Label: Information for the User

Propofol Baxter 10 mg/ml Injectable Emulsion and Infusion Solution EFG

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What is Propofol Baxter and how is it used

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

3. How to use Propofol Baxter

4. Possible adverse 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 the 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 1 month.
• 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 1 month during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.

No use Propofol Baxter

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

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 fat emulsions must be used with moderation. (See notes on intensive care medicine 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 irrigation or hypovolemia should be considered. Propofol clearance 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 predominates, 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, Propofol Baxter may cause involuntary movements in patients when used for sedation during surgical procedures. In procedures that require a motionless 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, administering Propofol Baxter without ensuring an airway may cause fatal respiratory complications. A sufficient 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.

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 based on this, 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 the 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 father or guardian should discuss the benefits, risks, timing, and duration of surgery and other procedures requiring anesthesia or sedation with the doctor.

Notes on Intensive Care Medicine by the Doctor

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, ECG of the Brugada type (ST segment in saddleback or vertical, elevations of the 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 considerimmediate 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 tissue oxygen supply and hemodynamic parameters. Appropriate treatment should be provided to patients with elevated intracranial pressure, with the aim of maintaining cerebral irrigation pressure during these treatment modifications.It is recalled to healthcare professionals 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. Propofol administration should be adjusted accordingly if monitoring indicates altered 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, it is recommended to maintain normothermia, provide carbohydrates, and ensure good hydration. The early presentation of mitochondrial disease exacerbation and "propofol infusion syndrome" may be similar.

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

a) 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. Administering the recommended doses for older children may cause relative overdose and severe cardiovascular depression and respiratory problems. Propofol should not be used for sedation in intensive care in patients 16 years or younger, as its safety and efficacy have not been demonstrated in this age group (see section 2.1).

b) Elderly

In the case of elderly patients, lower doses are required for the 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 selected blood propofol concentration should also be reduced. A further 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 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 agents for anesthesia (inhalation anesthesia
• Analgesics
• Muscle relaxants
• Local anesthetics

With regional anesthesia techniques, smaller doses of Propofol Baxter may be required. No signs of 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. Deep hypotension has been reported after propofol anesthesia induction in patients treated with rifampicin. With additional premedication with opioids, apnea may occur more frequently and for a longer period.

Use of Propofol Baxter with Food, Drinks, and Alcohol

Do not drink alcohol after Propofol Baxter administration.

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 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 (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 may be used as an anesthetic during pregnancy termination.

Breastfeeding

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

Inform your doctor or pharmacist if you are pregnant, breastfeeding, or intend to become pregnant before using this medication.

Fertility

The safety of propofol during fertility has not been established.

Driving and Operating Machines

After Propofol Baxter administration, the patient should be observed for an adequate period of time, and they should be advised that their 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, 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 soy.

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.

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 taken. 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 of the chest in 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

Trauma, poisoning, and complications of therapeutic procedures

Very rare:surgical fever

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 of rapid progression (sometimes 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 through the Spanish System for the 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 ingredient 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 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.

Appearance of the product and contents of the package

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

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

Package sizes:

20-milliliter vials in packages of 5 and 10 vials.

50-milliliter vials in packages of 1 vial.

100-milliliter 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 10 mg/ml Emulsion zur Injektion/Infusion

Spain:Propofol Baxter 10 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 its correct handling and preparation. It is not a sufficient basis for deciding whether the medication can be administered. 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 specialist 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 patient.

Cardiovascular and respiratory functions should be continuously monitored (e.g., ECG, pulse oximeter) and the necessary devices 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 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 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. 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 a single administration of Propofol Baxter 1%.

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

Propofol Baxter does not contain antimicrobial preservatives and may favor 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 should be maintained for Propofol Baxter, as well as for the perfusion equipment used during the entire 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.

Perfusion of propofol 10 mg/ml without dilution:

A syringe pump or volumetric pump should be used for the perfusion ofPropofol Baxterwithout dilution.

As is customary 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.

Perfusion of propofol 10 mg/ml diluted:

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

It can be diluted 1 part of Propofol Baxter with a maximum of 4 parts of 5% glucose solution (minimum concentration of 2 mg of propofol/ml). The ready-to-use mixture should be prepared aseptically immediately before administration and should be used within 6 hours.

Propofol Baxter should not be mixed with other injectable or perfused solutions. However, it can be added to a continuous infusion 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 anesthesia induction, Propofol Baxter can be mixed with lidocaine immediately before administration (20 parts ofPropofol Baxterwith up to 1 part of lidocaine 1%).

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 respective perfusion system are forsingle usein asinglepatient. Opened vials should be discarded after use.

6. 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 signs of anesthesia onset are observed. Most adults under 55 years of age will require a total dose of 1.5 to 2.5 mg of propofol/kg 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 body weight. Lower administration doses 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 perfusion, the dose and perfusion rate should be adjusted for each individual. Generally, the dose is 4 to 12 mg of propofol/kg body weight per hour to maintain a satisfactory level of anesthesia. A reduced maintenance dose of approximately 4 mg of propofol/kg 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 further reduced 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 signs of anesthesia onset 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, especially between 1 month and 3 years, the required dose may be higher (2.5 – 4 mg of propofol/kg body weight). In patients with ASA III and IV, lower doses are recommended (see section 4.4).

Maintenance of general anesthesia

General anesthesia can be maintained by administering Propofol Baxter by perfusion or by repeated injections in bolus to maintain the required depth of anesthesia. The required administration rate varies greatly between patients, but rates in the range of 9 to 15 mg/kg 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 III and IV (see section 2.2).

Sedation of patients over 16 years in intensive care units

For sedation of patients with assisted ventilation in intensive care units, 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 body weight per hour (see section 2.2). Perfusion doses above 4.0 mg of propofol/kg body weight/h are not recommended (see section 2.2).

The use of Propofol Baxter by controlled infusion (TCI) for sedation in intensive care units is not recommended.

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 the usual emergency equipment for accidents should be readily available.

Most patients will require between 0.5 and 1 mg of propofol/kg body weight over 1 to 5 minutes 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 between 1.5 and 4.5 mg of propofol/kg body weight/h.

In case of the need to rapidly increase the depth of sedation, it can be complemented by administering a bolus of 10-20 mg.

Patients with ASA III and IV may require lower doses, and the administration rate may need to be reduced. Older patients may also require lower doses.

Note

In elderly patients, reduced doses for the induction of anesthesia with Propofol Baxter should be used. 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 the maintenance of anesthesia and sedation, the perfusion rate and the selected blood concentration of propofol should also be reduced.

Additional dose reduction and perfusion rate reduction are required in patients with ASA 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 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 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 body weight per hour. In case of the need to rapidly increase the depth of sedation, it can be complemented by administering a bolus of up to 1 mg/kg body weight

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 units.

7. Duration of administration

The duration of administration should not exceed 7 days

8. Marketing authorization holder

Baxter Holding B.V.