The drug is administered only intravenously.
To reduce pain at the initial injection, the induction dose of Pofol immediately before administration can be mixed in a plastic syringe with lidocaine 10 mg / ml for injection at the rate of 1 part of injection of lidocaine into 20 parts of Pofol.
Pofol does not contain antimicrobial preservatives and, like any lipid emulsion, can serve as a favorable medium for microorganisms. Pofol is typed in a sterile syringe or perfusor with aseptic rules immediately after opening the ampoule or vial and injected immediately. Aseptic conditions must be met both in relation to Pofol and in the apparatus for administration during the entire period of administration. Drugs or liquids used in combination with Pofol should be administered near the place of Pofola administration and using the same cannula. Pofol can not be injected through a microbiological filter.
Pofol 10 mg / ml can be administered both un-diluted and diluted for infusion. Each ampoule or vial before injection or dilution should be carefully inspected for abnormalities. If any changes are found, the drug should not be used. Shake well before use. The remains of any solutions should be destroyed.
In cases where Pofol is used in undiluted form, proper equipment should be used to ensure the required infusion rate.For this purpose, drop counters, metered infusion or syringe pumps are quite suitable. Using a conventional infusion set does not allow to prevent accidental overdose with a sufficient degree of reliability. When determining the maximum volume of propofol in the burette, the risk of uncontrolled infusion should be considered. Simultaneously with Propofol, 10 mg / ml is allowed to enter sodium chloride or a solution of dextrose through Y-shaped connector.
Pofol 10 mg / ml can be diluted with 0.9% sodium chloride solution or 5% dextrose solution for infusions. Dilute should be no more than 5 times (the minimum content of propofol 2 mg / ml), and use for this purpose a packet of PVC or a glass bottle for infusions. If an infusion bag of PVC is used, it is necessary to take a full package and prepare the solution by casting a part of the infusion liquid and replacing it with an equal volume of propofol. Particular attention should be paid to the preparation of the solution in aseptic conditions immediately before administration. Any dilute solutions should be used within 6 hours after preparation. The remains of any solutions must be destroyed.
Cultivation of Pofola and its simultaneous application in combination with other drugs
| Methodology simultaneous introduction of drugs | Excipient or solvent | Preparation | Measures precautions |
| Preliminary mixing | 5% dextrose solution for intravenous infusion | Mix 1 part of Pofola 10 mg / ml and 4 parts of 5% dextrose solution for intravenous infusion in a PVC bag or glass vial. When diluted in bags of PVC, it is recommended to fill the bag completely, replacing the equivalent volume of Pofola. | Cook in aseptic conditions, immediately before use. The mixture remains stable for 6 hours. |
| A solution of lidocaine hydrochloride for injection (0.5% or 1%, without preservatives). | Mix 20 parts of Pofola 10 mg / ml with 1 (or less) part of a 0.5% or 1% solution of lidocaine hydrochloride for injection. | Cook in aseptic conditions, immediately before use. Use only for anesthesia. |
| Simultaneous administration with Y- shaped connector | 5% dextrose solution for intravenous infusion or 0.9% sodium chloride solution for intravenous infusion. | Simultaneous administration with Y- shaped connector. | Place Y-shaped connector near the injection site. |
The dose of Pofola 10 mg / ml is individually selected by an experienced anesthesiologist depending on the weight of the patient, sensitivity to propofol and other concomitant medications. Pofol is also used for sedation in surgical and diagnostic procedures, and there is experience in its use in combination with spinal and epidural anesthesia. It is recommended to titrate propofol depending on the patient's reaction until the appearance of clinical signs of anesthesia.
Adults
Introductory anesthesia
Pofol can be used for introductory anesthesia through slow bolus administration or infusion. The dose of the drug, regardless of the presence or absence of premedication, for adults with an average body weight, with a satisfactory overall condition, should be titrated individually (20-40 mg of propofol every 10 seconds), depending on the patient's response to the appearance of clinical signs of anesthesia.
For the majority of patients under the age of 55 years and patients 1 and 2 degrees ASA (American Society of Anesthesiologist) it will most likely be necessary to enter propofol in a dose of 1.5-2.5 mg / kg body weight; older than 55 years and patients 3 and 4 degrees ASA, especially with weakened cardiac function, smaller doses will be needed, and a total dose of 10 mg / ml of Pofola can be reduced to a minimum of 1 mg / kg of body weight. In such patients, the drug should be administered at a lower rate - approximately 2 ml (or 20 mg) every 10 seconds. The total dose can be reduced at a lower rate of administration (20-50 mg / min).
Maintaining general anesthesia
Maintenance of the necessary depth of anesthesia is carried out through continuous infusion or repeated bolus injections of Pofola 10 mg / ml.
Continuous infusion
The required infusion rate varies markedly in different patients. To maintain general anesthesia should be prescribed propofol in a dose of 4-12 mg / kg / h. More elderly, weakened patients, as well as patients with hypovolaemia or ASA 3 and 4 degrees, the dose should be reduced to 4 mg / kg / h. With the onset of anesthesia (approximately within the first 10-20 minutes), some patients may be shown a slightly increased infusion rate (8-10 mg / kg / h).
Repeated bolus injections in a dose of 25-50 mg (2.5-5.0 ml), depending on the patient's reaction.Elderly patients should not be prescribed fast bolus injections (single or repeated), as this can lead to cardiovascular failure.
Providing a sedative effect for patients on artificial respiration during intensive care
For sedation during intensive care, it is recommended that propofol by continuous infusion. The rate of infusion is determined by the desired depth of sedation. Most patients can achieve a sufficient level of sedation with a dose of propofol 0.3-0.4 mg / kg / h. It is recommended that dose-setting specialists do not exceed the dose of 4 mg / kg / h (see "Special instructions") if possible. The duration of permanent infusion of propofol should not exceed 7 days. To ensure sedation in intensive care units, it is not recommended to administer propofol with the help of TCI (Targeted controlled infusion).
Sedation for surgical and diagnostic procedures
The dose should be selected individually depending on the clinical response of the patient. Sufficient sedation for surgical and diagnostic procedures is usually achieved by first administering 0.5-1 mg / kg / h for 1-5 minutes, and then maintained at constant infusion at a rate of 1.0 to 4.5 mg / kg / h.If it becomes necessary to obtain a greater sedative effect, it is additionally possible to administer a bolus dose of propofol in
10-20 mg. Patients with ASA 3 and 4 degrees and elderly patients may need to reduce the dose and rate of administration.
Children
Introduction to anesthesia
Pofol not prescribed for children under 3 years.
To introduce anesthesia dose Pofola 10 mg / ml should be slowly titrated depending on 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 patients older than 8 years for the introduction of anesthesia are likely to have a dose of approximately 2.5 mg per kg body weight Pofola 10 mg / ml. For children younger than 8 years, the doses may be higher (2.5-4 mg / kg). Children at risk of anesthesia ASA 3 and 4 degrees - in smaller doses.
Maintaining general anesthesia
Anesthesia is maintained through the administration of Pofola 10 mg / ml through continuous infusions or repeated bolus injections. Dosage should be selected individually, but to achieve the required anesthesia, a sufficient infusion rate is usually 9-15 mg / kg / h.
Sedation with intensive care, surgical and diagnostic procedures
Propofol for sedation with intensive care is not prescribed to patients aged 16 years or younger (see "Contraindications"),
When propofol was used in children without recommendations, serious side effects (including deaths) were observed, although the causal relationship between these phenomena and the use of propofol was not proven. Side effects were most often encountered in children with respiratory infections when doses exceeding recommended levels were prescribed.