Diprivan, 10 mg/ml, emulsion for intravenous administration, 20 ml, 5 pcs.

Pharmacological properties of the drug Diprivan

Pharmacodynamics . Propofol is a general anesthetic that has a short-term effect and induces rapid drug sleep for approximately 30 seconds. Usually, recovery of consciousness occurs quickly. The mechanism of action, as in the case of other anesthetic agents, is not properly explained. As a rule, when propofol is used for induction of anesthesia and its maintenance, a decrease in average blood pressure and slight changes in heart rate are noted. However, during maintenance of anesthesia, hemodynamic parameters usually remain relatively stable. Although respiratory depression may occur following administration of propofol, any effects similar to those seen with other intravenous anesthetics are easily controlled in a clinical setting. Propofol reduces cerebral blood flow, intracranial pressure and reduces cerebral metabolism. The decrease in intracranial pressure is more pronounced in patients with initially elevated intracranial pressure. Awakening is usually quick and clear, and the incidence of headache and postoperative nausea and vomiting is low. Propofol in therapeutic concentrations does not inhibit the synthesis of adrenal hormones. Pharmacokinetics. The decrease in propofol concentration after administration of a bolus dose or after stopping the infusion can be described using an open three-phase model: 1st phase - very rapid distribution (half-life is 2-4 minutes), 2nd - rapid elimination from the body (half-life - 30-30 minutes). 60 min), 3rd - a slower phase, which is characterized by the redistribution of propofol from weakly perfused tissue into the blood. Propofol is widely distributed and quickly eliminated from the body (total clearance - 1.5–2 l/min). The drug is metabolized mainly in the liver, resulting in the formation of inactive compounds propofol and its corresponding quinol, which are excreted in the urine. When propofol is used to maintain anesthesia, its concentration in the blood asymptotically reaches a stable level that corresponds to the rate of its administration. Within the recommended infusion rates, the pharmacokinetics of the drug is linear.

Use of the drug Diprivan

As a rule, Diprivan requires additional use of painkillers. Combines well with spinal and epidural anesthesia, with drugs used for premedication, muscle relaxants, inhalants and analgesics; pharmacological incompatibility between these drugs has not been identified. Adults Induction of anesthesia Diprivan can be administered by slow bolus or infusion. Regardless of whether premedication was administered or not, Diprivan is recommended to be titrated (bolus or infusion of approximately 40 mg every 10 s for an adult patient in satisfactory condition) depending on the patient's response until clinical signs of anesthesia appear. For most adult patients under the age of 55 years, the dose of Diprivan is 1.5–2.5 mg/kg. The total dose required can be reduced by using a lower rate of administration (20–50 mg/min). For patients over 55 years of age, a lower dose is usually needed. In ASA (American Association of Anesthesiologists) class 3 and 4 patients, administration should be carried out at a lower rate (about 20 mg every 10 s). Maintenance of general anesthesia Anesthesia can be maintained by continuous infusion of Diprivan or repeated bolus injections to maintain the required depth of anesthesia. Continuous infusion The rate of administration varies greatly depending on the individual patient. Typically, a rate in the range of 4–12 mg/kg/h will maintain adequate anesthesia. Repeat bolus When using the repeat bolus technique, a dose of 25–50 mg is administered depending on clinical need. Providing sedation during intensive care For adult patients receiving mechanical ventilation and undergoing intensive care, Diprivan is recommended to be used by continuous infusion. The infusion rate should be adjusted according to the depth of sedation required, but a rate of 0.3–4.0 mg/kg/h should provide satisfactory sedation. Providing sedation while maintaining consciousness during surgical or diagnostic procedures. The dose is selected individually and titrated until a clinical response is obtained. For most patients, when sedation is initiated, the required dose is 0.5–1 mg/kg, administered over 1–5 minutes. Maintaining sedation is achieved by titrating the Diprivan dose to the desired degree of sedation - for most patients this dose is 1.5-4.5 mg/kg/hour. In addition to infusion administration, a bolus dose of 10–20 mg may be necessary to enhance the depth of sedation. In patients of ASA class 3 and 4, the dose should be reduced. Elderly patients The dose of Diprivan required for induction of anesthesia should be reduced. When reducing it, the physical condition and age of the patient should be taken into account. The reduced dose should be administered more slowly and titrated according to the patient's response. When using Diprivan for maintenance anesthesia or to achieve sedation, the infusion rate or concentration should be reduced. In ASA class 3–4 patients, the dose and rate of administration should be even lower. In elderly patients, rapid bolus administration (single or repeated) is not carried out due to the risk of depression of the cardiac and respiratory systems. Children Induction of anesthesia The use of Diprivan in children under 1 year of age is not recommended. When using Diprivan to provide induction of anesthesia in children, the drug should be administered slowly until clinical signs of anesthesia occur. The dose should be adjusted according to age and/or body weight. For most children over the age of 8 years, about 2.5 mg/kg Diprivan is usually needed for induction of anesthesia. For children younger than this age, doses may be higher. For children classified as ASA grades 3–4, a lower dose is recommended. Maintenance of general anesthesia In children over 1 year of age, anesthesia can be maintained with a continuous infusion of Diprivan or by repeated bolus injections as necessary to maintain the required depth of anesthesia. The rate of administration varies widely among patients, but a dose range of 9–15 mg/kg/h usually achieves adequate anesthesia. Method of administration Diprivan can be used for infusion undiluted using plastic syringes or glass infusion bottles. When Diprivan is used undiluted for maintenance anesthesia, it is recommended to always use perfusers or infusion pumps to control the rate of administration. Diprivan can also be used by diluting it in 5% dextrose solution in polyvinyl chloride (PVC) bags or glass bottles. The solution, which should not exceed a ratio of 1:5 (2 mg propofol/ml), should be prepared in accordance with aseptic rules immediately before use. The mixture remains stable for 6 hours. Dilution can be carried out using various technical infusion systems, but an infusion set used independently may cause accidental uncontrolled administration of large volumes of Diprivan solution. A burette, drop counter or metering pump should always be included in the infusion set. The risk of uncontrolled infusion should be taken into account when calculating the maximum amount of solution in the burette. Diprivan can be administered through a tee with a valve by adding it to 5% dextrose solution for intravenous administration, 0.9% sodium chloride solution for intravenous administration or 4% dextrose solution with 0.18% r -sodium chloride rum for intravenous administration. Diprivan can be premixed with alfentanil 500 mcg/ml in a ratio of 20:1–50:1 and administered intravenously. The mixture should be prepared under aseptic conditions and used within 6 hours after preparation. To reduce the severity of pain during administration, Diprivan can be mixed with 1% lidocaine solution in a plastic syringe in a ratio of 20:1 or 20:0.5, respectively, immediately before use. Dilution of Diprivan and its simultaneous use with other drugs or solutions for administration.

Diprivan®

As a rule, Diprivan® requires additional use of analgesics.

Diprivan® is combined with spinal and epidural anesthesia; with drugs commonly used for premedication; with muscle relaxants, inhalation anesthesia and analgesics, and no pharmacological incompatibility was noted. Lower doses of Diprivan may be required in cases where general anesthesia is used as an adjunct to regional anesthesia techniques.

For guidance on administering Diprivan® at target concentrations using an infusion system that includes the appropriate Diprivuser software, see section E. This use is limited to the induction and maintenance of general anesthesia in adults. The target infusion system is not recommended for sedation in intensive care unit patients, for conscious sedation, or in children.

A. ADULTS

Induction of general anesthesia

Diprivan® can be used to induce anesthesia by slow bolus injection or infusion. Regardless of whether premedication was carried out or not, the administration of Diprivan® is recommended to be titrated (bolus injections or infusion of approximately 40 mg every 10 seconds - the average adult in satisfactory condition) depending on the patient's response until clinical signs of anesthesia appear. For most adult patients under the age of 55 years, the average dose of Diprivan® is 1.5-2.5 mg/kg. The required total dose can be reduced by using lower rates of administration (20-50 mg/min). For patients older than this age, a lower dose is usually required. Patients in ASA classes 3 and 4 (American Society of Anesthesiology (ASA) Classification) should be administered at a lower rate (approximately 20 mg every 10 seconds).

Maintaining general anesthesia

Anesthesia can be maintained either by a continuous infusion of Diprivan® or by repeated bolus injections as necessary to maintain the required depth of anesthesia.

Continuous infusion

The required rate of administration varies significantly depending on the individual characteristics of the patients. Typically, a rate of 4-12 mg/kg/h will maintain adequate anesthesia.

Repeated bolus injections

If a technique involving repeated bolus injections is used, increasing doses from 25 mg to 50 mg are used depending on clinical need.

Sedation during intensive care

Administration of the drug Diprivan® using the Diprifusor ICC system for sedation of patients during intensive care is not recommended.

When using the drug Diprivan® for sedation of adult patients on mechanical ventilation and receiving intensive care, it is recommended to use it by continuous infusion. The infusion rate should be adjusted based on the depth of sedation required, but a rate of 0.3 to 4.0 mg/kg/hour should achieve satisfactory sedation. The infusion rate should not exceed 4.0 mg/kg/hour unless the potential benefit to the patient outweighs the risk of side effects.

Sedation of conscious patients during surgical and diagnostic procedures

Administration of the drug Diprivan® using the Diprifusor ICC system for sedation while maintaining consciousness is not recommended.

To provide sedation during surgical and diagnostic procedures, the rate of administration and dose should be individualized based on the patient's clinical response.

For most patients, 0.5-1.0 mg/kg over 1-5 minutes is required to produce sedation.

To maintain sedation, the infusion rate should be adjusted according to the desired depth of sedation; most patients require a rate of 1.5-4.5 mg/kg/hour. If a rapid increase in the depth of sedation is required, then a bolus injection of 10-20 mg of Diprivan® can be used as an addition to the infusion. For patients in ASA classes 3 and 4, a reduction in dose and rate of administration may be required.

B. ELDERLY PATIENTS

In elderly patients, lower doses of Diprivan® are required for induction of anesthesia. When reducing the dose, one should be guided by the physical status and age of the patient. The reduced dose should be administered at a slower rate than usual and titrated based on patient response. When using Diprivan® for maintenance of anesthesia or for sedation, the infusion rate or “target conDiprifuser” is not used for any indication.

Induction of general anesthesia

Diprivan® is not recommended for use in children under 1 month of age (see section "Contraindications").

When using Diprivan® to ensure induction of anesthesia in children, it is recommended to administer it slowly until clinical signs of anesthesia appear. The dose should be adjusted according to the age and/or weight of the child.

For most children over 8 years of age, approximately 2.5 mg/kg of Diprivan® is likely to be required to induce anesthesia.

For children aged 1 month to 8 years, the required dose may be higher. A lower dose is recommended for children in ASA classes 3 and 4.

Maintaining general anesthesia

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

Maintenance of anesthesia is achieved by administering Diprivan® through a continuous infusion or through repeated bolus injections required to maintain the required depth of anesthesia. The required rate of administration varies significantly among different patients; satisfactory anesthesia is usually achieved at an infusion rate of 9-15 mg/kg/h.

Sedation of conscious patients during surgical and diagnostic procedures

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

To provide short-term sedation during surgical and diagnostic procedures, the rate of administration and dose should be individualized based on the patient's clinical response.

In most cases, the onset of sedation is achieved by administering the drug at a dose of 1-2 mg/kg for at least 1 minute. To maintain sedation, the infusion rate should be adjusted according to the required depth of sedation; for most patients, a rate of 1.5-9 mg/kg/hour is required. If a rapid increase in the depth of sedation is required, then a bolus administration of Diprivan® at a dose of up to 1 mg/kg can be used as an addition to the infusion.

For patients in ASA classes 3 and 4, a reduction in dose and rate of administration may be required.

Sedation during intensive care

Diprivan® is not recommended for sedation in children, since its safety and effectiveness in this use have not yet been confirmed. Serious adverse events (including deaths) have been reported from unlicensed use, although no causal relationship to Diprivan has been established. These adverse events were most often observed in children with respiratory tract infections who were administered doses higher than recommended adult doses.

D. INTRODUCTION

Diprivan® can be administered undiluted using plastic syringes or glass infusion bottles or glass syringes filled with Diprivan®. In cases where Diprivan® is used undiluted to maintain general anesthesia, it is recommended to always use perfusers or infusion pumps in order to control the rate of administration.

Diprivan® can also be used diluted with 5% dextrose solution only, intended for intravenous administration, in PVC bags or glass vials. A solution, the dilution of which should not exceed a ratio of 1:5 (2 mg/ml propofol), must be prepared in accordance with aseptic rules immediately before use. The mixture remains stable for 6 hours.

A diluted solution of Diprivan® can be administered using a variety of controlled infusion systems; however, the use of such devices alone does not completely avoid the risk of accidental, uncontrolled administration of large volumes of diluted Diprivan®. Burettes, drop counters or metering pumps should always be part of the infusion line. When choosing the maximum volume of diluted Diprivan® in the burette, the risk of uncontrolled administration should be taken into account.

Diprivan® can be administered through a valved tee close to the injection site while administering 5% dextrose IV, 0.9% sodium chloride IV, or 4% dextrose with 0.18% sodium chloride IV .

The ready-to-use glass syringe has less piston resistance than a plastic disposable syringe and is easier to move. When administering Diprivan® manually using a ready-to-use glass syringe, the infusion system between the syringe and the patient should not be left open unless supervised by medical personnel.

Adequate compatibility must be ensured when using a ready-to-use glass syringe in a syringe pump. In particular, the pump design must prevent siphonage and must provide an occlusion alarm at pressures not exceeding 1000 mmHg. If a programmable or equivalent pump is used, which allows the use of different syringes, then only the “BD” 50/60 ml Plastipak mode is selected when using a ready-to-use glass syringe. Diprivan® can be premixed with alfentanil injection containing 500 mcg/ml alfentanil in a volume ratio of 20:1 to 50:1. Mixtures should be prepared using sterile equipment and used within 6 hours of preparation.

To reduce pain when starting administration, the induction dose of Diprivan® can be mixed immediately before administration with lidocaine for injection in a plastic syringe in the following proportion: 20 parts of Diprivan® and up to one part of either 0.5% or 1% lidocaine injection solution .

DILUTION OF DIPRIVAN® AND JOINT ADMINISTRATION IN COMBINATION WITH OTHER MEDICINES OR INFUSION SOLUTIONS

E. INFUSION AT TARGET CONCENTRATION - ADMINISTRATION OF THE DRUG DIPRIVAN® USING THE SYSTEM FOR AND CC "DIPRIFUSOR" IN ADULTS

Administration of Diprivan® using the Diprifusor ICC system is limited to periods of induction and maintenance of general anesthesia in adults. Not recommended for sedation in intensive care, to provide conscious sedation or in children.

Diprivan® can be administered by the ICC method only using the Diprifusor ICC system, which includes the Diprifusor software. These systems will function only after recognizing the electronic tag on a ready-to-use glass syringe filled with Diprivan®.

The Diprifusor ICC system will automatically adjust the rate of administration of the Diprivan® drug to the concentration that was recognized by the system. Users should be familiar with the infusion pump manual, the administration of Diprivan® using the FCI method, and the correct use of the syringe recognition system as outlined in the training manual provided by AstraZeneca.

This system gives the anesthesiologist the opportunity to achieve the desired speed of induction and depth of anesthesia and control them by setting and regulating the target (predicted) concentration of propofol in the patient's blood.

The Diprifusor ICC system assumes that the initial concentration of propofol in the patient's blood is 0. Therefore, patients who have previously received propofol may need to select lower initial target concentrations when initiating Diprivan® with the Diprifusor ICC. It is also not recommended to resume operation of the Diprifusor ICC in the previous mode after it has been turned off.

Guidance for selecting target propofol concentrations is provided below. Due to individual differences in the pharmacokinetics and pharmacodynamics of propofol in both premedicated and unpremedicated patients, the target concentration of propofol should be titrated depending on the patient's clinical response in order to achieve the required depth of anesthesia.

In adult patients under 55 years of age, anesthesia can usually be induced with target propofol concentrations of 4 to 8 mcg/mL. An initial target propofol concentration of 4 mcg/ml is recommended for patients receiving premedication; a concentration of 6 mcg/ml is recommended for patients without premedication. The induction time of anesthesia at these target concentrations is typically 60-120 seconds. Higher values ​​will result in faster induction of anesthesia but may be associated with greater hemodynamic and respiratory depression.

Lower initial target concentrations should be used in patients over 55 years of age and in ASA classes 3 and 4 patients. Target concentrations can be further increased gradually by 0.5 to 1.0 mcg/mL at 1-minute intervals to achieve gradual induction of anesthesia.

In general, additional analgesia is required, and the amount of reduction in target concentrations to maintain anesthesia will depend on the amount of additional analgesia administered. Target propofol concentrations ranging from 3 to 6 mcg/mL usually maintain an adequate level of general anesthesia.

The predicted concentration of propofol upon awakening is generally in the range of 1.0-2.0 mcg/ml and will depend on the level of analgesia during the period of maintenance of anesthesia.

Sedation during intensive care

Typically, a target blood concentration of propofol in the range of 0.2-2.0 mcg/ml is required. Diprivan should be initiated at a low target concentration and the dose titrated based on patient response to achieve the desired depth of sedation.

Side effects of the drug Diprivan

Induction of anesthesia with Diprivan is usually gentle with minimal signs of agitation. The most commonly reported pharmacologically expected adverse events for anesthetics were hypotension. Taking into account the nature of anesthesia and the condition of patients undergoing intensive care, the events reported may be related to the procedures performed or the condition of the patients. Possible side effects are shown in the table.

(1) Can be reduced by using the large veins of the forearm and cubital fossa. Local pain when administering Diprivan 1% can also be reduced by adding lidocaine solution (see APPLICATION). (2) Rarely, hypotension may require IV fluids and a reduction in the dose of Diprivan. (3) Severe bradycardia was rare, and there were isolated reports of asystole. (4) Due to the sudden cessation of Diprivan administration during intensive care. (5) Rare reports of rhabdomyolysis when Diprivan was used at doses of 4 mg/kg/h in intensive care unit patients.

Unlicensed use of the drug in pediatric doses in newborns can lead to depression of the cardiovascular and respiratory systems.

Diprivan, 10 mg/ml, emulsion for intravenous administration, 20 ml, 5 pcs.

As a rule, Diprivan® requires additional use of analgesics.

Diprivan® is combined with spinal and epidural anesthesia; with drugs usually used for premedication; with muscle relaxants, inhalation anesthesia and analgesics, and no pharmacological incompatibility was noted. Lower doses of Diprivan may be required in cases where general anesthesia is used as an adjunct to regional anesthesia techniques.

For guidance on administering Diprivan® at target concentrations using an infusion system that includes the appropriate Diprivuser software, see section E. This use is limited to the induction and maintenance of general anesthesia in adults. The target infusion system is not recommended for sedation in intensive care unit patients, for conscious sedation, or in children.

A. ADULTS

Induction of general anesthesia

Diprivan® can be used to induce anesthesia by slow bolus injection or infusion. Regardless of whether premedication was carried out or not, the administration of Diprivan® is recommended to be titrated (bolus injections or infusion of approximately 40 mg every 10 s - for the average adult in satisfactory condition) depending on the patient's response until clinical signs of anesthesia appear. For most adult patients under the age of 55 years, the average dose of Diprivan® is 1.5–2.5 mg/kg. The total dose required can be reduced by using lower rates of administration (20–50 mg/min). For patients older than this age, a lower dose is usually required. Patients in ASA classes 3 and 4 (American Society of Anesthesiology (ASA) Classification) should be administered at a lower rate (approximately 20 mg every 10 s).

Maintaining general anesthesia

Anesthesia can be maintained either by a continuous infusion of Diprivan® or by repeated bolus injections as necessary to maintain the required depth of anesthesia.

Continuous infusion.

The required rate of administration varies significantly depending on the individual characteristics of the patients. Typically, a rate of 4–12 mg/kg/h will maintain adequate anesthesia.

Repeated bolus injections.

If a technique involving repeated bolus injections is used, increasing doses from 25 to 50 mg are used depending on clinical need.

Sedation during intensive care

Administration of the drug Diprivan® using the Diprifusor ICC system for sedation of patients during intensive care is not recommended.

When using the drug Diprivan® for sedation of adult patients on mechanical ventilation and receiving intensive care, it is recommended to use it by continuous infusion. The infusion rate should be adjusted based on the depth of sedation required, but a rate of 0.3 to 4 mg/kg/h should achieve satisfactory sedation. The infusion rate should not exceed 4 mg/kg/hour unless the potential benefit to the patient outweighs the risk of side effects.

Sedation of conscious patients during surgical and diagnostic procedures

Administration of the drug Diprivan® using the Diprifusor ICC system for sedation while maintaining consciousness is not recommended.

To provide sedation during surgical and diagnostic procedures, the rate of administration and dose should be individualized based on the patient's clinical response.

For most patients, 0.5–1 mg/kg over 1–5 minutes is required to produce sedation.

To maintain sedation, the infusion rate should be adjusted according to the required depth of sedation; a rate of 1.5–4.5 mg/kg/h is required for most patients. If a rapid increase in the depth of sedation is required, a bolus of 10–20 mg of Diprivan® can be used as an addition to the infusion. For patients in ASA classes 3 and 4, a reduction in dose and rate of administration may be required.

B. ELDERLY PATIENTS

In elderly patients, lower doses of Diprivan® are required for induction of anesthesia. When reducing the dose, one should be guided by the physical status and age of the patient. The reduced dose should be administered at a slower rate than usual and titrated based on patient response. When using Diprivan® for maintenance of anesthesia or for sedation, the infusion rate or “target concentration” of the drug should be reduced. For patients in ASA classes 3 and 4, further reductions in dose and rate of administration may be necessary. To avoid depression of the cardiovascular and respiratory systems, rapid bolus administration (single or repeated) is not recommended for elderly patients.

B. CHILDREN

In children, it is not recommended to administer Diprivan® using the Diprifusor ICC system under any indication.

Induction of general anesthesia

Diprivan® is not recommended for use in children under 1 month of age (see section “Contraindications”).

When using Diprivan® to ensure induction of anesthesia in children, it is recommended to administer it slowly until clinical signs of anesthesia appear. The dose should be adjusted according to the age and/or weight of the child. For most children over 8 years of age, approximately 2.5 mg/kg Diprivan® is likely to be required to induce anesthesia. For children aged 1 month to 8 years, the required dose may be higher. A lower dose is recommended for children in ASA classes 3 and 4.

Maintaining general anesthesia

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

Maintenance of anesthesia is achieved by administering Diprivan® through a continuous infusion or through repeated bolus injections required to maintain the required depth of anesthesia. The required rate of administration varies significantly among different patients; satisfactory anesthesia is usually achieved with an infusion rate of 9–15 mg/kg/h.

Sedation of conscious patients during surgical and diagnostic procedures

Diprivan® is not recommended for conscious sedation in children, as its safety and effectiveness in this application have not yet been confirmed.

Sedation during intensive care

Diprivan® is not recommended for sedation in children, because its safety and effectiveness in this application have not yet been confirmed. Serious adverse events (including deaths) have been reported during unlicensed use, although no causal relationship to Diprivan has been established. These adverse events were most often observed in children with respiratory tract infections who were administered doses higher than recommended adult doses.

D. INTRODUCTION

Diprivan® can be administered undiluted using plastic syringes or glass infusion bottles or glass syringes filled with Diprivan®. In cases where Diprivan® is used undiluted to maintain general anesthesia, it is recommended to always use perfusers or infusion pumps in order to control the rate of administration.

Diprivan® can also be used diluted with only 5% dextrose solution, intended for intravenous administration, in PVC bags or glass bottles. A solution, the dilution of which should not exceed a ratio of 1:5 (2 mg/ml propofol), must be prepared in accordance with aseptic rules immediately before use. The mixture remains stable for 6 hours.

Diprivan® reconstituted solution can be administered using a variety of controlled infusion systems, but the use of such devices alone does not completely avoid the risk of accidental, uncontrolled administration of large volumes of Diprivan® reconstituted solution. Burettes, drop counters or metering pumps should always be part of the infusion line. When choosing the maximum volume of diluted Diprivan® in the burette, the risk of uncontrolled administration should be taken into account.

Diprivan® can be administered through a tee with a valve close to the injection site, simultaneously with the introduction of 5% dextrose solution for IV administration, 0.9% sodium chloride solution for IV administration, or 4% dextrose solution with 0.18% sodium solution chloride for intravenous administration.

The ready-to-use glass syringe has less piston resistance than a plastic disposable syringe and is easier to move. When administering Diprivan® manually using a ready-to-use glass syringe, the infusion system between the syringe and the patient should not be left open unless supervised by medical personnel.

Adequate compatibility must be ensured when using a ready-to-use glass syringe in a syringe pump. In particular, the pump design must prevent siphonage and must provide an occlusion alarm at pressures not exceeding 1000 mmHg. If a programmable or equivalent pump is used, which allows for the use of different syringes, then only the “B-D” 50/60 ml PLASTIPAK mode is selected when using a ready-to-use glass syringe.

Diprivan® can be premixed with alfentanil injection containing 500 mcg/ml alfentanil in a volume ratio of 20:1 to 50:1. Mixtures should be prepared using sterile equipment and used within 6 hours of preparation.

To reduce pain when starting administration, the induction dose of Diprivan® can be mixed immediately before administration with lidocaine for injection in a plastic syringe in the following proportion: 20 parts of Diprivan® and up to one part of either 0.5 or 1% lidocaine injection solution.

Dilution of the drug Diprivan® and co-administration in combination with other drugs or infusion solutions

E. INFUSION AT TARGET CONCENTRATION - ADMINISTRATION OF DIPRIVAN® USING THE DIPRIFUSOR ICC SYSTEM IN ADULTS

Administration of Diprivan® using the Diprifusor ICC system is limited to periods of induction and maintenance of general anesthesia in adults. Not recommended for sedation in intensive care, to provide conscious sedation or in children.

Diprivan® can be administered by the ICC method only using the Diprifusor ICC system, which includes the Diprifusor software. These systems will function only after recognizing the electronic tag on a ready-to-use glass syringe filled with Diprivan®.

The Diprifusor ICC system will automatically adjust the rate of administration of the Diprivan® drug to the concentration that was recognized by the system. Users should be familiar with the infusion pump manual, the administration of Diprivan® using the FCI method, and the correct use of the syringe recognition system as outlined in the training manual provided by AstraZeneca.

This system gives the anesthesiologist the opportunity to achieve the desired speed of induction and depth of anesthesia and control them by setting and regulating the target (predicted) concentration of propofol in the patient's blood.

The Diprifusor ICC system assumes that the initial concentration of propofol in the patient's blood is 0. Therefore, patients who have previously received propofol may need to select lower initial target concentrations when initiating Diprivan® with the Diprifusor ICC. It is also not recommended to resume operation of the Diprifusor ICC in the previous mode after it has been turned off.

Guidance for selecting target propofol concentrations is provided below. Due to individual differences in the pharmacokinetics and pharmacodynamics of propofol in both premedicated and unpremedicated patients, the target concentration of propofol should be titrated depending on the patient's clinical response in order to achieve the required depth of anesthesia.

In adult patients under 55 years of age, anesthesia can usually be induced with target propofol concentrations of 4 to 8 mcg/mL. An initial target propofol concentration of 4 mcg/ml is recommended for patients receiving premedication; a concentration of 6 mcg/ml is recommended for patients without premedication. The induction time of anesthesia at these target concentrations is typically 60–120 s. Higher values ​​will result in faster induction of anesthesia but may be associated with greater hemodynamic and respiratory depression.

Lower initial target concentrations should be used in patients over 55 years of age and in ASA classes 3 and 4 patients. Target concentrations can then be gradually increased by 0.5 to 1.0 mcg/mL at 1-minute intervals to achieve gradual induction of anesthesia.

In general, additional analgesia is required, and the amount of reduction in target concentrations to maintain anesthesia will depend on the amount of additional analgesia administered. Target propofol concentrations ranging from 3 to 6 mcg/mL usually maintain an adequate level of general anesthesia.

The predicted concentration of propofol upon awakening is generally in the range of 1–2 μg/ml and will depend on the level of analgesia during maintenance of anesthesia.

Sedation during intensive care

A target blood concentration of propofol in the range of 0.2–2.0 mcg/mL is usually required. Diprivan should be initiated at a low target concentration and the dose titrated based on patient response to achieve the desired depth of sedation.

Special instructions for the use of the drug Diprivan

Diprivan should only be used by an experienced anesthesiologist or personnel with special training in assisting patients during intensive care; subject to the availability of equipment for resuscitation measures and constant monitoring of the functions of the cardiovascular and respiratory systems. Equipment for maintaining an open airway, performing mechanical ventilation, oxygen enrichment, as well as for other resuscitation measures must always be in working order. Administration of Diprivan by a person performing a diagnostic procedure or surgical procedure is not allowed. When sedating Diprivan is administered during surgical or diagnostic procedures, the patient should be closely monitored for early signs of hypotension, airway obstruction, and oxygen desaturation. As with other anesthetics, when Diprivan is administered to achieve sedation during a surgical procedure, patients may experience involuntary movements. This poses a certain risk during surgical procedures that require immobilization of the patient. To ensure complete recovery of the patient after anesthesia, a certain period of observation is necessary before discharge from the hospital. Very rarely, the use of Diprivan may be associated with a period of postoperative loss of consciousness and be accompanied by an increase in muscle tone. This is sometimes noted before the patient awakens. An unconscious patient should be monitored, although consciousness may return spontaneously. As with the use of other injectable anesthetics, special monitoring and caution should be observed in patients with cardiac, pulmonary, renal or hepatic impairment, as well as in dehydrated and debilitated patients. Diprivan does not have a sufficient vagolytic effect. If it is necessary to use Diprivan simultaneously with other drugs that cause bradycardia, it is advisable to carry out premedication with intravenous administration of an anticholinergic agent before induction of anesthesia or during the period of maintaining anesthesia. If Diprivan is administered to a patient with epilepsy, there is a risk of seizures. The necessary attention should be paid to patients with lipid metabolism disorders, as well as other conditions requiring careful use of lipid emulsions. It is recommended to monitor blood lipid levels when Diprivan is prescribed to patients with an increased risk of excessive fat accumulation. If monitoring indicates insufficient removal of fat from the body, the use of Diprivan should be adjusted appropriately. When simultaneous intravenous administration of another drug containing lipids to the patient, the dose should be reduced, taking into account the amount of lipids administered as part of Diprivan. 1.0 ml of Diprivan solution contains about 0.1 g of fat. Diprivan is not recommended for induction and maintenance of anesthesia in newborns. According to reports of unlicensed use in newborns at doses recommended for children aged 1–16 years, depression of the cardiovascular and respiratory systems is possible. Diprivan should not be used to achieve sedation in prematurely born children receiving intensive care. It is not recommended to use Diprivan to achieve sedation in children diagnosed with croup or epiglotitis, and in patients undergoing intensive care. Providing sedation during surgical or diagnostic procedures Diprivan is not recommended for sedation during surgical or diagnostic procedures in children because its safety and effectiveness have not been proven in this group of patients. Special Warnings for Intensive Care Unit Metabolic acidosis, rhabdomyolysis, hyperkalemia, and/or heart failure (some fatal) have been reported very rarely in critically ill patients in the intensive care unit receiving Diprivan for sedation. This probably indicates a lack of oxygen supply to the tissues. However, a cause-and-effect relationship between these phenomena and the use of Diprivan has not been established. All sedatives and therapeutic drugs (including Diprivan) used in intensive care units must be titrated to maintain optimal oxygen supply and hemodynamic parameters. EDTA (ethylenediaminetetraacetic acid), which is part of the drug, forms chelate complexes with metal ions, including zinc ions. The need for zinc supplementation should be considered during long-term use of Diprivan, especially in patients with zinc deficiency, such as burns, diarrhea and/or sepsis. Diprivan does not contain antimicrobial preservatives and can serve as a favorable environment for the growth of microorganisms. When filling a sterile syringe or perfuser with Diprivan, you should adhere to the rules of asepsis: the drug must be drawn up immediately after opening the ampoule or after removing the protective seal from the vial stopper. Administration should begin immediately. Aseptic conditions during the infusion must be ensured for both Diprivan and the equipment for administration. Any infusion solutions added to the Diprivan infusion line should be administered as close to the cannula location as possible. Diprivan cannot be administered through a microbiological filter. A syringe with Diprivan is used for each individual patient only once. According to the rules established for other lipid emulsions, the duration of administration of Diprivan should not exceed 12 hours. At the end of the drug infusion or 12 hours of the infusion period, it is necessary to replace the equipment for administering Diprivan. When administering muscle relaxants, you should not use the same intravenous infusion system that was used for Diprivan, without prior rinsing. Providing sedation during intensive care Diprivan is not recommended as a sedative for children, since its effectiveness and safety have not been proven in this group of patients. Although a causal relationship has not been established, there have been reports of serious adverse events (including deaths) with unlicensed use, and these events have most often been observed in children with respiratory tract infections who were administered the drug at doses higher than recommended adult doses. Caution regarding use: the container with Diprivan should be shaken before use. Any remaining contents of the container must be destroyed after use. Pregnancy and lactation Diprivan should not be used during pregnancy and lactation. Diprivan is prescribed for termination of pregnancy in the first trimester. Diprivan should not be used in obstetrics as an anesthetic, since it penetrates the placental barrier and its use can cause neonatal depression. When Diprivan is administered during breastfeeding, safety for newborns has not been established. Driving and operating machinery Patients should be informed that anesthesia may adversely affect the ability to drive or operate machinery.

Instructions for use DIPROSPAN® (DIPROSPAN)

Diprospan® is administered intramuscularly (if systemic entry of GCS into the body is necessary) and directly into the affected soft tissues, for intra-articular, periarticular, intrasynovial, intradermal and intralesional administration.

The dosage regimen and route of administration are set individually, depending on the indications, severity of the disease and the patient’s response to treatment. The drug should be used in the minimum dose and for the shortest possible period.

The dose should be adjusted to obtain a satisfactory clinical effect. If a satisfactory clinical effect does not appear after a certain period of time, treatment with Diprospan® should be discontinued and other therapy should be started.

IM injection

For systemic therapy, the initial dose of Diprospan® in most cases is 1-2 ml. The administration is repeated if necessary, depending on the patient’s condition. The drug is injected deep intramuscularly into the gluteal region.

In severe conditions (systemic lupus erythematosus and status asthmaticus),

requiring emergency treatment, the initial dose of the drug may be 2 ml.

For dermatological diseases

the dose is usually 1 ml.

For diseases of the respiratory system

The effect of the drug begins within a few hours after the intramuscular injection of Diprospan®.

For bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis

a significant improvement in the condition is achieved after administration in a dose of 1-2 ml.

For acute and chronic bursitis

the initial dose for intramuscular administration is 1-2 ml. If necessary, carry out several repeated injections.

Local administration

When administered locally, simultaneous use of a local anesthetic drug is necessary only in isolated cases. If simultaneous administration of a local anesthetic drug is desired, then use a 1% or 2% solution of procaine hydrochloride or lidocaine using dosage forms that do not contain parabens. The use of anesthetics that contain methylparaben, propylparaben, phenol and other similar substances is not permitted.

When using an anesthetic in combination with the drug Diprospan®, first draw the required dose of the drug into a syringe from the bottle, then draw the required amount of local anesthetic from the ampoule into the same syringe and shake for a short period of time.

For acute bursitis

(subdeltoid, subscapularis, ulnar and prepatellar) the introduction of 1-2 ml of Diprospan® into the synovial bursa can relieve pain and completely restore mobility within several hours.

For the treatment of chronic bursitis

the drug is used in smaller doses after stopping an acute attack of the disease.

For acute tendosynovitis, tendonitis and peritendinitis

one injection of the drug Diprospan® alleviates the patient’s condition; for
chronic conditions
the injection of the drug should be repeated depending on the reaction. It is necessary to avoid injecting the drug directly into the tendon.

For rheumatoid arthritis and osteoarthritis

intra-articular administration of the drug in a dose of 0.5-2 ml reduces pain, tenderness and stiffness of the joints within 2-4 hours after administration. The duration of the therapeutic effect of the drug varies significantly and can be 4 weeks or more.

Recommended doses of the drug when administered to large joints

make up 1-2 ml;
medium -
0.5-1 ml;
in small ones
- 0.25-0.5 ml.

For some skin diseases

the drug is administered intradermally directly into the lesion at a dose of 0.2 ml/cm2. The lesion site is evenly pricked using a tuberculin syringe and a needle, which has a diameter of approximately 0.9 mm. The total dose of the drug administered to all injection sites within 1 week should not exceed 1 ml.

Recommended single doses of Diprospan® (with intervals between injections of 1 week) for hard calluses are 0.25-0.5 ml (usually 2 injections are effective); with a spur - 0.5 ml; for stiffness of the big toe - 0.5 ml; for a synovial cyst - from 0.25 to 0.5 ml; for tenosynovitis - 0.5 ml; for acute gouty arthritis - from 0.5 to 1 ml. For administration, it is recommended to use a tuberculin syringe with a needle that has a diameter of approximately 1 mm.

After achieving a therapeutic effect, the maintenance dose is selected by gradually reducing the initial dose by reducing the concentration of betamethasone in the solution, which is administered at appropriate time intervals. The dose reduction is continued until the minimum effective dose is reached.

If a stressful situation occurs or is threatened (which is not related to the disease), an increase in the dose of the drug may be required.

Discontinuation of the drug after long-term therapy should be carried out by gradually reducing the dose. The patient's condition is monitored for at least a year after completion of long-term therapy or after using the drug in high doses.