting treatment with Propofol Baxter, discuss with your doctor, anesthesiologist, or nurse:

• if the patient has ever had a seizure or convulsion;
• if the patient has ever had a very high level of fat in the blood;
• if the patient has ever had problems with fat metabolism;
• if the patient's body has lost a lot of water (hypovolemia);
• if the patient has any other health problems, such as heart, breathing, kidney, or liver problems;
• if the patient has been feeling unwell for some time;
• if the patient has a mitochondrial disease.

After receiving Propofol Baxter, the patient may experience its effects. The patient should not leave the hospital without being accompanied by another person.

Children and adolescents

Propofol Baxter is not recommended for use in newborns, as this patient group has not been sufficiently studied. Propofol Baxter should not be used in children and adolescents under 16 years of age for sedation in intensive care units, as the safety and efficacy of propofol in this indication have not been established in this age group.

Elderly patients

In elderly patients, smaller doses of Propofol Baxter are required for induction of anesthesia. The patient's overall health and age should be taken into account. The reduced dose should be administered more slowly and titrated according to the patient's response.

Propofol Baxter and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Some of these medicines may lower blood pressure or cause respiratory depression, and concomitant use with Propofol Baxter may enhance these adverse effects. In particular, inform your doctor about the use of the following medicines:

• Rifampicin, as it may lower blood pressure when used with general anesthesia.
• Certain sedatives and painkillers, such as benzodiazepines and opioids, as they may enhance the effect of propofol.
• Valproate, as the dose of propofol may need to be reduced if used concomitantly.

Using Propofol Baxter with food, drink, and alcohol

Do not consume alcohol in any form after receiving Propofol Baxter.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before receiving this medicine. PregnancyPropofol Baxter should not be used in pregnant women unless absolutely necessary. BreastfeedingStudies in breastfeeding women have shown that small amounts of propofol pass into human milk. Therefore, breastfeeding should be avoided for 24 hours after administration of propofol. Milk expressed during this time should be discarded.

Driving and using machines

After receiving propofol, the patient may still feel drowsy for some time. They should not drive or operate tools or machines until the effects of the medicine have worn off.

• If the patient can return home soon after receiving Propofol Baxter, they should not drive a car or use any tools or machines.
• The patient should ask their doctor when they can resume these activities and return to work.

Propofol Baxter contains soybean oil

Propofol Baxter contains soybean oil. It should not be used in patients with known hypersensitivity to peanuts or soy.

Propofol Baxter contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per vial, which is considered to be essentially 'sodium-free'.

3. How to receive Propofol Baxter

Propofol Baxter, in the form of an injection or infusion, will be administered to the patient into a vein, usually on the back of the hand or forearm. Propofol Baxter should only be administered by doctors who have been trained in the field of anesthesiology or in intensive care units. Sedation or anesthesia with Propofol Baxter should not be performed by the same person who is performing the surgical or diagnostic procedure. To maintain sleep or sedation, relieve pain, maintain healthy breathing, and stable blood pressure, the patient may need several different medicines. The doctor will decide when and what medicines the patient needs.

Dosage

The dose of Propofol Baxter used depends on the patient's age, weight, overall health, and premedication. The doctor will use the appropriate dose to induce and maintain general anesthesia or achieve the required depth of sedation, carefully monitoring the patient's reactions and vital signs (pulse, blood pressure, breathing, etc.). If there are any further doubts about the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, Propofol Baxter can cause side effects, although not everybody gets them.

Possible side effects

Induction and maintenance of anesthesia and sedation with propofol are usually smooth, with minimal signs of excitement. The most commonly reported adverse effects are hypotension and respiratory depression. The type, severity, and frequency of these effects, which have been observed in patients receiving propofol, depend on the patient's health, the type of procedure, and the procedures used. In particular, the following adverse effects have been observed:

Very common (may affect more than 1 in 10 people)

• Pain at the injection site during administration of anesthesia

Common (affects 1 to 10 people in 100)(may affect no more than 1 in 10 people)

• Spontaneous movements and muscle twitching during induction of anesthesia, headache during recovery
• Slow heart rate (bradycardia).
• Low blood pressure (hypotension).
• Rapid breathing (hyperventilation) and cough during induction of anesthesia, transient ineffective breathing (apnea) during induction of anesthesia.
• Cough during induction of anesthesia, nausea, and vomiting during recovery.
• Flush during induction of anesthesia.

Uncommon (may affect no more than 1 in 100 people)

• Blood clotting in part of the circulatory system (thrombophlebitis) and vein inflammation.
• Cough during maintenance of anesthesia.

Rare (may affect no more than 1 in 1000 people)

• Dizziness, shivering, and feeling cold during recovery,
• epileptic-like episodes with seizures and muscle spasms causing arching of the head, neck, and spine (opisthotonus) during induction, maintenance, and recovery (very rarely delayed by several hours to several days)
• Cough during recovery.

Very rare (may affect no more than 1 in 10,000 people)

• Severe allergic reactions (anaphylaxis), which can include angioedema, respiratory failure due to bronchospasm, skin rash, and hypotension.
• Loss of consciousness after surgery.
• Fluid accumulation in the lungs, which can cause shortness of breath (may also occur after recovery).
• Pancreatitis.
• Changes in urine color after prolonged administration of Propofol Baxter.
• Lack of sexual inhibitions.
• Tissue damage.
• Postoperative fever.

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

• Excess acid in the blood due to metabolic disorders (metabolic acidosis),
• high potassium levels in the blood,
• high lipid levels in the blood.
• Euphoric mood during recovery,
• abuse and dependence on the medicine.
• Involuntary movements.
• Heart rhythm disturbances,
• heart failure.
• Ineffective breathing (dose-dependent respiratory depression).
• Liver enlargement.
• Breakdown of striated muscle fibers (rhabdomyolysis).
• Kidney failure.
• Local pain, swelling after accidental extravascular administration.
• Prolonged, often painful erection (priapism).
• Changes in ECG tracing.
• Hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain, and liver tenderness (indicated as pain in the upper right part of the chest), sometimes with loss of appetite].

When administered concomitantly with lidocaine, the following adverse effects may rarely occur:

• dizziness
• vomiting
• drowsiness,
• seizures,
• bradycardia
• arrhythmia
• shock.

Soybean oil can very rarely cause allergic reactions.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides: 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. Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Propofol Baxter

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and label on the vial after: EXP. The expiry date refers to the last day of the month stated. Store at a temperature below 25°C. Do not freeze. After first opening, the medicine should be used immediately. Dilutions should only be made with glucose 50 mg/ml (5%) injection solution, sodium chloride 9 mg/ml (0,9%) injection solution, or a combination of sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) injection solution, and lidocaine 10 mg/ml (1%) injection solution without preservatives. The mixture should be prepared under aseptic conditions (with controlled and validated conditions) immediately before administration and should be administered within 12 hours of preparation. Shake before use. Do not use this medicine if, after shaking, two layers are visible. Only use homogeneous solutions and undamaged vials. The solution is for single use only. Any unused emulsion should be discarded. The anesthesiologist and pharmacist are responsible for the proper storage, use, and disposal of Propofol Baxter.

6. Contents of the packaging and other information

What Propofol Baxter contains

The active substance is propofol. 1 ml of the emulsion for injection/infusion contains 10 mg of propofol. A 20 ml vial contains 200 mg of propofol. A 50 ml vial contains 500 mg of propofol. A 100 ml vial contains 1000 mg of propofol. The other ingredients are purified soybean oil, medium-chain triglycerides, glycerol, egg lecithin, sodium oleate, sodium hydroxide (for pH adjustment), and water for injections.

What Propofol Baxter looks like and contents of the pack

White oil-in-water emulsion for injection/infusion. Propofol Baxter is available in: Emulsion for injection/infusion in a colorless glass vial (type II) with a gray rubber stopper. Pack sizes: Colorless glass vial (type II) with a capacity of 20 ml with a gray rubber stopper, pack contains 1, 5, or 10 vials. Colorless glass vial (type II) with a capacity of 50 ml with a gray rubber stopper, pack contains 1 or 10 vials. Colorless glass vial (type II) with a capacity of 100 ml with a gray rubber stopper, pack contains 1 or 10 vials. Not all pack sizes may be marketed.

Marketing authorization holder For Austria, Czech Republic, Estonia, Hungary, Ireland, Italy, Lithuania, Portugal, France, Denmark, Finland, Germany, Norway, Sweden, Latvia, Poland, Slovenia, Romania, Greece

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

For the Netherlands

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

For the United Kingdom

Baxter Healthcare Limited Caxton Way Thetford, Norfolk IP24 3SE, United Kingdom

Manufacturer

UAB Norameda, Vilnius, Lithuania Bieffe Medital S.p.A., Via Nuova Provinciale 23034 Grossotto (SO), Italy SIA “UNIFARMA” Vangažu iela 23, Riga, Latvia

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

Date of last revision of the leaflet: 05.08.2024

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Leaflet containing medical information

Information intended for healthcare professionals only

This information leaflet is a shortened version of the Summary of Product Characteristics (SPC).

More information can be found in the SPC.

Instructions for handling the medicinal product

Propofol Baxter may only be administered by doctors who are specialists in the field of anesthesiology or intensive care. Sedation or anesthesia with Propofol Baxter should not be performed by the same person who is performing the surgical or diagnostic procedure. The patient's cardiovascular and respiratory functions should be constantly monitored (e.g., ECG, pulse oximetry). Ensure constant, direct access to standard resuscitation equipment used in the event of incidents during general anesthesia or sedation.

Instructions for the shelf life after opening or after preparation

Chemical and physical stability has been demonstrated for 12 hours at 25°C. Shelf life after dilution: The mixture should be prepared under aseptic conditions (with controlled and validated conditions) immediately before administration and should be administered within 12 hours of preparation. Use immediately after first opening. Single use only. Any unused product should be discarded. The infusion system and the remaining product should be discarded after 12 hours.

Instructions for use

Before administration, the rubber stopper of the vial should be disinfected with alcohol spray or an alcohol swab. Vials should be shaken before use. Propofol Baxter should be administered intravenously using a plastic syringe or glass vial, or as a mixture with 5% glucose solution in a PVC bag or glass vial. Propofol Baxter does not contain preservatives and may be a medium for microbial growth. The emulsion should be drawn up into a sterile syringe or infusion set immediately after the vial has been opened. The product should be started immediately afteropening. Throughout the infusion period, aseptic conditions should be maintained for Propofol Baxter and the infusion equipment. Medicines or fluids added to the infusion line through which Propofol Baxter is being administered should be introduced close to the venous injection site. Propofol Baxter should not be administered through infusion systems equipped with microbial filters. When using parenteral nutrition, the fat content of Propofol Baxter should be taken into account. 1.0 ml of Propofol Baxter contains 0.1 g of fat. Administration of undiluted Propofol BaxterFor infusion of undiluted Propofol Baxter, a syringe pump or volumetric pump should be used. The duration of infusion of Propofol Baxter using a singleinfusion system should not exceed 12 hours, as with all fat emulsion infusions. At the end of the infusion, but no later than 12 hours after the start of the infusion, the remaining volume of Propofol Baxter and the infusion system should not be used further. If necessary, the infusion system should be replaced. Administration of diluted Propofol Baxter:Infusion of diluted Propofol Baxter should be performed using a controlled infusion system (burette or volumetric pump) to prevent accidental administration of too large a volume of diluted Propofol Baxter. Propofol Baxter may only be diluted with: glucose 50 mg/ml (5%) injection solution, sodium chloride 9 mg/ml (0.9%) injection solution, or a combination of sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) injection solution, and lidocaine 10 mg/ml (1%) injection solution without preservatives. The final concentration of propofol should not be less than 2 mg/ml. It is possible to administer Propofol Baxter concurrently with 5% glucose (50 mg/ml) injection solution, 0.9% sodium chloride (9 mg/ml) injection solution, or a combination of 0.18% sodium chloride (1.8 mg/ml) and 4% glucose (40 mg/ml) injection solution using a Y-connector close to the injection site. The maximum dilution should not exceed 1 part Propofol Baxter to 4 parts glucose 50 mg/ml (5%) injection solution, sodium chloride 9 mg/ml (0.9%) injection solution, or a combination of sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) injection solution (minimum concentration 2 mg propofol/ml). The mixture should be prepared under aseptic conditions (with controlled and validated conditions) immediately before administration and should be administered within 12 hours of preparation. To alleviate pain at the injection site, lidocaine can be injected directly before administration of Propofol Baxter or mixed directly before administration with a preservative-free lidocaine 1% injection solution (a solution containing 20 parts propofol and a maximum of 1 part 1% lidocaine injection solution) under controlled and validated aseptic conditions. The mixture should be administered within 12 hours of preparation. If muscle relaxants (such as atracurium and mivacurium) are administered through the same intravenous line as Propofol Baxter, the line should be flushed before their administration. The contents of the vial and the entire infusion set used to administer it are intended for singleuse in onepatient.

Dosage General anesthesia in adults

Induction of anesthesiaPropofol Baxter should be administered gradually (at a rate of 20–40 mg propofol per 10 seconds) until the clinical signs of induction of anesthesia are achieved. In most adults under 55 years of age, the required total dose is usually 1.5–2.5 mg propofol per kg body weight (kg bw). For patients classified as ASA III and IV, especially those with a history of cardiovascular disease and elderly patients, the total dose of Propofol Baxter may need to be reduced to 1 mg propofol/kg bw. This may require slowing the infusion rate of Propofol Baxter (to approximately 20 mg propofol per 10 seconds). Maintenance of anesthesiaAnesthesia can be maintained by administering Propofol Baxter as a continuous infusion or repeated bolus injections. Continuous infusionTo maintain anesthesia, the dose and infusion rate should be adjusted individually. The dose required to achieve a satisfactory level of anesthesia usually ranges from 4 to 12 mg propofol/kg bw per hour. In elderly patients in poor general health or patients with hypovolemia and patients classified as ASA III and IV, the dose may be reduced to 4 mg propofol/kg bw per hour. Repeated bolus injectionsTo maintain anesthesia, the basic dose is usually 25–50 mg propofol (corresponding to 2.5–5 ml Propofol Baxter). General anesthesia in children from 1 month of ageInduction of anesthesiaPropofol Baxter should be administered gradually and slowly until clinical signs of induction of anesthesia are achieved. 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 anesthesia is approximately 2.5 mg propofol/kg bw. In younger children, especially between 1 month and 3 years of age, the required dose may be higher (2.5–4 mg propofol/kg bw). Smaller doses are recommended for patients classified as ASA III and IV. Maintenance of anesthesiaMaintenance of the required depth of anesthesia can be achieved by administering Propofol Baxter as an infusion or repeated bolus injections. The required doses vary considerably between patients; however, a satisfactory level of anesthesia is usually achieved at doses ranging from 9 to 15 mg propofol/kg bw per hour. In younger children, especially between 1 month and 3 years of age, the required dose may be higher. Smaller doses are recommended for patients classified as ASA III and IV. Sedation of patients over 16 years of age in intensive care unitsTo achieve sedation in mechanically ventilated patients in intensive care units, Propofol Baxter should be administered as a continuous infusion. The dosage should be adjusted according to the required level of sedation. The desired level of sedation is usually achieved at a dose range of 0.3–4.0 mg propofol/kg bw per hour. Propofol Baxter should not be used for sedation in patients under 16 years of age in intensive care units. It is not recommended to administer Propofol Baxter using a Target Controlled Infusion (TCI) system for sedation in intensive care units. Sedation of adults during surgical and diagnostic proceduresDuring administration of Propofol Baxter, the patient should be constantly monitored for signs of hypotension, airway obstruction, and hypoxia, and standard rescue equipment should be available. To induce sedation, a dose of 0.5–1.0 mg propofol/kg bw over 1–5 minutes is usually required. To maintain sedation, the dosage should be adjusted according to the desired level of sedation and is usually 1.5–4.5 mg propofol/kg bw per hour. In addition to infusion, if rapid deepening of sedation is required, a single bolus injection of 10–20 mg may be used. In patients classified as ASA III and IV, a reduced dose and slower administration may be necessary. A smaller dose may also be necessary in patients over 55 years of age. Sedation of children over 1 month of age during surgical and diagnostic proceduresThe dosage and intervals between doses should be adjusted according to the desired depth of sedation and clinical response. In most patients, sedation can be achieved with a dose of 1–2 mg propofol/kg bw. Maintenance of sedation is achieved by gradually increasing the dose of Propofol Baxter as an infusion until the desired depth of sedation is achieved. In most patients, the required dose ranges from 1.5 to 9 mg propofol/kg bw per hour. If rapid deepening of sedation is required, the infusion can be supplemented with single bolus injections of up to 1 mg/kg bw. In patients classified as ASA III and IV, smaller doses may be necessary.

Propofol Baxter should not be used for sedation in children under 16 years of age in intensive care units.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned below. glucose 50 mg/ml (5%) injection solution, sodium chloride 9 mg/ml (0.9%) injection solution, or a combination of sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) injection solution, and preservative-free lidocaine 10 mg/ml (1%) injection solution. Muscle relaxants such as atracurium and mivacurium should not be administered without prior flushing of the same intravenous line as Propofol Baxter.

Overdose

Overdose may lead to cardiovascular and respiratory depression. Apnea requires artificial ventilation. In the case of cardiovascular depression, standard measures should be taken to lower the head and/or substitute plasma and administer vasoconstrictors.

Duration of use

Propofol Baxter can be used for a maximum of 7 days.