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

    1 ml contains:

    active substance: propofol 20.0 mg;

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

    Description:

    A white homogeneous emulsion with a weak phenolic odor.

    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 Kabi 20 mg / ml is a high-speed intravenous anesthetic for administration to general anesthesia, for its maintenance, and also for sedation of patients during intensive therapy.

    After intravenous administration of propofol hypnotic action begins quickly. Depending on the speed of administration, the time to anesthesia is 30-40 seconds.

    After a single bolus administration, the duration of action is short (4-6 minutes) due to rapid metabolism and excretion.

    Duration of general anesthesia, depending on the dose and associated drugs, ranging from 10 minutes to 1 hour.

    From anesthesia, the patient wakes up quickly and with clear consciousness. Possibility to open the eye appears after 10 minutes, recovery to the speech response occurs within 3 minutes after opening the eyes.

    No special places for cumulation were found.

    With the use of Propofol Kabi 20 mg / ml for the introduction into anesthesia and to maintain it, there is a decrease in the average blood pressure and a slight change in the heart rate. However, hemodynamic parameters usually remain relatively stable during maintenance of general anesthesia and the frequency of adverse hemodynamic changes is low.

    After administration of Propofol Cabi 20 mg / ml, respiratory depression may occur, but these effects qualitatively similar to those that arise with the use of other intravenous agents for general anesthesia, and are easily amenable to clinical control.

    Propofol Kabi 20 mg / ml reduces cerebral blood flow, intracranial pressure and reduces cerebral metabolism. Decrease in intracranial pressure was significant in patients with an increased baseline value of intracranial pressure.

    Propofol Cabi 20 mg / ml is an emulsion containing the active substance propofol and a mixture of long chain (LCT) and medium chain (MCT) triglycerides.

    Included in the fat emulsion medium chain triglycerides (MCT) reduce the amount of free propofol in the aqueous phase of the emulsion, which leads to a decrease in soreness when the drug is administered.

    In addition, medium chain triglycerides increase metabolism, which leads to decrease in the concentration of triglycerides in plasma.

    Pharmacokinetics:

    Propofol binds 98% to plasma proteins. Propofol kinetics after intravenous bolus injection can be presented in the form of a three-part model: a rapid distribution phase (elimination half-life of 2-4 minutes), a β-elimination phase (half-life of 30-60 minutes) and γ-phase elimination (half-life period 200-300 minutes).

    During the course of γ-phase the decrease in the concentration of propofol in the blood is slow because of a prolonged redistribution from adipose tissue. In clinical settings, this phase does not affect the time of awakening. The central volume of distribution is 0.2-0.79 l / kg, the equilibrium volume of distribution is 1.8-5.3 l / kg.

    Propofol is metabolized predominantly by conjugation in the liver at a clearance of about 2 L / min, but the metabolism also occurs outside the liver.

    Clearance in children is higher than in adults.

    The half-life after intravenous infusion was between 277 and 403 minutes. Inactive metabolites are mostly excreted by the kidneys (about 88%). Only 0.3% of the dose is excreted unchanged in the urine.

    With maintenance of general anesthesia in the usual regime, there was no significant cumulation of propofol after surgical procedures of at least 5 hours.

    Within the recommended infusion rates, the pharmacokinetics of propofol are linear character.

    Indications:

    - Induction and maintenance of general anesthesia in adults and children older than 3 years;

    - sedation, of patients on artificial ventilation (IVL), in adults and children over 16 years of age.

    Contraindications:

    - Hypersensitivity to propofol or any of the components of the drug;

    - Pregnancy and lactation (up to 24 hours after propofol administration);

    - Children under 3 years old. Propofol Kabi 20 mg / ml is not recommended for general anesthesia in children (under 3 years of age, because the concentration of 20 mg / ml is difficult to titrate, and for young children a very small amount of drug is required.) For children from 1 month to 3 years, Propofol Cabi 10 mg / ml, provided that the planned dose does not exceed 100 mg / h;

    - for sedation of patients under the age of 16 years, inclusive;

    - Propofol Kabi 20 mg / ml is not recommended for patients undergoing electroconvulsive therapy.

    Carefully:

    As with the use of other agents for non-inhaling general anesthesia, exercise 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.

    In patients with impaired function of the heart, lungs, kidney or liver, elderly and debilitated people, patients with hypovolemia or epilepsy, patients with impaired consciousness Propofol Kabi 20 mg / ml should be administered at a reduced rate.

    Before using Propofol Cabi 20 mg / ml, compensation should be obtained cardiovascular or respiratory failure and hypovolemia.

    Before anesthesia, a patient with epilepsy must be convinced that he is receiving antiepileptic therapy. Although several studies have shown the effectiveness of propofol in the treatment of epileptic status, it can also increase the risk of seizures.

    In patients with severe heart failure and other serious heart conditions, Propofol Cabi 20 mg / ml can be administered only with extreme caution and under constant supervision.

    Particular care should be taken in patients with impaired lipid metabolism and other conditions in which it is necessary to inject fat emulsions carefully. If the patient receives parenteral nutrition, it is necessary to take into account the amount of fat supplied by the infusion of the Propofol Kabi emulsion 20 mg / ml. In 1.0 ml of the emulsion contains 0.1 g of fat. When treatment in the intensive care unit after 3 days, it is necessary to determine the concentration of lipids. Given a higher dose in obese patients, the risk of developing hemodynamic disorders should be considered.

    Particular care should be taken in patients with high intracranial pressure and low mean arterial pressure, given the increased risk of a significant drop in intracranial perfusion pressure.

    During the modification of therapy, patients with increased intracranial pressure should be given adequate treatment to improve perfusion pressure of the brain.
    Pregnancy and lactation:

    Propofol Cabi 10 mg / ml penetrates the placental barrier and can exert a depressing effect on the fetus. Contraindicated during pregnancy, as well as in high doses above 2.5 mg / kg for general anesthesia or (6 mg / kg / h) to maintain anesthesia during delivery.

    Exception is the operation of abortion.

    A small amount of Propofol Kabi enters the breast milk. In this regard, it is not recommended to breast-feed for 24 hours after the administration of propofol.

    Dosing and Administration:

    Only intravenously.

    Propofol Kabi 20 mg / ml can be used only by anesthetists in hospitals or adequately equipped outpatient departments, as well as in intensive care units.

    When administering Propofol Kabi 20 mg / ml, the doctor should have the equipment usually used for general anesthesia, including cardiovascular function monitoring (ECG, pulse oximetry) and resuscitation facilities. The dose of Propofol Kabi 20 mg / ml should be selected individually, taking into account the patient's response and premedication.

    As a rule, when using the drug, additional administration of analgesic drugs is required.

    General anesthesia in adults

    Introduction to general anesthesia:

    When administered in a general anesthetic, Propofol Kabi 20 mg / mL should be administered fractional (approximately 20-40 mg of propofol every 10 seconds), until the appearance of clinical signs of anesthesia.

    The usual dose for adults under the age of 55 years is 1.5-2.5 mg / kg body weight.

    In older patients and in patients with grade III and IV severity, the classification by the American Society of Anesthesiologists (ASA), especially with impaired function of the heart, the required dose is usually lower.

    The total dose of Propofol Cabi 20 mg / ml can be reduced to a minimum of 1 mg / kg.

    A slower administration of Propofol Kabi 20 mg / ml is required: approximately 1 ml (20 mg of propofol) every 10 seconds.

    Maintaining anesthesia

    To maintain general anesthesia, Propofol Kabi 20 mg / ml is injected continuously in droplets or repeatedly in the form of boluses.

    For maintenance anesthesia propofol apply in a dose of 4-12 mg / kg of weight.

    With less severe surgical interventions, for example, minimally invasive, a maintenance dose can be reduced to about 4 mg / kg body weight / hour.

    In elderly, patients with unstable general condition, patients with impaired cardiac function or hypovolemia and patients with grade III-IV severity, the ASA classification can be reduced even more, given the severity of the condition and the technique of anesthesia.

    General anesthesia in children older than 3 years

    Propofol Kabi 20 mg / ml is not recommended for general anesthesia in children under 3 years of age, since the concentration of 20 mg / ml of the emulsion is difficult to titrate, and small children need a very small amount of the drug. For children aged 1 month to 3 years, it is recommended to use Propofol Kabi 10 mg / ml, with a dose should be less than 100 mg / h.

    Introduction to general anesthesia

    When administered to general anesthesia, slow titration of the Propofol Kabi dose of 20 mg / ml is recommended until the appearance of clinical signs of general anesthesia.

    The dose is chosen taking into account the age and / or body weight.

    In children over the age of 8, the dose necessary for administration to general anesthesia is approximately 2.5 mg / kg body weight.

    In young children, the dose may be higher. The drug is started with a dose of 3 mg / kg. If necessary, additional doses of 1 mg / kg may be administered.

    Children from high-risk groups (III-IV severity of ASA classification) are recommended to have lower doses.

    Maintaining anesthesia

    To maintain general anesthesia, a continuous infusion of 9-15 mg / kg / h is administered. There are no data on repeated injections of propofol to maintain general anesthesia in children.

    The dose is selected individually. It is necessary to pay special attention to the adequacy of anesthesia.

    Sedation in adults in intensive care units

    For sedation during mechanical ventilation in the intensive care units, Propofol Kabi 20 mg / mL is recommended to be administered by continuous infusion. The dose is selected taking into account the necessary depth of sedation. Usually adequate sedation can be achieved with a propofol administration rate of 0.3-4.0 mg / kg / h. Increase the rate of administration of more than 4.0 mg / kg / h is not recommended.

    Propofol Kabi 20 mg / ml should not be used for sedation in intensive care units in patients aged 16 years and under.

    Methods of administration

    For intravenous administration.

    Propofol Cabi 20 mg / ml is administered intravenously undiluted, as a continuous infusion.

    Propofol Cabi 20 mg / ml can not be used for repeated bolus injection in order to maintain anesthesia.

    When administering Propofol Kabi 20 mg / ml, it is recommended to control the infusion rate with a burette, a syringe or IV infusion pump.

    The vial should be shaken before the introduction.

    Apply only a homogeneous product from an intact vial.

    Before use, the rubber membrane should be treated with alcohol.

    Since Propofol Cabi 20 mg / ml 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 vial. Introduction must begin without delay.

    During the entire period of administration of Propofol Kabi 20 mg / ml, the rules of aseptic work with the drug and the system for parenteral infusion should be observed.

    Other drugs or solutions that need to be administered concurrently with the administration of Propofol Cabi 20 mg / ml should be injected into the dropper through a Y-shaped connector or valve.

    Propofol Cabi 20 mg / ml should not be mixed with other solutions for intravenous administration. However, through the cannula of a dropper, you can simultaneously inject 5% glucose solution, 0.9% or 0.18% sodium chloride solution and 4% glucose solution.

    Propofol Kabi 20 mg / ml can not be administered via an antibacterial filter.

    Propofol Cabi 20 mg / ml and other infusion systems containing propofol, are intended only for single use and only for one patient individually.

    Any residues of the Propofol Kabi emulsion 20 mg / ml should be disposed of after use.

    As with other fat emulsions, the duration of administration of Propofol Cabi 20 mg / ml with a single infusion system should not exceed 12 hours. After 12 hours, the infusion system and the tank with Propofol Kabi 20 mg / ml should be replaced.

    To reduce pain when injected, the infusion should be injected into a larger vein, or a solution of lidocaine can be administered just before the infusion of Propofol Kabi 20 mg / ml.

    Muscle relaxants, such as atracurium and myovacury, can be administered via the same catheter only after jet washing.

    Duration of application should not exceed 7 days.

    Side effects:

    Common side effects of Propofol Kabi 20 mg / mL are lowering blood pressure and suppressing respiratory function. These effects depend on the dose of propofol, as well as the type of premedication and concomitant therapy.

    The following classification of side effects is given below:

    Very frequent (> 1:10), frequent (from> 1: 100 to <1:10), infrequent (from> 1: 1000 to <1: 100), rare (from> 1:10 000 to <1: 1000), very rare (<1:10 000); unknown (side effects, the frequency of which is difficult to assess, based on available data).

    Within each group, adverse effects are presented in order of decreasing clinical importance:

    Immune disorders:

    Rare:

    Anaphylactic reactions, including Quincke's edema, bronchospasm, erythema and lowering of blood pressure.

    Metabolic disorders:

    Frequent:

    Hypertriglyceridemia

    Mental disorders:

    Rare:

    Euphoria and increased sexual function during the recovery period.

    Neurological disorders:

    Frequent:

    Spontaneous movements and myoclonus during administration to anesthesia, minimal excitation.

    Rare:

    Headache, dizziness, chills and cold sensations during the recovery period.

    Epileptiform seizures, including convulsions and opisthotonus.

    Very rare:

    Late epileptiform seizures that develop after a few hours or days.

    The risk of seizures in patients with epilepsy after the administration of propofol.

    Cases of unconsciousness after surgery.

    Changes in the heart / vascular disorders:

    Frequent:

    During the introduction to anesthesia, lowering blood pressure, bradycardia, tachycardia, "hot flashes".

    Infrequent:

    A marked decrease in blood pressure.

    It may be necessary to reduce the rate of administration of Propofol Cabi 20 mg / ml and / or substitution of fluid, if necessary, vasoconstrictor. It should be considered the possibility of a sharp decrease in blood pressure in patients with impaired coronary or cerebral blood flow or patients with hypovolemia.

    Increasing bradycardia, up to asystole, during general anesthesia.

    Possible intravenous administration of m-holinoblokatorov during the introduction to the general anesthesia or during anesthesia.

    Rare:

    Arrhythmia in the recovery period.

    Thrombosis and phlebitis.

    Changes in the respiratory, thoracic and mediastinal systems:

    Frequent:

    With the introduction of anesthesia, hyperventilation, transient apnea, cough, hiccough.

    Infrequent:

    Cough during anesthesia.

    Rare:

    Cough during the recovery period.

    Very rare:

    Pulmonary edema.

    Gastrointestinal disorders:

    Rare:

    Nausea and vomiting during recovery.

    Very rare:

    After the administration of propofol, cases of pancreatitis have been described, although a causal relationship has not been established.

    Changes in the skin and subcutaneous tissues:

    Very rare:

    Severe tissue changes after accidental paravenosis.

    Changes in the kidneys and urinary tract:

    Rare:

    Change in the color of urine after prolonged use of propofol.

    General and local reactions:

    Very Frequent:

    Pain at the injection site.

    Pain at the injection site of propofol can be minimized by the simultaneous administration of lidocaine or infusion of the drug into the larger vein of the forearm or the ulnar fossa.

    With the introduction of lidocaine rarely (> 1:10 000 to <1: 1000), the following adverse effects were observed: dizziness, vomiting, drowsiness, convulsions, bradycardia, cardiac arrhythmias and shock.

    Rare:

    Postoperative fever.

    Very rare:

    Separate cases of severe adverse effects in the form of a complex of symptoms are described: rhabdomyolysis, metabolic acidosis, hyperkalemia and heart failure, sometimes with a fatal outcome. In most cases, these symptoms were observed in intensive care units in patients receiving a dose exceeding 4 mg / kg / h.

    Overdose:

    Overdose can lead to depression of the functions of the cardiovascular system and respiration. When suppressing the respiratory system, artificial ventilation is performed.If the cardiovascular system is disturbed, the head end of the bed should be lowered and the introduction of plasma substitutes and / or vasopressor agents should begin.

    Interaction:

    Propofol Cabi 20 mg / ml can be used in conjunction with other drugs commonly used for premedication, inhalation anesthesia, analgesics, muscle relaxants or local anesthetics.

    Some central-action drugs can have an overwhelming effect on the cardiovascular system and respiratory system and can enhance the effect of propofol. If general anesthesia is combined with a local one, lower doses may be used.

    Combined use of benzodiazepines, m-holinoblokatorov. or inhalational anesthetics sometimes causes an increase in anesthesia and a decrease in respiratory rate.

    After premedication with narcotic analgesics, it is possible to enhance and prolong the sedative effect 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 Kabi 10 mg / ml on a background of premedication with inhalation anesthetics or analgesics, can potentiate anesthesia and side effects from the cardiovascular system.

    The combined use of drugs that suppress the central nervous system, such as alcohol, general anesthetics, narcotic analgesics, leads to a pronounced manifestation of their sedative effect.

    If the administration of Propofol Cabi 20, mg / ml is combined with parenterally injected drugs depressing the central nervous system, it is possible 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 increase in the frequency of apnea.

    After administration of suxamethonium, or neostigmine methyl sulphate may be observed bradycardia and cardiac arrest.

    In patients receiving ciclosporin, cases of leukoencephalopathy are described with the introduction of fat emulsions, such as propofol.

    Special instructions:

    Propofol Kabi 20 mg / ml does not reduce the tone of the vagus nerve, and its use in a number of cases is accompanied by bradycardia (sometimes pronounced), as well as asystole.

    Before induction or during maintenance of general anesthesia, Propofol Kabi 20 mg / ml should consider the possibility of intravenous m-holinoblokatorov,especially in cases of a supposedly enhanced tone of the vagus nerve or with the use of Propofol Kabi 20 mg / ml together with other drugs that can cause bradycardia.

    To relieve pain at the injection site with the induction of general anesthesia, Propofol Kabi 20 mg / ml before the administration of the emulsion of the drug can be administered lidocaine. When using lidocaine should be taken into account that it can not be used in patients with hereditary porphyria.

    Propofol Kabi 20 mg / ml can be used only by doctors who have been trained in anesthesia or intensive care.

    Propofol Kabi 20 mg / ml should not be administered by personnel performing surgical procedures.

    Efficacy and safety of Propofol Kabi 20 mg / ml for (background) sedation of children under 16 years of age has not been studied. In case of unauthorized use of the drug for (background) sedation of children under 16 years of age, serious side effects have been reported, including death, although the cause-and-effect relationship in these cases has not been established. In particular, cases of metabolic acidosis, hyperlipidemia, rhabdomyolysis and / or heart failure are noted.These effects were most often observed in children with respiratory infections receiving doses of the drug in intensive care units that exceed the doses for adults. Similarly, in adults who received the drug for more than 58 hours at a rate of more than 5 mg / kg / h, rare cases of metabolic acidosis, rhabdomyolysis, hyperkalemia and / or rapidly progressive heart failure (in some cases fatal) were noted. This rate exceeds the maximum rate of 4 mg / kg / hr recommended for the use of the drug for the purpose of sedating patients in intensive care units.

    Heart failure in such cases is usually not sensitive to maintenance therapy with inotropic drugs.

    If possible, the dose of 4 mg / kg / hour, usually sufficient for sedation of patients undergoing mechanical ventilation in intensive care units (with a treatment duration of more than 1 day) should not be exceeded.

    Doctors should be cautious about these side effects, and at the first signs of their occurrence, reduce the dose or switch to other sedatives.

    The rate of administration of Propofol Cabi 20 mg / ml should be reduced in patients with congenital dementia, epilepsy patients, with cardiac, lung, liver and kidney function disorders, with hypovolemic conditions.

    In some cases, after the use of Propofol Kabi 20 mg / ml, there was a period of postoperative unconsciousness of the patient, accompanied by increased muscle tone. Although consciousness returned on its own, patients who are in an unconscious state require careful observation.

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

    Propofol Cabi 20 mg / ml contains soybean oil, which in rare cases can cause severe allergic reactions.

    This drug contains less than 1 mmol of sodium (23 mg of sodium) in 100 ml, which practically allows it to be considered a drug that does not contain sodium.

    During the entire infusion period, the principles of asepsis should be observed for both the Propofol Kabi 20 mg / ml preparation and the infusion equipment. Parallel administration of other drugs through the infusion system for Propofol Kabi 20 mg / mL should be carried out as close as possible tocannula.

    Propofol Cabi 20 mg / ml and all infusion equipment for its administration can used only once and only for one patient.

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

    After the administration of Propofol Kabi 20 mg / ml, the patient should be under the supervision of a physician within the appropriate time.

    The patient should be informed that he should not drive vehicles and mechanisms, should avoid drinking alcohol and work in potentially dangerous conditions on the day of taking the drug.

    The patient can only be released home with an accompanying person.

    Form release / dosage:

    Emulsion for intravenous administration, 10 mg / ml.

    Packaging:

    For 15 ml or 20 ml in ampoules of colorless type I (Hebrew Farm.), Marked with a dot.

    5 or 10 ampoules per carton or plastic packagings together with instructions for use in a cardboard box.

    50 ml per bottle of colorless glass type II (Hebrew Pharm.), sealed with stoppers made of halobutyl rubber and coated with aluminum caps with plastic caps to control the first opening (Hebrew Pharm.).

    For 1, 5 or 10 vials, along with instructions for use in a cardboard pack.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Do not freeze!

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:For hospitals
    Registration number:PL-000875
    Date of registration:18.10.2011
    The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany
    Information update date: & nbsp06.09.2015
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