General instructions
Propofol-Lipuro 10 mg / ml should be used only in hospitals or appropriately equipped day hospitals with staff trained in anesthesia or intensive care. Under constant monitoring should be the functions of blood circulation and respiration (eg, ECG, pulse oximetry). Conditions must be provided for the restoration and maintenance of airway patency, ventilation, and conditions for resuscitation. For sedation during surgical procedures or diagnostic procedures, Propofol-Lipuro 10 mg / mL should not be used by personnel who perform a surgical procedure or diagnostic procedure.
With the administration of the drug Propofol-Lipuro 10 mg / ml usually requires additional administration of an anesthetic.
Mode of application
Intravenously.
Propofol-Lipuro 10 mg / ml is administered intravenously by injection or extended infusion in undiluted or diluted form. To dilute the drug can be used 5% glucose solution, 0.9% sodium chloride solution, 0.18% sodium chloride solution or 4% glucose solution.
Before use, the preparation must be shaken, the ampoule neck or the surface of the vial of the vial must be disinfected with medical alcohol (by rubbing or by spraying). Used ampoules or vials should be discarded.
Infusion of undiluted Propofol-Lipuro 10 mg / ml
For prolonged infusion of the drug Propofol-Lipuro 10 mg / ml in order to control the rate of infusion, it is recommended to always use infusion systems, syringe and volumetric infusion pumps.
Infusion dilute drug Propofol-Lipuro 10 mg / ml
For prolonged infusion of the drug Propofol-Lipuro 10 mg / ml in order to control the rate of infusion and prevent accidental uncontrolled injection of large volumes of diluted drug Propofol-Lipuro 10 mg / ml, it is recommended to always use infusion systems, syringe and volumetric infusion pumps.
Maximum dilution should not exceed 1 part of Propofol-Lipuro 10mg / ml in 4 parts of 5% glucose solution, 0.9% sodium chloride solution, 0.18% sodium chloride solution or 4% glucose solution (minimum concentration of propofol should be 2 mg / ml). The mixture should be prepared under aseptic conditions immediately before administration and should be used within 6 hours after preparation.
To reduce pain during the initial administration of Propofol-Lipuro 10 mg / ml can be mixed with 1% solution of lidocaine for injection, no preservatives (with 20 parts of the drug Propofol-Lipuro 10 mg / ml can be mixed up to 1 part of 1% lidocaine solution for injections).
The infusion system used for the preparation of Propofol-Lipuro 10 mg / ml should be washed before the introduction of muscle relaxants atrakurium and myvacurium. Propofol can also be administered by infusion at the target concentration. Since there are various devices on the market that allow infusion to be carried out at the target concentration, please use the recommended dosage in accordance with the operating instructions for the device.
Doses
Propofol-Lipuro 10 mg / ml is administered intravenously. The dose is selected individually, according to the patient's response.
General anesthesia for adults
Introductory anesthesia
For introductory anesthesia, the drug is administered by titration (20-40 mg propofol every 10 seconds) until clinical signs of anesthesia appear.
Adult patients under 55 years of age usually require 1.5 to 2.5 mg propofol / kg body weight.
Patients over 55 years of age and patients of grades III and IV ASA (American Society of Anesthesiologists), especially with heart failure, the dose of propofol should be reduced. The total dose can be reduced to 1 mg / kg of body weight, the rate of administration of the drug in such patients also decreases and should be about 2 ml, corresponding to 20 mg every 10 seconds.
Supportive anesthesia
Anesthesia is maintained either by prolonged infusion of the drug, or by repeated bolus injections.
When bolus injection is used, the bolus volume, depending on the clinical indication, may increase from 2.5 ml of the drug (25 mg of propofol) to 5.0 ml of the drug (50 mg of propofol), depending on the patient's condition.
To maintain anesthesia by prolonged infusion, the required dose is usually in the range 4-12 mg / kg body weight / hour.
Elderly patients and patients with severe general condition, Class III and IV patients ASA, as well as patients with hypovolemia, the dose may be reduced if necessary, depending on the severity of the patient's condition and the procedure of anesthesia.
General anesthesia in children older than 1 month
Introductory anesthesia
For introductory anesthesia propofol is introduced by the method of slow titration in accordance with the patient's reaction before the appearance of clinical signs of anesthesia. The dose is selected depending on the age and / or body weight.
Most children over the age of 8 years for introductory anesthesia require about 2.5 mg propofol / kg body weight. For children younger than 8 years, especially at the age of 1 month to 3 years, the required dose may be higher (2.5-4 mg / kg body weight).
Supportive anesthesia
Anesthesia can be maintained by administering Propofol-Lipuro 10 mg / ml as infusion or repeated bolus injections to maintain the required degree of anesthesia. The required rate of administration varies significantly in different patients, but the rate of administration in the range 9-15 mg / kg body weight / h usually provides satisfactory anesthesia.In young children, especially between the ages of 1 month and 3 years, the required dose may be higher.
In children of grades III and IV ASA a dose reduction is recommended.
Provision of sedation in patients who are on artificial ventilation in the intensive care unit
In the case of application of the drug in patients who are on ventilator, the method of prolonged infusion is recommended. In this case, the rate of administration will depend on the desired degree of sedation and is usually 0.3-4.0 mg / kg body weight / h.
Children under 16 years to ensure sedation in intensive care propofol not assigned.
The introduction of propofol at the target concentration for sedation in the intensive care unit is not recommended.
Provision of sedation in diagnostic and surgical procedures in adults
The dose and rate of administration of the drug are chosen depending on the response of the patient. Most patients require a dose of 0.5-1.0 mg / kg body weight for 1-5 minutes to achieve sedation. Maintenance of sedative effect is achieved by titration of propofol until the required level of sedation.Most patients require 1.5-4.5 mg / kg body weight / h. Infusion can be supplemented by bolus injection of 10-20 mg (1-2 ml of Propofol-Lipuro 10 mg / ml), if a rapid increase in sedation depth is required.
For patients older than 55 years and patients in grades III and IV ASA dose and rate of administration should be reduced.
Provision of sedation in diagnostic and surgical manipulations in children older than 1 month
The dose and rate of administration should be adjusted in accordance with the necessary depth of sedation and the response of the patient. Most pediatric patients require a dose of 1-2 mg propofol / kg body weight to achieve a sedative effect. Maintenance of sedation can be provided by titrating Propofol-Lipuro 10 mg / ml to the required level of sedation. Most patients need a dose of propofol 1,5-9 mg / kg / h. Infusion may be supplemented by bolus administration of a dose of up to 1 mg / kg body weight if a rapid increase in sedation depth is required.
In children of grades III and IV ASA a dose reduction is recommended.
Duration of application
The maximum period of administration of propofol is 7 days.