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International name

Propofol

Group affiliation

Anesthetic non-inhalant drug

Dosage form

Emulsion for intravenous administration

pharmachologic effect

Product for non-inhalation general anesthesia, which has a fast (after 30-60 s) and short-term effect. Does not have an initial stimulating effect.

Reduces BPSS, BP, MOC, cerebral blood flow, intracranial and intraocular pressure.

The development of sleep is caused by a nonspecific effect on the ion channels of neuronal membranes in the central nervous system. Strengthens GABAergic processes in the brain.

Recovery from anesthesia is usually not accompanied by headache, postoperative nausea or vomiting.

Indications

Induction of anesthesia, maintenance of anesthesia, sedation of patients during mechanical ventilation, surgical and diagnostic procedures.

Contraindications

Hypersensitivity. Caution. Epilepsy, hypovolemia, lipid metabolism disorders, severe decompensated cardiovascular diseases, respiratory system, kidneys and liver, anemia, severely weakened patients, pregnancy, lactation, childhood(up to 3 years – for general anesthesia, up to 16 years – for providing sedative effect during mechanical ventilation).

Side effects

During induction of general anesthesia - decreased blood pressure, bradycardia, short-term apnea, rarely - epileptiform movements (convulsions, opisthotonus), pulmonary edema, pain along the vein during injection.

During the period of awakening - nausea, vomiting, headache.

After prolonged use - change in urine color, anaphylaxis, bronchospasm, skin hyperemia, decreased blood pressure, postoperative fever, sexual disinhibition, at the injection site - thrombosis, phlebitis.

Application and dosage

For induction of anesthesia, regardless of the presence or absence of premedication, adults (with average body weight, with satisfactory general condition) - intravenously, by “titrating” 40 mg every 10 s until the appearance of clinical signs anesthesia.

For most patients under the age of 55 years and patients of ASA (American Society of Anesthesiologists) classes I and II, the dose is 1.5-2.5 mg/kg; over 55 years of age and in patients of ASA classes III and IV, lower doses are 1-1.5 mg/kg (approximately 20 mg every 10 s until induction of general anesthesia).

For children over 8 years of age, IV slowly until clinical signs of sleep onset appear. The dose is selected according to age and/or body weight. Average dose– 2.5 mg/kg; for children under 8 years of age, doses may be higher. Children with anesthesia risk of ASA classes III and IV - in lower doses.

The introductory dose during the initial administration, immediately before administration, is recommended to be mixed with lidocaine for injection in a plastic syringe in the proportion: 20 parts of propofol and 1 part of a 0.5-1% solution of lidocaine hydrochloride. The mixture is prepared under aseptic conditions.

To maintain anesthesia, use either an intravenous drip or a repeated bolus. When performing a continuous infusion, the rate of administration is set individually. Typically, a rate of 4-12 mg/kg/h will maintain adequate anesthesia. With repeated bolus injections, depending on clinical picture anesthesia, prescribed in doses of 25-50 mg.

For children, to ensure adequate general anesthesia, administer at a rate of 9-15 mg/kg/h or through repeated bolus doses required to maintain the required depth of anesthesia.

To provide sedation during the procedure intensive care in patients on mechanical ventilation, it is administered intravenously. The infusion rate is set individually, taking into account the desired depth of sedation. As a rule, an infusion rate of 0.3-4 mg/kg/h ensures satisfactory hypnotic effect. Continuous administration should not exceed 7 days.

Use of official solutions: use plastic syringes or glass bottles for infusion, perfusers or infusion pumps to control the rate of administration. The duration of continuous infusion of undiluted propofol should not exceed 12 hours.

Administration after preliminary dilution: mix 1 part of propofol and 5 parts of a 5% dextrose solution for intravenous infusion in polyvinyl chloride bags or glass bottles. Concentration active substance in a diluted solution should not be less than 2 mg/ml. When breeding in polyvinyl chloride bags, it is recommended to fill the bag completely; preparation of a diluted solution should be carried out by removing the infusion solution and replacing it with an equivalent volume of propofol. The solution is prepared under aseptic conditions immediately before use. The mixture remains stable for 6 hours at a temperature of 2-25 degrees C.

Simultaneous administration of propofol and other solutions using a tee with a valve: 5% dextrose solution for IV infusion, 0.9% NaCl solution or 4% dextrose solution with 0.18% are used as additives or solvents NaCl solution for intravenous infusion. A tee with a valve is placed next to the propofol injection site. The diluted solution is administered using controlled infusion systems or infusion pumps (perfusers). This prevents the risk of uncontrolled administration.

special instructions

The injection should only be given by specially trained personnel, provided that immediate performing mechanical ventilation, oxygen therapy and resuscitation measures in full.

It is necessary to monitor the concentration of lipids in the blood in cases where propofol is prescribed to patients at particular risk of fat retention (if the removal of fats from the body is insufficient, the dosage regimen should be adjusted).

With simultaneous intravenous administration of propofol and other drugs containing lipids, their doses should be adjusted, taking into account that 1 ml of propofol contains 0.1 g of fat.

In cases where there is a possibility of developing side effects associated with activation of the n.vagus, it is advisable to administer an m-anticholinergic blocker intravenously before induction of anesthesia.

Risk of occurrence pain along the vein can be significantly reduced when carrying out infusions through large-diameter veins or with the simultaneous administration of a lidocaine solution.

After using propofol, care must be taken when driving vehicles and engaging in other potentially dangerous activities. dangerous species activities that require increased concentration and speed of psychomotor reactions.

Interaction

It goes well with spinal and epidural anesthesia, with drugs used for premedication, with muscle relaxants and analgesics.

Medicines that reduce heart rate increase the risk of developing severe bradycardia, narcotic analgesics– risk of apnea.

Pharmaceutically incompatible with infusion solutions other drugs, compatible with 5% dextrose solution, lidocaine.

Reviews of the drug Propofol Abbott: 1

Svetlana

After taking propafol (used during a colonoscopy), my vision worsened; blurriness appeared, which went away the next day. Hoarseness appeared, more than a day passed, the situation did not improve. I drank an antiallergic drug.

Write your review

Do you use Propofol Abbott as an analogue or vice versa its analogues?

Catad_pgroup General anesthetics

Propofol 1% Fresenius - official instructions by application

INSTRUCTIONS
by application medicinal product for medical use

Registration number:

Trade name of the drug:

Propofol Kabi

International nonproprietary name:

propofol

Dosage form:

emulsion for intravenous administration

Compound

1 ml contains
active substance: propofol – 10.0 mg; Excipients: soybean oil – 50.0 mg, medium chain triglycerides – 50.0 mg, phospholipids egg yolk– 12.0 mg, glycerol – 22.5 mg, oleic acid 0.4 – 0.8 mg, sodium hydroxide – q.s. (0.05-0.11 mg), water for injection – up to 1 ml.

Description.
White homogeneous emulsion with a weak phenolic odor.

Pharmacotherapeutic group:

Means for non-inhalation general anesthesia.

ATX code N01AX10

Pharmacological properties

Pharmacodynamics
Propofol Kabi 10 mg/ml is a fast-acting intravenous anesthetic for induction and maintenance of general anesthesia, as well as for sedation of patients during intensive care.
After intravenous administration of propofol, the hypnotic effect begins quickly.
Depending on the speed of administration, the time before induction of anesthesia is 30-40 seconds. After a single bolus administration, the duration of action is short (4-6 minutes) due to rapid metabolism and elimination.
Duration of general anesthesia, depending on dose and concomitant medications, ranges from 10 minutes to 1 hour.
The patient awakens from anesthesia quickly and with a clear consciousness. The opportunity to open the eyes appears after 10 minutes, the restoration of the speech response occurs over the next 3 minutes.
Special places no accumulation was detected.
When using Propofol Kabi 10 mg/ml for induction of anesthesia and for its maintenance, a decrease in average values is observed blood pressure and slight changes in heart rate. However, hemodynamic parameters usually remain relatively stable during maintenance of general anesthesia, and the incidence of adverse hemodynamic changes is low.
After administration of Propofol Kabi 10 mg/ml, respiratory depression may occur, but these effects are qualitatively similar topics that arise when using other intravenous agents, for general anesthesia and are easily controlled in clinical settings. Propofol Kabi 10 mg/ml reduces cerebral blood flow, intracranial pressure and reduces cerebral metabolism. The decrease in intracranial pressure can be significant in patients with initial increased value this indicator. Propofol Kabi 10 mg/ml is an emulsion containing the active active substance propofol and a mixture of long chain triglycerides (LCT) and medium chain triglycerides (MCT). Medium chain triglycerides (MCTs) included in the emulsion reduce the amount of free propofol in the aqueous phase of the emulsion, which leads to a decrease in pain during drug administration. In addition, medium chain triglycerides increase metabolism, which leads to a decrease in total concentration triglycerides in plasma.

Pharmacokinetics
Propofol is 98% bound to plasma proteins. The kinetics of propofol after intravenous bolus injection can be represented as a three-part model: fast phase distribution (half-life 2-4 minutes), β-phase elimination (half-life 30-60 minutes) and γ-phase elimination (half-life 200-300 minutes). During the γ-phase, the decrease in the concentration of propofol in the blood occurs slowly due to prolonged redistribution from adipose tissue. In a clinical setting, this phase does not affect the time of awakening. The central volume of distribution is 0.2-0.79 l/kg, the equilibrium volume of distribution is 1.8-5.3 l/kg. Propofol is metabolized primarily by conjugation in the liver, as well as outside the liver, with a clearance of about 2 l/min. Clearance in children is higher than in adults. Half-life after intravenous infusion ranged from 277 to 403 minutes. Inactive metabolites are excreted mostly by the kidneys (about 88%). Only 0.3% of the administered drug is excreted unchanged in the urine.
When general anesthesia was maintained as usual, no significant accumulation of propofol L was observed after surgical procedures lasting at least 5 hours.
Within the recommended infusion rates, the pharmacokinetics of propofol are linear.

Indications for use:

Induction and maintenance of general anesthesia in adults and children over 1 month;
Sedation of patients on mechanical ventilation (ALV) in adults and children over 16 years of age;
Sedation of conscious patients during surgical and diagnostic procedures in conscious adults, as monotherapy or in combination with local anesthesia.

Contraindications

hypersensitivity to propofol or any of the components of the drug;
pregnancy and lactation (up to 24 hours after using propofol);
children up to 1 month;
Propofol Kabi 10 mg/ml is not recommended for use for sedation in children under 16 years of age inclusive;
Propofol Kabi 10 mg/ml is not recommended for use in patients undergoing electroconvulsive therapy.

Carefully
As with other drugs for non-inhalation general anesthesia, caution should be exercised in patients with cardiovascular, respiratory, renal or hepatic disorders, as well as in patients with epilepsy, hypovolemia, lipid metabolism disorders or in debilitated patients.
In patients with impaired cardiac, pulmonary, renal or liver function, elderly and debilitated people, patients with hypovolemia or epilepsy, patients with impaired consciousness, Propofol Kabi 10 mg/ml should be administered at a reduced rate. Before starting the use of Propofol Kabi 10 mg/ml, compensation of cardiovascular or respiratory failure and hypovolemia. Before anesthesia is administered to a patient with epilepsy, it is necessary to ensure that he is receiving antiepileptic therapy. Although several studies have shown the effectiveness of propofol in treating status epilepticus, it may also increase the risk of developing seizures.
In patients with severe heart failure and other severe heart diseases, Propofol Kabi 10 mg/ml should only be administered with extreme caution and under constant monitoring.
Particular caution should be observed in patients with lipid metabolic disorders and other conditions in which fat emulsions must be administered carefully. If the patient receives parenteral nutrition, it is necessary to take into account the amount of fat supplied during the infusion of Propofol Kabi emulsion 10 mg/ml. 1.0 ml of emulsion contains 0.1 g of fat. When treated in the intensive care unit, lipid concentrations should be determined after 3 days. Given the higher dose in obese patients, the risk of hemodynamic disturbances should be taken into account.
Particular care should be taken in patients with high intracranial pressure and low mean arterial pressure, given increased risk significant drop in intracranial perfusion pressure.
Patients with increased intracranial pressure should be given adequate treatment to improve cerebral perfusion pressure.
Particular caution should be observed when using Propofol Kabi 10 mg/ml for anesthesia in newborns and children under 3 years of age, although there is currently no evidence that the pharmacodynamics and pharmacokinetics of propofol in these children differs from those over 3 years of age.

Pregnancy and breastfeeding

Propofol Kabi 10 mg/ml penetrates the placental barrier and may have a depressant effect on the fetus. Contraindicated during pregnancy, as well as in high doses above 2.5 mg/kg for general anesthesia or (6 mg/kg/h) for maintaining anesthesia during delivery.
The exception is operations to terminate a pregnancy.
A small amount of Propofol Kabi 10 mg/ml enters the breast milk. In this regard, breastfeeding is not recommended within 24 hours after administration of Propofol Kabi 10 mg/ml.

Directions for use and doses

Only intravenously.
Propofol Kabi. 10 mg/ml can only be used by anesthesiologists in hospitals or specialized outpatient departments, as well as in intensive care units. When administering Propofol Kabi 10 mg/ml, the physician should have at his disposal the equipment usually used during general anesthesia, including means of monitoring function of cardio-vascular system(ECG, pulse oximetry) and resuscitation equipment. When sedating during surgical and diagnostic procedures, Propofol Kabi 10 mg/ml should not be administered by the same doctor who performs these procedures.
The dose of Propofol Kabi 10 mg/ml must be selected individually, taking into account premedication and the patient's response.
As a rule, when using the drug it is required additional introduction analgesic drugs.
General anesthesia in adults
Introduction to general anesthesia:
When administered under general anesthesia, Propofol Kabi 10 mg/ml should be administered in small doses (approximately 20-40 mg of propofol every 10 seconds) until clinical signs of anesthesia appear.
Usual dose for adults under the age of 55 years is 1.5-2.5 mg/kg body weight.
In older patients and patients with grades III and IV severity of the condition according to the classification of the American Society of Anesthesiologists (ASA). In patients with impaired cardiac function, the dose of Propofol Kabi 10 mg/ml is reduced. The total dose of Propofol Kabi 10 mg/ml can be reduced to a minimum of 1 mg/kg. Slower administration of Propofol Kabi 10 mg/ml is required: approximately 2 ml (20 mg) every 10 seconds.
Maintenance of anesthesia:
To maintain general anesthesia, Propofol Kabi 10 mg/ml is administered continuously by drip or repeatedly in the form of boluses.
To maintain anesthesia by continuous infusion, the dose and rate of administration of Propofol Kabi 10 mg/ml is selected individually, usually 4-12 mg/kg body weight/hour is administered.
For less severe surgical interventions ah, for example, minimally invasive, it is possible to reduce the maintenance dose to approximately 4 mg / kg body weight / hour. Dose reduction below 4 mg/kg body weight/hour is indicated for elderly patients with unstable general condition, patients with impaired cardiac function or hypovolemia and patients with III-IV degree severity of the condition according to the ASA classification. To maintain anesthesia through repeated bolus injections, Propofol Kabi 10 mg/ml should be administered in a dose of 25 to 50 mg, which corresponds to 2.5-5 ml of the drug.
In elderly patients, rapid bolus administration (single or repeated) is not advisable, as it can lead to suppression of cardiac and pulmonary function.
General anesthesia in children older than 1 month
Due to the lack of experience with the use of Propofol Kabi 10 mg/ml, it should not be used for general anesthesia in children under 1 month of age.
Introduction to general anesthesia:
When introducing general anesthesia, it is recommended to slowly titrate the dose of Propofol Kabi 10 mg/ml until clinical signs of general anesthesia appear. The dose is selected taking into account age and/or body weight.
In children over 8 years of age, the dose required to administer general anesthesia is approximately 2.5 mg/kg body weight.
In children younger age The use of the drug begins with a dose of 3 mg/kg. If necessary, additional doses of 1 mg/kg can be administered. For children at risk (ASA grades III and IV), lower doses are recommended.
Maintaining anesthesia.
To maintain anesthesia in children through continuous infusion, the recommended doses of Propofol Kabi 10 mg/ml are 9-15 mg/kg body weight per hour.
Children under 3 years of age may require more high dose within the recommended doses per kilogram of body weight, compared to older children. The dose should be selected individually. Particular attention should be paid to the adequacy of pain relief.
The maximum duration of application should not exceed approximately 60 minutes, except in specific situations requiring more long-term use, for example, malignant hyperthermia, when cannot be used inhalational anesthetics.
Sedation in adults in intensive care units
For sedation during mechanical ventilation in intensive care units, Propofol Kabi 10 mg/ml is recommended to be administered by continuous infusion. The dose is selected taking into account the required depth of sedation. Typically, adequate sedation can be achieved at a propofol administration rate of 0.3-4.0 mg/kg/h. It is not recommended to increase the rate of administration to more than 4.0 mg/kg/h.
Propofol Kabi 10 mg/ml should not be used for sedation in intensive care units in patients 16 years of age or younger.
Sedation for diagnostic and surgical procedures in adults
When sedating during surgical and diagnostic procedures, doses and rates of administration are adjusted based on clinical response. In most patients, sedation begins within 1-5 minutes after administration of propofol at a dose of 0.5-1 mg/kg.
Subsequently, the dose of Propofol Kabi 10 mg/ml is selected taking into account the required depth of sedation. In most patients, the required rate of administration is 1.5-4.5 mg/kg/hour.
If a rapid increase in the depth of sedation is required, in addition to the infusion, it is possible to additionally administer a bolus of propofol 10-20 mg (1-2 ml of Propofol Kabi 10 mg/ml). In patients over 55 years of age and patients with ASA grades III and IV required dose propofol may be lower and the infusion rate should be reduced. Propofol Kabi 10 mg/ml should not be used for sedation during diagnostic and surgical procedures in patients aged 16 years or younger.
Methods of administration.
For intravenous administration.
It is allowed to administer Propofol Kabi 10 mg/ml undiluted.
The ampoule or bottle should be shaken before administration. Use only a homogeneous drug from an intact ampoule or bottle.
Before use, treat the rubber membrane of the bottle or the neck of the ampoule with alcohol.
Dilution of Propofol Kabi 10 mg/ml is recommended only with 5% glucose solution for intravenous administration or 0.9% sodium chloride solution for intravenous administration in glass bottles.
Since Propofol Kabi 10 mg/ml is a fat emulsion that does not contain preservatives and has no antimicrobial activity, the drug can serve as a favorable environment for rapid growth microorganisms.
The emulsion should be drawn into a sterile syringe or dropper immediately after opening the ampoule or vial. Administration of the drug must be started without delay.
During the entire period of administration of Propofol Kabi 10 mg/ml, the rules for aseptic work with the drug and the parenteral infusion system must be observed. When co-administered Propofol Kabi 10 mg/ml with other medicines and solutions in the same system, it is recommended that the latter be administered through a Y-shaped connector or valve.
Propofol Kabi 10 mg/ml cannot be mixed with other solutions for intravenous administration. However, 5% glucose solution, 0.9% sodium chloride solution, or 0.18% sodium chloride solution and 4% glucose solution can be administered simultaneously through the IV cannula.
Propofol Kabi 10 mg/ml cannot be administered through an antibacterial filter.
Propofol Kabi 10 mg/ml droppers containing propofol are intended only for single injection or infusions only one patient individually.
Remains of Propofol Kabi 10 mg/ml emulsion after use should be destroyed
Infusion of undiluted Propofol Kabi 10 mg/ml.
When infusing undiluted Propofol Kabi 10 mg/ml, it is recommended to always use devices to control the volume of the drug administered, such as a drop counter, syringe pumps or volumetric infusion pumps.
When administering fat emulsions, including Propofol Kabi 10 mg/ml, it is recommended to use the same infusion system for no more than 12 hours. After 12 hours of use, the system containing Propofol Kabi 10 mg/ml or the container with the drug should be replaced.
Infusion of diluted Propofol Kabi 10 mg/ml.
For administration of diluted Propofol Kabi 10 mg/ml it is possible to use various options systems for intravenous infusions. However, the use of standard systems does not guarantee against accidental uncontrolled administration of large volumes of diluted popofol.
The IV system should include devices to control the volume of drug administered, such as a drop counter, burette, or volumetric infusion pump. When determining the maximum dilution of the burette, the risk of introducing large doses propofol.
The maximum dilution of Propofol Kabi 10 mg/ml should not exceed 1 part of propofol to 4 parts of 5% glucose solution for intravenous administration or 0.9% sodium chloride solution for intravenous administration (the content of the active substance in the diluted solution should not be less than 2 mg/ml ). The dilution is prepared under aseptic conditions immediately before administration of the drug; the infusion should be completed no later than 6 hours after preparing the dilution.
Propofol Kabi 10 mg/ml should not be diluted with other solutions for infusion or injection. However, co-administration of a 5% glucose solution, 0.9% sodium chloride solution with Propofol Kabi 10 mg/ml through a tee with a valve in close proximity to the injection site is allowed.
To reduce pain at the injection site of Propofol Kabi 10 mg/ml, lidocaine can be administered immediately before the start of infusions.
In addition, before infusion, Propofol Kabi 10 mg/ml can be mixed with preservative-free lidocaine (20 parts propofol and 1 part 1% lidocaine solution). Muscle relaxants such as atracurium besylate and mivacurium chloride can be administered at the site of administration of Propofol Kabi 10 mg/ml only after jet irrigation. The system for administering undiluted Propofol Kabi 10 mg/ml should be replaced at the end of the 12-hour period after opening the ampoule or vial.
Dilution of Propofol Kabi 10 mg/ml with glucose solution for intravenous administration 5% or sodium chloride solution for intravenous administration 0.9% should be carried out under aseptic conditions immediately before infusion, administration should be completed within 6 hours after dilution.
The duration of use should not exceed 7 days.

Side effects

Common side effects of Propofol Kabi 10 mg/ml are decreased blood pressure and suppressed respiratory function. These effects depend on the dose of propofol, as well as the type of premedication and concomitant therapy.
The classification of side effects is as follows:
Very frequent (≥1:10)
Frequent (from ≥1:100 to<1:10)
Uncommon (from ≥1:1000 to<1:100)
Rare (from ≥1:10,000 to<1:1000)
Very rare (<1:10 000); неизвестные (побочные эффекты, частоту которых трудно оценить исходя из доступных данных).
Within each group, undesirable effects are presented in descending order of their clinical significance:
Immune disorders:
Rare:
Anaphylactic reactions, including angioedema, bronchospasm, erythema and decreased blood pressure.
Metabolic disorders:
Frequent:
Hypertriglyceridemia
Mental disorders:
Rare:
Euphoria and increased sexual function during the recovery period.
Neurological disorders:
Frequent:
Spontaneous movements and myoclonus during induction of anesthesia, minimal agitation.
Rare:
Headache, dizziness, chills and cold sensations during the recovery period.
Epileptiform seizures, including convulsions and opisthotonos.
Very rare:
Late epileptiform seizures, developing over several hours or days. Risk of seizures in patients with epilepsy after administration of propofol. Cases of lack of consciousness after surgery.
Cardiac changes/vascular disorders:
Frequent:
During induction of anesthesia, decreased blood pressure, bradycardia, tachycardia, “hot flashes”.
Uncommon:
Marked decrease in blood pressure.
It may be necessary to reduce the rate of administration of Propofol Kabi 10 mg/ml and/or fluid replacement, and, if necessary, vasoconstrictors. The possibility of a sharp decrease in blood pressure in patients with impaired coronary or cerebral blood flow or in patients with hypovolemia should be taken into account. Increasing bradycardia, up to asystole, during general anesthesia. Intravenous administration of m-anticholinergic blockers is possible during induction of general anesthesia or during maintenance anesthesia.
Rare:
Arrhythmia during the recovery period.
Thrombosis and phlebitis.
Changes in the respiratory system, chest and mediastinum
Frequent:
When inducing anesthesia, hyperventilation, transient apnea, cough, hiccups.
Uncommon:
Cough during maintenance anesthesia.
Rare:
Cough during the recovery period.
Very rare:
Pulmonary edema.
Gastrointestinal disorders:
Rare:
Nausea and vomiting during recovery.
Very rare:
Cases of pancreatitis have been described following the administration of propofol, although a cause-and-effect relationship has not been established.
Changes in the skin and subcutaneous tissues:
Very rare:
Severe tissue changes after accidental paravenous injection.
Changes in the kidneys and urinary tract:
Rare:
Change in urine color after prolonged use of propofol.
General and local reactions:
Very common:
Pain at the injection site.
Pain at the propofol injection site can be minimized by simultaneous administration of lidocaine or infusion of the drug into a larger forearm vein or cubital fossa.
When combined with lidocaine, it is rare (from ≥1:10,000 to<1:1000) наблюдались следующие нежелательные эффекты: головокружение, рвота, сонливость, судороги, брадикардия, аритмии сердца и шок.
Rare:
Postoperative fever.
Very rare:
Isolated cases of severe undesirable effects in the form of a complex of symptoms have been described: rhabdomyolysis, metabolic acidosis, hyperkalemia and heart failure, sometimes with death. In most cases, these symptoms were observed in intensive care units in patients receiving doses greater than 4 mg/kg/h.

Overdose

An overdose can lead to depression of the functions of the cardiovascular system and breathing. If the respiratory system is suppressed, artificial ventilation is performed. If the function of the cardiovascular system is impaired, the head of the bed should be lowered and the administration of plasma expanders and/or vasopressors should be started.

Interaction with other drugs

Propofol Kabi 10 mg/ml can be used in conjunction with other drugs usually used for premedication, inhalation anesthesia, analgesics, muscle relaxants or local anesthetics. Some centrally acting drugs may have a suppressive effect on the cardiovascular and respiratory systems and may enhance the effect of propofol. If general anesthesia is combined with local anesthesia, lower doses may be used.
The combined use of benzodiazepines, m-anticholinergics or inhalational anesthetics sometimes causes prolongation of anesthesia and a decrease in respiratory rate.
After premedication with narcotic analgesics, the sedative effect of propofol may be enhanced and prolonged, as well as an increase in the frequency and duration of apnea. It should be taken into account that the use of Propofol Kabi 10 mg/ml during premedication simultaneously with inhalational anesthetics or analgesics may potentiate anesthesia and side effects from the cardiovascular system. The combined use of drugs that suppress the central nervous system, for example, alcohol, general anesthetics, narcotic analgesics, leads to a pronounced manifestation of their sedative effect.
If the administration of Propofol Kabi 10 mg/ml is combined with parenterally administered drugs that depress the central nervous system, severe respiratory and cardiac depression is possible.
After administration of fentanyl, a transient increase in the concentration of propofol in the blood is possible, accompanied by an increase in the likelihood of apnea.
After administration of suxamethonium or neostigmine methyl sulfate, bradycardia and cardiac arrest may occur.
In patients receiving cyclosporine, cases of leukoencephalopathy have been described when administered fat emulsions such as propofol.

special instructions

Propofol Kabi 10 mg/ml does not reduce the tone of the vagus nerve, and its use in some cases is accompanied by bradycardia (sometimes pronounced), as well as asystole.
Before induction or during maintenance of general anesthesia with Propofol Kabi 10 mg/ml, the possibility of intravenous administration of m-anticholinergic agents should be considered, especially in cases of suspected increased vagal tone or when Propofol Kabi 10 mg/ml is used in combination with other drugs that can cause bradycardia.
To relieve pain at the injection site when inducing general anesthesia with Propofol Kabi 10 mg/ml, lidocaine can be administered before administering the drug emulsion. When using lidocaine, it should be taken into account that it cannot be used in patients with hereditary porphyria.
Propofol Kabi 10 mg/ml can only be used by physicians trained in anesthesiology or intensive care.
Propofol Kabi 10 mg/ml should not be administered by personnel performing diagnostic or surgical procedures.
Efficacy and safety of Propofol Kabi. 10 mg/ml has not been studied for (background) sedation in children under 16 years of age. Serious adverse events, including death, have been reported in unapproved use of the drug for (background) sedation in children under 16 years of age, although a causal relationship has not been established. In particular, cases of metabolic acidosis, hyperlipidemia, rhabdomyolysis and/or heart failure have been reported. These effects were most often observed in children with respiratory tract infections receiving doses of the drug in intensive care units that exceeded adult doses. Similarly, rare cases of metabolic acidosis, rhabdomyolysis, hyperkalemia, and/or rapidly progressive heart failure (in some cases fatal) have been reported in adults treated for longer than 58 hours at rates greater than 5 mg/kg/hour. This rate exceeds the maximum rate of 4 mg/kg/hour recommended for use of the drug for the purpose of sedation of patients in intensive care units.
Heart failure in such cases is usually not responsive to maintenance therapy with inotropes.
If possible, the dose of 4 mg/kg/hour should not be exceeded, which is usually sufficient for sedation of patients on mechanical ventilation in intensive care units (for treatment durations of more than 1 day). It is necessary to be wary of these side effects, and at the first sign of their occurrence, reduce the dose or switch to other sedatives.
The rate of administration of Propofol Kabi 10 mg/ml should also be reduced in patients with congenital dementia, patients with epilepsy, with impaired function of the heart, lungs, liver and kidneys, and with hypovolemic conditions.
In some cases, after using Propofol Kabi 10 mg/ml, a period of postoperative unconsciousness of the patient was observed, accompanied by increased muscle tone. Although consciousness returns spontaneously, patients who are unconscious require careful monitoring.
Before discharging the patient from the clinic, you should ensure that he has fully recovered from general anesthesia.
Propofol Kabi 10 mg/ml contains soybean oil, which in rare cases can cause severe allergic reactions.
This medicinal product contains less than 1 mmol of sodium (23 mg sodium) per 100 ml, which makes it practically a sodium-free medicinal product.
During the entire infusion period, the principles of asepsis should be observed both in relation to the drug Propofol Kabi 10 mg/ml and in relation to the infusion equipment. Parallel administration of other drugs through the infusion system for Propofol Kabi 10 mg/ml should be carried out as close to the cannula as possible. Propofol Kabi 10 mg/ml and all infusion equipment for its administration can be used only once and only for one patient.

Driving a car and working with machinery

After administration of Propofol Kabi 10 mg/ml, the patient should be under medical supervision for an appropriate period of time. The patient should be informed that he should not drive vehicles or machinery, should avoid drinking alcohol and working in potentially hazardous conditions on the day of taking the drug.
The patient can be sent home only with an accompanying person.

Release form

Emulsion for intravenous administration 10 mg/ml.
15 ml or 20 ml in type I colorless glass ampoules (Eur. Pharm.). marked with a dot. 5 or 10 ampoules in cardboard or plastic blisters along with instructions for use in a cardboard box.
50 ml in bottles of colorless glass type 11 (Eur. Pharm.), sealed with halobutyl rubber stoppers and rolled aluminum caps with plastic lids to control the first opening (Eur. Pharm.). 1, 5 or 10 bottles along with instructions for use in a cardboard box.

Vacation conditions

Dispensed with a doctor's prescription.
Use only in hospital settings.

Storage conditions

Store at a temperature not exceeding 25° C.
Do not freeze.
Keep out of the reach of children.

Best before date

3 years.
Do not use after expiration date.

Applicant/Manufacturer

Fresenius Kabi Deutschland GmbH, D-61346, Bad Homburg w.d.H, Germany.
Manufactured by Fresenius Kabi Austria GmbH, Austria. Graz, Hafnerstrasse 36, 8055.

Claims should be sent to the Representative Office in Russia at:
125167, Moscow, Leningradsky Prospekt, 37, building 9

Gross formula

C12H18O

Pharmacological group of the substance Propofol

Nosological classification (ICD-10)

CAS code

2078-54-8

Pharmacology

pharmachologic effect- anesthetic, sedative.

It has a nonspecific effect at the level of lipid membranes of CNS neurons. Does not have an initial stimulating effect. Recovery from anesthesia is usually not accompanied by headache, postoperative nausea or vomiting. In most patients, general anesthesia occurs within 30-60 seconds. The duration of anesthesia, depending on the dose and accompanying drugs, ranges from 10 minutes to 1 hour. From anesthesia, the patient awakens quickly and with a clear consciousness, the opportunity to open his eyes appears after 10 minutes.

It is well distributed and quickly eliminated, clearance varies from 1.6 to 3.4 l/min in an adult weighing 70 kg. T1/2 after IV infusion - from 277 to 403 minutes. The kinetics of propofol after IV bolus infusion can be represented as a three-part model: fast distribution phase (T 1/2 - 2-4 min), β-phase elimination (T 1/2 - 30-60 min) and γ-phase elimination (T 1/2 - 200-300 min). During the γ-phase, the decrease in drug concentration in the blood occurs slowly due to prolonged redistribution from adipose tissue. Plasma protein binding - 97%. Metabolized primarily by conjugation in the liver, as well as outside the liver. Inactive metabolites are excreted primarily by the kidneys (about 88%). It overcomes histohematic barriers well, incl. placental, BBB. Passes into breast milk in small quantities. When anesthesia was maintained as usual, no significant accumulation of propofol was observed after surgical procedures lasting up to 5 hours.

Use of the substance Propofol

Induction of anesthesia, maintenance of general anesthesia; sedation of patients during mechanical ventilation, surgical and diagnostic procedures.

Contraindications

Hypersensitivity, children's age: up to 1 month - for induction of anesthesia and maintenance of anesthesia, up to 16 years - to provide sedation during intensive care.

Restrictions on use

Epilepsy, hypovolemia, lipid metabolism disorders, severe decompensated diseases of the cardiovascular system, respiratory system, kidneys and liver, anemia, in elderly and weakened patients, pregnancy, lactation.

Use during pregnancy and breastfeeding

Propofol crosses the placental barrier and may have a depressant effect on the fetus. Contraindicated during pregnancy, as well as in high doses for anesthesia during delivery (except for termination of pregnancy).

Data from studies conducted in nursing mothers indicate that small amounts of propofol pass into breast milk. It is not considered to pose a risk to the infant if the mother begins breastfeeding within a few hours of propofol administration.

Side effects of the substance Propofol

Decreased blood pressure, bradycardia (sometimes severe), short-term respiratory arrest, shortness of breath; rarely - convulsions, opisthotonus, pulmonary edema; during the period of awakening - headache, nausea, vomiting, postoperative fever (rarely); local - pain at the injection site, rarely - phlebitis and vein thrombosis.

Interaction

Compatible with drugs for spinal and epidural anesthesia, with drugs used for premedication, with muscle relaxants and analgesics.

Overdose

Symptoms: depression of the cardiovascular and respiratory systems.

Treatment: symptomatic against the background of mechanical ventilation (oxygen), maintaining hemodynamics (administration of fluids and vasopressors).

Routes of administration

Precautions for the substance Propofol

In cases where there is a possibility of developing side effects associated with activation of the vagus nerve, it is advisable to administer an anticholinergic drug intravenously before induction of anesthesia. Should not be used in obstetric practice, because propofol penetrates the placental barrier and can cause neonatal depression (may be used in the first trimester during abortion operations).

The risk of pain along the vein can be significantly reduced when infusions are administered through large-diameter veins or with the simultaneous administration of lidocaine solution. The injection can only be given by specially trained personnel if it is possible to immediately use mechanical ventilation, oxygen therapy, and full resuscitation measures.

Interactions with other active ingredients

Trade names

Name	The value of the Vyshkowski Index ®
	0.0103

Instructions:

1 ml of emulsion for injection contains propofol 10 mg; in an ampoule 20 ml, in a blister pack 5 ampoules.

pharmachologic effect

Pharmacological action - anesthesia.

Pharmacodynamics

Causes a rapid (within about 30 s) onset of medicated sleep.

Indications for Propofol Abbott

General anesthesia; providing a sedative effect in critical conditions during mechanical ventilation.

Contraindications

Hypersensitivity.

Side effects of Propofol Abbott

During induction of anesthesia: hypotension, apnea; while maintaining anesthesia: epileptiform movements, convulsions, opisthotonus, change in urine color, bradycardia, asystole, hypovolemia; rarely - pulmonary edema, signs of anaphylaxis (bronchospasm, erythema); upon awakening: nausea, vomiting, headache, fever, sexual disinhibition.

Interaction

Enhances the effect of bradycardic drugs.

Directions for use and doses

IV, by titration method (until clinical signs of anesthesia appear). Adults: during induction of anesthesia - 2-2.5 mg/kg (under the age of 55 years) 4 ml every 10 s, 1.5 mg/kg (over the age of 55 years) 2 ml every 10 s; to maintain anesthesia - 4-12 mg/kg (continuous IV infusion), 2.5-5 ml (repeated bolus injections); to ensure a sedative effect - with an infusion rate of 1-4 mg/kg/h (sedation is provided for 48 hours).

Children over 3 years of age: for induction of anesthesia - 2.5 mg/kg, for the purpose of maintaining anesthesia - at an infusion rate of 9-15 mg/kg/h or bolus.

Precautionary measures

Use with caution for anesthesia in patients with epilepsy (convulsions may develop), diseases of the cardiovascular system, kidneys, liver, decreased blood volume or severely weakened. When maintaining anesthesia by continuous or bolus administration in patients with lipid metabolism disorders, it is necessary to monitor blood lipids and, if they increase, reduce the dose.