The drug should be used only in hospitals or properly equippedday hospitals with personnel who have special training in anesthesia or intensive care. Constant monitoring should include the functions of respiration and circulation. Conditions must be ensured for maintaining airway patency, ventilation, and conditions for resuscitation. For sedation during surgical or diagnostic procedures, the drug should not be administered by personnel who perform a surgical procedure or a diagnostic procedure.
The dose of the drug must be selected individually, taking into account the premedication and the patient's response.
As a rule, when using the drug, additional administration of analgesic drugs is required.
ADULTS
Induction of general anesthesia
Regardless of whether premedication has been or is not performed, it is recommended to titrate the dose of the drug (as a bolus injection or infusion of approximately 40 mg (4 mL) every 10 seconds for adult patients with satisfactory health status), depending on the patient's response to clinical signs of anesthesia . For most adult patients under 55 years of age, the dose is 1.5 to 2.5 mg / kg body weight.The required total dose can be reduced by reducing the rate of administration (from 2 to 5 ml (20-50 mg / min)). For patients aged 55 years, as a rule, the dose is lower. Patients of grades III and IV on a scale ASA (American Society of Anesthesiologist - American Society of Anesthesiologists) should inject the drug at a lower rate (approximately 2 ml (20 mg) every 10 seconds).
Maintaining general anesthesia
Anesthesia can be maintained by administering Propofol-Novo through continuous infusion or repeated bolus injections to prevent signs of insufficient anesthesia. Normalization of the state after anesthesia occurs, as a rule, quickly, so it is important to maintain the introduction of the drug Propofol-Novo before the end of the procedure.
Continuous infusion
The required rate of administration varies considerably depending on the individual characteristics of the patients, but, as a rule, the speed within 4-12 mg / kg / h provides adequate anesthesia.
With less stressful surgical interventions, for example, minimally invasive, usually a maintenance dose of about 4 mg / kg / h is usually sufficient.
Elderly patients, patients with unstable general condition, with impaired cardiac function, hypovolemia and patients III - IV classes of risk by classification ASA the dose may be reduced depending on the severity of the condition and the method of anesthesia.
Repeated bolus administration
If a technique involving repeated bolus injections is used, then the administration of increasing doses from 25 mg (2.5 ml) to 50 mg (5 ml) is made according to clinical need.
In elderly patients, rapid bolus administration (single or multiple) is not advisable, since it can lead to depression of cardiac and respiratory activity.
Sedation during intensive care
To ensure a sedative effect in intensive care, it is recommended to administer the drug by continuous infusion. The rate of infusion should depend on the necessary depth of sedation. For most patients, a sufficient sedative effect can be achieved with the administration of the drug at a dose of 0.3-4 mg / kg / h. The upper limit of the speed of infusion to ensure sedation in resuscitation should not exceed 4 mg / kg / h, except when the benefit exceeds the risk. The drug Propofol-Novo is not indicated to provide a sedative effect in the intensive care of patients under the age of 16 years.
The introduction of the drug with the help of the ICC system (infusion of the target concentration) for sedation of patients during intensive therapy is not recommended.
Sedation for surgical and diagnostic procedures
To ensure sedation during surgical or diagnostic procedures propofol can be used in isolation or in combination with local or conduction anesthesia. The rate of drug administration and dose should be selected individually and titrated depending on the clinical response. For most patients, the onset of sedation requires the administration of 0.5 to 1 mg / kg of the drug for 1 to 5 minutes.
Maintenance of sedative effect can be provided by titrating infusion of the drug to the required level of sedative effect; for most patients, 1.5 to 4.5 mg / kg / h is needed. In addition to infusion, a bolus of 10 to 20 mg can be given if a rapid onset of a deep sedative effect is necessary. For patients older than 55 years and for patients III - IV class of risk by classification ASA it may be necessary to reduce the dose and the rate of administration of the drug.
CHILDREN
The introduction of propofol to children with the help of the ICC system is not recommended.
Induction of general anesthesia
Propofol-Novo is not recommended for induction of anesthesia in children under 1 month of age. When used as an initial anesthetic for children, propofol-Novo should be administered slowly until clinical signs of anesthesia appear. The dose should be adjusted according to age and / or body weight.
For most children from the age of 8 years, approximately 2.5 mg / kg body weight is usually needed for induction. For children under the age of 8 years, especially at the age of 1 month to 3 years, the required dose may be higher (2.5-4 mg / kg).
For children III - IV classes of risk by classification ASA reduced doses are recommended.
Maintaining general anesthesia
Propofol-Novo is not recommended for maintenance of anesthesia in children under 1 month of age.
Anesthesia can be maintained by administering Propofol-Novo in the form of continuous infusion or repeated bolus injections to prevent clinical signs of insufficient anesthesia. The required rate of administration varies considerably in depending on the individual characteristics of the patients, but the speed within 9-15 mg / kg / hour, as a rule, ensures the maintenance of adequate anesthesia.
For children aged 1 month to 3 years, compared with older children, higher doses of the drug may be required within the recommended dose range. The dose should be adjusted individually and with special attention to monitor the adequacy of anesthesia.
For children III - IV classes of risk by classification ASA lower doses are recommended.
Sedation during intensive care
Propofol is not recommended for sedation in children 16 years of age or younger, since its safety and efficacy in this application have not yet been confirmed. In the unlicensed use of propofol, serious adverse events were noted, including deaths, although there was no causal relationship with the use of the drug. These adverse events were most often observed in children with respiratory tract infections that received doses exceeding the recommended doses for adults.
Sedation for surgical and diagnostic procedures
Propofol is not recommended for use in children under 1 month of age.
To ensure sedation during surgical or diagnostic procedures propofol can be used in isolation or in combination with local or conduction anesthesia. The rate of drug administration and dose should be selected individually and titrated depending on the clinical response. For most patients, 1 to 2 mg / kg of the drug is needed for at least 1 minute for the onset of sedation.
Maintenance of sedative effect can be provided by titrating infusion of the drug to the required level of sedative effect; for most patients, from 1.5 to 9 mg / kg / h is needed. In addition to infusion, a bolus dose of up to 1 mg / kg can be given if a rapid onset of a deep sedative effect is necessary.
Patients III - IV class of risk by classification ASA it may be necessary to reduce the dose and the rate of administration of the drug.
Method of administration
For intravenous administration.
Only for single use.
Vial should be shaken before use.
If the shaking of the emulsion is observed after shaking, the preparation should not be used.
Use only if the emulsion is homogeneous and the packaging is intact.Before use, the rubber stopper of the bottle should be treated with alcohol.
Since Propofol-Novo 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 package. The preparation should be started without delay.
During the entire period of administration of Propofol-Novo, you must follow the rules of aseptic work with the drug and the system for parenteral infusion.
With the co-administration of Propofol-Novo with other drugs and solutions in the same system, the introduction of the latter is recommended through a tee with a valve in close proximity to the site of administration of the drug. Propofol-Novo can not be administered via a microbiological filter.
The drug Propofol-Novo and any infusion system containing Propofol-Novo, are intended only for a single entry introduction of one patient.
Any residues of the Propofol-Nov emulsion should be destroyed after use.
The total time of drug administration through one infusion system should not exceed 12 hours. After 12 hours of use, the infusion system containing Propofol-Novo or the container with the drug should be replaced.
The drug does not cause analgesic effect and therefore, as a rule, in addition to Propofol-Novo, additional analgesics are needed.
For the infusion, the drug Propofol-Novo can be used undiluted or diluted with only 5% dextrose solution in PVC bags for infusion or glass vials for infusions. Dilution, the ratio of which should not exceed 1: 5 (2 mg propofol per 1 ml), should be carried out under aseptic conditions immediately before administration; the solution should be used within 6 hours after dilution.
When using the diluted drug Propofol-Novo, it is recommended that the volume of 5% dextrose solution removed from the infusion bag during the dilution process be completely replaced by the volume of the Propofol-Novo emulsion (see the table below for breeding and concurrent use).
A diluted drug can be administered using a variety of techniques for controlling infusion,but the use of only a set for infusion does not completely avoid the accidental uncontrolled infusion of large volumes of diluted drug Propofol-Novo. Burettes, drip counters or dosing pumps should always be part of the infusion line. The risk of uncontrolled infusion should always be considered when calculating the maximum volume of the drug Propofol-Novo in the burette.
When using undiluted drug Propofol-Novo to maintain anesthesia, it is recommended to always use equipment such as a syringe pump or a volumetric infusion pump to control the rate of administration. The compatibility of electronic equipment must be ensured.
The drug Propofol-Novo can be administered through Y-shaped connector, installed near the injection site, with the infusion of the following drugs:
- 5% dextrose solution for infusion;
- 0.9% solution of sodium chloride for infusion;
- 4% dextrose solution with 0.18% sodium chloride solution for infusion. The pre-filled glass syringe has a smaller fractional piston resistance compared to a plastic disposable syringe, and is easier to drive.Therefore, when administering Propofol-Novo by hand using a pre-filled syringe, the system for infusion between the syringe and The patient should not be left open in the absence of supervision by medical personnel.
Appropriate compatibility should be ensured in the event that a pre-filled syringe is used in a syringe pump. In particular, the design of the pump must prevent siphoning and should have a clogging alarm at a pressure of not more than 1000 mm Hg. Art. If a programmable or equivalent pump is used, which allows the use of different syringes, then in the case of using the drug Propofol-Novo in the form of a pre-filled syringe, only the "B-D" 50/60 ml PLASTIPAK.
The preparation of Propofol-Novo can be pre-mixed with alfentanil for injections containing 500 μg / ml of alfentanil in a volume ratio of 20: 1 to 50: 1. Mixtures should be prepared under aseptic conditions and used within 6 hours after preparation.
To reduce pain at the beginning of the injection, the drug Propofol-Novo can be mixed with 0.5% or 1% solution of lidocaine for injections that does not contain preservatives (see the table below for breeding and simultaneous use).In this case, preliminary skin tests should be carried out on the tolerability of lidocaine.
Attention: lidocaine contraindicated in patients with hereditary acute porphyria!
Guidance on the target concentrations of propofol are given below. In connection with the individual differences in the pharmacokinetics and pharmacodynamics of propofol, patients, regardless of whether they underwent premedication, the target concentration of propofol should be titrated depending on the clinical response in order to achieve the required depth of anesthesia.
Induction and maintenance of general anesthesia
In adult patients under 55 years of age, anesthesia can usually be induced by targeted concentrations of propofol in the range of 4 to 8 μg / ml. An initial target concentration of 4 μg / ml is recommended for patients undergoing premedication and a concentration of 6 μg / ml for patients who have not undergone premedication. The induction time at these target concentrations is usually within the range of 60 to 120 seconds. Higher target concentrations will lead to rapid induction of anesthesia, but may cause more pronounced suppression of hemodynamics and respiration.
A smaller initial target concentration should be used in patients aged 55 years and patients in grades III and IV according to the classification ASA. The target concentration can then be gradually increased by a value from 0.5 to 1 μg / ml at intervals of 1 min to achieve a gradual induction of anesthesia.
As a rule, additional analgesia is required, and the amount by which target concentrations can be reduced to maintain anesthesia will depend on the amount of analgesics applied simultaneously. Target concentrations of propofol in the range of 3 to 6 μg / ml usually maintain a sufficient level of anesthesia.
The predicted concentration of propofol for awakening is usually in the range of 1 to 2 μg / ml, and depends on the level of analgesia during the period of anesthesia maintenance.
Ensuring a sedative effect during intensive care
Usually, the desired concentration of propofol in the blood in the range of 0.2 - 2 μg / ml is needed. The preparation should be started with a low target concentration,
which should be titrated depending on the patient's response to achieve the necessary depth of sedation.
Dilution of the drug Propofol-Novo and simultaneous use with other drugs or infusion solutions.
Method of simultaneous application
| Additive or solvent | Preparation | Caveats |
Pre-mixing
| 5% dextrose solution for intravenous infusion | Mix 1 part of Propofol-Novo (10 mg / ml) and 4 parts of 5% dextrose solution for intravenous infusion in PVC bags or in glass vials for infusion. When diluted in PVC bags, it is recommended that the bag be full, and the diluted solution should be prepared by removing portions of the volume of the infusion solution, replacing the equivalents with the volume of the Propofol-Novo preparation. | Cook in aseptic conditions, immediately before use. The mixture remains stable for 6 hours.
|
| | Lidocaine hydrochloride for injection (0.5% or 1% solution without preservatives) | Mix 20 parts of Propofol-Novo (10 mg / ml) and 1 part of 0.5% or 1% lidocaine hydrochloride solution for injection. | Prepare the mixture in aseptic conditions immediately before administration. Use only for induction. |
| Alfentanil for injection (500 μg / ml) | Mix Propofol-Novo with alfentanil for injection in a volume ratio of 20: 1 to 50: 1. | Prepare the mixture in aseptic conditions; use within 6 hours after preparation
|
| Simultaneous administration with Y-like connector | 5% dextrose solution for intravenous administration | Simultaneous administration with Y-like connector. | To place Y-like a connector near the injection site. |
| 0.9% solution of sodium chloride for infusions | See above. | See above. |
| 4% dextrose solution with 0.18% sodium chloride solution for infusion. | See above. | See above. |
If lidocaine is used to dilute the drug, information on the safety of lidocaine should be taken into account.
Muscle relaxants, such as atracurium and myvacurium, can be injected through the infusion a system used to administer Propofol-Novo, only after it has been rinsed. Duration of application should not exceed 7 days.