Leaflet: information for the user

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

Read this 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, consult your doctor, pharmacist or nurse.

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

1. What is Propofol Baxter and how it is used

2. What you need to know before starting to use Propofol Baxter

3. How to use Propofol Baxter

4. Possible side effects

5. Storage of Propofol Baxter

6. Contents of the package and additional information

Propofol Baxter is a short-acting anesthetic that is injected into a vein.It belongs to a group of medications known as “general anesthetics” (narcotics). General anesthetics are used to produce unconsciousness (a type of sleep) while operations or other treatments are being performed. They can also be used to sedate patients (to make them feel drowsy, but not completely asleep).

Propofol Baxter is used for:

• To initiate and maintain anesthesia in adults and children over 3 years old.
• To sedate (calm) patients over 16 years old who are on mechanical ventilation in the intensive care unit (ICU).
• To sedate adults and children over 3 years old during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia

No use Propofol Baxter

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

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

Propofol Baxter should be administeredmore 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).

Before administration, any cardiac, circulatory, and respiratory insufficiency and hypovolemia should be treated if possible.

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

Patients with severe heart disease should be administered Propofol Baxter with caution and under controlled conditions.

The use of Propofol Baxter in people 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 rate slows down) with occasional severe consequences (cardiac arrest). Therefore, the 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 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.

Like other sedatives, when Propofol Baxter is used for sedation during surgical procedures, involuntary movements of the patient may occur. In procedures that require an immobile patient, these movements may pose a risk to the success of the operation.

Abuse and dependence on propofol have been reported, primarily by healthcare professionals. Like other general anesthetics, administration of Propofol Baxter without ensuring an airway may cause fatal respiratory complications. A suitable period should be allowed before discharge to ensure complete recovery after the use of Propofol.

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

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

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

-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 the deficiencies.

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

Notes onintensive care bythedoctor

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

Additionally, reports have been received of combinations of the following adverse reactions: metabolic acidosis, rhabdomyolysis, hyperkalemia, hepatomegaly, renal insufficiency, hyperlipidemia, cardiac arrhythmia, Brugada ECG (ST segment elevation or vertical, elevated right precordial leads [V1V3] and negative T wave) and rapidly progressive heart failure that generally does not respond to inotropic support.

These combinations of events are also known as "propofol infusion syndrome".

These events were observed mainly in patients with severe head trauma 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 tissue oxygen supply; severe neurological damage and/or sepsis; High doses of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropes, and/or propofol (usually at propofol doses greater than 4 mg/kg/h for more than 48 hours).

The medical team should remain alert to these possible adverse effects in patients with the above risk factors and consider theimmediate interruptionof propofol administration at the first signs of the symptoms mentioned above. All sedatives 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 modifications of treatment.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 have a risk of elevated blood lipid levels, it is recommended to monitor blood lipid levels. Propofol administration should be adjusted accordingly, if the monitoring indicates an alteration of lipid metabolism. If the patient is receiving concomitantly another intravenous lipid, the amount of lipid perfused as part of Propofol Baxter should be taken into account. 1.0 ml of propofol contains 0.1 g of fat.

Additional information

Care should be taken 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, normothermia should be maintained, carbohydrates should be provided, and good hydration should be ensured. The early presentation of mitochondrial disease exacerbation and "propofol perfusion syndrome" may be similar.

Propofol Baxterdoes not contain antimicrobial preservatives and may allow the growth of microorganisms due to its composition.

Sodium edetate binds to metal ions, including zinc chelate complexes, and therefore reduces the growth of microorganisms. The need for zinc supplements 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).

a) Children

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

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

b) Elderly

In elderly patients, lower doses are required for induction of anesthesia with Propofol Baxter. 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, the infusion rate and the selected blood propofol concentration should also be reduced. An additional reduction in dose and infusion rate is required for patients with ASA III and IV grades. In this population, rapid bolus administration (single or repeated) should not be used, as it may cause cardiopulmonary depression.

Use of Propofol Baxter and other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

Specifically, inform your doctor, anesthesiologist, or healthcare professional if you are takingmidazolam (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 agents for anesthesia (inhalation anesthesia
• Analgesics
• Muscle relaxants
• Local anesthetics

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

Some of the agents mentioned may reduce blood pressure or affect respiration and, therefore, may cause cumulative effects when Propofol Baxter is used. A deep drop in blood pressure 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 period.

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 can be used during induced abortion.

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

Lactation

Studies in lactating mothers showed that propofol is eliminated in small amounts through breast milk. Therefore, women should suspend lactation and discard breast milkfor 24 hours after propofol administration.

Fertility

The safety of propofol during fertility has not been established.

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

Do not use propofol unless absolutely necessary if you are pregnant.

Do not breastfeed while receiving propofol and discard breast milk for 24 hours after receiving propofol.

Driving and operating machinery

After administration of Propofol Baxter, the patient should be observed for an adequate period of time, and they should be advised that their ability to drive and operate machinery 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, they should be accompanied by another person.

Propofol Baxter contains sodium and soybean oil (E322)

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

Propofol Baxter contains soybean oil. Do not use this medication in case of allergy to peanuts or soybeans.

Administration Form

For intravenous injection/infusion.

Propofol Baxter must only be administered by specialist anesthesiologists or in intensive care unit patients. Propofol must not be administered by the same person performing the surgical procedure or diagnostic technique when used for sedation or anesthesia in the same setting.

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

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

Additional analgesics are generally required to prevent pain during injection.

It is not recommended to administer Propofol Baxter boluses

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, breathing, etc.).

If you use more Propofol Baxter than you should.

Circulatory and respiratory depression may occur. In the event of respiratory arrest, artificial respiration is required, and in the event of a drop in blood pressure, standard 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 other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The 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

Unknown:cannot be estimated from available data

Possible side effects:

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

Immune system disorders

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

Metabolism and nutrition disorders

Unknown frequency:metabolic acidosis5, elevated blood potassium levels5, hyperlipidemia5

Mental and behavioral disorders

Unknown frequency:euphoric mood during the wakeful phase; drug abuse and dependence8

Nervous system disorders

Common:spontaneous movements and muscle spasms during anesthesia induction, headache during the wakeful phase

Rare:dizziness, chills, and sensation of cold during recovery, seizures similar to epilepsy with convulsions and opisthotonus during induction, maintenance, and recovery (very rarely delayed for hours to a few days).

Very rare:postoperative unconsciousness (see section 2.2)

Unknown frequency:involuntary movements

Cardiac disorders

Common:bradycardia1

Very rare:pulmonary edema

Unknown frequency:cardiac arrhythmia5, acute heart failure5,7

Vascular disorders

Common:hypotension2

Uncommon:thrombosis and phlebitis

Respiratory, thoracic, and mediastinal disorders

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

Uncommon:cough during maintenance

Rare:cough during the recovery phase

Unknown frequency:respiratory depression (dose-dependent)

Gastrointestinal disorders

Common:hiccups during induction, nausea and vomiting during recovery.

Very rare:pancreatitis

Hepatobiliary disorders

Unknown frequency:hepatomegaly5hepatitis (liver inflammation), acute liver failure (symptoms may include yellow skin and eyes, itching, dark urine, stomach pain, and sensitivity in the liver (indicated by pain below the front part of the chest on the right side), sometimes with loss of appetite).

Musculoskeletal and connective tissue disorders

Unknown frequency:breakdown of striated muscle fibers (rhabdomyolysis)3,5

Renal and urinary disorders

Very rare:urine discoloration after prolonged administration of Propofol Baxter

Unknown frequency:renal insufficiency5

Reproductive and breast disorders

Very rare:sexual disinhibition

Unknown frequency:prolonged and often painful erection (priapism)

General disorders and administration site conditions

Very common:local pain after the first injection4

Common:tingling during anesthesia induction

Very rare:severe tissue reactions and tissue necrosis9after accidental extravascular administration

Unknown frequency:local pain, swelling, after accidental extravascular administration

Investigations

Unknown frequency:ECG changes (Brugada syndrome)5,6

Injury, poisoning and procedural complications

Very rare:surgical site infection

The following side 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.

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

2Hypotension may occasionally require the use of intravenous fluids and a reduction in the rate of Propofol Baxter administration.

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

4May be minimized by concomitant administration of lidocaine and using thick veins of the forearm or antecubital fossa.

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

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

7Acute heart failure (often fatal) in adults. Heart failure in these cases usually does not respond to supportive treatment with inotropes.

8Drug abuse and dependence, mainly by healthcare professionals.

9Necrosis with tissue viability alteration has been reported.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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

Storage Conditions

Do not store at a temperature above 25°C.

Do not freeze.

Once opened, the product must be used immediately.

Your doctor or anesthesiologist or the hospital pharmacist is responsible for proper storage, use, and disposal of the medication.

Composition of Propofol Baxter

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

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

Each 50-milliliter vial contains 500 mg of propofol.

Appearance of the product and contents of the package

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

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

Package sizes :

50-mL vials in packages of 1 vial.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

BAXTER HOLDING B.V.

Kobaltweg 49, 3542CE Utrecht

Holland

Responsible manufacturer:

UAB NORAMEDA

Didzioji vandens g. 7-8

91246 Kleipeda, Lithuania

Bieffe Medital S.P.A.,

Via Nuova Provinciale,

IT- 23034 GROSOTTO

Italy

For more information about this medication, please contact the local representative of the marketing authorization holder:

Baxter S.L.

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

This medication is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: September 2024

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es

Medical information

This information is intended solely for healthcare professionals:

This informative section is a summary of the Technical Dossier of the medication and is limited to the instructions for correct handling and preparation. It is not a sufficient basis for deciding whether the medication can be administered. Please consult the Technical Dossier for more information.

1. Preparation

Propofol Baxter emulsion for injection/infusion

2. Important information about other ingredients of Propofol Baxter

Sodium: This medication 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 soybeans, do not use this medication.

3. Handling instructions

Propofol Baxter should only be administered by specialized anesthesiologists or 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 in the same procedure.

Cardiovascular and respiratory functions should be continuously monitored (e.g., ECG, pulse oximeter), and the necessary equipment for maintaining open airways, artificial ventilation, and other resuscitation devices should be readily available.

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

The duration of perfusion of Propofol 10 mg/ml without dilution through 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 a single administration of Propofol Baxter.

5. Instructions for use

Before use, the surface of the rubber stopper should be cleaned with alcohol spray or a moistened swab with alcohol. 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.

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 aspirated aseptically using a sterile syringe or in an administration device immediately after breaking the seal of the vial. Administration should be initiated immediately.

Strict aseptic conditions of Propofol Baxter, as well as the perfusion equipment used, must be maintained throughout the perfusion period. Concomitant administration of any other medication or fluids added to the perfusion line of Propofol Baxter should be performed near the cannula. Propofol Baxter should not be administered through perfusion equipment containing microbiological filters.

If patients receive concomitant other intravenous lipids, the amount of lipids perfused as part of Propofol Baxter should be taken into account. 1.0 ml of Propofol Baxter contains 0.1 g of fat.

As with lipid emulsions, perfusion 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 perfusion line should be discarded or replaced if necessary.

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

A perfusion pump or volumetric pump should be used for perfusion.

To reduce pain at the injection site during induction of anesthesia with Propofol Baxter, lidocaine can be injected immediately before administering it.

Relaxants such as atracurium or mivacurium should only be administered after flushing the same perfusion 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 should be discarded after use.

6. Posology

General anesthesia in adults

Induction of anesthesia

For the induction of general anesthesia, the dose of Propofol Baxter should be adjusted to 20 to 40 mg of propofol per 10 seconds, depending on 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 patients over 55 years of age and in patients with ASA III and IV (American Society of Anesthesiologists), especially those with cardiac dysfunction, the total dose of Propofol Baxter may need to be reduced to 1 mg of propofol/kg of body weight. Lower doses of Propofol Baxter administration (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 general anesthesia by continuous perfusion, the dose and perfusion 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 for less stressful surgical procedures, such as minimally invasive surgery.

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

General anesthesia in children over 3 years

Induction of anesthesia

For the 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 will require approximately 2.5 mg of propofol/kg of body weight for the induction of anesthesia. In younger children, the required dose may be higher (2.5-4 mg of propofol/kg of body weight). In patients with ASA III and IV, lower doses are recommended.

Maintenance of general anesthesia

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

Lower doses are recommended for patients with ASA III and IV. Experience with children under 3 years is inadequate

Sedation of patients over 16 years in the intensive care unit

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

Sedation in the intensive care unit is not recommended using the Perfusión Controlada Dirigida (TCI) system.

Sedation for diagnostic and surgical procedures in adult patients

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

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 regulating the perfusion rate 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 rapid deepening of sedation is necessary, it can be complemented by administering a bolus of 10-20 mg.

Patients with ASA III and IV may require lower doses, and the perfusion rate may need to be reduced. Patients over 55 years of age may also require lower doses.

Sedation of children over 3 years for surgical and diagnostic procedures

The dose and intervals between doses should be adjusted according to the required depth of sedation and clinical response. Most pediatric patients will 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 perfusion rate of Propofol Baxter to the desired depth of sedation. Most patients will require 1.5 to 9 mg of propofol/kg of body weight/h.

Patients with ASA III and IV may require lower doses.

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

7. Duration of administration

The duration of administration should not exceed 7 days.

8. Marketing authorization holder

Baxter Holding B.V.