PROPOFOL BAXTER 10mg/ml Injectable Emulsion for Infusion

Introduction

Package Leaflet: Information for the User

Propofol Baxter 10 mg/ml injectable and perfusion emulsion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Propofol Baxter and what is it used for
2. What you need to know before you start using Propofol Baxter
3. How to use Propofol Baxter
4. Possible side effects
5. Storage of Propofol Baxter
6. Contents of the pack and further information

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

Propofol Baxter is a short-acting anesthetic that is injected into a vein. It belongs to the group of medicines called "general anesthetics" (narcotics). General anesthetics are used to produce unconsciousness (a type of sleep) while operations or other treatments are being carried out. They can also be used to sedate you (to make you feel drowsy, but not completely asleep).

Propofol Baxter is used for:

• Starting and maintaining anesthesia in adults and children over 1 month old.
• Sedating (calming) patients over 16 years old who are on artificial respiration in the intensive care unit (ICU).
• Sedating adults and children over 1 month old during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.

2. What you need to know before you start using Propofol Baxter

Do not use Propofol Baxter

• if you are allergic to propofol, soy, peanut, or any of the other components of this medicine (listed in section 6),
• in patients 16 years or younger for sedation in intensive care (see section 2.2).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Propofol Baxter.

Special caution is required when using Propofol Baxter in the following cases:

• If you have very high levels of lipids in your blood.
• If you have a disease in which fat-containing emulsions should be used with moderation. (See notes on intensive medical care by the doctor).

Propofol Baxter should be administered more slowlythan usual in patients who,

• are in poor general health,
• have problems with the functioning of their heart, lungs, kidneys, or liver,
• have lost a large amount of water (hypovolemia).

If possible, before administration, any cardiac, circulatory, and respiratory failure and hypovolemia should be treated

A marked drop in blood pressure may require the administration of plasma substitutes, possibly vasoconstrictors, and slower administration of Propofol Baxter. The possibility of a massive drop in blood pressure should be taken into account in patients with reduced coronary or cerebral perfusion or with hypovolemia. The clearance of propofol depends on blood flow. Therefore, concomitant medication that reduces cardiac output will also reduce the clearance of propofol.

Patients with severe heart disease should be given Propofol Baxter with caution and in a controlled manner.

The use of Propofol Baxter in patients with epilepsy may cause a seizure. If Propofol Baxter is administered in combination with lidocaine, it should be noted that lidocaine should not be administered to patients with acute porphyria.

Propofol Baxter lacks vagolytic activity. Its use has been associated with reports of bradycardia (when the heart beats slow down) with an occasionally serious outcome (cardiac arrest). Therefore, the administration of an anticholinergic agent intravenously before induction or during the maintenance of anesthesia with Propofol should be considered, especially in situations where vagal tone predominates, or when used in combination with other agents that may cause bradycardia.

When Propofol Baxter is administered for sedation during surgical and diagnostic procedures, patients should be continuously monitored for early signs of hypotension, airway obstruction, and oxygen desaturation.

As with other sedative agents, when Propofol Baxter is used for sedation during surgical procedures, involuntary patient movements may occur. In procedures that require an immobile patient, these movements may jeopardize the success of the operation.

There have been reports of misuse and dependence on propofol, predominantly by healthcare professionals. As with other general anesthetics, the administration of Propofol Baxter without ensuring a secure airway may lead to life-threatening respiratory complications. An adequate period is needed before the patient is discharged to ensure complete recovery after the use of Propofol.

In rare cases, the use of Propofol Baxter may be associated with the development of a postoperative unconsciousness period, which may be accompanied by an increase in muscle tone. This depends on whether the patient was previously awake or not. Although recovery is spontaneous, adequate care should be given to the unconscious patient.

The deterioration induced by Propofol Baxter is generally not detectable after more than 12 hours.

When warning patients about the effects of Propofol Baxter, the type of procedure, concomitant medication, age, and patient condition should be taken into account, and they should be advised:

• not to go home without accompaniment.
• when they can resume manual activities or perform hazardous tasks (e.g., driving a motor vehicle).
• that the use of other sedatives (e.g., benzodiazepines, opioids, alcohol) may prolong and increase deficiencies.

Studies in young animals and clinical data suggest that repeated or prolonged use of anesthetics or sedatives in children under 3 years and in pregnant women in the last trimester of pregnancy may have adverse effects on the child's brain development. The parent or guardian should discuss the benefits, risks, timing, and duration of surgery and other procedures that require anesthesia or sedatives with the doctor.

Notes onintensivemedicalcarebythedoctor

The use of propofol emulsion infusions for sedation in intensive care is associated with a group of metabolic disorders and organ failure that can lead to death.

Additionally, reports have been received of combinations of the following adverse reactions: metabolic acidosis, rhabdomyolysis, hyperkalemia, hepatomegaly, renal failure, hyperlipidemia, cardiac arrhythmia, Brugada-type ECG (saddle-shaped or vertical ST segment, elevated right precordial leads [V1-V3], and negative T wave), and rapidly progressive cardiac failure that generally does not respond to inotropic support treatment.

These events were observed mainly in patients with severe head injuries and in children with respiratory tract infections who received doses higher than those recommended for adults for sedation in the intensive care unit.

The following appear to be the main risk factors for the development of these events: decreased oxygen supply to tissues; severe neurological damage and/or sepsis; high doses of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropics, and/or propofol (usually at propofol doses greater than 4 mg/kg/h for more than 48 hours).

The medical team should be alert to these possible adverse effects in patients with the above risk factors and consider immediate discontinuation of propofol administration at the first signs of the symptoms mentioned above. All sedative and therapeutic agents used in the intensive care unit (ICU) should be adjusted to maintain optimal oxygen supply and hemodynamic parameters. Appropriate treatment should be provided to patients with elevated intracranial pressure, in order to maintain cerebral perfusion pressure during these treatment modifications. Healthcare professionals are reminded that, if possible, the recommended dose of 4 mg/kg/h should not be exceeded.

Attention should be paid to lipid metabolism disorders or other conditions in which lipid emulsions should be used with caution.

If Propofol Baxter is administered to patients who may be at risk of elevated blood lipid levels, it is recommended to monitor blood lipid levels. The administration of propofol should be adjusted accordingly if the monitoring indicates a disturbance in lipid metabolism. If the patient is concomitantly receiving another intravenous lipid, the amount of lipids perfused as part of Propofol Baxter should be taken into account. 1.0 ml of propofol contains 0.1 g of fat.

Additional information

Caution should be exercised in patients with mitochondrial disease. In these patients, exacerbation of their disease may occur when they are subjected to anesthesia, surgery, and intensive care. In these patients, it is recommended to maintain normothermia, carbohydrate supply, and good hydration. The early presentation of exacerbation of mitochondrial disease and "propofol infusion syndrome" may be similar.

Propofol Baxter does not contain antimicrobial preservatives, and microbial growth is possible due to its composition.

• Children

Propofol Baxter is not recommended for use in neonates, as this patient population has not been fully investigated. Pharmacokinetic data indicate that clearance is significantly reduced in neonates and has very high interindividual variability. When administering the recommended doses for children, relative overdose and severe cardiovascular depression and respiratory problems may occur. Propofol should not be used for sedation in intensive care in patients 16 years or younger, as its safety and efficacy for sedation in this age group have not been established (see section 2.1).

• Elderly

In the case of elderly patients, lower doses are required for the induction of anesthesia with Propofol Baxter. The patient's overall medical condition and age should be taken into account. The reduced dose should be administered more slowly and adjusted according to response. When Propofol Baxter is used for the maintenance of anesthesia and for sedation, the infusion rate and the selected propofol blood concentration should also be reduced. An additional reduction in dose and infusion rate is necessary for patients with ASA grades III and IV. In this population, rapid bolus administration (single or repeated) should not be used, as it may cause cardiopulmonary depression.

Using Propofol Baxter and other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

In particular, tell your doctor, anesthesiologist, or healthcare professional if you are taking midazolam (used to induce sedation [a very relaxed state of calm, drowsiness, or sleep] and to relieve anxiety and muscle tension).

Propofol Baxter is compatible with other agents used for anesthesia, i.e., with:

• inhalation anesthetics (inhalation anesthesia)
• analgesics
• muscle relaxants
• local anesthetics

With regional anesthesia techniques, smaller doses of Propofol Baxter may be required. No indications of serious interactions have been observed.

Some of the mentioned agents may reduce blood pressure or affect respiration, and therefore, cumulative effects may occur when using Propofol Baxter. Profound hypotension has been reported after the induction of anesthesia with propofol in patients treated with rifampicin. With additional premedication with opioids, apnea may occur more frequently and for a longer period.

Using Propofol Baxter with food, drinks, and alcohol

You should not drink alcohol after the administration of Propofol Baxter.

Pregnancy, breastfeeding, and fertility

Pregnancy

The safety of propofol during pregnancy has not been established. Animal studies have shown reproductive toxicity. Therefore, Propofol Baxter should only be used during pregnancy if it is absolutely necessary.

However, propofol Baxter can be used during an induced abortion.

Propofol crosses the placenta and may be associated with respiratory and cardiovascular collapse (depression of vital functions) in neonates. High doses (more than 2.5 mg of propofol/kg body weight for induction or 6 mg of propofol/kg body weight per hour for maintenance of anesthesia) should be avoided. Propofol can be used as an anesthetic during the termination of pregnancy.

Breastfeeding

Studies in breastfeeding mothers have shown that propofol is eliminated in small amounts in breast milk. Therefore, women should stop breastfeeding and discard breast milk for 24 hours after the administration of propofol.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Fertility

The safety of propofol during fertility has not been established.

Driving and using machines

After the administration of Propofol Baxter, the patient should be kept under observation for an adequate period and warned that the ability to drive and operate machines may be affected for some time after administration. Generally, no alterations related to Propofol Baxter are observed after more than 12 hours (see section 2.2). When returning home, the patient should be accompanied by another person.

Propofol Baxter contains sodium and soybean oil (E322)

This medicine contains less than 1 mmol of sodium (23 mg) per 100 ml; this is, essentially "sodium-free".

Propofol Baxter contains soybean oil. Do not use this medicine if you are allergic to peanut or soy.

3. How to use Propofol Baxter

Method of administration

For intravenous injection/infusion.

Propofol Baxter should only be administered by specialist doctors in anesthesia or in the treatment of patients in intensive care. Propofol should not be administered by the same person who performs the surgical procedure or diagnostic technique when used for sedation or anesthesia in the same.

Cardiovascular and respiratory functions should be constantly monitored (e.g., ECG, pulse oximeter), and devices necessary to maintain open airways, for artificial ventilation, and other resuscitation devices should be available at all times.

The dose should be individualized based on previous medication and patient response.

Generally, additional administration of analgesics is required to prevent pain on injection.

Dosage

The administered dose varies according to age, body weight, physical condition, and previous medication. Your doctor will administer the correct dose to initiate and maintain anesthesia or to achieve the required level of sedation, closely monitoring your physical response and vital signs (pulse, blood pressure, respiration, etc.).

If you use more Propofol Baxter than you should

Circulatory and respiratory depression may occur. In the case of respiratory arrest, artificial respiration is required, and in the case of a drop in blood pressure, usual measures will be taken, such as lowering the patient's head, possibly plasma substitutes (blood replacement agents), and, if necessary, vasoconstrictors.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Information on the frequency of adverse reactions is based on the following categories:

Very frequent: more than 1 in 10 people

Common: 1 to 10 in 100 people

Uncommon: 1 to 10 in 1,000 people

Rare: 1 to 10 in 10,000 people

Very rare: less than 1 in 10,000

Not known: cannot be estimated from the available data

Possible Adverse Effects:

Induction and maintenance of anesthesia or sedation with propofol are generally smooth with minimal evidence of excitement. The most frequently reported adverse effects are hypotension and alteration of the respiratory center's response capacity (respiratory depression). The type, severity, and frequency of these effects observed in patients administered propofol depend on the state of health, type of procedure, and therapeutic measures taken. In particular, the following adverse effects have been observed:

Immune System Disorders

Very rare: severe hypersensitivity reactions (anaphylaxis) that may include angioedema, difficulty breathing due to bronchospasm, skin reddening, and blood pressure drop

Metabolic and Nutrition Disorders

Frequency not known: metabolic acidosis, increased potassium levels in blood, hyperlipidemia

Psychiatric Disorders

Frequency not known: euphoric mood during the waking phase; drug abuse and dependence

Nervous System Disorders

Frequent: spontaneous movements and muscle spasms during anesthesia induction, headache during the waking phase

Rare: dizziness, chills, and feeling of cold during recovery, epileptic-like convulsions with convulsions and opisthotonus during induction, maintenance, and recovery (very rarely delayed by hours to a few days)

Very rare: postoperative unconsciousness (see section 2.2)

Frequency not known: involuntary movements

Cardiac Disorders

Frequent: bradycardia

Very rare: pulmonary edema

Frequency not known: cardiac arrhythmia, cardiac failure

Vascular Disorders

Frequent: hypotension

Uncommon: thrombosis and phlebitis

Respiratory, Thoracic, and Mediastinal Disorders

Frequent: hyperventilation and cough during anesthesia induction, temporary respiratory arrest during anesthesia induction

Uncommon: cough during maintenance

Rare: cough during the recovery phase

Frequency not known: respiratory depression (dose-dependent)

Gastrointestinal Disorders

Frequent: Hiccup during induction, nausea, and vomiting during the recovery phase

Very rare: pancreatitis

Hepatobiliary Disorders

Frequency not known: hepatomegaly, hepatitis (inflammation of the liver), acute liver failure (symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and sensitivity in the liver, indicated by pain below the front part of the rib cage on the right side), sometimes with loss of appetite

Musculoskeletal and Connective Tissue Disorders

Frequency not known: dissolution of striated muscle fibers (rhabdomyolysis)

Renal and Urinary Disorders

Very rare: urine discoloration after prolonged administration of Propofol Baxter

Frequency not known: renal failure

Reproductive System and Breast Disorders

Very rare: sexual disinhibition

Frequency not known: prolonged and often painful erection (priapism)

General Disorders and Administration Site Conditions

Very frequent: local pain after the first injection

Frequent: flushing during anesthesia induction

Very rare: severe tissue reactions and tissue necrosis after accidental extravascular administration

Frequency not known: local pain, swelling after accidental extravascular administration

Investigations

Frequency not known: changes in ECG (Brugada syndrome)

Injury, Poisoning, and Procedural Complications

Very rare: postoperative fever

The following adverse effects may occur after simultaneous administration of lidocaine: dizziness, vomiting, somnolence, convulsions, bradycardia, arrhythmias, and shock

Soybean oil can cause allergic reactions in very rare cases

1 Severe bradycardias are rare. Isolated cases of progression to asystole have been reported

2 Occasionally, hypotension may require the use of intravenous fluids and a reduction in the administration rate of Propofol Baxter

3 Rare cases of rhabdomyolysis have been reported when propofol was administered at doses higher than 4 mg of propofol per kg of body weight per hour for sedation in the intensive care unit (ICU)

4 This can be minimized by concomitant administration of lidocaine and using large veins of the forearm or antecubital fossa

5 The combination of these reactions, also reported as "propofol infusion syndrome", can be observed in severely ill patients who often have multiple risk factors for the development of these events (see section 2.2)

6 Brugada syndrome - elevated ST segment and inverted T wave in ECG

7 Rapidly progressive cardiac failure (sometimes fatal) in adults. Cardiac failure in these cases usually does not respond to treatment with inotropics

8 Drug abuse and dependence, mainly by healthcare professionals

9 Tissue necrosis with altered tissue viability has been reported

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine

5. Storage of Propofol Baxter

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiration date stated on the packaging and label after CAD. The expiration date is the last day of the month indicated

Storage Conditions

Do not store above 25°C

Do not freeze

Once opened, the product must be used immediately

Your doctor, anesthesiologist, or hospital pharmacist are responsible for the correct storage, use, and disposal of the medicine

6. Container Content and Additional Information

Composition of Propofol Baxter

• The active ingredient is propofol.
• The other components are refined soybean oil, medium-chain triglycerides, glycerol, egg lecithin, sodium hydroxide (for pH adjustment), and water for injectable preparations.

Each milliliter of injectable and infusion emulsion contains 10 mg of propofol.

Each 20-milliliter vial contains 200 mg of propofol.

Each 50-milliliter vial contains 500 mg of propofol.

Each 100-milliliter vial contains 1000 mg of propofol.

Product Appearance and Container Content

White, oil-in-water injectable and infusion emulsion.

This medication is supplied in colorless glass vials (type II) with a gray bromobutyl rubber stopper.

Container sizes:

20-ml vials in packs of 5 and 10 vials.

50-ml vials in packs of 1 vial.

100-ml vials in packs of 1 vial.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

BAXTER HOLDING B.V.

Kobaltweg 49, 3542CE Utrecht

Netherlands

Manufacturer:

UAB NORAMEDA

Didzioji vandens g. 7-8

91246 Klaipeda, Lithuania

Bieffe Medital S.P.A.,

Via Nuova Provinciale,

IT- 23034 Grosotto

Italy

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Baxter S.L.

Pouet de Camilo, 2. 46394 Ribarroja del Turia (Valencia) Spain

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

Germany: Propofol Baxter 10 mg/ml Emulsion zur Injektion/ Infusion

Spain: Propofol Baxter 10 mg/ml emulsión inyectable y para perfusión EFG

Date of last revision of this leaflet: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es

Medical Information

This information is intended solely for healthcare professionals:

This informational section is a summary of the Medicinal Product Characteristics and is limited to instructions for its correct handling and preparation. It is not a sufficient basis for deciding whether the medicinal product can be administered. Consult the Medicinal Product Characteristics for more information.

1. Preparation

Propofol Baxter emulsion for injection/infusion

1. Important information about other ingredients of Propofol Baxter

Sodium: This medicinal product contains less than 1 mmol of sodium (=23 mg) per dose, i.e., it is essentially "sodium-free".

Soybean oil: Propofol Baxter contains soybean oil. If you are allergic to peanuts or soy, do not use this medicinal product.

1. Handling Instructions

Propofol Baxter should only be administered by specialist medical professionals in anesthesia or in the treatment of patients in intensive care. Propofol Baxter must not be administered by the same person who is performing the diagnostic or surgical procedure when used for sedation or anesthesia in the same.

Cardiovascular and respiratory functions should be constantly monitored (e.g., ECG, pulse oximeter) and the necessary devices should be available at all times to maintain open airways, for artificial ventilation, and other resuscitation devices.

1. Information on the shelf life after opening or after preparation

The duration of infusion of Propofol 10 mg/ml undiluted using a perfusion system should not exceed 12 hours. After the first opening and/or dilution, the product should be used immediately.

Opened vials should be discarded after single administration of Propofol Baxter.

1. Instructions for use

Before use, the surface of the rubber stopper should be cleaned with spray alcohol or an alcohol-soaked swab. The rubber stopper does not contain latex. Vials should be shaken before use. If two layers are observed after shaking, the emulsion should not be used. Opened vials should be discarded after single administration of Propofol Baxter 1%.

Propofol Baxter is administered intravenously, even undiluted in plastic syringes or glass vials.

Propofol Baxter does not contain antimicrobial preservatives and may promote the growth of microorganisms due to its composition. The emulsion should be extracted aseptically using a sterile syringe or in an administration set immediately after breaking the vial seal. Administration should be started immediately.

Strict aseptic conditions of Propofol Baxter and the perfusion equipment used should be maintained throughout the infusion period. Concomitant administration of any other medicinal product or fluids added to the Propofol Baxter infusion line should be performed near the cannula. Propofol Baxter should not be administered through perfusion equipment containing microbiological filters.

If patients are receiving other intravenous lipids concomitantly, the amount of lipids infused as part of Propofol Baxter should be taken into account. 1.0 ml of Propofol Baxter contains 0.1 g of fat.

Infusion of propofol 10 mg/ml undiluted:

A perfusion pump or volumetric pump should be used for the infusion of Propofol Baxter undiluted.

As is usual with lipid emulsions, the infusion of Propofol Baxter through a perfusion system should not exceed 12 hours. At the end of the process or after 12 hours, whichever comes first, both the remaining propofol and the infusion line should be discarded or replaced if necessary.

Infusion of propofol 10 mg/ml diluted:

When Propofol Baxter is administered diluted by infusion, burettes or volumetric perfusion pumps should always be used to avoid the risk of accidental overdose of Propofol Baxter.

1 part of Propofol Baxter may be diluted with up to 4 parts of 5% glucose solution (minimum concentration of 2 mg of propofol/ml). The ready-to-use mixture should be prepared under aseptic conditions immediately before administration and should be used within the following 6 hours.

Propofol Baxter should not be mixed with other injectable or infusion solutions. However, it can be added to a continuous infusion solution of 5% glucose, 0.9% sodium chloride, or 4% glucose/0.18% sodium chloride using a Y-connector at the injection site.

To reduce pain at the injection site during the induction of anesthesia, Propofol Baxter may be mixed with lidocaine immediately before administration (20 parts of Propofol Baxter with up to 1 part of lidocaine at 1%).

Muscle relaxants of the atracurium or mivacurium type should only be administered after flushing the same infusion site used for Propofol Baxter.

The content of a vial and the respective perfusion system are for single use in a single patient. Opened vials should be discarded after use.

1. Dosage

General Anesthesia in Adults

Induction of Anesthesia

For the induction of general anesthesia, the dose of Propofol Baxter should be adjusted at a rate of 20 to 40 mg of propofol, every 10 seconds, according to the patient's response until clinical signs show the onset of anesthesia. Most adults under 55 years of age will require a total dose of 1.5 to 2.5 mg of propofol/kg of body weight.

In elderly patients and in patients with ASA grades III and IV (American Society of Anesthesiologists), especially those with impaired cardiac function, the total dose of Propofol Baxter may need to be reduced to 1 mg of propofol/kg of body weight. Lower doses of administration of Propofol Baxter (approximately 2 ml of the 10 mg/ml emulsion (20 mg of propofol) every 10 seconds) should be used.

Maintenance of General Anesthesia

For the maintenance of anesthesia by continuous infusion, the dose and infusion rate should be adjusted for each individual. Generally, the dose is 4 to 12 mg of propofol/kg of body weight per hour to maintain a satisfactory level of anesthesia. A reduced maintenance dose of approximately 4 mg of propofol/kg of body weight/h may be sufficient during less stressful surgical procedures, such as minimally invasive surgery.

In elderly patients, unstable patients, patients with impaired cardiac function, hypovolemic patients, and patients with ASA grades III and IV, the dose of Propofol Baxter may need to be reduced further depending on the severity of the patient's condition and the anesthetic technique used.

General Anesthesia in Children Over 1 Month

Induction of Anesthesia

For the induction of anesthesia, Propofol Baxter should be administered slowly until clinical signs of the onset of anesthesia are observed. The dose should be adjusted according to age and/or body weight. Most children over 8 years of age will require approximately 2.5 mg of propofol/kg of body weight for the induction of anesthesia. In younger children, especially between 1 month and 3 years, the required dose may be higher (2.5 – 4 mg of propofol/kg of body weight). In patients with ASA grades III and IV, lower doses are recommended (see section 4.4).

Maintenance of General Anesthesia

Anesthesia can be maintained by administering Propofol Baxter by infusion or by repeated bolus injections to maintain the required depth of anesthesia. The required administration rate varies considerably between patients, but rates in the range of 9 to 15 mg/kg of body weight/h generally achieve satisfactory anesthesia. In younger children, especially between 1 month and 3 years, the required dose may be higher.

Lower doses are recommended for patients with ASA grades III and IV (see section 2.2).

Sedation of Patients Over 16 Years in the Intensive Care Unit

For the sedation of patients with assisted ventilation in intensive care, Propofol Baxter should be administered by continuous infusion. The dose should be adjusted according to the required depth of sedation. Satisfactory sedation can usually be achieved with doses in the range of 0.3 to 4.0 mg of propofol/kg of body weight per hour (see section 2.2). Infusion doses above 4.0 mg of propofol/kg of body weight/h are not recommended (see section 2.2).

Administration of Propofol Baxter using the Target-Controlled Infusion (TCI) system is not recommended for sedation in the intensive care unit.

Sedation for Diagnostic and Surgical Procedures in Adult Patients

During the administration of Propofol Baxter, the patient should be continuously monitored for signs of hypotension, airway obstruction, and oxygen desaturation, and standard emergency equipment should be available for accidents.

Most patients will require between 0.5 and 1 mg of propofol/kg of body weight over 1 to 5 minutes for the onset of sedation. Maintenance of sedation can be achieved by adjusting the infusion administration to the desired depth of sedation. Most patients will require between 1.5 and 4.5 mg of propofol/kg of body weight/h.

If it is necessary to rapidly increase the depth of sedation, this can be supplemented by administering a bolus of 10-20 mg.

Patients with ASA grades III and IV may require lower doses, and it may be necessary to reduce the administration rate. A lower dose may also be necessary in patients over 55 years of age.

Note

In the case of elderly patients, lower doses are required for the induction of anesthesia with Propofol Baxter. The patient's overall medical condition and age should be taken into account. The reduced dose should be administered more slowly and adjusted according to the response.

When Propofol Baxter is used for the maintenance of anesthesia and sedation, the perfusion rate and the selected propofol blood concentration should also be reduced.

A further reduction in dose and perfusion rate is necessary in patients with ASA grades III and IV. Rapid bolus administration (single or repeated) should not be used in the elderly, as this can cause cardiopulmonary depression.

Sedation of Children Over 1 Month for Surgical and Diagnostic Procedures

The dose and intervals between doses are adjusted according to the required depth of sedation and clinical response. Most pediatric patients require 1 to 2 mg of propofol/kg of body weight for the onset of sedation. Maintenance of sedation can be achieved by adjusting the Propofol Baxter infusion to the desired depth of sedation. Most patients require 1.5 to 9 mg of propofol/kg of body weight per hour. If it is necessary to rapidly increase the depth of sedation, this can be supplemented by administering a bolus of up to 1 mg/kg body weight.

Patients with ASA grades III and IV may require lower doses.

Propofol Baxter is contraindicated in children 16 years of age or less for the indication of sedation in intensive care.

1. Duration of Administration

The duration of administration should not exceed 7 days

1. Marketing Authorization Holder

Baxter Holding B.V.