Expiration date: 01/2026

The composition and form of issue: 

Emulsion for intravenous injection 1 ml contains:

propofol 10 mg

excipients: soybean oil 100 mg egg yolk phospholipids 12 mg glycerol is 22.5 mg disodium salt of EDTA (anhydrous equivalent) of 0.055 mg of sodium hydroxide in an amount necessary for adjusting pH to 7.5–8.5 water for injection to 1 ml 

in a glass 20 ml ampoules, 5 ampoules in a plastic retainer in the stack cartons or 50 ml glass syringe with polypropylene plunger and connector Luer, in a contour acheikova package 1 syringe in a cardboard pack 1 pack.

Description pharmaceutical form:

White or almost white homogeneous emulsion. Prolonged standing may be a slight stratification.

Indications:

• induction and maintenance of General anesthesia
  
• sedation of patients on mechanical ventilation during intensive care
  
• sedation of patients who were conscious during surgical and diagnostic procedures.
  

Contraindications:

• hypersensitivity to any component of the drug
  
• induction and maintenance of General anaesthesia in children younger than 1 month
  
• sedation of patients under the age of 16 years, on mechanical ventilation during intensive care
  
• sedation of patients under the age of 16 years, being in mind during surgical and diagnostic procedures
  
• pregnancy, and the use in obstetric practice, except for the interruption of pregnancy in the first trimester
  
• the period of breastfeeding.
  

Caution: as the use of other/in anaesthetics, you should exercise caution in relation to patients with cardiovascular, respiratory, renal or hepatic disorders, as well as in relation to patients with epilepsy, hypoglycemia, disorders of lipid metabolism or in debilitated patients.

Application of pregnancy and breast-feeding:

Pregnancy

Diprivan should not be used during pregnancy. However, Diprivan used during termination of pregnancy in the first trimester.

Obstetrics

Diprivan, penetrates through the placental barrier and its use may be associated with neonatal depression. It should not be used in obstetrics as anesthetic.

Breastfeeding

For newborns, breastfeeding, have not been established the safety of the drug, Diprivan in lactating women. In this regard, it is not recommended breastfeeding during the use of the drug, Diprivan.

Side effects:

As a rule, induction of anaesthesia occurs with minimal signs of arousal. The most common adverse reactions are predictable from the point of view of pharmacology side effects of any means for General anesthesia, such as decreased blood pressure. Cases reported in Association with anaesthesia and intensive therapy, may also be associated with the ongoing procedures or with the patient's condition.

Method of application and dose:

As a rule, Diprivan requires additional use of analgesic drugs.

Diprivan, combined spinal and epidural anesthesia drugs commonly used for sedation with muscle relaxants, inhalation anesthetic and analgesic, while not mentioned pharmacological incompatibilities. Lower doses of the drug, Diprivan may be required in cases where General anesthesia is used as a Supplement to applied methods of regional anesthesia.

Manual administration of the drug, Diprivan at the target concentration with the infusion system, including appropriate software "Dobrevtsi", see D. of This application is limited to the induction and maintenance of General anesthesia in adults. System infusion at the target concentration (ICC) "Depriving" not recommended for sedation of patients in intensive care units, to receive sedation with preservation of consciousness, or in children.

A. ADULTS

Induction of General anesthesia

Diprivan can be used for induction of anaesthesia by slow bolus injection or infusion. Regardless of whether conducted or not conducted premedication, administration of the drug, Diprivan it is recommended to titrate (bolus injection or infusion of approximately 40 mg every 10 seconds — for an average adult in a satisfactory condition) depending on the patient's response to the onset of clinical signs of anesthesia. For most adult patients aged up to 55 years, the average dose of Diprivan is 1.5–2.5 mg/kg. The required total dose can be reduced by using a lower application rate (20-50 mg/min). For patients over that age, as a rule, requires a lower dose. Patients 3 and 4 classes ASA (physical status Classification of the patient American Society of Anesthesiology (ASA) Classification) the introduction should be with a lower rate (approximately 20 mg every 10 seconds).

The maintenance of General anesthesia

Anesthesia can be maintained or continuous infusion of the drug, Diprivan, or by repeat bolus injections needed to maintain the desired depth of anaesthesia.

Constant infusion.The required rate of administration varies considerably depending on the individual characteristics of patients. Typically, a speed in the range of 4-12 mg/kg/h ensures the maintenance of adequate anesthesia.

Repeated bolus injections.If you use a technique involving repeat bolus injections is used, the introduction of increasing doses from 25 mg to 50 mg depending on clinical need.

Sedation during intensive care

The introduction of the drug, Diprivan through the system ICC of "Depriving" for sedation of patients in intensive care is not recommended.

When using the drug, Depravedly sedation of adult patients on mechanical ventilation and receiving intensive care, it is recommended to apply by continuous infusion. The infusion rate should be adjusted to the required depth of sedation, but the speed is in the range of 0.3–4 mg/kg/h should achieve satisfactory sedation. The infusion rate should not exceed 4 mg/kg/h, with the exception of cases when the potential benefit to the patient outweighs the risk of side effects.

Sedation of patients in mind during surgical and diagnostic procedures

The introduction of the drug, Diprivan through the system ICC of "Depriving" for sedation with preservation of consciousness is not recommended.

To provide sedation during surgical and diagnostic procedures, speed of administration and dose should be chosen individually depending on the clinical response of the patient.

For most patients will require 0.5–1 mg/kg over 1-5 min for the occurrence of sedation.

To maintain sedation, the infusion rate should be adjusted according to the required depth of sedation for most patients, a speed in the range of 1.5–4.5 mg/kg/h If you want a quick increase of the depth of sedation, as a Supplement to the infusion can be used as a bolus of 10-20 mg of the drug, Diprivan. For patients 3 and 4 classes ASA may require a lower dose and speed of administration.

B. ELDERLY PATIENTS

Older patients for the induction of anesthesia required lower doses of the drug, Diprivan. Dose reduction should be guided by the physical status and age of the patient. A reduced dose should be given at a slower speed than usual and Mitrovitsa depending on the response of the patient. When using the drug, Diprivan for maintenance of anaesthesia or sedation the rate of infusion or the "target concentration" of the drug must be reduced. For patients 3 and 4 classes ASA may require further reduction of the dose and speed of administration. In order to avoid the oppression of the cardiovascular and respiratory systems of elderly patients is not recommended rapid bolus administration (single or repeated).

CHILDREN

Not recommended for children to enter Diprivan through a system of ICC "Depriving" under no evidence.

Induction of General anesthesia

Diprivan not recommended for use in children under the age of 1 month (see section "Contraindications").

In applying the drug, Diprivan to ensure the induction of anesthesia in children it is recommended to introduce slowly to the onset of clinical signs of the onset of anesthesia. The dose should be adjusted in accordance with the age and/or weight of the child. For most children over the age of 8 years for induction of anesthesia is likely to require approximately 2.5 mg/kg of the drug, Diprivan. For children aged 1 month to 8 years required dose may be higher. A lower dose recommended for children 3 and 4 classes ASA.

The maintenance of General anesthesia

Diprivan not recommended for use in children under the age of 1 month.

Maintenance of anesthesia is achieved by injection of the drug, Diprivan through continuous infusion or through repeated bolus injections required to maintain the required depth of anaesthesia. The required rate of administration varies considerably in different patients are usually provided satisfactory anesthesia with infusion rates in the range of 9-15 mg/kg/h.

Sedation of patients in mind during surgical and diagnostic procedures

Diprivan, not recommended for sedation with preservation of consciousness in children, as its safety and effectiveness for this use has not yet been confirmed.

Sedation during intensive care

Diprivan, not recommended for sedation in children because safety and effectiveness in this application has not yet been confirmed. For unlicensed use, there have been serious adverse events (including deaths), although a causal relationship with the drug, Diprivan has not been established. These adverse phenomena are often observed in children with infections of the respiratory tract, which were injected doses in excess of recommended doses for adults.

G. INTRODUCTION

Diprivan, can be administered undiluted using plastic syringes or glass vials for infusion or filled with a drug, Diprivan glass syringes. In those cases where Diprivan used in undiluted form for maintenance of General anesthesia, it is recommended to always use perfuzora or infusion pumps to control the rate of administration.

Diprivan, you can also use diluted only with 5% dextrose solution designed for on/in the introduction, in bags made of PVC or in glass vials. Solution, the dilution of which should not exceed the ratio of 1:5 (2 mg/ml of propofol), should be prepared in accordance with the rules of asepsis immediately before use. The mixture remains stable for 6 h

The diluted solution of the drug, Diprivan can be entered using a variety of adjustable systems for infusion, but the use of such devices does not allow to completely avoid the risk of accidental, uncontrolled introduction of large amounts of diluted drug Diprivan. Burettes, meters drops or dosing pumps should always be part of the line for a infusion. When you select the maximum amount of the dissolved drug Diprivan in the burette should be aware of the risk of an uncontrolled introduction.

Diprivan, you can enter through a tee with a valve close to the injection site, simultaneously with the introduction of a 5% solution of dextrose for on/in the introduction 0.9% solution of sodium chloride for the on/in the introduction or 4% dextrose with 0.18% sodium chloride solution for I/V administration.

Ready-to-use glass syringe has less resistance of the piston compared to a plastic disposable syringe and the lighter is actuated. With the introduction of the drug, Diprivan manually using ready-to-use glass syringe, the infusion system between the syringe and the patient cannot be left open when there is no monitoring by medical personnel.

Appropriate compatibility should be ensured in case of use of ready-to-use glass syringe in the syringe pump. In particular, the pump design must prevent sibonisweni and should provide emergency lights on the obstruction at a pressure of 1000 mm Hg.St. If using a programmable or equivalent pump, allowing the use of various syringes in the case of use of ready-to-use glass syringe is selected, only the mode "B—D" PLASTIPAK 50/60 ml.

Diprivan can be pre-mixed with Alfentanil for injection containing 500 µg/ml were Alfentanil, in a volume ratio of 20:1-50:1. The mixture should be prepared using sterile equipment, and use within 6 h after preparation.

To reduce pain at the beginning of the introduction of an induction dose of Diprivan immediately before administration can be mixed with lidocaine injection in a plastic syringe in the following proportions: 20 parts of the drug Diprivan and prep and drape to one portion of either the 0.5 or 1% lidocaine solution for injection.

Overdose:

Accidental overdose can probably cause depression of CVS activity and respiration. In case of respiratory depression should conduct a ventilator with oxygen. When depression of cardiovascular activity, in severe cases, may require the introduction of plasma expanders and Pressor means.

Special instructions:

Diprivan should not be mixed before use with any other injection or infusion solutions except 5% dextrose solution in PVC bags or glass bottles for infusion, lidocaine for injection, or Alfentanil for injection in plastic syringes.

With the introduction of the muscle relaxants atracurium of besilate and mivakuriya chloride should not be used the same infusion line for drug Diprivan, without prior washing.

Diprivan should be applied by staff with training in anaesthesia (or, in appropriate situations, doctors trained in providing care to patients during intensive care). For patients must continuously monitor the equipment to maintain a free airway, artificial ventilation, oxygen enrichment and other resuscitation facilities must always be ready to use. Diprivan not be the person performing the diagnostic or surgical procedure.

When using the drug, Diprivan during surgical or diagnostic procedures for sedation with preservation of consciousness requires a constant monitoring of the patient to detect early signs of decline in blood pressure, airway obstruction and insufficient blood oxygen saturation.

As the use of other sedative drugs, with the drug, Diprivan for sedation during operative intervention possible involuntary movements of patients. During procedures requiring immobility these movements may be hazardous to plot surgery.

Adequate period of time to monitor the patient to ensure full recovery after General anesthesia. In very rare cases after use of the drug, Diprivan perhaps the lack of consciousness in the postoperative period, which may be accompanied by increased muscle tone. Sometimes loss of consciousness occurs after a period of wakefulness. In spite of the spontaneous awakening, in patients who are unconscious must have the proper supervision.

Diprivan has a weak m-holinoblokiruta activity and its use is associated with cases of bradycardia (which sometimes is of a serious nature), and asystole.. It is advisable to/in the introduction of m-holinoblokirutego agent prior to induction of anesthesia or during its maintenance, especially in cases where there is a possibility of the predominance of vagal tone, or when Diprivan used in combination with other drugs that may cause bradycardia.

If Diprivan administered to the patient suffering from epilepsy, have a risk of seizures.

Proper attention should be paid to patients with impaired lipid metabolism, as well as other conditions requiring cautious use of lipid emulsions.

It is recommended to monitor the concentration of lipids in the blood in cases where Diprivan prescribed to patients who are at particular risk of accumulation of lipids. In that case, if the monitoring indicates a lack of removing fat from the body, the introduction of the drug, Diprivan should be adjusted appropriately. Simultaneous in/in the introduction to the patient other lipid means the dose should be reduced taking into account the amount of lipid administered in a preparation, Diprivan 1.0 ml, Diprivan contains approximately 0.1 g of lipid.

Note to section "Sedation during intensive care"

It was reported about rare cases of metabolic acidosis, rhabdomyolysis, hyperkalemia and/or cardiac failure, in some cases with a fatal outcome in critically ill patients receiving Diprivan for sedation during intensive care. The most likely risk factors for these events were: the decline in the provision of tissues with oxygen, a serious neurological injury and/or sepsis, high-dose the following pharmacologically active agents — vasoconstrictors, steroids, cardiotonic funds and/or propofol. All sedatives and therapeutic drugs used during intensive therapy (including Diprivan) should Mitrovitsa to maintain an optimal supply of oxygen to tissues and optimal hemodynamic parameters.

Part of the drug EDTA forms chelate complexes with metal ions including zinc ions. You should consider additional purpose of zinc long-term use of the drug, Diprivan, especially in patients with predisposition to zinc deficiency, such as burns, diarrhea and/or sepsis.

Diprivan, does not contain antimicrobial preservatives and may provide a favorable environment for microbial growth. When filling the drug, Diprivan sterile syringe and infusion line should comply with the rules of asepsis the drug you need to dial immediately after opening the ampoule. The introduction should begin immediately. Aseptic conditions should be ensured during the whole infusion period in respect of the drug, Diprivan and apparatus for the introduction. Any infusion fluids added to an infusion line combined with preparation, Diprivan®, you must enter as close as possible to the location of the cannula. Diprivan, you cannot enter through the microbial filter.

Syringe with the drug, Diprivan is disposable and is intended for use in one patient. In accordance with other lipid emulsions of the rules, the duration of continuous drug infusion, Diprivan should not exceed 12 h after drug infusion or after a 12-hour period must be replaced as a container of drug, Diprivan and infusion line.

Capacity with the drug, Diprivan to use should be shake. The contents of the vessel remaining in any quantity after use, should be destroyed.

Aseptic conditions must be provided in respect of the drug, Diprivan and apparatus for the introduction.

Effects on ability to drive and other mechanisms. Patients should be informed that General anesthesia for some time after the event may impair the execution of skills requires work, such as driving or operating machinery.

Review:

Before using the drug you must read the instructions for use.