Diprivan of 10 mg/ml

General characteristics. Structure:

Active agent: пропофол 10 mg
Excipients: soybeans oil of 100 mg, phospholipids of an egg yolk of 12 mg, глицерол 22,5 mg, ethylene diamine tetraacetic acid the EDTA disodium salt (an anhydrous equivalent) of 0,055 mg, sodium hydroxide in the quantity necessary for adjustment рН to 7,5-8,5; water for injections to 1 ml.

Description. White or almost white color homogeneous emulsion. At long standing easy stratification can be observed.

Pharmacological properties:

Pharmacodynamics. Propofol (2,6-diizopropilfenol) is short-range means for the general anesthesia with action quick start within about 30 seconds. Usually an exit comes from the general anesthesia quickly. The mechanism of effect of the drug Diprivan®, as well as all means for the general anesthesia, is insufficiently clear.
As a rule, at use of the drug Diprivan® for induction of anesthesia and for its maintenance decrease in average arterial pressure and little changes of heart rate is observed. Nevertheless, hemodynamic parameters usually remain rather steady during anesthesia maintenance, and the frequency of adverse hemodynamic changes low.
Though after administration of the drug Diprivan® there can be respiratory depression, any of these effects are qualitatively similar that arise at use of other intravenous anesthetics and easily give in to control in clinical conditions.
Диприван® reduces a cerebral blood stream, intracranial pressure and reduces cerebral metabolism. Reduction of intracranial pressure is more expressed at patients with initially increased intracranial pressure.
Exit usually comes from an anesthesia quickly, with clear consciousness and is followed by low interest of cases of a headache. As a rule, after drug Diprivan® anesthesia cases of postoperative nausea and vomiting meet less than after inhalation anesthesia. Perhaps, it is connected with antiemetic effect of a propofol.
Диприван® at the concentration which are usually reached in clinical conditions does not suppress synthesis of adrenal hormones.

Pharmacokinetics. Decrease in concentration of a propofol after introduction of a bolyusny dose or after the termination of infusion can be described by means of open three-chambered model. The first phase is characterized by very bystry distribution (the period of semi-distribution is equal to 2-4 minutes), the second - bystry removal (the elimination half-life is equal to 30-60 minutes). Further slower final phase of which redistribution of a propofol from slaboperfuziruyemy fabric in blood is characteristic follows.
Propofol is quickly distributed and quickly brought from an organism (the general clearance is equal to 1,5-2 l/min). Removal of a propofol is carried out by metabolism, mainly, in a liver therefore conjugates of a propofol and corresponding to it хинол which removal happens kidneys are formed.
When Diprivan® apply to anesthesia maintenance, concentration it in blood asymptotically reaches the equilibrium value corresponding to rate of administering. Within the recommended infusion speeds the pharmacokinetics of the drug Diprivan® has linear character.
With increase in age of the patient pharmacokinetic changes are that that at in bolyusny administration of the drug Diprivan® in a blood plasma higher concentration of drug are noted. High plasma concentration can cause cardiovascular and respiratory effects, such as a lowering of arterial pressure, an apnoea, obstruction of respiratory tracts, decrease in oxygenation of blood in elderly patients. As a result, at elderly patients lower doses of the drug Diprivan® for induction are recommended
and maintenance of anesthesia, providing sedation. (See the section "Route of Administration and Doses") differences in pharmacokinetics of a propofol at patients with chronic cirrhosis or a chronic renal failure in comparison with adult patients with normal function of a liver and kidneys are not revealed.
The pharmacokinetics of a propofol at patients with an acute liver and renal failure was not studied.

Indications to use:

Induction and maintenance of the general anesthesia. Sedation of the patients who are on the artificial ventilation of the lungs (AVL) during an intensive care. Sedation of the patients who are in consciousness during surgical and diagnostic procedures.

Route of administration and doses:

As a rule, Diprivan® demands additional use of analgeziruyushy means.
Диприван® it is combined with spinal and epidural anesthesia; with the medicines which are usually used for premedication; with muscle relaxants, means for inhalation anesthesia and analgeziruyushchy means, at the same time pharmacological incompatibility was not noted. Lower doses of the drug Diprivan® can be required when the general anesthesia is used as addition to the applied methods of regional anesthesia.
You watch the guide to administration of the drug Diprivan® to target concentration by means of the infusional system including the corresponding software Diprifyyuzor in the section D. This use is limited to induction and maintenance of the general anesthesia at adults. Diprifyyuzor is not recommended to use system of infusion on target concentration (ITsK) for sedation at patients in intensive care units, for receiving sedation with consciousness preservation, or at children.
AND. ADULTS
Induction of the general anesthesia
Диприван® it is possible to apply to induction of anesthesia by means of slow bolyusny injections or infusion. Irrespective of it was carried out or premedication was not carried out, administration of the drug Diprivan® is recommended to titrate (bolyusny injections or infusion about 40 mg each 10 seconds - the average adult in satisfactory condition) depending on reaction of the patient before emergence of clinical signs of anesthesia. For most of adult patients aged up to 55 years the average dose of the drug Diprivan® makes 1,5-2,5 mg/kg. The necessary total dose can be reduced, using lower rates of administering (20-50 mg/min.). For patients is more senior than this age, as a rule, lower dose is required. Patients of 3 and 4 classes ASA (Classification of the physical status of the patient of American Society of Anesthesiology (ASA) Classification) should carry out introduction with lower speed (about 20 mg each 10 seconds).
Maintenance of the general anesthesia
Anesthesia can be supported or continuous infusion of the drug Diprivan®, or by means of the repeated bolyusny injections necessary for maintenance of required depth of anesthesia.
Continuous infusion
Necessary rate of administering considerably varies depending on specific features of patients. As a rule, speed within 4-12 mg/kg/h provides maintenance of adequate anesthesia.
Repeated bolyusny injections
If the equipment including repeated bolyusny injections is used, then introduction of the accruing doses from 25 mg to 50 mg depending on clinical need is used.
Sedation during an intensive care
Administration of the drug Diprivan® by means of system ITsK "Diprifyyuzor" for sedation of patients during an intensive care is not recommended.
When using the drug Diprivan® it is recommended to be applied to sedation of the adult patients who are on IVL and receiving an intensive care by means of continuous infusion. Speed of infusion should be adjusted taking into account the necessary depth of sedation, but speed within 0,3-4,0 mg/kg/h has to provide achievement of satisfactory sedation. Speed of infusion should not exceed 4,0 mg/kg/h, except for cases when the potential advantage for the patient outweighs risk of side effects.
Sedation of the patients who are in consciousness during the surgical and diagnostic procedures
Administration of the drug Diprivan® by means of system ITsK "Diprifyyuzor" for sedation with preservation of consciousness is not recommended.
For providing sedation during the surgical and diagnostic procedures rate of administering and a dose have to be selected individually depending on the clinical answer of the patient.
Most of patients requires 0,5 - 1,0 mg/kg within 1 - 5 minutes for emergence of sedation.
For maintenance of sedation the speed of infusion should be adjusted according to the necessary depth of sedation; most of patients requires speed within 1,5 - 4,5 mg/kg/h. If bystry increase in depth of sedation is required, then as addition to infusion bolyusny introduction of 10 - 20 mg of the drug Diprivan® can be used. For patients of 3 and 4 classes ASA the dose decline and rates of administering can be required.
B. PATIENTS OF ADVANCED AGE
At elderly patients for an introduction anesthesia lower doses of the drug Diprivan® are required. At reduction of a dose it is necessary to be guided by the physical status and age of the patient. The reduced dose has to be entered with a smaller speed, than usually and to be titrated depending on the answer of the patient. When using the drug Diprivan® for maintenance of anesthesia or for sedation the speed of infusion or "target concentration" of drug has to be reduced. For patients of 3 and 4 classes ASA the further dose decline and rates of administering can be required. In order to avoid oppression of cardiovascular and respiratory systems by the elderly patient bystry bolyusny introduction is not recommended (single or repeated).
CENTURY. CHILDREN
At children it is not recommended to enter Diprivan® by means of system ITsK "Diprifyyuzor" at any indications.
Induction of the general anesthesia
Диприван® it is not recommended to apply at children aged up to 1 month (see the section "Contraindications").
At use of the drug Diprivan® for ensuring induction of anesthesia at children it is recommended to be entered slowly before emergence of clinical signs of approach of anesthesia. The dose should be adjusted according to age and/or body weight of the child. For most of children 8 years for anesthesia induction are aged more senior probably about 2,5 mg/kg of the drug Diprivan® will be required. For children aged from 1 month up to 8 years the necessary dose can be higher. Lower dose is recommended for children of 3 and 4 classes ASA.
Maintenance of the general anesthesia
Диприван® it is not recommended to apply at children aged up to 1 month.
Maintenance of anesthesia is reached by administration of the drug Diprivan® by means of continuous infusion or by means of the repeated bolyusny injections demanded for maintenance of necessary depth of anesthesia. Necessary rate of administering differs in a considerable image at various patients; satisfactory anesthesia is usually provided at a speed of infusion within 9-15 mg/kg/h.
Sedation of the patients who are in consciousness during the surgical and diagnostic procedures
Диприван® it is not recommended to apply to sedation with preservation of consciousness at children as its safety and efficiency at this use are not confirmed yet.
Sedation during an intensive care
Диприван® it is not recommended to apply to sedation at children as its safety and efficiency at this use are not confirmed yet. At unlicensed use the serious adverse phenomena were noted (including cases of a lethal outcome) though to relationship of cause and effect using the drug Diprivan® it was not established. These adverse phenomena were most often observed at children with existence of respiratory infections which entered the doses exceeding the recommended doses for adults.
. INTRODUCTION
Диприван® it is possible to enter not divorced with use of plastic syringes or glass bottles for infusion or the glass syringes filled with the drug Diprivan®. When Diprivan® apply in not divorced look to maintenance of the general anesthesia, it is always recommended to use perfusors or infuzomata to exercise control of rate of administering.
Диприван® it is also possible to apply only the solution divorced 5%
Dextrosums, intended for intravenous administration, in bags from PVC or in glass bottles. Solution which cultivation should not exceed ratios 1:5 (2 mg/ml of a propofol) has to be prepared according to rules of an asepsis just before use. Mix keeps stability within 6 hours.
Divorced solution of the drug Diprivan® can be entered with use of various adjustable systems for infusion, however, use only of similar devices does not allow to avoid completely risk of accidental, uncontrollable introduction of large volumes of the divorced drug Diprivan®. Burettes, counters of drops or dispensing pumps always have to be a part of the line for infusion. At the choice of the maximum volume of the divorced drug Diprivan® in the burette it must be kept in mind risk of uncontrollable introduction.
Диприван® it is possible to enter through a tee with the valve close to the place of an injection, along with introduction of 5% of solution of a dextrose for intravenous administration, 0,9% of solution of sodium of chloride for intravenous administration or 4% of solution of a dextrose from 0,18% chloride sodium solution for intravenous administration.
The glass syringe, ready to the use, has the smaller resistance of the piston in comparison with the plastic one-time syringe and is easier set in motion. At administration of the drug Diprivan® manually by means of the glass syringe, ready to use, for infusion between the syringe and the patient it is impossible to leave system open in the absence of observation from medical personnel.
The corresponding compatibility has to be provided in case of use of the glass syringe, ready to use, in the spray pump. In particular, the design of the pump has to prevent siphoning and has to provide the alarm system about obstruction with a pressure no more than 1000 mm hg. If the pump programmable or equivalent to it assuming a possibility of use of various syringes is used, then in case of use of the glass syringe, ready to use, only PLASTIPAK ml mode "B-D" 50/60 is chosen.
Диприван® it is possible to mix previously with the alfentanil for injections containing 500 mkg/ml of alfentanil in a volume ratio 20:1 - 50:1. Mix should be prepared, using the sterile equipment and to apply within 6 hours after preparation.
For reduction of pain at the beginning of introduction the induction dose of the drug Diprivan® just before introduction can be mixed with lidocaine for injections in the plastic syringe in the following proportion: 20 parts of the drug Diprivan® and to one part of either 0,5%, or 1% of solution of lidocaine for injections.
CULTIVATION OF THE DRUG DIPRIVAN® AND JOINT INTRODUCTION IN COMBINATION WITH OTHER MEDICINES OR INFUSION SOLUTIONS

                                          Medicine Caution Preparation method
simultaneous    or infusional 
uses           solution
The preliminary  5% solution of a dextrose      to Mix 1 part                 to Prepare in
mixing           for in/in administrations              of the drug Diprivan®        of aseptic
                                                                      and to 4 parts of 5%             conditions,
                                                                      dextrose solution for      directly
                                                                      in/in introductions or in           before use.
                                                                       bags from polyvinyl -        Mix keeps
                                                                       chloride (PVC), or in        stability in
                                                                      glass bottles.         current of 6 hours.
                                                                       At cultivation in bags 
                                                                       from PVC it is recommended, 
                                                                        that the bag was full, 
                                                                       solution prepares 
                                                                       by removal of a part 
                                                                       volume of solution of a dextrose 
                                                                       with its substitution ekviva-
                                                                        lentny volume 
                                                                       drug Diprivan®.
                                    Lidocaine for              to Mix 20 parts              to Prepare, observing 
                                     injections (0,5%          of the drug Diprivan®         of a condition of an asepsis,
                                      or 1% without                and to 1 part of 0,5%               directly
                                     preservatives)             or 1% of solution                 before use.
                                                                        lidocaine     to Apply to injections only 
                                                                                                                  for induction 
                                                                                                                   anesthesia.
                                    Alfentanil for           to Mix Diprivan®           to Prepare, observing
                                    injections                     with                   asepsis condition alfentanil,
                                     (500 mkg/ml)                for injections in volume  just before
                                                                        ratio 20:1 - 50:1      uses. To apply 
                                                                                                                    within 6 hours later 
                                                                                                                    preparations.
Odnovremen-         5% dextrose solution     Simultaneous introduction
Nov         for in/in introductions              to carry out introduction with the help
tee from                                                      a tee with the valve.
the valve               of 0,9%         you See solution of sodium above.                   You see above.
                                chloride for in/in
                                introductions
                                Solution                     you See 4% above.                    You see above.
                                Dextrosums from 0,18%
                                sodium solution
                                chloride for in/in
                                introductions

. INFUSION ON TARGET CONCENTRATION - ADMINISTRATION OF THE DRUG DIPRIVAN® BY MEANS OF SYSTEM FOR ITSK DIPRIFYYUZOR AT ADULTS
Administration of the drug Diprivan® by means of system ITsK "Diprifyyuzor" is limited to the periods of induction and maintenance of the general anesthesia at adults. Use for sedation in an intensive care, for providing sedation with preservation of consciousness or at children is not recommended.
Диприван® it can be entered by the ITsK method only by means of the system ITsK "Diprifyyuzor" including the software Diprifyyuzor. These systems will function only after recognition of an electronic tag on the glass syringe, ready to use, filled with the drug Diprivan®.
System ITsK "Diprifyyuzor" will automatically regulate rate of administering of the drug Diprivan® of that concentration which was distinguished by system. Users have to be acquainted with a grant on work with the infusional pump, with administration of the drug Diprivan® as the ITsK method, with the correct use of system of recognition of the syringe that is stated in the manual provided by Astrazenek's company.
This system gives to the anesthesiologist the chance to reach the desirable speed of induction and depth of an anesthesia and to manage them by means of installation and regulation of the target (predicted) concentration of a propofol in the patient's blood.
System ITsK "Diprifyyuzor" assumes that initial concentration of a propofol is equal in blood of the patient to 0. Therefore, for the patients receiving пропофол earlier, perhaps it is necessary to choose lower initial target concentration at the beginning of administration of the drug Diprivan® by means of ITsK "Diprifyyuzor". Also it is not recommended to resume work of ITsK "Diprifyyuzor" as before after its shutdown.
The guide to the choice of target concentration of a propofol is attached below. Due to the individual distinctions of pharmacokinetics and a pharmacodynamics of a propofol at patients as received premedication, not received that, target concentration of a propofol has to be titrated depending on the clinical answer of the patient for the purpose of achievement of necessary depth of anesthesia.
At adult patients aged up to 55 years anesthesia can be, as a rule, induced by target concentration of a propofol from 4 to 8 mkg/ml. Initial target concentration of a propofol of 4 mkg/ml is recommended to the patients who received premedication, concentration of 6 mkg/ml is recommended to patients without premedication. Time of induction of anesthesia at these target concentration makes, as a rule, 60 - 120 seconds. Higher values will lead to more bystry induction of anesthesia, but can be connected with more expressed oppression of a hemodynamics and function of breath.
Smaller initial target concentration should be used at patients 55 years and at patients of 3 and 4 classes ASA are more senior. Target concentration can be gradually increased further by bucketed size from 0,5 to 1,0 mkg/ml 1 minute for achievement of gradual induction of anesthesia.
As a rule, the additional analgesia is necessary, and the size of decrease in target concentration for maintenance of an anesthesia will depend on quantity of in addition entered analgeziruyushchy means. Target concentration of a propofol ranging from 3 to 6 mkg/ml usually support the sufficient level of the general anesthesia.
The predicted concentration of a propofol when awakening is, generally within 1,0 - 2,0 mkg/ml and will depend on analgesia level during maintenance of an anesthesia.
Sedation during an intensive care
Usually target concentration of a propofol in blood in the range of 0,2 - 2,0 mkg/ml is required. Administration of the drug Diprivan® should be begun at low target concentration and to titrate a dose depending on reaction of the patient for achievement of desirable depth of sedation.

Features of use:

Диприван® it has to be applied by the personnel having preparation in the field of anesthesia (or, in the corresponding situations, the doctors who had training on assistance to patients during an intensive care). For patients it is necessary to carry out continuous monitoring, the equipment for maintenance of free passability of respiratory tracts, for carrying out artificial ventilation of the lungs, oxygen enrichment, and also other resuscitation means have to be constantly ready to use. Диприван® it should not be entered by the person performing the diagnostic or surgical procedure.
When using the drug Diprivan® during the surgical or diagnostic procedures sedation with consciousness preservation, requires constant observation of the patient for identification of precursory symptoms of a lowering of arterial pressure, obstruction of respiratory tracts and insufficient saturation of blood oxygen.
As well as at use of other sedative drugs, at administration of the drug Diprivan® for providing sedation at an operative measure the involuntary movements of patients are possible. At the procedures demanding observance of an immovability, these movements can be dangerous to the site of an operative measure.
The adequate span is necessary for observation of the patient for providing a complete recovery after the general anesthesia. Seldom or never after use of the drug Diprivan® lack of consciousness in the postoperative period is possible that can be followed by increase in a muscle tone. Sometimes the loss of consciousness occurs after the wakefulness period. Despite spontaneous awakening, for the patient who is in unconsciousness appropriate observation has to be established.
Диприван® the m-holinoblokiruyushchey has activity weak and its use is connected with bradycardia cases (which sometimes has serious character), and also with an asystolia. Reasonablly intravenous administration of m-holinoblokiruyushchego of means before induction of anesthesia or during its maintenance, especially when there is a probability of dominance of a tone of a vagus nerve or when Diprivan® apply in combination with other means which can become the bradycardia reason.
If Diprivan® enter to the patient having epilepsy there is a risk of developing of spasms.
The due attention should be paid to patients with disturbances of lipidic metabolism, and also at other states demanding careful use of lipidic emulsions.
 It is recommended to carry out monitoring of concentration of lipids to blood in cases when Diprivan® appoint to patients who are subject to extra risk of accumulation of lipids. If monitoring demonstrates insufficient removal of fats from an organism, administration of the drug Diprivan® should be corrected properly. At simultaneous intravenous administration the patient of other lipidic means should reduce its dose, taking quantity of the lipid entered as a part of the drug Diprivan® into consideration; 1,0 ml of the drug Diprivan® contain about 0,1 g of lipids.
The note to the section "Sedation during an Intensive Care":
It was reported about very exceptional cases of a metabolic acidosis, rabdomioliz, hyperpotassemia, and/or heart failure, in certain cases from the death at the seriously ill patients receiving Diprivan® for providing sedation during an intensive care. The most probable risk factors of development of the listed events were: decrease in providing fabrics with oxygen, serious neurologic injuries and/or sepsis, high doses of the active means following pharmacological – vasoconstrictors, steroids, cardiotonic means and/or a propofol. All sedative and therapeutic drugs used during an intensive care (including Diprivan®), have to be titrated for maintenance of optimum supply of fabrics with oxygen and optimum hemodynamic parameters.
Being a part of drug EDTA forms chelate complexes with ions of metals, including zinc ions. It is necessary to consider the possibility of additional purpose of zinc at prolonged use of the drug Diprivan®, especially at the patients having predisposition to deficit of zinc, for example, at burns, diarrhea and/or sepsis.
Диприван® does not contain antimicrobic preservatives and can serve as the favorable environment for growth of microorganisms. When filling with the drug Diprivan® of the sterile syringe or the infusional line it is necessary to follow rules of an asepsis; drug needs to be gathered at once after opening of an ampoule. Introduction should be begun immediately. Aseptic conditions have to be provided during all infusional period as concerning the drug Diprivan®, and the equipment for introduction. Any infusion solutions added to the infusional line in combination with preparatay Diprivan® should be entered as it is possible closer to the location of a cannula. Диприван® it is impossible to enter via the microbiological filter.
The syringe with the drug Diprivan® is one-time and is intended for use for one patient. According to the rules established for other lipidic emulsions, duration of continuous infusion of the drug Diprivan® should not exceed 12 hours. Upon termination of infusion of drug or after 12 hour periods it is necessary to replace both capacity with the drug Diprivan®, and the infusional line.
To sleduyetvstryakhnut tanks with the drug Diprivan® before the use. The capacity contents which remained in any quantity after its use have to be destroyed.
Aseptic conditions have to be provided as concerning the drug Diprivan®, and the equipment for introduction.
INFLUENCE ON ABILITY TO DRIVE THE CAR AND OTHER MECHANISMS
Patients should be informed that the general anesthesia after its carrying out can worsen for some time performance of the demanding skills of works, such as control of vehicles or work with the equipment.

Side effects:

The general
As a rule, induction of anesthesia proceeds with the minimum signs of excitement. The most often found side reactions are side effects of any means, predictable from the point of view of pharmacology, for the general anesthesia, for example, a lowering of arterial pressure. Cases about which it was reported in connection with anesthesia and an intensive care can be also connected with the carried-out procedures or with a condition of the patient.

                  Very often General reactions                  of Bol in an injection site
(> 1/10)                       and reactions in the place             at induction of anesthesia (1)
                                    introductions:
                           Often General:                              A syndrome of "cancellation" at children (4)
(> 1/100, <1/10)         from outside cordial        Decrease or increase
                                   vascular system:           arterial pressure (2),
                                                                               bradycardia (3), "inflow"
                                                                              blood at children (4)
                                   From outside gastro       Vomiting and nausea
                                    intestinal path:              during awakening
                                   From central     Headache
                                    nervous system:              during awakening
                                   From respiratory     Temporary an apnoea in time
                                    systems:                            anesthesia induction
Infrequently                       from outside cardiac         Arrhythmia, fibrinferments
(> 1/1000, <1/100)      vascular system:            and phlebitis
Seldom                           Disturbances from outside       Epileptiform attacks,  
(> 1/10 000, <1/1000)  central nervous         including spasms and an opisthotonos in time
                                     systems:                            during anesthesia induction,
                                                                                maintenance of anesthesia and awakening
                 Very seldom Skeletal and muscular          
(<1/10 000)                 effects, connecting
                                    fabric:                                    Rabdomioliz (5)
                                    Procedural complications:    Postoperative fever
                                    From gastro
                                    intestinal path:                 Pancreatitis
                                    From kidneys and
                                    urinary system:     Urine decolouration 
                                                                                at long introduction
                                    From immune
                                     systems:                             The anaphylaxis can be shown 
                                                                                 in a look: Quincke's disease, 
                                                                                  bronchospasm, erythema and decrease 
                                                                                  arterial pressure
                                    Disturbances from outside
                                    reproductive system:     Sexual disinhibition
                                    From cordial
                                      vascular system:           Asystolia, fluid lungs
                                    From central
                                     nervous system:                Postoperative unconscious
                                                                                     state

(1) Pain in an injection site can be reduced by means of administration of drug in veins of a forearm and an elbow bend, big by the size. Pain can be also reduced at joint administration of the drug Diprivan® with lidocaine (see the section "Route of Administration and Doses", part G)
(2) The lowering of arterial pressure can cause the necessity of intravenous administration of liquid and reduction of rate of administering of the drug Diprivan®.
(3) Serious cases of bradycardia meet seldom. There are isolated messages on progressing of bradycardia up to an asystolia.
(4) Arises during sharp phase-out of the drug Diprivan® during an intensive care.
(5) It was reported on very exceptional cases of a rabdomioliz at use of the drug Diprivan® in doses more than 4 mg/kg/h for sedation at an intensive care.
During induction of anesthesia depending on a dose of the drug Diprivan®i of the accompanying therapy insignificant excitement can be observed.
Seldom or never at administration of drug of Diprivan® in doses more than 4 mg/kg/h for sedation at an intensive care were reported about cases of a metabolic acidosis, a hyperpotassemia and heart failure, sometimes with a lethal outcome.
It was reported about cases of dystonia, dyskinesia and lipidemia.
In a phase of awakening the fever, a cryesthesia, dizziness, cough can sometimes be observed.

Interaction with other medicines:

INTERACTION WITH OTHER MEDICINES AND OTHER TYPES OF MEDICINAL INTERACTION
Диприван® it was used in a combination to spinal and epidural anesthesia, to means for premedication, muscle relaxants, means for inhalation anesthesia and analgeziruyushchy means; pharmacological incompatibility was not noted. Lower doses of the drug Diprivan® can be required when the general anesthesia is used as addition to the applied methods of regional anesthesia.
INCOMPATIBILITY
Диприван® it is not necessary to mix before use with any other injection or infusion solutions, except for 5% of solution of a dextrose in bags from PVC or in glass bottles for injection, lidocaine for injections or alfentanil for injections in plastic syringes.
At introduction of muscle relaxants an atrakuriya of a bezilat and a mivakuriya of chloride it is not necessary to use the same infusional line, as for the drug Diprivan®, without its preliminary washing.

Contraindications:

Hypersensitivity to any of drug components;
 Induction and maintenance of the general anesthesia at children are younger than 1 month;
 Sedation of patients aged up to 16 years which are on the artificial ventilation of the lungs (AVL) during an intensive care;
 Sedation of patients aged up to 16 years which are in consciousness during surgical and diagnostic procedures;
 Pregnancy, and also use in obstetric practice, except for abortion in the first trimester;
 Breastfeeding period.
With care: as well as at use of other intravenous anesthetics, it is necessary to show care concerning patients with cardiovascular, respiratory, renal or hepatic disturbances, and also concerning patients with epilepsy, a hypovolemia, disturbances of lipidic exchange or at the weakened patients.
USE AT PREGNANCY AND DURING BREASTFEEDING
Pregnancy
Диприван® it is not necessary to apply during pregnancy. However Diprivan® apply during abortion in the first trimester.
Obstetrics
Диприван® gets through a placental barrier and its use it can be connected with a neonatal depression. It should not be applied in obstetrics as anesthetic.
Breastfeeding period
For the newborns who are on breastfeeding safety of use of the drug Diprivan® for the feeding women was not established. In this regard, breastfeeding is not recommended during drug Diprivan® use.

Overdose:

The accidental overdose can probably become the reason of oppression of activity of cardiovascular system and breath. In case of respiratory depression it is necessary to carry out artificial ventilation of the lungs with oxygen. At oppression of cardiovascular activity in hard cases introduction of plasma substituting and pressor means can be required.

Storage conditions:

At a temperature from 2 to 25 °C. Not to freeze. To store in the places unavailable to children. A period of validity for ampoules: 3 years. For syringes: 2 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Emulsion for intravenous administration, 10 mg/ml.
On 20 ml in glass ampoules. 5 ampoules in the plastic fixer in a cardboard pack with the application instruction.
On 50 ml in the glass syringe with a polypropylene plunger and Lyuer's connector. The syringe in a blister strip packaging. One blister strip packaging with the application instruction in a cardboard pack.