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Catad_pgroup General anesthetics

Propofol 1% Fresenius - official instructions by application

INSTRUCTIONS
by application medicinal product for medical use

Registration number:

Trade name of the drug:

Propofol Kabi

International nonproprietary name:

propofol

Dosage form:

emulsion for intravenous administration

Compound

1 ml contains
active substance: propofol – 10.0 mg; excipients: soybean oil – 50.0 mg, medium chain triglycerides – 50.0 mg, phospholipids egg yolk– 12.0 mg, glycerol – 22.5 mg, oleic acid 0.4 – 0.8 mg, sodium hydroxide – q.s. (0.05-0.11 mg), water for injection – up to 1 ml.

Description.
White homogeneous emulsion with a weak phenolic odor.

Pharmacotherapeutic group:

Product for non-inhalation general anesthesia.

ATX code N01AX10

Pharmacological properties

Pharmacodynamics
Propofol Kabi 10 mg/ml is a fast-acting intravenous anesthetic for induction and maintenance of general anesthesia, as well as for sedation of patients during intensive care.
After intravenous administration of propofol, the hypnotic effect begins quickly.
Depending on the speed of administration, the time before induction of anesthesia is 30-40 seconds. After a single bolus administration, the duration of action is short (4-6 minutes) due to rapid metabolism and elimination.
Duration of general anesthesia, depending on dose and concomitant medications, ranges from 10 minutes to 1 hour.
The patient awakens from anesthesia quickly and with a clear consciousness. The opportunity to open the eyes appears after 10 minutes, the restoration of the speech response occurs over the next 3 minutes.
Special places no accumulation was detected.
When using Propofol Kabi 10 mg/ml for induction of anesthesia and for its maintenance, a decrease in average values is observed blood pressure and slight changes in heart rate. However, hemodynamic parameters usually remain relatively stable during maintenance of general anesthesia, and the incidence of adverse hemodynamic changes is low.
After administration of Propofol Kabi 10 mg/ml, respiratory depression may occur, but these effects are qualitatively similar topics that arise when using other intravenous agents, for general anesthesia and are easy to control in clinical settings. Propofol Kabi 10 mg/ml reduces cerebral blood flow, intracranial pressure and reduces cerebral metabolism. The decrease in intracranial pressure can be significant in patients with increased value this indicator. Propofol Kabi 10 mg/ml is an emulsion containing the active active substance propofol and a mixture of long chain triglycerides (LCT) and medium chain triglycerides (MCT). Medium chain triglycerides (MCTs) included in the emulsion reduce the amount of free propofol in the aqueous phase of the emulsion, which leads to a decrease in pain during drug administration. In addition, medium chain triglycerides increase metabolism, which leads to a decrease in total concentration triglycerides in plasma.

Pharmacokinetics
Propofol is 98% bound to plasma proteins. The kinetics of propofol after intravenous bolus injection can be represented as a three-part model: fast phase distribution (half-life 2-4 minutes), β-phase elimination (half-life 30-60 minutes) and γ-phase elimination (half-life 200-300 minutes). During the γ-phase, the decrease in the concentration of propofol in the blood occurs slowly due to prolonged redistribution from adipose tissue. In a clinical setting, 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 primarily by conjugation in the liver, as well as outside the liver, with a clearance of about 2 l/min. Clearance in children is higher than in adults. Half-life after intravenous infusion ranged from 277 to 403 minutes. Inactive metabolites are excreted mostly by the kidneys (about 88%). Only 0.3% of the administered drug is excreted unchanged in the urine.
When general anesthesia was maintained as usual, no significant accumulation of propofol L was observed after surgical procedures lasting at least 5 hours.
Within the recommended infusion rates, the pharmacokinetics of propofol are linear.

Indications for use:

Induction and maintenance of general anesthesia in adults and children over 1 month;
Sedation of patients undergoing artificial ventilation lungs (ventilation), in adults and children over 16 years of age;
Sedation of conscious patients during surgical and diagnostic procedures in conscious adults, as monotherapy or in combination with local anesthesia.

Contraindications

hypersensitivity to propofol or any of the components of the drug;
pregnancy and lactation (up to 24 hours after using propofol);
children up to 1 month;
Propofol Kabi 10 mg/ml is not recommended for use for sedation in children under 16 years of age inclusive;
Propofol Kabi 10 mg/ml is not recommended for use in patients undergoing electroconvulsive therapy.

With caution
As with other drugs for non-inhalation general anesthesia, caution should be exercised in patients with cardiovascular, respiratory, renal or hepatic disorders, as well as in patients with epilepsy, hypovolemia, lipid metabolism disorders or debilitated patients.
In patients with impaired cardiac, pulmonary, renal or liver function, elderly and debilitated people, patients with hypovolemia or epilepsy, patients with impaired consciousness, Propofol Kabi 10 mg/ml should be administered at a reduced rate. Before starting the use of Propofol Kabi 10 mg/ml, compensation of cardiovascular or respiratory failure and hypovolemia. Before anesthesia is administered to a patient with epilepsy, it is necessary to ensure that he is receiving antiepileptic therapy. Although several studies have shown the effectiveness of propofol in treating status epilepticus, it may also increase the risk of developing seizures.
In patients with severe heart failure and other severe heart diseases, Propofol Kabi 10 mg/ml should only be administered with extreme caution and under constant monitoring.
Particular caution should be observed in patients with lipid metabolic disorders and other conditions in which fat emulsions must be administered carefully. If the patient receives parenteral nutrition, it is necessary to take into account the amount of fat supplied during the infusion of Propofol Kabi 10 mg/ml emulsion. 1.0 ml of emulsion contains 0.1 g of fat. When treated in the intensive care unit, lipid concentrations should be determined after 3 days. Given the higher dose in obese patients, the risk of hemodynamic disturbances should be taken into account.
Particular care should be taken in patients with high intracranial pressure and low mean arterial pressure, given increased risk significant drop in intracranial perfusion pressure.
Patients with increased intracranial pressure should be given adequate treatment to improve cerebral perfusion pressure.
Particular caution should be observed when using Propofol Kabi 10 mg/ml for anesthesia in newborns and children under 3 years of age, although there is currently no evidence that the pharmacodynamics and pharmacokinetics of propofol in these children differs from children over 3 years of age.

Pregnancy and breastfeeding

Propofol Kabi 10 mg/ml penetrates the placental barrier and may have a depressant 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) for maintaining anesthesia during delivery.
The exception is operations to terminate a pregnancy.
A small amount of Propofol Kabi 10 mg/ml enters the breast milk. In this regard, breastfeeding is not recommended within 24 hours after administration of Propofol Kabi 10 mg/ml.

Directions for use and doses

Only intravenously.
Propofol Kabi. 10 mg/ml can only be used by anesthesiologists in hospitals or specialized outpatient departments, as well as in intensive care units. When administering Propofol Kabi 10 mg/ml, the physician should have at his disposal the equipment usually used during general anesthesia, including means of monitoring function cardiovascular system(ECG, pulse oximetry) and resuscitation equipment. When sedating during surgical and diagnostic procedures, Propofol Kabi 10 mg/ml should not be administered by the same doctor who performs these procedures.
The dose of Propofol Kabi 10 mg/ml must be selected individually, taking into account premedication and the patient's response.
As a rule, when using the drug it is required additional introduction analgesic drugs.
General anesthesia in adults
Introduction to general anesthesia:
When administered under general anesthesia, Propofol Kabi 10 mg/ml should be administered in fractions (approximately 20-40 mg of propofol every 10 seconds) until clinical signs anesthesia.
Usual dose for adults under the age of 55 years is 1.5-2.5 mg/kg body weight.
In older patients and patients with grades III and IV severity of the condition according to the classification of the American Society of Anesthesiologists (ASA). In patients with impaired cardiac function, the dose of Propofol Kabi 10 mg/ml is reduced. The total dose of Propofol Kabi 10 mg/ml can be reduced to a minimum of 1 mg/kg. Slower administration of Propofol Kabi 10 mg/ml is required: approximately 2 ml (20 mg) every 10 seconds.
Maintenance of anesthesia:
To maintain general anesthesia, Propofol Kabi 10 mg/ml is administered continuously by drip or repeatedly in the form of boluses.
To maintain anesthesia by continuous infusion, the dose and rate of administration of Propofol Kabi 10 mg/ml is selected individually, usually 4-12 mg/kg body weight/hour is administered.
For less severe surgical interventions ah, for example, minimally invasive, it is possible to reduce the maintenance dose to approximately 4 mg / kg body weight / hour. Dose reduction below 4 mg/kg body weight/hour is indicated for elderly patients with unstable general condition, patients with impaired cardiac function or hypovolemia and patients with III-IV degree severity of the condition according to the ASA classification. To maintain anesthesia through repeated bolus injections, Propofol Kabi 10 mg/ml should be administered in a dose of 25 to 50 mg, which corresponds to 2.5-5 ml of the drug.
In elderly patients, rapid bolus administration (single or repeated) is not advisable, as it can lead to suppression of cardiac and pulmonary function.
General anesthesia in children older than 1 month
Due to the lack of experience with the use of Propofol Kabi 10 mg/ml, it should not be used for general anesthesia in children under 1 month of age.
Introduction to general anesthesia:
When introducing general anesthesia, it is recommended to slowly titrate the dose of Propofol Kabi 10 mg/ml until clinical signs of general anesthesia appear. The dose is selected taking into account age and/or body weight.
In children over 8 years of age, the dose required to administer general anesthesia is approximately 2.5 mg/kg body weight.
In children younger age The use of the drug begins with a dose of 3 mg/kg. If necessary, additional doses of 1 mg/kg can be administered. For children at risk (ASA grades III and IV), lower doses are recommended.
Maintaining anesthesia.
To maintain anesthesia in children through continuous infusion, the recommended doses of Propofol Kabi 10 mg/ml are 9-15 mg/kg body weight per hour.
Children under 3 years of age may require more high dose within the limits of recommended doses per kilogram of body weight, compared with older children. The dose must be selected individually. Particular attention should be paid to the adequacy of pain relief.
The maximum duration of application should not exceed approximately 60 minutes, except in specific situations requiring more long-term use, for example, malignant hyperthermia, when cannot be used inhalational anesthetics.
Sedation in adults in intensive care units
For sedation during mechanical ventilation in intensive care units, Propofol Kabi 10 mg/ml is recommended to be administered by continuous infusion. The dose is selected taking into account the required depth sedative effect. Typically, adequate sedation can be achieved at a propofol administration rate of 0.3-4.0 mg/kg/h. It is not recommended to increase the rate of administration to more than 4.0 mg/kg/h.
Propofol Kabi 10 mg/ml should not be used for sedation in intensive care units in patients 16 years of age or younger.
Sedation for diagnostic and surgical procedures in adults
For sedation during surgical and diagnostic procedures, doses and rates of administration are adjusted based on clinical response. In most patients, sedation begins within 1-5 minutes after administration of propofol at a dose of 0.5-1 mg/kg.
Subsequently, the dose of Propofol Kabi 10 mg/ml is selected taking into account the required depth of sedation. In most patients, the required rate of administration is 1.5-4.5 mg/kg/hour.
If a rapid increase in the depth of sedation is required, in addition to the infusion, it is possible to additionally administer a bolus of propofol 10-20 mg (1-2 ml of Propofol Kabi 10 mg/ml). In patients over 55 years of age and patients with ASA grades III and IV required dose propofol may be lower and the infusion rate should be reduced. Propofol Kabi 10 mg/ml should not be used for sedation during diagnostic and surgical procedures in patients aged 16 years or younger.
Methods of administration.
For intravenous administration.
It is allowed to administer Propofol Kabi 10 mg/ml undiluted.
The ampoule or bottle should be shaken before administration. Use only a homogeneous drug from an intact ampoule or bottle.
Before use, treat the rubber membrane of the bottle or the neck of the ampoule with alcohol.
Dilution of Propofol Kabi 10 mg/ml is recommended only with 5% glucose solution for intravenous administration or 0.9% sodium chloride solution for intravenous administration in glass bottles.
Since Propofol Kabi 10 mg/ml is a fat emulsion that does not contain preservatives and has no antimicrobial activity, the drug can serve as a favorable environment for rapid growth microorganisms.
The emulsion should be drawn into a sterile syringe or dropper immediately after opening the ampoule or vial. Administration of the drug must be started without delay.
During the entire period of administration of Propofol Kabi 10 mg/ml, the rules for aseptic handling of the drug and the parenteral infusion system must be observed. When co-administered Propofol Kabi 10 mg/ml with other medicines and solutions in the same system, it is recommended that the latter be administered through a Y-shaped connector or valve.
Propofol Kabi 10 mg/ml cannot be mixed with other solutions for intravenous administration. However, 5% glucose solution, 0.9% sodium chloride solution, or 0.18% sodium chloride solution and 4% glucose solution can be administered simultaneously through the IV cannula.
Propofol Kabi 10 mg/ml cannot be administered through an antibacterial filter.
Propofol Kabi 10 mg/ml droppers containing propofol are intended only for single injection or infusions only one patient individually.
Remains of Propofol Kabi 10 mg/ml emulsion after use should be destroyed
Infusion of undiluted Propofol Kabi 10 mg/ml.
When infusing undiluted Propofol Kabi 10 mg/ml, it is recommended to always use devices to control the volume of the drug administered, such as a drop counter, syringe pumps or volumetric infusion pumps.
When administering fat emulsions, including Propofol Kabi 10 mg/ml, it is recommended to use the same infusion system for no more than 12 hours. After 12 hours of use, the system containing Propofol Kabi 10 mg/ml or the container with the drug should be replaced.
Infusion of diluted Propofol Kabi 10 mg/ml.
For administration of diluted Propofol Kabi 10 mg/ml it is possible to use various options systems for intravenous infusions. However, the use of standard systems does not guarantee against accidental uncontrolled administration of large volumes of diluted popofol.
The IV system should include devices to monitor the volume of drug administered, such as a drop counter, burette, or volumetric infusion pump. When determining the maximum burette dilution, the risk of introducing large doses propofol.
The maximum dilution of Propofol Kabi 10 mg/ml should not exceed 1 part propofol to 4 parts 5% glucose solution for intravenous administration or 0.9% sodium chloride solution for intravenous administration (content active substance in the diluted solution should not be less than 2 mg/ml). The dilution is prepared under aseptic conditions immediately before administration of the drug; the infusion should be completed no later than 6 hours after preparing the dilution.
Propofol Kabi 10 mg/ml should not be diluted with other solutions for infusion or injection. However, co-administration of 5% glucose solution, 0.9% sodium chloride solution with Propofol Kabi 10 mg/ml through a tee with a valve in close proximity to the injection site is allowed.
To reduce pain at the injection site of Propofol Kabi 10 mg/ml, lidocaine can be administered immediately before the start of infusions.
In addition, before infusion, Propofol Kabi 10 mg/ml can be mixed with preservative-free lidocaine (20 parts propofol and 1 part 1% lidocaine solution). Muscle relaxants such as atracurium besylate and mivacurium chloride can be administered at the site of administration of Propofol Kabi 10 mg/ml only after jet irrigation. The system for administering undiluted Propofol Kabi 10 mg/ml should be replaced at the end of the 12-hour period after opening the ampoule or vial.
Dilution of Propofol Kabi 10 mg/ml with glucose solution for intravenous administration 5% or sodium chloride solution for intravenous administration 0.9% should be carried out under aseptic conditions immediately before infusion, administration should be completed within 6 hours after dilution.
The duration of use should not exceed 7 days.

Side effects

Common side effects of Propofol Kabi 10 mg/ml are decreased blood pressure and suppressed respiratory function. These effects depend on the dose of propofol, as well as the type of premedication and concomitant therapy.
The following classification is given below side effects:
Very frequent (≥1:10)
Frequent (from ≥1:100 to<1:10)
Uncommon (from ≥1:1000 to<1:100)
Rare (from ≥1:10,000 to<1:1000)
Very rare (<1:10 000); неизвестные (побочные эффекты, частоту которых трудно оценить исходя из доступных данных).
Within each group, undesirable effects are presented in descending order of their clinical significance:
Immune disorders:
Rare:
Anaphylactic reactions, including angioedema, bronchospasm, erythema and decreased 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 induction of anesthesia, minimal agitation.
Rare:
Headache, dizziness, chills and cold sensations during the recovery period.
Epileptiform seizures, including convulsions and opisthotonos.
Very rare:
Late epileptiform seizures, developing over several hours or days. Risk of seizures in patients with epilepsy after administration of propofol. Cases of lack of consciousness after surgery.
Cardiac changes/vascular disorders:
Frequent:
During induction of anesthesia, decreased blood pressure, bradycardia, tachycardia, “hot flashes.”
Uncommon:
Marked decrease in blood pressure.
It may be necessary to reduce the rate of administration of Propofol Kabi 10 mg/ml and/or fluid replacement, and, if necessary, vasoconstrictors. The possibility of a sharp decrease in blood pressure in patients with impaired coronary or cerebral blood flow or in patients with hypovolemia should be taken into account. Increasing bradycardia, up to asystole, during general anesthesia. Intravenous administration of m-anticholinergic blockers is possible during induction of general anesthesia or during maintenance anesthesia.
Rare:
Arrhythmia during the recovery period.
Thrombosis and phlebitis.
Changes in the respiratory system, chest and mediastinum
Frequent:
When induction of anesthesia there is hyperventilation, transient apnea, cough, hiccups.
Uncommon:
Cough during maintenance anesthesia.
Rare:
Cough during the recovery period.
Very rare:
Pulmonary edema.
Gastrointestinal disorders:
Rare:
Nausea and vomiting during recovery.
Very rare:
Cases of pancreatitis have been described after administration of propofol, although a cause-and-effect relationship has not been established.
Changes in the skin and subcutaneous tissues:
Very rare:
Severe tissue changes after accidental paravenous injection.
Changes in the kidneys and urinary tract:
Rare:
Change in urine color after prolonged use of propofol.
General and local reactions:
Very common:
Pain at the injection site.
Pain at the propofol injection site can be minimized by simultaneous administration of lidocaine or infusion of the drug into a larger forearm vein or cubital fossa.
When combined with lidocaine, it is rare (from ≥1:10,000 to<1:1000) наблюдались следующие нежелательные эффекты: головокружение, рвота, сонливость, судороги, брадикардия, аритмии сердца и шок.
Rare:
Postoperative fever.
Very rare:
Isolated cases of severe undesirable effects in the form of a complex of symptoms have been described: rhabdomyolysis, metabolic acidosis, hyperkalemia and heart failure, sometimes with death. In most cases, these symptoms were observed in intensive care units in patients receiving doses greater than 4 mg/kg/h.

Overdose

An overdose can lead to depression of the functions of the cardiovascular system and breathing. If the respiratory system is suppressed, artificial ventilation is performed. If the function of the cardiovascular system is impaired, the head of the bed should be lowered and the administration of plasma expanders and/or vasopressors should be started.

Interaction with other drugs

Propofol Kabi 10 mg/ml can be used in conjunction with other drugs usually used for premedication, inhalation anesthesia, analgesics, muscle relaxants or local anesthetics. Some centrally acting drugs may have a suppressive effect on the cardiovascular and respiratory systems and may enhance the effect of propofol. If general anesthesia is combined with local anesthesia, lower doses may be used.
The combined use of benzodiazepines, m-anticholinergics or inhalational anesthetics sometimes causes prolongation of anesthesia and a decrease in respiratory rate.
After premedication with narcotic analgesics, the sedative effect of propofol may be enhanced and prolonged, 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 during premedication simultaneously with inhalational anesthetics or analgesics may potentiate anesthesia and side effects from the cardiovascular system. The combined use of drugs that suppress the central nervous system, for example, alcohol, general anesthetics, narcotic analgesics, leads to a pronounced manifestation of their sedative effect.
If the administration of Propofol Kabi 10 mg/ml is combined with parenterally administered drugs that depress the central nervous system, severe respiratory and cardiac depression is possible.
After administration of fentanyl, a transient increase in the concentration of propofol in the blood is possible, accompanied by an increase in the likelihood of apnea.
After administration of suxamethonium or neostigmine methyl sulfate, bradycardia and cardiac arrest may occur.
In patients receiving cyclosporine, cases of leukoencephalopathy have been described when administered fat emulsions such as propofol.

Special instructions

Propofol Kabi 10 mg/ml does not reduce the tone of the vagus nerve, and its use in some cases is accompanied by bradycardia (sometimes pronounced), as well as asystole.
Before induction or during maintenance of general anesthesia with Propofol Kabi 10 mg/ml, the possibility of intravenous administration of m-anticholinergic agents should be considered, especially in cases of suspected increased vagal tone or when Propofol Kabi 10 mg/ml is used in combination with other drugs that can cause bradycardia.
To relieve pain at the injection site when inducing general anesthesia with Propofol Kabi 10 mg/ml, lidocaine can be administered before administering the drug emulsion. When using lidocaine, it should be taken into account that it cannot be used in patients with hereditary porphyria.
Propofol Kabi 10 mg/ml can only be used by physicians trained in anesthesiology or intensive care.
Propofol Kabi 10 mg/ml should not be administered by personnel performing diagnostic or surgical procedures.
Efficacy and safety of Propofol Kabi. 10 mg/ml has not been studied for (background) sedation in children under 16 years of age. Serious adverse events, including death, have been reported when the drug is used unapproved for (background) sedation in children under 16 years of age, although a causal relationship has not been established. In particular, cases of metabolic acidosis, hyperlipidemia, rhabdomyolysis and/or heart failure have been reported. These effects were most often observed in children with respiratory tract infections receiving doses of the drug in intensive care units that exceeded adult doses. Similarly, rare cases of metabolic acidosis, rhabdomyolysis, hyperkalemia, and/or rapidly progressive heart failure (in some cases fatal) have been reported in adults treated for longer than 58 hours at rates greater than 5 mg/kg/hour. This rate exceeds the maximum rate of 4 mg/kg/hour recommended for use of the drug for the purpose of sedation of patients in intensive care units.
Heart failure in such cases is usually not responsive to maintenance therapy with inotropes.
If possible, the dose of 4 mg/kg/hour should not be exceeded, which is usually sufficient for sedation of patients on mechanical ventilation in intensive care units (for treatment durations of more than 1 day). It is necessary to be wary of these side effects, and at the first sign of their occurrence, reduce the dose or switch to other sedatives.
The rate of administration of Propofol Kabi 10 mg/ml should also be reduced in patients with congenital dementia, patients with epilepsy, with impaired function of the heart, lungs, liver and kidneys, and with hypovolemic conditions.
In some cases, after using Propofol Kabi 10 mg/ml, a period of postoperative unconsciousness of the patient was observed, accompanied by increased muscle tone. Although consciousness returns spontaneously, patients who are unconscious require careful monitoring.
Before discharging the patient from the clinic, you should ensure that he has fully recovered from general anesthesia.
Propofol Kabi 10 mg/ml contains soybean oil, which in rare cases can cause severe allergic reactions.
This medicinal product contains less than 1 mmol of sodium (23 mg sodium) per 100 ml, which makes it practically a sodium-free medicinal product.
During the entire infusion period, the principles of asepsis should be observed both in relation to the drug Propofol Kabi 10 mg/ml and in relation to the infusion equipment. Parallel administration of other drugs through the infusion system for Propofol Kabi 10 mg/ml should be carried out as close to the cannula as possible. Propofol Kabi 10 mg/ml and all infusion equipment for its administration can be used only once and only for one patient.

Driving a car and working with machinery

After administration of Propofol Kabi 10 mg/ml, the patient should be under medical supervision for an appropriate period of time. The patient should be informed that he should not drive vehicles or machinery, should avoid drinking alcohol and working in potentially hazardous conditions on the day of taking the drug.
The patient can be sent home only with an accompanying person.

Release form

Emulsion for intravenous administration 10 mg/ml.
15 ml or 20 ml in type I colorless glass ampoules (Eur. Pharm.). marked with a dot. 5 or 10 ampoules in cardboard or plastic blisters along with instructions for use in a cardboard box.
50 ml in bottles of colorless glass type 11 (Eur. Pharm.), sealed with halobutyl rubber stoppers and rolled aluminum caps with plastic lids to control the first opening (Eur. Pharm.). 1, 5 or 10 bottles along with instructions for use in a cardboard box.

Vacation conditions

Dispensed with a doctor's prescription.
Use only in hospital settings.

Storage conditions

Store at a temperature not exceeding 25° C.
Do not freeze.
Keep out of the reach of children.

Best before date

3 years.
Do not use after expiration date.

Applicant/Manufacturer

Fresenius Kabi Deutschland GmbH, D-61346, Bad Homburg w.d.H, Germany.
Manufactured by Fresenius Kabi Austria GmbH, Austria. Graz, Hafnerstrasse 36, 8055.

Claims should be sent to the Representative Office in Russia at:
125167, Moscow, Leningradsky Prospekt, 37, building 9

Olesya 02/27/2019 08:36

A 9-year-old baby was given anesthesia for a FGS examination. The next morning, severe headaches began in the morning, we didn’t even go to school. Could there be a cork from the “propofol” ambassador? What should we do? This is already how the second morning passes

Nina Viktorovna 12/07/2018 15:15

Hello, doctor. Three days ago I had a diagnostic uterine curettage under propofol. I fell asleep quickly, woke up easily and without pain. But for three days now my blood pressure has been 100-110-115-120/65-70 without taking pills for hypertension. I have been hypertensive for over 20 years. I took Con-cor 5 mg daily, Cardosal 20/12.5 (diuretic), and in the evening Lerkamen 10 mg. Now I only take Con-cor 12.5 mg and Lerkamen 10 mg in the evening. Is this normal? How soon will it end? Or should I contact a cardiologist? Or am I no longer hypertensive? Thanks for the answer.

Alexandra 01.12.2018 10:11

On November 29, I had a small gynecological operation: diagnostic curettage. In less than 20 minutes I woke up after it and noticed almost immediately as I woke up that my sense of smell and taste had significantly decreased. More smell. I was in the hospital for another day, but my sense of smell did not return. Before leaving, I asked the anesthesiologist what they injected me with and he said propofol. I told me about the side effect and he answered me that one or two days and it will pass, but I don’t notice that it goes away. I didn’t take any other medications before the surgery; in the evening of the same day I was given a large dose of antibiotics and I took metronidazole, but I’m sure it was from propofol. I didn’t find anything about such a side effect on the Internet and it surprised me. Everyone writes that the drug is wonderful. Apart from the side effects, I didn’t like it. Even after waking up, I took a long time to leave, although some other women were much better at leaving that day right in front of me. Will the sense of smell really return completely and, if anything, does it need to be treated? I'm uncomfortable and scared right now

Yulia 11/21/2018 09:05

Hello! I am undergoing planned surgery to remove my gallbladder. There will be general anesthesia with mechanical ventilation. I'm not afraid of surgery, I'm afraid of anesthesia to the point of panic. After all, this will be the first time and I don’t know how my body will react to this drug. I read that you can not wake up, die, fall into a coma. Even Michael Jackson died from propofol. Of the chronic diseases, only VSD with tachycardia... How to calm yourself down? When I think that I’m going to lie down on the operating table and they’re putting me to sleep, there are tears in my eyes that I’m going to die... I had epidural anesthesia during a cesarean section, no problems arose, I don’t seem to be allergic to anything except penicillin. I don't smoke. Of the chronic diseases, only VSD with tachycardia....now I’m collecting tests, getting ready and I’m all exhausted. When I think that they will put me on the table and put me to sleep, and suddenly I die and that’s it, tears flow in a stream and I can’t calm down. But there is nowhere to go, the operation is inevitable. Tell me how I can calm down and not think badly. There are so many horror stories in my head that I mentally say goodbye to my loved ones... Thank you.

Ekaterina 10/30/2018 08:06

Good afternoon, I had a hysteroscopy with propofol, after I felt good, and after 2 hours at home pain began in the neck (the veins seemed to hurt) and then spread to the chest, it hurts severely when I inhale, it’s already been 3 days, I had the syndrome WPW AND RFA was 10 years ago, should I worry and go to a cardiologist or are these just side effects from the anesthesia and will pass?

Olga 09.14.2018 16:38

Hello. An FGS and FGDS examination was prescribed under medicinal sleep. I have rhinitis, with vasoconstrictor drops my nose is breathing for some time. Tell me, is this a contraindication, and will there be any breathing problems during the study? Thank you!

Anastasia 08/30/2018 18:27

We did a hetyroscopy, under anesthesia with propofol 1%, everything went fine. I fell asleep and woke up quickly, it wasn’t bad. The only thing was that towards evening the place where it was injected began to hurt, and it was painful to straighten my arm. It hurts less when bent. There are no bruises or swelling. How long will it hurt? And why does it hurt? The only thing they prescribed was to drink ascurutin for 10 days.

Natalya 08/17/2018 11:03

Good afternoon. When bleeding started after gastroscopy, my mother was given propofol anesthesia with a total dosage of 400 mg. Mom's weight is about 60 kg. A day later they could not revive her. Later, my mother developed pulmonary edema. Could this be due to an overdose or too long anesthesia?

Julia 07/03/2018 15:23

Good afternoon. I need to treat the teeth of a 3-year-4-month-old child. The dentist offers treatment - sedation with the drug "Propofol", the treatment will take approximately 2-2.5 hours. I’m worried, for days now I’ve been reading all sorts of reviews about Propofol, in some annotations they write that they do not recommend using this drug as sedation for children... And isn’t it too long for a child of this age to be under this drug for 2-2.5 hours ? Is it worth going for it...I'm looking for answers everywhere.

Yana 06.27.2018 10:03

Hello, over the past 3 months I have undergone two simple operations, one under spinal anesthesia, the second under spinal anesthesia and propofol. Now I feel rapid fatigue, my bronchial asthma has worsened, and neurotic symptoms have appeared that I suffered from before, but which have not appeared for more than 20 years. Could all this be a side effect of anesthesia? Thanks in advance for your answer.

Olga 06/14/2018 10:59

Good afternoon, doctor! I have a panicky fear of anesthesia - I’m afraid I won’t wake up. The very thought of an upcoming operation causes tachycardia, lack of appetite, “bear sickness” and all the accompanying unpleasant sensations associated with stress. The head of the department refused to give me spinal anesthesia for her own reasons. Tell me, can propofol affect the human body in such a way that it may not wake up?

Yulia 05/06/2018 23:13

Hello, after taking propofol, the next day I started having a severe runny nose, nasal congestion, and I was constantly sneezing. Before the anesthesia she was healthy, without any malaise. Tell me what could be the consequences of using anesthesia. They did a colonoscopy + gastroscopy

Irina 04/03/2018 08:12

Hello! My veins were removed under anesthesia and propofol. After the operation, I began to shake, I was freezing, I turned blue, these were the last words I heard, I woke up only 12 hours later, all wrapped in blankets, I was on a drip. What could give such a reaction? I have another operation to remove the thyroid gland, and I’m already afraid of anesthesia. Please tell me what to do and is it possible to check the reaction to anesthesia in advance? Thanks in advance for your answer.

Ksenia 03/29/2018 20:24

Hello! Please tell me, I’m going to have rhinoplasty, I’ve been taking the contraceptive Logest for almost a year, the gynecologist said to stop it while the tests are being collected and the operation is not worth it, that on the contrary, there will be less bruises later. The surgeon said to cancel them during the collection of tests and the operation. What are the dangers of taking Logest during surgery? Can it have a bad effect on general anesthesia? Should I cancel his appointment or not?

Valery 03/15/2018 19:14

I am 70 years old and need a colonoscopy. I did it before and it’s very painful; I couldn’t even carry the colonoscope all the way through. I want to try it with sedation. Is it possible to use propofol or midazolam if there is cerebral atherosclerosis, elevated LDL cholesterol, and 15 years ago a diagnosis of coronary heart disease and angina pectoris was made.

Larisa 01/29/2018 19:19

Good afternoon Can I use propofol for a colonoscopy? I used to have my teeth removed under propofol, everything was fine. Now there are 4000 VVCs on the monitor, the cardiac echo is normal. Can I use propofol now? Will VES get worse?

Galina 12/20/2017 12:12

I am 68 years old. A colonoscopy was performed and the medicine propofol was administered. I immediately fell asleep. After waking up, the doctors said that something went wrong during the procedure and a respiratory spasm occurred. They didn't do a colonoscopy. 20 years ago I had psoriasis. There are no chronic diseases. I don't smoke. What could have caused this reaction? Why should I have a colonoscopy?

Alexey 12/17/2017 05:13

Hello! It’s been 4 years since they stopped selling Relanium (even tablets) in pharmacies. Previously, injection of Relanium helped with PA, even intramuscularly. Now we have to take heavy doses of antipsychotics, which is not without further side effects. Can you tell me whether propofol can be used in this case? And how many mg can you inject at a time? And what happens if you inject it intramuscularly? Thank you

Aliena 12/14/2017 16:39

Hello. I am 30 years old. I am terrified of dentists and therefore there is an option to have all my teeth done in two times with propofol sedation for two hours for each appointment. Unfortunately, I cannot boast of good health. I suffer from moderate replacement hydrocephalus of the brain, right bundle branch block, and subclinical hypothyroidism. The tests showed a slight decrease in hematocrit to 34.7, TSH increased to 5.64 with normal T3 and T4 (hormone replacement therapy has not yet been prescribed), hemoglobin decreased to 114. Urinalysis is normal. I myself feel very weak, no energy, drowsiness. Is it possible to treat teeth under sedation with propofol in this condition? Or should I choose another method? Since anxiety causes a panic attack, dizziness and tachycardia, treatment without drug sedation is not possible. Are there other ways to calm the patient besides sedation (sedative injections maybe?) in which I would have time to adapt to the process, because... Is it the beginning of dental treatment (sitting in a chair, beginning of drilling) that poses more stress, and not its further process?

Elena 12/13/2017 17:59

Hello! I’m about to have a colonoscopy under general anesthesia (propofol), I’m 28 years old, I have hypertension and tachycardia, I’m taking bisoprolol 1.25 mg. The ECG shows local intraventricular conduction disturbances. Please tell me whether it’s dangerous to do propofol and nothing will happen from combining propofol with bisoprolol?! Thank you in advance for your answer!!!

Gelya 01.12.2017 01:20

Normal anesthesia. But after leaving him, you can’t put two words together and you can’t tell your life story to the nurse. You just tell the facts that you remember, and say the reason - I can’t remember why it happened or happened, then I’ll remember :-). Well, when leaving it, I remember that they asked, “What did you dream about?” I say, I visited that world, it’s good there and my whole family supports me. I remember this phrase, but what was going on in that world - how the grandmother whispered... It’s a pity... Apparently they came to support me... I remember only the positive aura of that journey.

Nadezhda 11/15/2017 11:36

Good afternoon We need to do a gastroscopy and colonoscopy! There are heart problems - paroxysmal tachycardia, AV block, mitral valve prolapse and rhythm disturbance! Can I have this anesthesia?

Irina 10.25.2017 23:56

It is necessary to perform an MRI on a child aged 2 years 6 months, the anesthesiologist assures that there is nothing wrong. What are the dangers of using propofol for a child of this age? How to make sure that you do not take an extra dose of the drug? If there is an overdose, what should the doctor do to correct the mistake and save the patient?

Marina 09.17.2017 16:23

Hello. 6 months ago I had a colonoscopy under fantanyl and versed. Ativan 2 mg was also taken 2 hours before the procedure. After the first dose there was no sleep or pain relief. I was given my second dose. After which I was paralyzed, my pulse and blood pressure skyrocketed and my breathing stopped. They injected me with Narcan. In the end it was released. The doctors said that I just had PA. I don't believe it. A couple of days later, a second attempt with propofol. My question: I understand that this is a different drug, will the same thing happen again? What happened to me the first time? I used fantanyl in 2012 and everything went well.

Ekaterina 09/08/2017 13:42

I am undergoing a planned operation that does not affect my quality of life. There are risks in using anesthesia, I can postpone it. I have tachycardia, varicose veins of the 2nd degree. Is it possible to undergo anesthesia with such chronic diseases?

Bridge 08/12/2017 07:22

I need to undergo FGS, it’s so scary to go, I want to go under anesthesia, I called the clinic and they said they work with propofol, the fact is that I have had bronchial asthma since birth, are there any contraindications? Can it stop the heart or lungs? Or cause bronchial spasm? And in general, if you use the Kokava sedation method, are there chances of not waking up?

Elena 07/07/2017 09:32

Hello! Tell me please! Child 1.8, caries of two teeth! When he sees dentists he becomes hysterical! The clinic offered to treat with propofol for 1 hour! How dangerous is it for that age? What could be the consequences? And should we agree? Thanks in advance.

Irina 06/17/2017 20:15

Hello! 10 years diagnosed with panic disorder. Just the thought of the dentist causes tachycardia, dizziness and nausea. I take antidepressants - Escitalopram. Is it possible to use Propofol for panic attacks? Won't this strengthen the attack field after waking up from sleep? Will there be a strong tachycardia? Thank you.

Oksana 05/23/2017 09:20

Hello, 2-3 days after hysteroscopy with tropofol, tightening pain in the legs appeared, from the knee to the heel, mainly in the calves. What could it be? 2 days have passed, but it does not go away.

Victoria 03/28/2017 09:35

I do an FGDS once a year with propofol because they take a biopsy. There is dyscirculatory encephalopathy of the 2nd degree. Will using propofol harm the brain? The noise in the head is constant despite treatment and does not go away. Thanks for the answer.

Evgeny 03/15/2017 08:54

Hello, tell me, are there any regulations or other documents established by the Ministry of Health that regulate the correct use of the drug Propofol? Our Mini Yorkie dog was injected with this drug right in the examination room at the veterinary clinic, and as a result she died immediately.

Anesthesiologist Danilov S.E. 21.02.2017 09:16

Yes, propofol can be used only by an anesthesiologist. The instructions for various types of drugs describe isolated cases of side effects, approximately 1 per million, or even several million, of medical use of the drug. Propofol is approved by the pharmaceutical committee for use in Russia.

Alesya 01/31/2017 22:36

Hello! A child of 2 years and 4 months had an MRI with propofol for 20 minutes, recovered from anesthesia quickly, everything was fine, only a little pale and a low temperature of 35.4 the next day. After 2.5 days, the child had strange behavior, he began to shake his head on the bed and could not stop, I had to hold him and calm him down, he could not immediately get to his feet, he was hanging. The next day I woke up in the same state as when I was recovering from anesthesia with a blank look, it got better as the day went on, and the next day I felt like I was drunk for half a day. Could this be a consequence of anesthesia?

Elena 01/26/2017 09:09

Hello! I'm going to do an FGDS under general anesthesia (profopol). The gag reflex is greatly increased. And in 7 days there will be surgery (most likely also with propofol). Isn't this dangerous? Is there any harm besides thickening the blood? I would be glad to do an FGD without anesthesia, but it doesn’t work out. And without FGD they will not perform the operation. Some kind of vicious circle.

Love 01/21/2017 09:25

Hello, doctor, I had a colonoscopy examination under anesthesia, propofol, anesthesia was injected past a vein for the first time, now my arm hurts, the temperature is swollen, 37.7, what can you advise, thanks in advance

Instructions:

1 ml of emulsion for injection contains propofol 10 mg; in an ampoule 20 ml, in a blister pack 5 ampoules.

Pharmacological action

Pharmacodynamics

Causes a rapid (within about 30 s) onset of medicated sleep.

Indications for Propofol Abbott

General anesthesia; providing a sedative effect in critical conditions during mechanical ventilation.

Contraindications

Hypersensitivity.

Side effects of Propofol Abbott

During induction of anesthesia: hypotension, apnea; while maintaining anesthesia: epileptiform movements, convulsions, opisthotonus, change in urine color, bradycardia, asystole, hypovolemia; rarely - pulmonary edema, signs of anaphylaxis (bronchospasm, erythema); upon awakening: nausea, vomiting, headache, fever, sexual disinhibition.

Interaction

Enhances the effect of bradycardic drugs.

Directions for use and doses

IV, by titration method (until clinical signs of anesthesia appear). Adults: during induction of anesthesia - 2-2.5 mg/kg (under the age of 55 years) 4 ml every 10 s, 1.5 mg/kg (over the age of 55 years) 2 ml every 10 s; to maintain anesthesia - 4-12 mg/kg (continuous IV infusion), 2.5-5 ml (repeated bolus injections); to ensure a sedative effect - with an infusion rate of 1-4 mg/kg/h (sedation is provided for 48 hours).

Children over 3 years of age: for induction of anesthesia - 2.5 mg/kg, for the purpose of maintaining anesthesia - at an infusion rate of 9-15 mg/kg/h or bolus.

Precautions

Use with caution for anesthesia in patients with epilepsy (convulsions may develop), diseases of the cardiovascular system, kidneys, liver, decreased blood volume or severely weakened. When maintaining anesthesia by continuous or bolus administration in patients with lipid metabolism disorders, it is necessary to monitor blood lipids and, if they increase, reduce the dose.