Propofol-Binergia - instructions for use, doses, side effects, contraindications

Excipients: soybean oil - 50.0 mg, medium chain triglycerides (medium chain triglycerides) - 50.0 mg, egg lecithin (egg yolk phospholipids) 12.0 mg, glycerol 25.0 mg, sodium oleate 0.30 mg, water for injection up to 1 ml.

Description:

The emulsion is white or almost white with a slight characteristic odor.With prolonged standing, a slight stratification may disappear, disappearing after shaking.

Pharmacotherapeutic group:Means for non-induction general anesthesia

ATX: & nbsp

N.01.A.X Other drugs for general anesthesia

N.01.A.X.10 Propofol

Pharmacodynamics:

Propofol (2,6-bis (1-methylethyl)phenol) is a short-acting agent for general anesthesia with a rapid onset of action for about 30 to 40 seconds. The duration of action after a single bolus is short and, depending on the metabolism and ability to excrete, is 4 to 6 minutes. Usually the output from general anesthesia occurs quickly.

The mechanism of action of propofol, as well as of all agents for general anesthesia, is not clear enough.

As a rule, with the use of propofol for introductory anesthesia and for maintaining it, a decrease in the mean arterial pressure and a slight change in the heart rate are observed. However, hemodynamic parameters usually remain relatively stable during maintenance of anesthesia and the frequency of adverse hemodynamic changes is low.

Although after the introduction of the drug may occur respiratory depression, any of these effects are qualitatively similar to those,that arise when other intravenous anesthetics are used and are easily amenable to clinical control.

Propofol reduces cerebral blood flow, intracranial pressure and reduces cerebral metabolism. The decrease in intracranial pressure is more pronounced in patients with initially increased intracranial pressure.

The withdrawal from anesthesia usually occurs quickly, with a clear consciousness and a low probability of a headache. As a rule, after anesthesia with propofol, cases of postoperative nausea and vomiting occur less frequently than after inhalation anesthesia. Perhaps this is due to the antiemetic effect of propofol.

Propofol at concentrations usually reached in clinical conditions does not suppress the synthesis of hormones of the adrenal cortex.

Propofol-Binergiya is an emulsion containing in its composition a mixture of medium- and long-chain triglycerides. The medium-chain triglycerides included in the emulsion reduce the amount of free propofol in the aqueous phase of the emulsion, which leads to a reduction in soreness when the preparation is administered.In addition, medium chain triglycerides increase metabolism, which leads to a decrease in the total concentration of triglycerides in the blood.

Pharmacokinetics:

Propofol binds 98% to plasma proteins.

The propofol kinetics after intravenous bolus injection or stopping infusion can be presented as an open three-chamber model. The first phase of rapid distribution (half-life 2-4 minutes), the second phase of rapid elimination (half-life 30 - 60 minutes). This is followed by a slower final phase (half-life of 200-300 minutes), which is characterized by the redistribution of propofol from mildly perfused tissue into the blood.

Propofol is rapidly distributed and rapidly excreted from the body (total clearance is 1,5-2 l / min). Excretion is carried out by metabolism mainly in the liver, resulting in the formation of propofol conjugates and the corresponding quinol, which is excreted by the kidneys (88% of the administered dose - in the form of metabolites, about 0.3% of the dose - in unchanged form).

When propofol is used to maintain anesthesia, its concentration in the blood asymptotically reaches an equilibrium value corresponding to the rate of administration.Within the recommended infusion rates, the pharmacokinetics of propofol is linear.

Indications:

- Induction and maintenance of general anesthesia;

- sedation of patients receiving intensive therapy and being on artificial ventilation (IVL);

- sedation of patients who are conscious, during diagnostic and surgical procedures.

Contraindications:

- Hypersensitivity to propofol, soy, peanuts or any of the components of the drug;

- induction and maintenance of general anesthesia in children younger than 1 month;

- sedation of patients under the age of 16 years who are on mechanical ventilation during intensive therapy;

- sedation of patients under 1 month of age who are conscious while performing surgical and diagnostic procedures;

- pregnancy, and also use in obstetrical practice, except for the termination of pregnancy in the first trimester;

- the period of breastfeeding.

Carefully:

As with other agents for non-general anesthesia, caution should be exercised in patients with cardiovascular, respiratory, renal or hepatic impairment, as well as in patients with epilepsy, hypovolemia, lipid metabolism disorders, or in weakened patients.

Pregnancy and lactation:

Pregnancy

The drug should not be used during pregnancy. but propofol can be used during abortion in the first trimester.

Obstetrics

The drug penetrates the placental barrier and can exert a depressing effect on the fetus. Do not use in obstetrics as an anesthetic.

Breastfeeding period

For infants who are breastfed, the safety of propofol in breastfeeding women has not been established. In this regard, it is not recommended to breast-feed during the use of the drug Propofol-Binergiya.

Dosing and Administration:

The drug Propofol-Binergia is combined with spinal and epidural anesthesia; with drugs commonly used for premedication; with muscle relaxants, means for inhalation anesthesia and analgesics, while there was no pharmacological incompatibility. Lower doses of Propofol-Binergia may be required in cases where general anesthesia is used as a supplement to the methods of regional anesthesia used.

The dose of the drug must be selected individually, taking into account the premedication and the patient's response.

ADULTS

Induction of general anesthesia

Propofol can be used to induce anesthesia through slow bolus injections or infusion. Regardless of whether premedication has been or is not performed, it is recommended to titrate the dose of the drug (as a bolus injection or infusion of approximately 40 mg (4 mL) every 10 seconds for adult patients with satisfactory health status), depending on the patient's response to clinical signs of anesthesia . For most adult patients under 55 years of age, the dose is 1.5 to 2.5 mg / kg. The required total dose can be reduced by reducing the rate of administration (from 2 to 5 ml (20-50 mg / min)). For patients over the age of 55 years, a dose, as a rule, is required. Patients III and IV grades on a scale ASA (American Society of Anesthesiologist - American Society of Anesthesiologists) should inject the drug at a lower rate (approximately 2 ml (20 mg) every 10 seconds).

Maintaining general anesthesia

Anesthesia can be maintained by administering Propofol-Binergia by continuous infusion or repeated bolus injections to prevent signs of insufficient anesthesia.Normalization of the state after anesthesia occurs, as a rule, quickly, so it is important to maintain the introduction of the drug Propofol-Binergia before the end of the procedure.

Continuous infusion

The required rate of administration varies considerably depending on the individual characteristics of the patients, but, as a rule, the speed within 4-12 mg / kg / h provides adequate anesthesia.

With less stressful surgical interventions, for example, minimally invasive, usually a maintenance dose of about 4 mg / kg / h is usually sufficient.

Elderly patients, patients with unstable general condition, with impaired cardiac function, hypovolemia and patients III - IV classes of risk by classification ASA the dose can be reduced (the recommended dose is 4 mg / kg / h), depending on the severity of the condition and the method of anesthesia.

Repeated bolus administration

If a technique involving repeated bolus injections is used, then the administration of increasing doses from 25 mg (2.5 ml) to 50 mg (5 ml) is made according to clinical need.

In elderly patients, rapid bolus administration (single or multiple) is not advisable, since it can lead to depression of cardiac and respiratory activity.

Sedation during intensive care

To ensure a sedative effect in intensive care, it is recommended to administer the drug by continuous infusion. The rate of infusion should depend on the necessary depth of sedation. For most patients, a sufficient sedative effect can be achieved with the administration of the drug at a dose of 0.3-4 mg / kg / h. The upper limit of the rate of infusion to ensure sedation in resuscitation should not exceed 4 mg / kg / h, unless the benefit exceeds the risk of side effects. The drug Propofol-Binergiya is not indicated for providing a sedative effect in the intensive care of patients under the age of 16 years.

The introduction of the drug with the help of the ICC system (infusion of the target concentration) for sedation of patients during intensive therapy is not recommended.

Sedation of patients who are conscious, during surgical and diagnostic procedures

The introduction of the drug Propofol-Binergia with the help of the ICC system for sedation with preservation of consciousness is not recommended.

To ensure sedation during surgical or diagnostic procedures, propofol can be used alone or in combination with local or conduction anesthesia.The rate of drug administration and dose should be selected individually and titrated depending on the clinical response. For most patients, the onset of a sedative effect requires the administration of 0.5 to 1 mg / kg for 1 to 5 minutes.

Maintenance of sedative effect can be provided by titrating infusion of the drug to the required level of sedative effect; for most patients, 1.5 to 4.5 mg / kg / h is needed. If a rapid increase in the depth of sedation is required, bolus administration of 10 to 20 mg may be recommended as an adjunct to the infusion. For patients older than 55 years and for patients III - IV class of risk by classification ASA it may be necessary to reduce the dose and the rate of administration of the drug.

CHILDREN

The introduction of propofol to children with the help of the ICC system is not recommended for any indication.

Induction of general anesthesia

Propofol-Binergiya is not recommended for the induction of anesthesia in children under 1 month of age. When used as an initial anesthetic for children, the drug Propofol-Binergia is recommended to be administered slowly until the appearance of clinical signs of anesthesia.The dose should be adjusted according to age and / or body weight.

For most children from the age of 8 years, in general, approximately 2.5 mg / kg is needed for induction. For children under the age of 8 years, especially at the age of 1 month to 3 years, the required dose may be higher (2.5-4 mg / kg).

For children III - IV classes of risk by classification ASA reduced doses are recommended.

Maintaining general anesthesia

Propofol-Binergiya is not recommended for maintenance of anesthesia in children under 1 month of age.

Anesthesia can be maintained by administering Propofol-Binergia as a continuous infusion or repeated bolus injections to prevent clinical signs of insufficient anesthesia. The required rate of administration varies considerably depending on the individual characteristics of the patients, but the rate within 9-15 mg / kg / hour, as a rule, ensures the maintenance of adequate anesthesia.

For children aged 1 month to 3 years, compared with older children, higher doses of the drug may be required within the recommended dose range. The dose should be adjusted individually and with special attention to monitor the adequacy of anesthesia.

For children III - IV classes of risk by classification ASA lower doses are recommended.

Sedation during intensive care

Propofol is not recommended for sedation in children, since its safety and efficacy in this application have not yet been confirmed. In the unlicensed use of propofol, serious adverse events were noted, including deaths, although there was no causal relationship with the use of the drug. These adverse events were most often observed in children with respiratory tract infections that received doses exceeding the recommended doses for adults.

Sedation for surgical and diagnostic procedures

Propofol is not recommended for use in children under 1 month of age.

To ensure sedation in surgical or diagnostic procedures, propofol can be used in isolation or in combination with local or conduction anesthesia. The rate of drug administration and dose should be selected individually and titrated depending on the clinical response. For most patients, the onset of a sedative effect requires the administration of 1 to 2 mg / kg for at least 1 minute.Maintenance of sedative effect can be provided by titrating infusion of the drug to the required level of sedative effect; for most patients, from 1.5 to 9 mg / kg / h is needed. In addition to infusion, a bolus dose of up to 1 mg / kg can be given if a rapid onset of a deep sedative effect is necessary.

Patients III - IV class of risk by classification ASA it may be necessary to reduce the dose and the rate of administration of the drug.

Method of administration

For intravenous administration.

Only for single use.

Ampoule should be shaken before use.

If the shaking of the emulsion is observed after shaking, the preparation should not be used. Use only if the emulsion is homogeneous and the packaging is intact.

Before use, the neck of the ampoule should be treated with alcohol.

Since Propofol-Binergia is a fat emulsion that does not contain preservatives and does not have antimicrobial activity, the preparation can serve as a favorable medium for rapid growth of microorganisms.

Emulsion should be typed in a sterile syringe or dropper immediately after opening the package.The preparation should be started without delay.

During the entire period of administration of the drug Propofol-Binergia, you must follow the rules of aseptic work with the drug and the system for parenteral infusion.

With the joint administration of the drug Propofol-Binergia with other drugs and solutions in the same system, the introduction of the latter is recommended through a tee with a valve in the immediate vicinity of the site of administration of the drug. Propofol-Binergia can not be administered via a microbiological filter.

The drug Propofol-Binergia and any infusion system containing Propofol-Binergia are intended only for single-entry introduction of one patient.

Any residues of the Propofol-Binergia emulsion should be disposed of after use. Propofol-Binergia can be used for infusions in a diluted and undiluted form. When administering Propofol-Binergia in the form of infusions, it is recommended to use devices to control the rate of administration (burettes, droppers, syringe pumps, including ICC systems) and volumetric pumps. The compatibility of electronic equipment must be ensured.

Infusion of undiluted preparation Propofol-Binergia

The total time of administration of the undiluted drug through one infusion system should not exceed 12 hours. After 12 hours of use, the infusion system containing Propofol-Binergium or the container with the drug should be replaced.

Infusion of a diluted preparation of Propofol-Binergia

For infusions of a diluted preparation of Propofol-Binergia, it is recommended to use devices to control the speed of infusions and to prevent accidental administration of large volumes of the drug. When choosing the maximum volume of diluted drug in a burette, the risk of uncontrolled administration should be taken into account. Propofol-Binergium should not be mixed before administration with other solutions except 5% dextrose solution for intravenous administration and 0.9% sodium chloride solution for intravenous administration. Maximum dilution should not exceed 1 part of the preparation in 4 parts 5 % dextrose solution for intravenous administration or 0.9% sodium chloride solution for intravenous administration (the final concentration of propofol in the diluted solution should be at least 2 mg / ml).Preparation should be carried out in aseptic conditions immediately before administration, the mixture should be used within no more than 6 hours after preparation.

Simultaneous administration of the drug with 5% dextrose solution for intravenous administration, 0.9% sodium chloride solution for intravenous administration, or 0.18% sodium chloride solution for intravenous administration in a 4% dextrose solution for intravenous administration via a tee with a valve in close proximity to site of the introduction of Propofol-Binergia.

Painful sensations in the administration of propofol can be reduced by joint administration with lidocaine. Immediately prior to administration, the induction dose of Propofol-Binergium can be mixed in a syringe with 1% lidocaine solution for injections without preservatives in the following proportion: 20 parts of Propofol-Binergia and up to 1 part 1 % lidocaine solution. Preparation should be carried out in aseptic conditions immediately before administration, the mixture should be used within no more than 6 hours after preparation. Use lidocaine for breeding children under 12 years with caution.

Attention: lidocaine contraindicated in patients with hereditary acute porphyria! Muscle relaxants, such as atrakurium and myvacurium, can be administered through the infusion system used to administer the Propofol-Binergia preparation only after it has been rinsed.

The drug Propofol-Binergiya can be administered with the help of infusion pumps or manually. In the case of the use of infusion pumps, appropriate compatibility must be ensured.

Infusion by target concentration (CI) - the introduction of the drug Propofol-Binergia with the help of infusion pumps.

The introduction of the drug Propofol-Binergia using the ICC system is limited to introduction into general anesthesia and its maintenance in adults. ICC is not recommended for sedation during intensive care and for sedation in diagnostic and surgical procedures, as well as sedation in children.

The preparation of Propofol-Binergia can be administered by the ICC method only with the help of a suitable ICC system having the appropriate software. Users should be familiarized with the manual for working with the infusion pump and with the introduction of the drug Propofol-Binergia by the ICS method.

This system enables the anesthesiologist to achieve and control the desired rate of anesthesia and depth of anesthesia by setting and controlling the target (predicted) concentration of propofol in the patient's blood.

Different methods of pumping systems should be taken into account, i.e. the ICC system assumes that the initial concentration of propofol in the patient's blood is 0. Therefore, for patients receiving propofol earlier, it is possible to choose lower initial target concentrations at the beginning of the administration of the preparation Propofol-Binergia by the ICS method. Also, it is not recommended to resume the operation of the ICC system in the previous mode after it is turned off. Guidance on the selection of target concentrations of propofol is presented below. Due to the individual differences in the pharmacokinetics and pharmacodynamics of propofol in patients who received premedication and who did not receive it, the target concentration of propofol should be titrated depending on the patient's clinical response in order to achieve the required depth of anesthesia.

Introduction to general anesthesia and maintenance by means of CIs

In adult patients under 55 years of age, anesthesia can usually be achieved by targeting propofol concentrations of 4 to 8 μg / ml. The initial target concentration of propofol 4 μg / ml is recommended for patients who have been premedicated, a concentration of 6 μg / ml is recommended for patients without premedication. The time of administration to anesthesia at these target concentrations is typically 60 to 120 seconds. Higher values will lead to faster administration to anesthesia, but may be associated with more severe hemodynamic depression and respiratory function. Smaller initial target concentrations should be used in patients over 55 years of age and in Class III and IV risk patients ASA. The target concentrations can then be gradually increased by a value of 0.5 to 1.0 μg / ml at intervals of 1 minute to achieve a gradual introduction into anesthesia. Typically, additional analgesia is required, and the amount of reduction in target concentrations to maintain anesthesia will depend on the amount of additional analgesics administered. Target concentrations of propofol in the range of 3 to 6 μg / ml usually maintain a sufficient level of general anesthesia.

The predicted concentration of propofol in the blood upon awakening is generally between 1.0 and 2.0 μg / ml and will depend on the level of analgesia during the maintenance of anesthesia.

Sedation during intensive therapy by ICP

Usually, a target concentration of propofol in the blood in the range 0.2-2.0 μg / ml is required. Administration of the drug Propofol-Binergia should be started at a low target concentration and titrate the dose depending on the patient's response to achieve the desired sedation depth.

Side effects:

Side effects are classified according to the frequency of occurrence as follows: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000 , <1/1000), very rarely (<1/10000), the frequency is unknown (it is impossible to determine the frequency of occurrence from the available data).

As a rule, induction of anesthesia proceeds with minimal signs of excitation. The most common adverse reactions are pharmacologically predictable side effects of any agent for general anesthesia, for example, lowering blood pressure. Cases reported in connection with anesthesia and intensive care may also be related to ongoing procedures or the condition of the patient.

Table of Adverse Reactions

Frequency development of	Class of organ system	Adverse Reactions
Very often (≥1 / 10)	General reactions of the disorder and disorders at the site of administration	Pain at the injection site with induction of anesthesia⁽¹⁾
Often (≥1/100, <1/10)	Are common	Syndrome of withdrawal in children⁽⁴⁾
	From the side of the cardiovascular system	Reduction or increase in blood pressure⁽²⁾, bradycardia⁽³⁾, "tide" of blood in children⁽⁴⁾
	From the gastrointestinal tract	Vomiting, nausea during awakening
	From the central nervous system	Headache during awakening
	From the respiratory system	During the induction of anesthesia, temporary apnea
Infrequently (≥1/1000, <1/100)	From the side of the cardiovascular system	Arrhythmia, thrombosis, phlebitis
Rarely (≥1/10000, <1/1000)	From the central nervous system	Epileptiform seizures, including convulsions and opisthotonos during induction of anesthesia, maintenance of anesthesia and awakening; euphoria
Very rarely (<1/10000)	Musculoskeletal effects, connective tissue	Rhabdomyolysis⁽⁵⁾
	Procedural complications	Postoperative fever
	From the gastrointestinal tract	Pancreatitis
	From the side of the kidneys and urinary system	Discoloration of urine with prolonged administration
	From the immune system	Anaphylaxis can manifest as angioedema, bronchospasm, erythema, blood pressure lowering
	From the side of the reproductive system	Sexual disinhibition
	From the side of the cardiovascular system	Asystole, pulmonary edema
	From the central nervous system	Postoperative unconsciousness

⁽¹⁾Pain at the injection site can be reduced by injecting the drug into larger forearm veins and an elbow fold. Pain sensations can also be reduced by the joint administration of the drug with lidocaine.

⁽²⁾Reducing blood pressure can cause the need for intravenous fluid and reduce the rate of administration of the drug.

⁽³⁾ Serious cases of bradycardia are rare. There are separate reports of progression of the bradycardia up to asystole.

⁽⁴⁾ Occurs during a sudden discontinuation of the drug during intensive therapy.

⁽⁵⁾ It is known about very rare cases of rhabdomyolysis with the use of the drug at a dose of more than 4 mg / kg / h for sedation with intensive therapy.

During the induction of anesthesia, slight excitation may be observed depending on the dose of the drug and concomitant therapy.

In very rare cases with the use of propofol in doses of more than 4 mg / kg / h for sedation in intensive care, there have been reports of metabolic acidosis, hyperkalemia and heart failure, sometimes fatal.

There have been reports of cases of dystonia, dyskinesia and hyperlipidemia.

In the phase of awakening, sometimes chills, a feeling of cold, dizziness, coughing can be observed.

Overdose:

Symptoms: oppression of the cardiovascular and respiratory system.

Treatment: In the case of respiratory depression, ventilation with oxygen should be performed. When oppressing the cardiovascular activity, the patient should be given a position with raised lower limbs, if necessary, plasma-substituting and vasopressor preparations should be administered.

Interaction:

Propofol can be used in combination with spinal and epidural anesthesia, means for premedication, inhalation anesthesia, analgesics, muscle relaxants or local anesthetics.Lower doses of propofol may be required in cases where general anesthesia is used as a supplement to the methods of regional anesthesia used.

Some drugs with a central mechanism of action can cause hemodynamic disorders and increase respiratory depression. Benzodiazepines, parasympatholytics, and inhaled anesthetics in combination with propofol can cause prolongation of anesthesia and reduce respiratory rate.

After additional premedication with narcotic analgesics, it is possible to enhance and prolong sedative action of propofol, as well as an increase in the frequency and duration of apnea.

It should be taken into account that the use of propofol on a background of premedication, concomitantly with inhalational anesthetics or analgesics, can potentiate anesthesia and side effects from the cardiovascular system.

Combined use with propofol drugs suppressing the central nervous system, such as alcohol, general anesthetics, narcotic analgesics leads to a pronounced manifestation of their sedative effect, which can cause severe respiratory depression and cardiac activity.

After the administration of fentanyl, there may be a transient increase in the concentration of propofol in the blood, accompanied by an increased likelihood of apnea.

After administration of suxamethonium or neostigmine methyl sulfate, bradycardia and cardiac arrest may occur.

When administered muscle relaxants atracurium and mivacurium should not use the same infusion system for propofol and that, without prior washing. It is recommended to administer these drugs after the administration of the drug Propofol-Binergia.

Special instructions:

The drug should be used by personnel who have trained in anesthesia (or, where appropriate, doctors trained to assist patients during intensive care). Patients need constant monitoring; equipment to maintain a free airway, for artificial ventilation, oxygen enrichment and other resuscitative facilities should be constantly ready for use. Propofol should not be administered by a person performing a diagnostic or surgical procedure.

When using the drug during surgical or diagnostic procedures for conscious sedation, constant monitoring of the patient is necessary to identify early signs of lowering blood pressure, airway obstruction and insufficient oxygen saturation.

As with the use of other sedatives, with the introduction of propofol to provide sedative effect during surgery, involuntary movements of patients are possible. In procedures requiring immobility, these movements may be dangerous for the site of surgery.

An adequate period of time for monitoring the patient is needed to ensure complete recovery after general anesthesia. In very rare cases, after the use of the drug Propofol-Binergia, there may be a lack of consciousness in the postoperative period that may be accompanied by an increase in muscle tone. Sometimes a loss of consciousness occurs after a period of wakefulness. In spite of a spontaneous awakening, the patient, who is in an unconscious state, must be properly supervised.The drug Propofol-Binergia has a weak m-cholinoblocking activity, and its use is associated with cases of bradycardia (which is sometimes serious), as well as with asystole.

It is expedient to intravenously administer the m-cholinoblocking agent before the induction of anesthesia or during the period of its maintenance, especially in those cases where there is a possibility of a predominance of the tone of the vagus nerve or when propofol apply in combination with other drugs that can cause bradycardia.

If propofol is administered to a patient with epilepsy, there is a risk of seizures. Appropriate attention should be paid to patients with lipid metabolism disorders and other conditions requiring careful application of fat emulsions.

It is recommended to monitor the concentration of lipids in the blood in cases where propofol is prescribed to patients who are at particular risk of lipid accumulation. In the event that monitoring indicates insufficient induction of fats from the body, the administration of the Propofol-Binergium preparation should be corrected as appropriate.With simultaneous intravenous administration to a patient of another lipid drug, the dose should be reduced, taking into account the amount of lipid administered in the formulation of Propofol-Binergia: 1.0 ml of the drug Propofol-Binergia contains approximately 0.1 g of lipids.

A note on the section "Sedation during intensive care":

There have been reports of rare cases of metabolic acidosis, ECG changes (similar to ECG changes in Brugada syndrome, including segment elevation ST), rhabdomyolysis, hyperkalemia, violations of liver and kidney function, hyperlipidemia, and / or rapidly progressive heart failure, in some cases fatal in seriously ill patients receiving propofol for sedation during intensive care. The most likely risk factors for these events were decreased oxygen supply to the tissues, serious neurological injuries and / or sepsis, high doses of pharmacologically active agents: vasoconstrictors, steroids, cardiotonic agents and / or propofol (usually at a rate of more than 4 mg / kg / hr 48 h). All sedative and therapeutic drugs used during intensive care,should be titrated to maintain the necessary supply of tissues with oxygen and optimal hemodynamic parameters.

Given the higher dose of the drug for patients with severe obesity, the risk of hemodynamic effects on the cardiovascular system should be taken into account.

It is recommended that, if possible, do not exceed a dose of 4 mg / kg / h for sedation of patients undergoing intensive ventilation in intensive care units.

In accordance with the established rules for other lipid emulsion rules, the duration of continuous infusion of the drug Propofol-Binergia should not exceed 12 hours. At the end of the infusion of the drug or after a 12-hour period, it is necessary to replace both the container with the drug Propofol-Binergia and the infusion line. Containers with propofol should be shaken before use. The contents of the container, left in any quantity after its use, must be disposed of.

Aseptic conditions should be provided both with respect to the preparation of Propofol-Binergia, and the equipment for administration.

Before discharge of the patient from the clinic, you should make sure of his complete recovery after general anesthesia.

Effect on the ability to drive transp. cf. and fur:

When using the drug, it is necessary to refrain from controlling vehicles, mechanisms and from practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

The action of propofol usually stops 12 hours after the end of the injection.

Form release / dosage:

Emulsion for intravenous administration of 10 mg / ml.

Packaging:

For 20 ml of the drug in ampoules of clear, colorless glass of the 1 st hydrolytic class.

5 ampoules in contour plastic packaging (pallet).

1 or 2 contour plastic packages (pallets) with ampoules together with the instructions for use and a vial ampoule or scarifier ampullum in a pack of cardboard or in a cardboard box.

If you use ampoules with a colored break point and a notch or a colored ring, the ampoule opener or ampoule ampoule opener is not inserted.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004564

Date of registration:29.11.2017

Expiration Date:29.11.2022

The owner of the registration certificate:BINERGIYA, CJSC BINERGIYA, CJSC Russia

Manufacturer: & nbsp

Armavir Biofactory, FKP

Information update date: & nbsp18.12.2017

Illustrated instructions

Instructions

Propofol-Binergia (Propofol-Binergia)