Active substancePropofolPropofol
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  • Dosage form: & nbspemulsion for intravenous administration
    Composition:

    In 1 ml of emulsion contains:

    active substance: propofol 10 mg;

    Excipients: soybean oil 100 mg, egg yolk phospholipids 12 mg, glycerol 22.5 mg, ethylenediaminetetraacetic acid disodium EDTA (anhydrous equivalent) 0.055 mg, sodium hydroxide in an amount necessary to adjust the pH to 7.5-8.5, water for injections up to 1 ml.

    Description:

    White or almost white color is a homogeneous emulsion. With prolonged standing, a slight stratification can be observed.

    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-diisopropylphenol) is a short-acting agent for general anesthesia with a rapid onset of action for about 30 seconds. Usually the output from general anesthesia occurs quickly. The mechanism of action of the drug Diprivan®, as well as of all agents for general anesthesia, is not clear enough.

    As a rule, when Diprivan is used, an average arterial pressure and small changes in the heart rate are observed to induce anesthesia and maintain it. Nevertheless, hemodynamic parameters usually remain relatively stable during maintenance of anesthesia, and the frequency of adverse hemodynamic changes is low.

    Although Diprivan® may cause respiratory depression, any of these effects are qualitatively similar to those that occur with the use of other intravenous anesthetics and are easily amenable to clinical control.

    Diprivan® 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 clear consciousness and is accompanied by a low percentage of headache cases. As a rule, after anesthesia with Diprivan, cases of postoperative nausea and vomiting are less common than after inhalation anesthesia. Perhaps this is due to the antiemetic effect of propofol.

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

    Pharmacokinetics:

    Reducing the concentration of propofol after the bolus dose or after stopping the infusion can be described using an open three-chamber model. The first phase is characterized by a very fast distribution (the half-distribution period is 2-4 minutes), the second - with a fast elimination (half-life is 30-60 minutes). Then follows a slower final phase, which is characterized by the redistribution of propofol from mildly perfused tissue into the blood.

    Propofol is quickly distributed and rapidly excreted from the body (total clearance is 1.5-2 l / min). The excretion of propofol is carried out by metabolism, mainly in the liver, resulting in the formation of propofol conjugates and the corresponding quinol, the excretion of which occurs by the kidneys.

    In cases where Diprivan® 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 the Diprivan® preparation is linear.

    With increasing patient's age, pharmacokinetic changes are such that when IV bolus Diprivan® is injected into the blood plasma, higher concentrations of the drug are noted. High plasma concentrations in elderly patients can cause cardiovascular and respiratory effects, such as lowering blood pressure, apnea, airway obstruction, decreased blood oxygenation. As a consequence, in elderly patients lower doses of Diprivan are recommended for induction and maintenance of anesthesia, providing a sedative effect. (Cm.section "Method of administration and dose")

    There were no differences in the pharmacokinetics of propofol in patients with chronic liver cirrhosis or chronic renal insufficiency compared with adult patients with normal liver and kidney function. The pharmacokinetics of propofol in patients with acute hepatic and renal insufficiency has not been studied.

    Indications:

    - Induction and maintenance of general anesthesia;

    - sedation of patients who are on artificial ventilation of lung ventilation), during intensive therapy;

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

    - Hypersensitivity to 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 artificial ventilation of lung ventilation), during intensive therapy;

    - sedation of patients under 1 month of age who are conscious during 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 the use of other intravenous Anesthetics should be used with caution 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

    Diprivan® should not be used during pregnancy. However, Diprivan® is used during the termination of pregnancy in the first trimester.

    Obstetrics

    Diprivan® penetrates the placental barrier and its use can be associated with neonatal depression. It should not be used in obstetrics as an anesthetic.

    Breastfeeding period

    For infants who are breastfed, the safety of Diprivan® in lactating women has not been established. In this regard, breastfeeding is not recommended during the use of Diprivan®.

    Dosing and Administration:

    As a rule, Diprivan® requires additional use of analgesic agents.

    Diprivan® 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 Diprivan® may be required in cases where general anesthesia is used as a supplement to the methods of regional anesthesia used.

    Guidance on the preparation of the introduction of Diprivan® target concentration by the infusion system that includes appropriate software "Diprifyuzor" See D. This use is limited to the induction and maintenance of general anesthesia in adults. The infusion system for the target concentration (DIC) "Diprifuge" is not recommended for sedation in patients in intensive care units, for a sedative effect with conserved consciousness, or in children.

    A. ADULTS

    Induction of general anesthesia

    Diprivan® can be used to induce anesthesia through slow bolus injections or infusion.Regardless of whether premedication was or was not performed, 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 before the appearance of clinical signs of anesthesia. For most adult patients under 55 years of age, the average dose of Diprivan® is 1.5-2.5 mg / kg. The required total dose can be reduced using lower administration rates (20-50 mg / min). For patients older than this age, usually a lower dose is required. Patients 3 and 4 classes ASA (Classification of the patient's physical status American Society of Anesthesiology (ASA) Classification), administration should be performed at a lower rate (approximately 20 mg every 10 seconds).

    Maintaining general anesthesia

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

    Continuous infusion

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

    Repeated bolus injections

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

    Sedation during intensive care

    The introduction of Diprivan® with the help of the Diprifuge system for the sedation of patients during intensive care is not recommended.

    When using the drug Diprivan ® for sedation of adult patients who are on ventilation and receiving intensive therapy, it is recommended to use it through continuous infusion. The rate of infusion should be adjusted to the required depth of sedation, but a rate of 0.3-4.0 mg / kg / h should ensure satisfactory sedation. The infusion rate should not exceed 4.0 mg / kg / h, unless the potential benefit to the patient outweighs the risk of side effects.

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

    The introduction of Diprivan® with the help of the Diprifusor system for sedation with preservation of consciousness is not recommended.

    To ensure sedation during surgical and diagnostic procedures, the rate of administration and dosage should be selected individually depending on the clinical response of the patient.

    For the majority of patients, 0.5-1.0 mg / kg is required for 1-5 minutes for the onset of sedation.

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

    B. Older patients

    Older patients require lower doses of Diprivan® for anesthesia. When reducing the dose should be guided by the physical status and age of the patient. A reduced dose should be administered at a lower rate than usual and titrated according to the patient's response. When using Diprivan ® to maintain anesthesia or sedation, the infusion rate or "target concentration" of the drug should be reduced. For patients 3 and 4 classes ASA a further reduction in dose and rate of administration may be required. To avoid oppression of the cardiovascular and respiratory systems, elderly patients are not recommended for rapid bolus administration (single or repeated).

    V. CHILDREN

    Children are not advised to administer Diprivan® with the help of the Diprifuge system at any indications.

    Induction of general anesthesia

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

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

    For most children over the age of 8, approximately 2.5 mg / kg of Diprivan® is probably needed to induce anesthesia.

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

    Maintaining general anesthesia

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

    Maintenance of anesthesia is achieved by the administration of Diprivan® through continuous infusion or by repeated bolus injections,Required to maintain the required depth of anesthesia. The required rate of administration differs significantly in different patients; satisfactory anesthesia is usually provided at infusion rate of 9-15 mg / kg / h.

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

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

    To ensure short-term sedation during surgical and diagnostic procedures, the rate of administration and dose should be selected individually depending on the clinical response of the patient.

    In most cases, the onset of sedation is achieved with the administration of the drug at a dose of 1-2 mg / kg for at least 1 minute. To maintain sedation, the infusion rate should be adjusted in accordance with the required depth of sedation; for most patients, a rate of 1.5-9 mg / kg / h is required. If a rapid increase in the depth of sedation is required, bolus injection of Diprivan® in a dose of up to 1 mg / kg may be used as an adjunct to the infusion.

    For patients in grade 3 and 4, ASA may require a reduction in dose and rate of administration.

    Sedation during intensive care

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

    D. INTRODUCTION

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

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

    A diluted solution of Diprivan® can be administered using a variety of adjustable infusion systems, however, the use of only such devices does not completely avoid the risk of accidental, uncontrolled administration of large volumes of diluted Diprivan®. Burettes, drip counters or dosing pumps should always be part of the infusion line. When choosing the maximum volume of diluted Diprivan® in a burette, one should keep in mind the risk of uncontrolled administration.

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

    A ready-to-use glass syringe has less piston resistance than a plastic disposable syringe and is easier to drive.When Diprivan® is administered manually with a ready-to-use glass syringe, the infusion system between the syringe and the patient should not be left open if there is no observation from the medical staff.

    Appropriate compatibility should be ensured if a ready-to-use glass syringe is used in a syringe pump. In particular, the design of the pump must prevent siphoning and should provide an alarm for clogging at a pressure of not more than 1000 mm Hg. If a programmable or equivalent pump is used, suggesting the possibility of using different syringes, then in the case of using a ready-to-use glass syringe, only the "B-D"50/60 ml Plastipak. Diprivan® can be pre-mixed with alfentanil for injection containing 500 μg / ml of alfentanil, in a volume ratio of 20: 1 to 50: 1. Mixtures should be prepared using sterile equipment, and applied within 6 hours after preparation.

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

    DIPRIVAN® DECOMPOSITION AND JOINT INTRODUCTION IN CONJUNCTION WITH OTHER MEDICINES OR INFUSION SOLUTIONS

    Method

    simultaneous

    applications

    Drug or infusion solution

    Preparation

    Caveats

    Preliminary

    mixing

    5% dextrose solution for intravenous administration

    Mix 1 part of the Diprivan® preparation and up to 4 parts of a 5% dextrose solution for intravenous administration or in bags of PVC (PVC) or in glass bottles. When diluted in PVC bags it is recommended that the bag be full, the solution is prepared by removing a portion of the volume of the dextrose solution, replacing it with an equivalent volume of the Diprivan® preparation

    Cooking vaseptic

    conditions, directly

    before use. The mixture remains stable for 6 hours


    Lidocaine for injection (0.5% or 1% without preservatives)

    Mix 20 parts of Diprivan® and up to 1 part of 0.5% or 1% solution of lidocaine for injection

    Cooking, observing the conditions of asepsis, immediately before

    application. To be used only for the induction of anesthesia


    Alfentanil for injection (500 μg / ml)

    Mix Diprivan® with alfentanil for injection in a volume ratio of 20: 1 to 50: 1

    Cook, observing the conditions of aseptic, immediately before use. Apply within 6 hours after

    cooking

    Simultaneous introduction of a tee with a valve

    5% dextrose solution for intravenous administration

    Simultaneous administration using a tee with a valve

    Tee with valve

    close to injection site


    0.9% solution of sodium chloride for intravenous administration

    See above

    See above


    4% dextrose solution with 0.18% sodium chloride solution for iv administration

    See above

    See above

    E. INFUSION ON TARGET CONCENTRATION - INTRODUCTION OF DIPRIVAN® DRUG WITH THE SYSTEM FOR AND THE DIPRIFYUSOR CENTER FOR ADULTS

    The introduction of Diprivan® with the help of the Diprifuge system is limited to periods of induction and maintenance of general anesthesia in adults. It is not recommended to use sedation in intensive care, to provide a sedative effect with the preservation of consciousness or in children.

    Diprivan® can be introduced by the ICC method only with the help of the Diprifusor ICP system, which includes the Diprifuser software. These systems will function only after recognizing the electronic label on a ready-to-use glass syringe filled with Diprivan®.

    The Diprifuge system will automatically adjust the rate of administration of the Diprivan® preparation to that concentration that was recognized by the system. Users should be familiarized with the manual for working with the infusion pump, with the introduction of Diprivan® by the ICC method, with the correct use of the syringe recognition system, as described in the training manual provided by AstraZeneca.

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

    The Diprifyuzor system assumes that the initial concentration of propofol in the patient's blood is 0. Therefore, for patients receiving propofol earlier, probably, it is necessary to choose lower initial target concentration at the beginning of introduction of preparation Diprivan® with the help of ICP "Diprifyuzor". Also, it is not recommended to resume the work of the Diprifusor IC in the previous mode after it was shut down.

    Guidance on the selection of target concentrations of propofol is attached 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.

    In adult patients under 55 years of age, anesthesia can usually be induced by targeted concentrations of propofol from 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 induction of anesthesia at these target concentrations is, as a rule, 60-120 seconds. Higher values ​​will lead to faster induction of anesthesia, but may be associated with more severe hemodynamic depression and respiratory function.

    Smaller initial target concentrations should be used in patients older than 55 years and in patients 3 and 4 classes ASA. The target concentrations can then be gradually increased by a value from 0.5 to 1.0 μg / ml at intervals of 1 minute to achieve a gradual induction of anesthesia.

    As a rule, 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 upon awakening is generally within 1.0-2.0 μg / ml and will depend on the level of analgesia during the period of anesthesia maintenance.

    Sedation during intensive care

    Typically, a target concentration of propofol in the blood in the range of 0.2-2.0 μg / ml is required. The administration of Diprivan® should be started at a low target concentration and titrated with dose depending on the patient's reaction for achieving the desired sedation depth.

    Side effects:

    General information

    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 to the condition of the patient.

    Very often (> 1/10)

    General reactions and reactions 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 and nausea during awakening

    From the central nervous system:

    Headache during awakening

    From the respiratory system:

    Temporary apnea during induction of anesthesia

    Infrequently

    (>1/1000, <1/100)

    From the side of the cardiovascular system:

    Arrhythmia, thrombosis and phlebitis

    Rarely

    (>1/10 000, < 1/1000)

    Disorders from the central nervous system:

    Epileptiform seizures, including convulsions and opisthotonos during induction of anesthesia, maintenance of anesthesia and awakening; euphoria

    Very rarely (<1 / 10,000)

    Musculoskeletal

    effects,

    connective tissue:

    Rhabdomyolysis(5)

    Procedural

    complications:

    Postoperative

    fever

    From the gastrointestinal tract:

    Pancreatitis

    From the side of the kidneys and

    urinary tract

    system:

    Discoloration of urine with prolonged administration

    From the immune system:

    Anaphylaxis can manifest itself in the form of: angioedema, bronchospasm, erythema and lowering of blood pressure

    Infringements from

    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 Diprivan® with lidocaine (see the section "Dosing and Administration", part D)

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

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

    (4) Occurs during the abrupt discontinuation of Diprivan® during intensive care.

    (5) It was reported that very rare cases of rhabdomyolysis with the use of Diprivan® in doses exceeding 4 mg / kg / h for sedation with intensive therapy.

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

    In very rare cases, when taking Diprivan® at 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:

    Accidental overdose, probably, can cause depression of the cardiovascular system and breathing. In case of oppression, breathing, artificial ventilation of the lungs with oxygen should be performed.When oppression of cardiovascular activity in severe cases, it may be necessary to introduce plasma-substituting and pressor means.

    Interaction:

    Diprivan® was used in combination with spinal and epidural anesthesia, with means for premedication, muscle relaxants, means for inhalation anesthesia and analgesics; pharmacological incompatibility was not noted. Lower doses of Diprivan® may be required in cases where general anesthesia is used as a supplement to the methods of regional anesthesia used.

    Incompatibility

    Diprivan® should not be mixed before use with any other injection or infusion solutions, except 5% dextrose solution in PVC bags or in glass infusion bottles, lidocaine for injection or alfentanil for injection in plastic syringes.

    With the introduction of muscle relaxants atrakury bezilate and myovac chloride, do not use the same infusion line as for Diprivan® without first rinsing it.

    Special instructions:

    Diprivan® should be used by personnel trained in anesthesia (or, if appropriate, by physicians trained to assist patients during intensive care). Patients should be constantly monitored, equipment to maintain free airway patency, for artificial ventilation of lungs, oxygen enrichment, as well as other resuscitation facilities should be constantly ready for use. Diprivan® should not be administered by a person performing a diagnostic or surgical procedure.

    When using Diprivan® during surgical or diagnostic procedures for sedation with preservation of consciousness, 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 the drug Diprivan ® 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 is needed to monitor the patient to ensure complete recovery after general anesthesia. In very rare cases, after using the Diprivan® drug, there may be a lack of consciousness in the postoperative period, which 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.

    Diprivan® 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 advisable to intravenously administer the m-cholinoblocking agent before the induction of anesthesia or during its maintenance, especially when there is a possibility of a predominance of the vagal nerve tone, or when Diprivan is used in combination with other agents that can cause bradycardia.

    In the event that Diprivan® is administered to a patient suffering from epilepsy, there is a risk of seizures.

    Appropriate attention should be given to patients with lipid metabolism disorders, as well as other conditions requiring careful application of lipid emulsions.

    It is recommended to monitor the concentration of lipids in the blood in cases where Diprivan® is prescribed to patients who are at particular risk of lipid accumulation. In the event that monitoring indicates an inadequate removal of fats from the body, the administration of Diprivan® 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 introduced into the Diprivan® preparation; 1.0 ml of Diprivan® contains approximately 0.1 g of lipids.

    Note to Section "Sedation during intensive care"

    Very rare cases of metabolic acidosis, ECG changes (similar to ECG changes in Brugada syndrome, including ST segment elevation), rhabdomyolysis, hyperkalemia, and / or congestive heart failure have been reported,in some cases with a fatal outcome in seriously ill

    patients receiving Diprivan® to provide a sedative effect during intensive care. The most likely factors listed events risk are: reduction of maintenance of oxygen to tissues, severe neurological trauma and / or sepsis, high doses of these pharmacologically active agents - vasoconstrictors, steroids, cardiotonic agents and / or propofol. All therapeutic and sedative medications used during the intensive care (including Diprivan®) should be titrated for optimal supply of oxygen to tissues and optimal hemodynamic parameters.

    Part of the preparation forms EDTA chelate complexes with metal ions including zinc ions. It should be considered supplemental assignment zinc prolonged use Diprivan® formulation, especially in patients who have a predisposition to zinc deficiency, such as burns, diarrhea and / or sepsis.

    Diprivan® contains no antimicrobial preservatives, and can serve as a good medium for microbial growth.Diprivan contains the disodium EDTA (anhydrous equivalent) of 0.055 mg in 1 ml as a microbial growth inhibitor. When Diprivan® is filled with a sterile syringe or infusion line, aseptic rules should be followed; the drug should be recruited immediately after opening the ampoule. The introduction should begin immediately. Aseptic conditions must be ensured throughout the infusion period both with regard to the Diprivan® preparation and the equipment for administration. Any infusion solutions added to the infusion line in conjunction with the Diprivan® preparation should be administered as close as possible to the location of the cannula. Diprivan® can not be administered via a microbiological filter.

    Syringe with Diprivan® is a disposable and is intended for use in one patient. In accordance with the rules established for other lipid emulsions, the duration of continuous infusion of Diprivan® should not exceed 12 hours. After the infusion of the drug or after a 12-hour period, it is necessary to replace both the container with the Diprivan® preparation and the infusion line.

    Containers with Diprivant® should be shaken before use.The contents of the container, left in any quantity after its use, must be destroyed.

    Aseptic conditions should be provided for both the Diprivan® preparation and the administration equipment.

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

    Patients should be informed that general anesthesia, for some time after it, may worsen the performance of skills requiring work, such as driving or working with machinery.

    Form release / dosage:

    Emulsion for intravenous administration, 10 mg / ml.

    Packaging:

    To 20 ml in glass ampoules. 5 ampoules in a plastic holder in a cardboard box with instructions for use.

    50 ml in a glass syringe with polypropylene plunger and Luer connector. A syringe in a contour squamous packaging. One contour mesh package with instructions for use in a cardboard bundle.

    Storage conditions:

    At a temperature of 2 to 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    For ampoules: 3 years.

    For syringes: 2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N013345 / 01
    Date of registration:18.03.2010
    The owner of the registration certificate:AstraZeneca UK LtdAstraZeneca UK Ltd United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspAstraZeneca Pharmaceuticals Ltd.AstraZeneca Pharmaceuticals Ltd.
    Information update date: & nbsp07.09.2015
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