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

    1 ml of the preparation contains:

    active substance: propofol 10 mg;

    Excipients: purified egg lecithin 12 mg, soybean oil 100 mg, glycerin 22.5 mg, water for injection up to 1 ml.

    Description:

    Milky white or milky-white with a yellowish or creamy hue emulsion type oil in water.

    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:

    Propovan is a means for non-anional anesthesia, with a short-term effect and causing a rapid onset of drug sleep, for about 30-60 seconds after administration. The duration of action after a single bolus is 4-6 minutes because of the high rate of metabolism and excretion. Virtually no analgesic effect.

    Awakening usually occurs quickly and with a clear consciousness, the incidence of headache, postoperative nausea and vomiting is low.

    In the application of Propovan for introductory anesthesia and maintenance of general anesthesia, there may be a decrease in blood pressure and bradycardia (manifestation of vagolytic activity), however, hemodynamic parameters usually remain relatively stable during maintenance of general anesthesia.

    After administration of Propovan, as with the use of other intravenous anesthetics, respiratory depression and other effects that can be easily controlled in clinical settings may occur.

    Propovan reduces cerebral blood flow, intracranial pressure and reduces cerebral metabolism (more pronounced in patients with an increased baseline value of intracranial pressure).

    Pharmacokinetics:

    After intravenous administration, about 98% of propofol binds to plasma proteins. The dynamics of changes in the concentration of the drug in the blood after the administration of the bolus dose or after the cessation of infusion is characterized by 3 phases. The first - α-phase is characterized by a very rapid distribution (2-4 min) - more than 50% of the dose passes into a well-perfused tissue, the second - the β-phase - by rapid elimination (T1/2 30-60 minutes). Then follows a slower final phase, which is characterized by the redistribution of propofol from weakly perfused tissues into the blood. The initial volume of distribution is 0.2-0.79 l / kg of body weight, a stable volume of distribution is 1.8-5.3 l / kg of body weight.

    Well overcomes the histohematological barriers (including placental, causes suppression of the fetal CNS).

    Metabolised in the liver by conjugation with glucuronic acid and sulfates with the formation of inactive metabolites. The drug is rapidly eliminated from the body - the total clearance is approximately 2 l / min. Clearance in children is higher than in adults. About 88% of the administered dose is excreted in the form of metabolites with urine.Within the recommended infusion rates, pharmacokinetics is linear.

    Indications:

    - Introductory anesthesia and maintenance of general anesthesia;

    - providing a sedative effect in patients undergoing artificial ventilation (IVL);

    - providing sedative effect in patients who are conscious during surgical and diagnostic procedures.

    Contraindications:

    Hypersensitivity to propofol or other components of the drug.

    Childhood:

    - up to 3 years - for general anesthesia,

    - up to 16 years - for sedation;

    Pregnancy.

    Carefully:

    As with the use of other intravenous agents for general anesthesia, care should be taken with regard to patients:

    - with heart diseases;

    - with cardiac and / or respiratory insufficiency;

    - with violations of the liver and kidneys;

    - with respiratory diseases;

    - with hypovolemia or severely weakened patients, as well as patients with hypotrophy;

    - with anemia;

    - with epilepsy

    Pregnancy and lactation:

    The drug should not be used during pregnancy, except for cases of use Propovana for termination of pregnancy in the first trimester.

    The drug penetrates the placental barrier, and its use can cause fetal depression. The drug should not be used in obstetrics as an anesthetic

    Safety for newborns that have been used for feeding mothers with Propovan is not established, therefore, breastfeeding should be suspended during the period of application of the drug.

    Dosing and Administration:

    The drug is administered intravenously.

    Method of application

    The preparation can be administered only by specially trained personnel while providing the possibility of immediate carrying out of artificial ventilation, oxygen therapy and resuscitation in full.

    Propovan does not contain antimicrobial substances and can serve as a favorable environment for the development of microorganisms. When the sterile syringe or perfusor is filled with Propovan, the aseptic rules should be followed; the drug must be recruited immediately after opening the vial. The introduction should begin immediately. Aseptic conditions must be observed both in relation to Propovan and in the apparatus for administration during the entire period of administration.Drugs or liquids used in combination with Propovan should be administered near the place of administration of Propovan and using the same cannula. Propovan should not be injected through a microbiological filter.

    In the event of signs of detachment of the oil phase, the preparation should not be used.

    Propovan can be used undiluted using plastic syringes or glass vials for infusions. In cases where Propovan is used undiluted to maintain general anesthesia, it is recommended to always use perfusors or infusomats in order to control the rate of administration.

    Propovan can be diluted 5% solution of dextrose in bags of polyvinyl chloride (PVC) or in glass bottles. Dilution of the solution should be carried out in a ratio of 1: 5 (2 mg propofol / ml for 1% Propovan) and in accordance with the rules of aseptic immediately before use. The mixture is stable for 6 hours. Diluted solution Propovan can be administered using a variety of adjustable infusion systems, but the use of only similar devices does not completely avoid the risk of accidental, uncontrolled introduction of large volumes of diluted Propovan.Burettes, drip counters or dosing pumps should always be part of the infusion line. When calculating the maximum volume of diluted propofol in a burette, one should keep in mind the risk of uncontrolled administration.

    Propovan can be introduced through a tee with a valve near the injection site in combination with a 5% solution of dextrose for intravenous administration, 0.9% solution of sodium chloride for intravenous administration or 4% solution of dextrose with 0.18% sodium chloride solution for intravenous administration.

    To reduce pain during the initial injection, the dose of Propovanum directly before administration can be mixed with lidocaine for injection in a plastic syringe in the following proportion: 20 parts Propovanone and one part 0.5% or 1% lidocaine solution.

    Duration of administration: Drink should not exceed 12 hours. At the end of the infusion of the drug or after 12 hours, it is necessary to replace the equipment for the administration of Propovan.

    The remaining portions of the drug must be destroyed.

    To reduce the likelihood of side effects associated with the activation of the vagus nerve, it is advisable to introduce intravenously M-cholinolytics before the initial anesthesia.

    Introductory anesthesia

    Propovan can be used for an introductory general anesthesia through a slow bolus or infusion. Regardless of whether premedication was or was not performed, the dose of Propovan is recommended to be titrated (bolus or infusion of approximately 40 mg every 10 seconds for an adult patient in a satisfactory condition), depending on the patient's reaction prior to the appearance of clinical signs of anesthesia. For most adult patients under 55 years of age, the average dose of Propovan is 1.5-2.5 mg / kg. The total required dose can be reduced using lower injection rates (20-50 mg / min). For patients older than 55 years, usually a lower dose is required. Patients 3 and 4 classes ASA (American Society of Anaesthesiologists, Grade 3 - patients with severe systemic disorders, Grade 4 - patients with severe life-threatening systemic disorders), administration should be performed at a lower rate (approximately 20 mg every 10 seconds).

    Maintaining general anesthesia

    Anesthesia can be maintained by continuous infusion. Propovan or by repeated injections of boluses required to maintain the necessary depth of general anesthesia.

    Continuous infusion: the necessary 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 general anesthesia.

    Bolus injection: depending on the clinical picture, doses of 25 to 50 mg are used.

    Propovan requires additional use of analgesics. Propovan is well combined with spinal and epidural anesthesia; with drugs commonly used for premedication; with muscle relaxants, means for inhalation anesthesia and analgesics. Lower doses of Propovan can be used in cases where general anesthesia is performed as a supplement to the methods of regional anesthesia used.

    Ensuring a sedative effect during intensive care

    When using the drug Propovan in order to provide a sedative effect in adult patients on ventilating and receiving intensive therapy, it is recommended to use it through continuous infusion. The rate of infusion should be adjusted according to the required depth of sedation.The rate of administration in the range 0.3-4.0 mg / kg / h should ensure a satisfactory sedative effect.

    Ensuring sedation in patients who are conscious, during surgical and diagnostic procedures

    To ensure a sedative effect in patients who are conscious during surgical and diagnostic procedures, the rate of administration and dose 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 a sedative effect, the infusion rate should be adjusted according to the required depth of sedation, at a rate of 1.5-4.5 mg / kg / h. As an additive to the infusion, bolus administration of 10-20 mg of Propovan can be used to rapidly increase the depth of sedation if required. For patients 3 and 4 classes ASA it may be necessary to reduce the dose and rate of administration.

    For elderly patients

    Propovan should be titrated depending on the reaction of the patient. Patients over 55 years of age usually require lower doses forintroductory anesthesia and to provide a sedative effect in the conduct of surgical and diagnostic procedures in the state of consciousness.

    Side effects:

    Common possible adverse reactions:

    As a rule, introductory anesthesia proceeds with minimal signs of excitation.

    During general anesthesia, depending on the dose, medications used for premedication, as well as other drugs, blood pressure (BP) may decrease and temporary apnea and bradycardia may occur.

    In some cases, during the maintenance of general anesthesia, a decrease in blood pressure may occur, in these cases, it may be necessary to reduce the rate of administration of Propovan, as well as intravenous fluids.

    During the awakening period, a small number of patients may experience nausea, vomiting, and headache.

    Rarely possible: epileptiform disorders (including convulsions and opisthotonus) during anesthesia, maintenance and awakening.

    Also, it is rare after the administration of Propovan to develop allergic reactions (angioedema, bronchospasm, erythema, lowering blood pressure). Cases of pulmonary edema are possible.

    There were reports of postoperative fever with the use of propofol.

    As with the use of other means for general anesthesia, there may be a sexual disinhibition.

    After prolonged use of Propovan in rare cases, discoloration of urine was observed.

    Possible local adverse reactions:

    Pain at the site of injection, which may be during introductory anesthesia, can be reduced by the simultaneous administration of lidocaine, and also using large forearms or elbow veins for insertion.

    Thrombosis and phlebitis are rare.

    Possible hyperemia of the skin.

    Overdose:

    Accidental overdose Propovana can cause a decrease in heart function and respiratory depression. In the case of respiratory depression, artificial ventilation should be performed using oxygen. In case of oppression of cardiovascular activity, the patient's head should be lowered, legs raised; if this condition is serious, it is necessary to introduce plasma-substituting solutions, vasopressor and / or anticholinergics.

    Interaction:

    Propovan is well combined with preparations for spinal and epidural anesthesia; with drugs used for premedication; with muscle relaxants, means for inhalation anesthesia and narcotic analgesics. Lower doses of Propovan may be required in cases where general anesthesia is used as a supplement to the methods of regional anesthesia used. Drugs that reduce the heart rate, increase the risk of severe bradycardia, opioid analgesics - the risk of apnea.

    Pharmaceutical incompatibility

    Before use, Propovan should not be mixed with any injectable solutions except:

    - 5% dextrose solution,

    - lidocaine hydrochloride for injection.

    With the introduction of muscle relaxants atrakurium and myvacurium, you should not use the same system for intravenous infusion as for Propovan, without first washing it.

    Special instructions:

    To provide a sedative effect in patients who are conscious during surgical and diagnostic procedures, constant observation is necessary to identify early signs of arterial hypotension, obstruction of the airways and insufficient oxygen saturation of blood.

    To guarantee the full recovery of the patient after general anesthesia, a certain period of time is required to monitor him before discharge from the hospital.

    The drug does not have sufficient vagolitic effect, and its use is associated with cases of bradycardia and asystole. In cases where there is a possibility of the prevalence of the action of the parasympathetic nervous system, or when Propovan is used in combination with other agents that can cause bradycardia, it seems appropriate before intravenous injection of an anticholinergic agent before or during an initial anesthetic.

    When injected, patients with epilepsy are at increased risk for developing convulsive syndrome.

    It is necessary to monitor the lipid content of the blood in cases where the drug is prescribed to patients with lipid metabolism disorders.

    With the simultaneous administration of the drug and other products containing lipids, it should be taken into account that 1 ml of propo contains 0.1 g of fat.

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

    After using the drug, it is necessary to refrain from driving vehicles and practicing potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Emulsion for intravenous administration, 1%.
    Packaging:

    For 20 ml in glass (type 1) ampoules. 5 ampoules per plastic container. 1 container with instructions for use in a cardboard box.

    To 50 ml in glass bottles, closed with a gray chlorobutyl stopper with aluminum obakkoy and protective cap.

    One bottle together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature below 25 ° C.

    Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    In case of signs of detachment of the oil phase, the preparation is not to be used.

    Terms of leave from pharmacies:For hospitals
    Registration number:П N015521 / 01
    Date of registration:18.06.2009
    The owner of the registration certificate:Piramal Enterprise LimitedPiramal Enterprise Limited India
    Manufacturer: & nbsp
    Representation: & nbspMEDINTORG, ZAOMEDINTORG, ZAO
    Information update date: & nbsp07.09.2015
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