Propofol Baxter 20 mg/ml emulsion for injection and infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Propofol Baxter 20 mg/ml emulsion for injection and for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist, or nurse.

• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Propofol Baxter is a short-acting anesthetic administered by intravenous injection. It belongs to a group of medicines known as "general anesthetics" (narcotics). General anesthetics are used to induce unconsciousness (a type of sleep) during surgical operations or other procedures. They may also be used to sedate you (make you feel drowsy, but not fully asleep).

Propofol Baxter is used for:

• Inducing and maintaining anesthesia in adults and children over 3 years of age.
• Sedating (calming) patients over 16 years of age who are on mechanical ventilation in the intensive care unit (ICU).
• Sedating adults and children over 3 years of age during diagnostic and surgical procedures, either alone or in combination with local or regional anesthesia.

2. What you need to know before using Propofol Baxter

Do not use Propofol Baxter

• if you are allergic to propofol, soy, peanuts, or any of the other components of this medicine (listed in section 6),
• in patients aged 16 years or younger for intensive care sedation (see section 2.2), or as anesthesia in patients under 3 years of age.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before Propofol Baxter is administered to you.

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

• If you have very high levels of lipids in the blood.
• If you have a condition where lipid-containing emulsions must be used with caution. (See notes on intensive care management by the physician.)

Propofol Baxter should be administered more slowly than usual in patients who:

• are in poor general health,
• have problems with heart, lung, kidney, or liver function,
• have lost a significant amount of fluid (hypovolemia).

If possible, any cardiac, circulatory, respiratory insufficiency, or hypovolemia should be treated prior to administration.

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

Propofol Baxter should be administered with caution and under close monitoring in patients with severe heart disease.

The use of Propofol Baxter in patients with epilepsy may trigger seizures. If Propofol Baxter is administered in combination with lidocaine, it should be noted that lidocaine must not be given to patients with acute hereditary porphyria.

Propofol Baxter lacks vagolytic activity. Its use has been associated with reports of bradycardia (slowing of the heartbeat), occasionally with serious outcomes (cardiac arrest). Therefore, intravenous administration of an anticholinergic agent should be considered before induction or during maintenance of anesthesia with Propofol, especially in situations where vagal tone is likely to predominate, 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 must be continuously monitored for early signs of hypotension, airway obstruction, and oxygen desaturation.

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

Misuse and dependence on propofol have been reported, predominantly among healthcare professionals. As with other general anesthetics, administration of Propofol Baxter without securing an airway may lead to fatal respiratory complications. An adequate recovery period is required before patient discharge to ensure complete recovery after Propofol use.

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

Impairment induced by Propofol Baxter is generally not detectable beyond 12 hours.

When advising 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 leave home unaccompanied,
• when they may 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 impairments.

Animal studies in young subjects and clinical data suggest that repeated or prolonged use of anesthetics or sedatives in children under 3 years of age and in pregnant women during the third trimester may have adverse effects on brain development in the child. Parents or guardians should discuss with the physician the benefits, risks, timing, and duration of surgery and other procedures requiring anesthesia or sedatives.

Notes on intensive care management by the physician

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

Additionally, reports have described combinations of the following adverse reactions: metabolic acidosis, rhabdomyolysis, hyperkalemia, hepatomegaly, renal failure, hyperlipidemia, cardiac arrhythmia, Brugada-type ECG (saddleback or upright ST segment, elevations in right precordial leads [V1–V3], and negative T waves), and rapidly progressive cardiac failure generally unresponsive to inotropic supportive treatment.

Combinations of these events are collectively referred to as "propofol infusion syndrome."

These events have occurred primarily in patients with severe traumatic brain injury and in children with respiratory tract infections who received doses exceeding those recommended for adults in intensive care sedation.

The following appear to be major risk factors for developing these events: reduced tissue oxygen delivery; severe neurological injury and/or sepsis; high doses of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropics, and/or propofol (usually propofol doses greater than 4 mg/kg/h for more than 48 hours).

Medical staff should remain vigilant for these potential adverse effects in patients with the above risk factors and consider immediate discontinuation of propofol administration at the first signs of the symptoms described above. All sedative and therapeutic agents used in the intensive care unit (ICU) should be adjusted to maintain optimal oxygen delivery and hemodynamic parameters. Appropriate treatment should be provided for patients with elevated intracranial pressure to maintain cerebral perfusion pressure during treatment modifications. Healthcare professionals are reminded not to exceed the recommended dose of 4 mg/kg/h if possible.

Care should be taken in patients with lipid metabolism disorders or other conditions where lipid emulsions must be used with caution.

If Propofol Baxter is administered to patients who may be at risk of elevated blood lipid levels, monitoring of blood lipid levels is recommended. Propofol administration should be appropriately adjusted if monitoring indicates impaired lipid metabolism. If the patient is concurrently receiving another intravenous lipid, the amount of lipids infused 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 disorders. In such patients, their condition may be exacerbated by anesthesia, surgery, and intensive care. Normothermia, carbohydrate supply, and adequate hydration are recommended in these patients. Early presentation of mitochondrial disorder exacerbation and "propofol infusion syndrome" may be similar.

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

Edetate disodium binds metal ions, including chelated zinc complexes, and thus reduces microbial growth. The need for zinc supplementation during prolonged administration of Propofol Baxter should be considered, especially in patients predisposed to zinc deficiency, such as those with burns, diarrhea, and/or severe sepsis (blood poisoning).

• Children

Propofol Baxter must not be used in children under 3 years of age due to the difficulty in accurately adjusting small volumes of Propofol Baxter in young children.

Propofol must not be used for intensive care sedation in patients aged 16 years or younger, as its safety and efficacy for sedation in this age group have not been established (see section 2.1).

• Elderly patients

Lower doses are required for anesthesia induction with Propofol Baxter in elderly patients. The patient's general 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 maintenance of anesthesia and sedation, infusion rate and target blood concentration of propofol should also be reduced. Further dose and infusion rate reduction is necessary for ASA III and IV patients. Rapid bolus administration (single or repeated) must not be used in this population, as it may cause cardiopulmonary depression.

Use of Propofol Baxter with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor, anesthetist, or healthcare professional if you are taking midazolam (used to induce sedation [a deeply 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:

• inhaled anesthetic agents (inhalational anesthesia),
• analgesics,
• muscle relaxants,
• local anesthetics.

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

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

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 absolutely necessary.

However, Propofol Baxter may be used during induced abortion.

Propofol crosses the placenta and may be associated with respiratory and cardiovascular collapse (depression of vital functions) in neonates. High doses should be avoided (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). Propofol may be used as an anesthetic during termination of pregnancy.

Breastfeeding

Studies in lactating mothers showed that propofol is excreted in small amounts in breast milk. Therefore, women should suspend breastfeeding and discard breast milk for 24 hours after propofol administration.

Fertility

The safety of propofol with regard to fertility has not been established.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use propofol during pregnancy unless absolutely necessary.

You must not breastfeed while receiving propofol, and breast milk should be discarded for 24 hours after receiving propofol.

Driving and using machines

After administration of Propofol Baxter, the patient should be observed for an adequate period of time, and should be warned that the ability to drive and operate machinery may be impaired for some time after administration. Generally, no Propofol Baxter-related impairments are observed beyond 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; hence, essentially "sodium-free."

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

3. How to use Propofol Baxter

Route of administration

For intravenous injection/infusion.

Propofol Baxter must only be administered by physicians specialized in anesthesia or in the care of patients in intensive care. Propofol should not be administered by the same person performing the surgical or diagnostic procedure when used for sedation or anesthesia during such procedures.

Cardiovascular and respiratory functions must be continuously monitored (e.g., ECG, pulse oximetry), and equipment necessary to maintain airway patency, artificial ventilation, and other resuscitation devices must be readily available at all times.

The dose should be individualized according to prior medication and patient response.

Additional analgesics are generally required to prevent injection pain.

Bolus administration of Propofol Baxter is not recommended.

Dosage

The administered dose varies depending on age, body weight, physical condition, and prior medication. Your doctor will administer the appropriate dose to induce 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 event of respiratory arrest, artificial ventilation is required. In the case of a drop in blood pressure, standard measures should be taken, such as lowering the patient's head, possibly plasma substitutes (blood volume expanders), and, if necessary, vasoconstrictor agents.

If you have any further questions about 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 everyone experiences them.

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

Very common: 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 people
Not known: cannot be estimated from the available data

Possible adverse effects:

Induction and maintenance of anaesthesia or sedation with propofol are generally smooth, with minimal evidence of excitation. The most frequently reported adverse effects are hypotension and impaired respiratory centre responsiveness (respiratory depression). The type, severity, and frequency of these effects observed in patients receiving propofol depend on the patient's health status, 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) which may include angioedema, difficulty breathing due to bronchospasm, skin redness, and drop in blood pressure

Metabolism and nutrition disorders

Frequency not known: metabolic acidosis^5, increased blood potassium levels^5, hyperlipidaemia^5

Psychiatric disorders

Frequency not known: euphoric mood during the wakefulness phase; drug abuse and drug dependence^8

Nervous system disorders

Common: spontaneous movements and muscle spasms during induction of anaesthesia, headache during the wakefulness phase
Rare: dizziness, chills, and feeling cold during recovery, epileptic-like seizures with convulsions and opisthotonos 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

Common: bradycardia^1
Very rare: pulmonary oedema
Frequency not known: cardiac arrhythmia^5, cardiac failure^5,7

Vascular disorders

Common: hypotension^2
Uncommon: thrombosis and phlebitis

Respiratory, thoracic and mediastinal disorders

Common: hyperventilation and cough during induction of anaesthesia, transient respiratory arrest during induction of anaesthesia
Uncommon: cough during maintenance
Rare: cough during the recovery phase
Frequency not known: respiratory depression (dose-dependent)

Gastrointestinal disorders

Common: hiccups during induction, nausea and vomiting during recovery
Very rare: inflammation of the pancreas

Hepatobiliary disorders

Frequency not known: hepatomegaly^5, hepatitis (liver inflammation), acute liver failure (symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and liver tenderness (indicated by pain below the front of the rib cage on the right side), sometimes with loss of appetite)

Musculoskeletal and connective tissue disorders

Frequency not known: breakdown of striated muscle fibres (rhabdomyolysis)^3,5

Renal and urinary disorders

Very rare: discoloration of urine after prolonged administration of Propofol Baxter
Frequency not known: renal failure^5

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 common: local pain after the first injection^4
Common: hot flushes during induction of anaesthesia
Very rare: severe tissue reactions and tissue necrosis^9 following accidental extravascular administration
Frequency not known: local pain, swelling, after accidental extravascular administration

Investigations

Frequency not known: changes in ECG (Brugada syndrome)*5,6*

Injury, poisoning and procedural complications

Very rare: fever after surgery

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

Soybean oil may 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 administration of intravenous fluids and a reduction in the infusion rate of Propofol Baxter.

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

4 Can be minimized by concomitant administration of lidocaine and using large forearm veins or veins in the antecubital fossa.

5 The combination of these reactions, also reported as “propofol infusion syndrome,” may be observed in critically ill patients who often have multiple risk factors for developing these events (see section 2.2).

6 Brugada syndrome – elevated ST segment and inverted T wave on ECG.

7 Rapidly progressive cardiac failure (sometimes fatal) in adults. Cardiac failure in these cases usually does not respond to inotropic support therapy.

8 Drug abuse and dependence, primarily among healthcare professionals.

9 Necrosis with impaired tissue viability has been reported.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the container and label after EXP. The expiry 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 or anaesthetist or the hospital pharmacist is responsible for the proper storage, use, and disposal of this medicine.

6. Contents of the pack and other information

Composition of Propofol Baxter

• The active substance is propofol.
• The other components are refined soybean oil, medium-chain triglycerides, glycerol, egg lecithin, sodium hydroxide (to adjust pH), water for injection.

Each milliliter of injectable and perfusion emulsion contains 20 mg of propofol.

Each 50 ml vial contains 500 mg of propofol.

Appearance of the product and contents of the pack

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

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

Pack sizes:

50 ml vials in packs of 1 vial.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

BAXTER HOLDING B.V.

Kobaltweg 49, 3542CE Utrecht

The Netherlands

Manufacturer:

Baxter S.A.

Boulevard René Branquart, 80

7860 Lessines

Belgium

Bieffe Medital S.P.A.,

Via Nuova Provinciale,

IT-23034 GROSOTTO

Italy

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Baxter S.L.

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

This medicine is authorized in the member states of the European Economic Area under the following names:

Germany: Propofol Baxter 20 mg/ml Emulsion zur Injektion/Infusion

Spain: Propofol Baxter 20 mg/ml emulsión inyectable y para perfusión EFG

Date of the most recent review of this leaflet: September 2024

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

Medical Information

This information is intended exclusively for healthcare professionals:

This informational section is a summary of the Summary of Product Characteristics and is limited to instructions for proper handling and preparation. It is not sufficient as a basis to decide whether the medicine may be administered. Please consult the Summary of Product Characteristics for further information.

1. Preparation

Propofol Baxter emulsion for injection/infusion

1. Important information about other ingredients in Propofol Baxter

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

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

1. Handling instructions

Propofol Baxter must only be administered by specialists in anesthesia or in the care of patients in intensive care units. Propofol Baxter should not be administered by the same person performing the diagnostic or surgical procedure when used for sedation or anesthesia.

Cardiovascular and respiratory functions must be continuously monitored (e.g., ECG, pulse oximeter), and devices necessary to maintain airway patency, artificial ventilation, and other resuscitation equipment must be readily available at all times.

1. Information on shelf life after opening or after preparation

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

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

1. Instructions for use

Before use, the surface of the rubber stopper must be cleaned with alcohol spray or an alcohol-moistened swab. The rubber stopper does not contain latex. Vials must be shaken before use. If two layers are observed after shaking, the emulsion must not be used.

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

Propofol Baxter does not contain antimicrobial preservatives and may favor microbial growth due to its composition. The emulsion must be withdrawn aseptically using a sterile syringe or into an administration set immediately after breaking the vial seal. Administration must begin immediately.

Strict aseptic conditions must be maintained for Propofol Baxter and for the perfusion equipment used throughout the entire infusion period. Concomitant administration of any other medication or fluids added to the Propofol Baxter infusion line should be performed close to the cannula. Propofol Baxter must not be administered through perfusion sets containing microbiological filters.

If patients are receiving concomitant intravenous lipid emulsions, the amount of lipids infused as part of Propofol Baxter must be taken into account. 1.0 ml of Propofol Baxter contains 0.1 g of fat.

As is customary with lipid emulsions, the infusion of Propofol Baxter via a perfusion system must not exceed 12 hours. At the end of the procedure or after 12 hours, whichever comes first, any remaining propofol and the infusion line must be discarded or replaced if necessary.

Propofol Baxter must not be mixed with other injectable solutions or infusions. However, it may be added to a continuous infusion of 5% glucose, 0.9% sodium chloride, or glucose (4%)/sodium chloride (0.18%) via a Y-connector at the injection site.

An infusion pump or volumetric pump must be used for perfusion.

To reduce injection site pain during anesthesia induction with Propofol Baxter, lidocaine may be injected immediately before administration.

Neuromuscular blocking agents such as atracurium or mivacurium should only be administered after flushing the same infusion site used for Propofol Baxter.

The contents of a vial and the corresponding perfusion system are for single use in a single patient. Opened vials must be discarded after use.

1. Dosage

General anesthesia in adults

Induction of anesthesia

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

In elderly patients and in patients classified as ASA 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 body weight. Lower administration rates 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 maintenance of anesthesia by continuous infusion, the dose and infusion rate must be individually adjusted. Generally, a dose of 4 to 12 mg of propofol/kg body weight per hour is required to maintain a satisfactory level of anesthesia. A reduced maintenance dose of approximately 4 mg of propofol/kg body weight/h may be sufficient during less stressful surgical procedures, such as minimally invasive surgery.

In elderly patients, patients with unstable general condition, patients with impaired cardiac function or hypovolemia, and patients classified as ASA III and IV, the dose of Propofol Baxter may be further reduced depending on the severity of the patient's condition and the anesthetic technique used.

General anesthesia in children over 3 years of age

Induction of anesthesia

For induction of anesthesia, Propofol Baxter is 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 require approximately 2.5 mg of propofol/kg body weight for anesthesia induction. In younger children, the required dose may be higher (2.5 – 4 mg of propofol/kg body weight). Lower doses are recommended for patients classified as ASA III and IV.

Maintenance of general anesthesia

The required depth of anesthesia can be maintained by administering Propofol Baxter via continuous infusion. The required infusion rate varies considerably between patients, but rates in the range of 9 to 15 mg of propofol/kg body weight/h generally achieve satisfactory anesthesia. In younger children, the required dose may be higher.

Lower doses are recommended for patients classified as ASA III and IV. Experience in children under 3 years of age is inadequate.

Sedation of patients over 16 years of age in intensive care units

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

The administration of Propofol Baxter via Target Controlled Infusion (TCI) systems is not recommended for sedation in intensive care units.

Sedation for diagnostic and surgical procedures in adult patients

During administration of Propofol Baxter, patients must be continuously monitored for signs of hypotension, airway obstruction, and oxygen desaturation, and standard emergency equipment must be readily available.

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

If rapid increase in sedation depth is required, this can be supplemented by bolus administration of 10–20 mg.

Patients classified as ASA III and IV may require lower doses, and the administration rate may need to be reduced. A lower dose may also be necessary in patients over 55 years of age.

Sedation of children over 3 years of age for surgical and diagnostic procedures

The dose and dosing intervals are adjusted according to the required depth of sedation and clinical response. Most pediatric patients require 1 to 2 mg of propofol/kg body weight to initiate sedation. Maintenance of sedation can be achieved by adjusting the Propofol Baxter infusion to the desired depth of sedation. Most patients require between 1.5 and 9 mg of propofol/kg body weight per hour.

Patients classified as ASA III and IV may require lower doses.

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

1. Duration of administration

The duration of administration must not exceed 7 days.

1. Marketing Authorization Holder

Baxter Holding B.V.