Diprofol

General characteristics. Structure:

Active ingredient: propofol;

1 ml of an emulsion contains a propofol of 10 mg;

excipients: oil soy, lecithin egg, glycerin, oleic acid, sodium hydroxide, water for injections.

Pharmacological properties:

Pharmacodynamics. Propofol is means of short action for the general anesthesia with quick start of action which comes approximately in 30 seconds. Usually recovery after the general anesthesia happens quickly. The action mechanism, as well as all means for the general anesthesia, is insufficiently clear. However it is considered that the sedative/analgesic effect of a propofol is caused by positive modulation of the inhibiting function of a neurotransmitter of GAMK through ligandupravlyaemy GAMKA receptors.

As a rule, at drug use Diprofol for induction and maintenance of anesthesia, is observed decrease in average arterial pressure and minor changes of heart rate. However hemodynamic indicators, as a rule, remain rather stable during the anesthesia maintenance period, and the frequency of emergence of undesirable hemodynamic changes is low.

Though after drug use Diprofol can arise respiratory depression, all effects are qualitatively similar to those which arise at use of other anesthetics for intravenous administration, and easily give in to control in clinical conditions.

Drug Diprofol reduces a cerebral blood stream, intracranial pressure and cerebral metabolism. Reduction of intracranial pressure is more expressed at patients with the raised initial indicators of intracranial pressure.

Exit from an anesthesia happens usually quickly, to clear consciousness and low frequency of developing of a headache, postoperative nausea and vomiting.

In the general ambassador of anesthesia drug Diprofol the frequency of developing of postoperative nausea and vomiting is less in comparison with that at use of means for inhalation anesthesia. It can be connected with less expressed ability of a propofol to cause vomiting.

Drug Diprofol at concentration which are usually reached in clinical conditions does not oppress synthesis of adrenal hormones.

Pharmacokinetics. Decrease in concentration of a propofol after bolyusny introduction of a dose or after the termination of infusion can be described by means of three-chambered open model with bystry distribution (the period of semi-distribution makes 2-4 minutes), bystry removal (the elimination half-life makes from 30 to 60 minutes) and slower final phase at which there is a redistribution of a propofol from slaboperfuzirovanny fabric.

Propofol is quickly distributed and quickly brought from an organism (the general clearance makes from 1,5 to 2 l/min). Removal of a propofol happens by metabolism, mainly in a liver owing to what inactive conjugates of a propofol and corresponding to it хинол which are removed with urine are formed.

If drug Diprofol is used for maintenance of anesthesia, its concentration in blood asimptomatichno reach indicators of the equilibrium state corresponding to rate of administering. The pharmacokinetics is linear within the recommended speeds of performing infusion of drug Diprofol.

Pharmaceutical characteristics

 

Main physical and chemical properties: homogeneous emulsion of white color. The emulsion should not show stratification signs.

Incompatibility.

Diprofol it is impossible to mix with other medical supplies, except for those which are specified in the section "Route of Administration and Doses".

Indications to use:

For induction and maintenance of the general anesthesia.
For providing sedation at patients to whom artificial ventilation of the lungs in the conditions of resuscitation is carried out.
For providing sedation when holding surgical and diagnostic procedures.

Route of administration and doses:

Induction of the general anesthesia

Adults

Irrespective of, it is carried out or premedication to the patient is not carried out, Diprofol (in the form of a bolyusny injection or infusion about 4 ml (40 mg) each 10 seconds for adult patients with satisfactory condition of health) depending on reaction of the patient before emergence of clinical signs of anesthesia is recommended to titrate a drug dose. For most of adult patients 55 years a drug dose are younger Diprofol makes 1,5-2,5 mg/kg. The necessary general dose can be lowered by reduction of rate of administering (from 2 to 5 ml (from 20 to 50 mg/min.)). For patients 55 years are more senior lower dose is necessary, as a rule. Patients III and IV classes on ASA scale (The American society of anesthesiologists) should administer the drug with a smaller speed (about 2 ml (20 mg) each 10 seconds).

Patsiyentypozhily age

Lower doses of drug are necessary for patients of advanced age for induction of anesthesia.

At reduction of a dose it is necessary to consider a physical condition and age of the patient. The reduced dose should be entered with a smaller speed and to titrate depending on the answer of the patient.

Children

Diprofol is not recommended for anesthesia induction to children aged up to 1 month.

At use as introduction anesthesia to children Diprofol is recommended to enter slowly before emergence of clinical signs of anesthesia. The dose should be korrigirovat according to age and/or body weight. For most of children 8 years for induction of anesthesia are more senior about 2,5 mg/kg of drug Diprofol are necessary, as a rule. For children the necessary dose can be younger than 8 years higher. Lower dose is recommended for children III and IV classes on ASA.

Maintenance of the general anesthesia

Adults

Anesthesia can be supported by administration of drug Diprofol in the form of continuous infusion or repeated bolyusny injections for the prevention of clinical signs of insufficient anesthesia. Normalization of a state after anesthesia happens, as a rule, quickly therefore it is important to support administration of drug Diprofol before the end of a procedure.

Continuous infusion

Necessary rate of administering considerably varies depending on specific features of patients, but, as a rule, speed within 4-12 mg/kg/h provides maintenance of adequate anesthesia.

Repeated bolyusny injections

If technology of use includes repeated bolyusny injections, then enter the increasing doses from 25 mg (2,5 ml) to 50 mg (5 ml) according to clinical need.

Patsiyentypozhily age

For patients of advanced age for anesthesia maintenance the speed of infusion or target concentration also should be reduced. For patients III and IV classes on ASA there will be necessary an additional dose decline and rates of administering. Patients of advanced age should not apply bystry bolyusny introduction (one-time or repeated) as it can lead to oppression of cardiac performance and breath.

Children

Diprofol is not recommended for maintenance of anesthesia at children aged up to 1 month.

Anesthesia can be supported by administration of drug Diprofol in the form of infusion or repeated bolyusny injections for the prevention of clinical signs of insufficient anesthesia. Necessary rate of administering considerably varies depending on specific features of patients, however speed within 9-15 mg/kg/h, as a rule, provides maintenance of adequate anesthesia.

For children 3 years in comparison with the senior children can be younger higher doses of drug within the range of the recommended doses are necessary. The dose should be korrigirovat individually and with special attention to control adequacy of anesthesia.

It is not necessary to exceed the maximum duration of administration of drug which makes about 60 min., except for cases of the specific indication for more prolonged use, for example, at a malignant hyperthermia when use of inhalation anesthetics is inadmissible.

Providing sedative эффектаво vremyaintensivny therapy

Adults

For providing sedation during an intensive care Diprofol by continuous infusion is recommended to administer the drug. Speed of infusion has to depend on the necessary depth of sedation. For most of patients sufficient sedation can be reached at administration of drug Diprofol in a dose                   of 0,3-4 mg/kg/h. The upper bound of speed of performing infusion for providing sedation in the conditions of resuscitation should not exceed 4 mg/kg/h, except for cases when the advantage exceeds risks. Drug Diprofol is not shown for providing sedation at an intensive care of patients 16 years are younger.

Drug Diprofol it is possible to part 5% with glucose solution (see below the table concerning cultivation and simultaneous use).

It is recommended to check levels of lipids in blood at drug use Diprofol to patients with extra risk of development of increase in levels of fats. Administration of drug Diprofol should be korrigirovat respectively if monitoring indicates insufficient removal of fats from an organism. If to the patient at the same time enter intravenously other means containing lipids it is necessary to reduce a drug dose, considering quantity of the lipids which came to an organism at Diprofol's infusion.

1 ml of drug Diprofol contains about 0,1 g of fats.

If duration of providing sedation exceeds 3 days, levels of lipids should be checked at all patients.

Patsiyentypozhily age

If drug Diprofol is used for providing sedation, infusion speed also should be reduced. Patients ІІІ and the IV class on ASA require an additional dose decline and rates of administering of drug. Patients of advanced age should not apply bystry bolyusny introduction (one-time or repeated) as it can lead to oppression of cardiac performance and breath.

Children

Drug Diprofol is contraindicated for providing sedation at children 16 years which carry out artificial ventilation of the lungs at an intensive care are younger.

Diprofola for providing sedation in the conditions of resuscitation at children should not exceed dose rate of administering recommended, except for cases when the advantage exceeds risks.

Providing sedation when carrying out a hirurgicheskikhila of diagnostic procedures

Adults

For providing sedation when holding surgical or diagnostic procedures rate of administering of drug should be selected individually and to titrate depending on the clinical answer.

Most of patients for approach of sedation requires introduction from 0,5 to 1 mg/kg within 1-5 minutes.

Maintenance of sedation can be provided by drug infusion titration Diprofol to the necessary level of expressiveness of sedation; most of patients requires from 1,5 to 4,5 mg/kg/h. Except infusion it is possible to carry out bolyusny introduction from 10 to 20 mg if bystry approach of deep sedation is necessary. For patients ІІІ and class ІV on ASA can be necessary a dose decline and rates of administering of drug.

Patsiyentypozhily age

If drug Diprofol is used for providing sedation, the speed of infusion or target concentration also should be reduced. ІІІ and class ІV on ASA is necessary for patients an additional dose decline and rates of administering. Patients of advanced age should not apply bystry bolyusny introduction (one-time or repeated) as it can lead to oppression of cardiac performance and breath.

Children

Drug Diprofol is not recommended for providing sedation at children as safety and efficiency of drug are not confirmed.

Use

Drug Diprofol has no analgetichesky effect and therefore, as a rule, except drug Diprofol, introduction of additional analgetichesky resources is necessary.

For performing infusion Diprofol not divorced can use drug, using glass containers, plastic syringes, or the glucose solution only divorced 5% (for intravenous infusions, Br. Pharm.) in bags from PVC for infusions or glass bottles for infusions. Cultivation which ratio should not exceed 1:5 (2 mg of a propofol on 1 ml) should be carried out in aseptic conditions just before introduction; solution should be used within 6 hours after cultivation.

At use of divorced drug Diprofol is recommended that the volume of 5% of solution of glucose removed from a bag for infusions during cultivation process completely was replaced with drug emulsion volume Diprofol (see below the table concerning cultivation and simultaneous use).

The divorced drug can be administered with use different the technician of control of performing infusion, however use only of set for infusion does not allow to avoid completely accidental not controlled infusional introduction of large volumes of divorced drug Diprofol. Burettes, counters of drops or dispensing pumps always have to be a part of the line for infusion. The risk of uncontrollable infusion should be considered always when calculating the maximum volume of drug Diprofol in the burette.

At use of not divorced drug Diprofol for maintenance of anesthesia is always recommended to use for control of rate of administering such device as the shpritsevy pump or the volumetric infusional pump.

The drug Diprofol can be administered via the Y-shaped connector installed near the place of an injection at infusion of such drugs:

– 5% glucose solution for intravenous infusions;

– 0,9% chloride sodium solution for intravenous infusions;

– 4 % dextrose solution from 0,18% chloride sodium solution for intravenous infusions.

Drug Diprofol can be mixed previously with alfentanily for injections which contains 500 mkg/ml of an alfentanil, in a volume ratio from 20:1 to 50:1. Mix should be prepared in aseptic conditions and to use within 6 hours after preparation.

For reduction of pain at the beginning of introduction drug Diprofol can be mixed from   0,5% or 1% lidocaine solution for injections which does not contain preservatives (see below the table concerning cultivation and simultaneous use). In this case it is necessary to carry out preliminary skin tests on portability of lidocaine.

Indications of rather target concentration of a propofol are given below. Due to the individual differences of pharmacokinetics and a pharmacodynamics of a propofol to patients irrespective of whether premedication is carried out by him, target concentration of a propofol should be titrated depending on the clinical answer for the purpose of achievement of necessary depth of anesthesia.

Induction and podderzhaniyeobshchy anesthesia

At adult patients aged up to 55 years anesthesia can be, as a rule, induced by target concentration of a propofol in the range from 4 to 8 mkg/ml. Initial target concentration of 4 mkg/ml is recommended for patients to whom premedication, and concentration of 6 mkg/ml – for patients to whom premedication was not carried out is carried out. Induction time at these target concentration is in limits, as a rule, of 60-120 seconds. Higher target concentration will lead to more bystry induction of anesthesia, but can render more expressed oppression of a hemodynamics and breath.

Smaller initial target concentration should be applied to patients 55 years and to patients III and IV classes on ASA are more senior. Target concentration can be increased further gradually by bucketed size from 0,5 to 1 mkg/ml 1 minute for achievement of gradual induction of anesthesia.

As a rule, the additional analgesia, and size at which it is possible to reduce target concentration for anesthesia maintenance is necessary, will depend on quantity of the analgetik which are applied at the same time. Target concentration of a propofol ranging from 3 to 6 mkg/ml usually support the sufficient level of anesthesia.

The predicted concentration of a propofol for awakening is, as a rule, ranging from 1 to 2 mkg/ml and depends on analgesia level during maintenance of an anesthesia.

Providing sedative эффектаво vremyaintensivny therapy

Target concentration of a propofol in blood in the range of 0,2-2 mkg/ml are usually necessary. Administration of drug should be begun with low target concentration which should be titrated depending on reaction of the patient for achievement of necessary depth of sedation.

Cultivation препаратаДипрофол and odnovremennoyeprimeneniyesdrugy was lekarstvennymisredstvamiit infusion solutions (see also section "Additional Cautions")

Odnovremennogoprimeneniye method	Additive or solvent	Preparation	Cautions
Preliminary mixing	5% glucose solution for intravenous infusions	To mix 1 part of drug Diprofol and 4 parts of 5% of solution of glucose for intravenous infusions in bags from PVC for infusions or in glass bottles for infusions. At cultivation in bags from PVC it is recommended that the bag was full, and divorced solution to prepare by removal of a part of volume of solution for infusion with substitution by the equivalent volume of drug Diprofol.	Prepare in aseptic conditions, just before use. Mix keeps stability within 6 hours.
	Lidocaine a hydrochloride for injections (0,5% or 1% without preservatives)	To mix 20 parts of drug Diprofol and 1 part of 0,5% or 1% of solution of lidocaine of a hydrochloride for injections.	To prepare mix in aseptic conditions, just before use. To apply only to induction.
	Alfentanil for injections (500 mkg/ml)	To mix drug Diprofol with alfentanily for injections in a volume ratio from 20:1 to 50:1.	To prepare mix in aseptic conditions; to apply within 6 hours after preparation.
Simultaneous introduction through Y-shaped connector	5% dextrose solution for intravenous administration	To carry out simultaneous introduction by means of the Y-shaped connector	To place Y-shaped the connector near the place of an injection.
	0,9% chloride sodium solution for intravenous infusions	See above.	See above.
	4% dextrose solution from 0,18% chloride sodium solution for intravenous infusions	See above.	See above.

Features of use:

Diprofol anesthesiologists or, in the corresponding situations, doctors who had training on assistance to patients during an intensive care have to administer the drug. It is necessary to control a condition of patients constantly, and the equipment for maintenance of passability of respiratory tracts, for carrying out artificial ventilation of the lungs, for enrichment by oxygen, and also other resuscitation means, have to be constantly ready to use. Diprofol should not administer the drug personnel which carry out the diagnostic or surgical procedure.

At drug use Diprofol for providing sedation during operational or diagnostic procedures the condition of the patient needs to be controlled constantly for identification of precursory symptoms of arterial hypotension, obstruction of respiratory tracts and insufficient saturation of blood oxygen.

As well as at use of other sedatives, at drug use Diprofol for providing sedation during operational procedures the patient can have involuntary movements. During the procedures demanding the patient's immovability, such involuntary movements can be dangerous to the site of an operative measure.

As well as at use of other anesthetics and sedative drugs for intravenous administration, patients should be warned not to take alcohol at least for 8 hours before administration of drug Diprofol.

Drug Diprofol should be used with care as sedative to patients to whom carry out certain procedures at which the spontaneous movements are especially contraindicated, for example at eye surgery.

As well as at use of other sedative drugs for intravenous administration, at drug co-administration Diprofol and such depressants of the central nervous system as powerful analgetik, sedation can be more expressed; also it is necessary to remember a possibility of oppression of respiratory and cardiovascular system.

It is necessary to adhere to extra care during bolyusny introduction for the purpose of holding operational procedures at patients with acute pulmonary insufficiency or respiratory depression.

Simultaneous use with depressants of the central nervous system, for example with alcohol, means for the general anesthesia, narcotic analgetika, will lead to more expressed their sedation. If Diprofol to use drug in a combination with depressants of the central action for parenteral administration, heavy oppression of respiratory and cardiovascular system can develop. Diprofol after an analgetik is recommended to administer the drug, and the dose should be titrated carefully before achievement of the answer at the patient.

During induction of anesthesia arterial hypotension and temporary an apnoea depending on a dose and use of drugs for premedication or other means can develop.

At development of arterial hypotension there can sometimes be necessary an intravenous administration of solutions and reduction of rate of administering of drug Diprofol during the anesthesia maintenance period.

It is necessary that there passed the sufficient span before the patient's extract from hospital for ensuring full normalization of a state after the general anesthesia.

Very seldom after drug use Diprofol is possible the period of postoperative unconsciousness that he can be followed by increase in a muscle tone. Can precede such state / not to precede the awakening period. Though recovery of a state is spontaneous, it is necessary to establish necessary observation of the condition of the patient which is in unconsciousness.

At drug use Diprofol to patients with epilepsy can take place risk of developing of spasms.

As well as at use of other anesthetics for intravenous administration, with care appoint drug to patients with disturbances from heart, system of breath, kidneys and a liver, and also at a hypovolemia, to patients of advanced age or the weakened patients.  

The risk of development of a relative vagal hyperactivity can amplify as drug Diprofol has no vagolytic activity; it is associated with messages on bradycardia (sometimes deep), and also asystolias.  

It is necessary to consider a question of intravenous administration of an anticholinergic before induction of anesthesia or during anesthesia maintenance, especially in cases when there is a probability of a prevalence of a vagal tone or when drug Diprofol is used in a combination with other means which can cause bradycardia.

The due attention should be paid to patients with disturbances of metabolism of fats, and also with other states which demand careful use of lipidic emulsions.

When performing electroconvulsive therapy use of drug is not recommended.

As well as at use of other anesthetics, during the period of recovery sexual disinhibition is possible.

It was also seldom reported about cases of a metabolic acidosis, a rabdomioliz, a hyperpotassemia and/or the fast-progressing heart failure (sometimes with a lethal outcome) at the adults receiving drug within more than 58 hours in the doses exceeding 5 mg/kg/h. Such dose exceeds the maximum dose of 4 mg/kg/h which is recommended for providing sedation in the conditions of resuscitation today. Such patients had mainly (but not only) serious brain injuries with the increased intracranial pressure. At heart failure in such cases the response to the supporting treatment by inotropic means, as a rule, was not observed. Doctors, if it is possible, should not exceed a dose  of 4 mg/kg/h. At purpose of drug it is necessary to remember such possible side reactions and to consider a question of a drug dose decline Diprofol or transfer into alternative sedative at emergence of the first signs of emergence of such symptoms. Patients with the increased intracranial pressure should carry out the corresponding treatment for maintenance of pressure of perfusion of a brain during such changes in treatment.

Dopolnitelnyepredosterezheniya

Drug Diprofol does not contain antimicrobic preservatives and can be the favorable environment for growth of microorganisms. Drug should be vstyakhnut before use. Not to use drug if division of phases of an emulsion after stirring is observed. It is necessary to gather drug Diprofol in aseptic conditions in the sterile syringe or a dropper directly after disclosure of an ampoule or after depressurization of a bottle. Introduction should be begun immediately. Aseptic conditions should be provided both in relation to drug Diprofol, and to the equipment for introduction during infusion. Any drugs or solutions added to the infusional line with drug Diprofol should be entered as it is possible closer to the location of a cannula. The drug Diprofol cannot be administered via the microbiological filter.

Drug Diprofol and all syringes containing Diprofol are intended for one-time use for each certain patient. At use for long maintenance of anesthesia or providing sedation at an intensive care also the tank with drug Diprofol through the corresponding intervals of time to delete and replace is recommended system for infusion.

Drug Diprofol is not recommended for use by the newborn for induction and maintenance of anesthesia. Data concerning use not according to indications indicate that when the range of doses to children (aged from 1 month up to 16 years) is applied the newborn, there can be a relative overdose that can lead to oppression of cardiac performance and breath.

Ability to influence speed of response at control of motor transport or work with other mechanisms

 

Patients should be informed that anesthesia can affect ability of performance of the processes demanding skills of control of motor transport or other equipment negatively.

Side effects:

The general

Anesthesia induction, as a rule, takes place smoothly, with the minimum signs of excitement. It was most often reported about pharmacological the side reactions predicted for anesthetics, such as arterial hypotension. Considering character of anesthesia and a condition of patients which carries out an intensive care, reactions about which it was reported can be connected with procedures which were carried out, or with a condition of patients.

Side effects on the frequency of emergence classify by such categories: very often   (> 1/10);   often  (> 1/100 and <1/10); infrequently (> 1/1000 and <1/100); seldom (> 1/10 000 and <1/1000); very seldom (<1/10 000).

Disturbances of the general of a sostoyaniyaa of a state, связанныесо drug route of administration:

very often – local pain at introduction (it can be minimized by introduction to big veins of a forearm and an elbow pole, and also by lignocainum solution addition); often – cancellation symptoms at children (after the sudden termination of administration of drug Diprofol during an intensive care).

Sostoronysosudisty system: often – arterial hypotension (seldom at arterial hypotension there can be necessary an intravenous administration of solutions and reduction of a dose of Diprofol), rushes of blood at children (after the sudden termination of administration of drug Diprofol during an intensive care); infrequently – thrombosis and phlebitis.

Sostorona of heart: often – bradycardia (serious bradycardia arises seldom, there were single messages on an asystolia); very seldom – a fluid lungs.

Sostoronydykhatelny system: often – temporary an apnoea during induction.

Path Sostoronyzheludochno-kishechnogo: often – nausea and vomiting during a recovery phase; very seldom – pancreatitis.

Sostorona of a nervous system: often – a headache during a recovery phase; seldom – the epileptiform movements, including spasms and an opisthotonos during introduction, maintenance and recovery of a state; very seldom – postoperative unconsciousness.

Sostoronykostno-myshechnoy sistemy of connecting fabric: very seldom – рабдомиолиз (when пропофол applied in doses over 4 mg/kg/h to patients to achievement of sedation in the conditions of resuscitation).

Injuries, otravleniyaioslozhneniya of procedures: very seldom – postoperative fever.

Sostorona of an urinary system: very seldom – urine discoloration after long introduction.

Sostoronyimmunny system: very seldom – an anaphylaxis (can include a Quincke's disease, a bronchospasm, an erythema and arterial hypotension).

Sostorona of a reproduktivnoysistemya of mammary glands: very seldom – a sexual freedom.

It was reported about a fluid lungs, arterial hypotension, an asystolia, bradycardia and spasms. Were seldom observed рабдомиолиз, a metabolic acidosis, a hyperpotassemia or heart failure, sometimes with a lethal outcome, at use of a propofol in doses over 4 mg/kg/h for achievement of sedation in the conditions of resuscitation.

Messages of rather non-licensed use of drug Diprofol for anesthesia induction  by the newborn indicate that oppression of cardiac performance and breath at use of the mode of dosing for children can develop.

Local

Local pain which can arise during an initial phase of anesthesia drug Diprofol can be minimized by simultaneous introduction of lignocainum (see the section "Route of Administration and Doses"), and also by introduction to big veins of a forearm and an elbow pole. Thrombosis and phlebitis I am observed seldom. Clinical cases of an ekstravazation and a research on animals indicate the minimum reaction from fabrics. Intra arterial injections an animal did not cause local reactions from fabrics.

Interaction with other medicines:

Drug Diprofol is used when carrying out spinal and epidural anesthesia, and also together with medicines which often apply to premedication. With muscle relaxants, inhalation means and analgetika of pharmacological incompatibility it was not observed. Other doses of drug Diprofol can be necessary in case the general anesthesia is applied as addition to methods of local anesthesia.

For premedication, means for an inhalation anesthesia, an analgetika, the sedative, anesthetizing effects of a propofol and oppression of cardiac performance and breath can supplement simultaneous use of other depressants of TsNS, such as drugs.

Contraindications:

To patients with the known hypersensitivity to a propofol or to any of excipients.
To children aged up to 1 month (for induction and maintenance of the general anesthesia).
Diprofol is contraindicated for providing sedation at an intensive care to patients 16 years are younger.
Diprofol is not recommended for providing sedation to children as safety and efficiency of drug are not confirmed.
 Is Diprofol's part soy oil therefore drug should not be used to patients with hypersensitivity to a peanut or soy.

Overdose:

The accidental overdose will probably lead to oppression of cordial activity and breath. In case of respiratory depression it is necessary to carry out artificial ventilation of the lungs using oxygen. At oppression of cardiovascular activity the head of the patient should be hung down, and at serious condition apply substitutes of a blood plasma and pressor means.

Use during pregnancy or feeding by a breast.

Safety of use of drug of Diprofol during pregnancy is not established. Therefore Diprofol it is not necessary to apply during pregnancy, except for emergency cases. However Diprofol applied at abortion in І a trimester.

Drug Diprofol gets through a placenta and can lead to a neonatal depression. Drug should not be used for anesthesia in obstetrics, except for emergency cases.

In cases of administration of drug Diprofol safety for newborns was not established to the women nursing. For drug use feeding by a breast it is necessary to stop and renew it not earlier than in 24 hours after drug phase-out.

Children

 

Detailed information see in the section "Route of Administration and Doses".

Drug Diprofol is not recommended for use at the general anesthesia to children up to 1 month. Safety and efficiency of use of drug Diprofol for providing (background) sedation at children is younger than 16 years are not confirmed. Though the causal interrelation is not established, at non-licensed use was reported about serious side reactions at (background) sedation at patients 16 years are younger (including cases with a lethal outcome).

In particular, the metabolic acidosis, a lipidemia, рабдомиолиз and/or heart failure were such reactions. The specified reactions most often were observed at children with infections of a respiratory path which received drug in the doses exceeding recommended for adults for providing sedation at an intensive care.

Storage conditions:

Period of validity. 3 years. Not to use drug after the termination of the period of validity specified on packaging. After opening of an ampoule (bottle) without cultivation – 12 hours; after cultivation – 6 hours. To store in the place protected from light at a temperature not above 25 °C. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 20 ml in an ampoule. On 50 ml in a bottle. On 5 ampoules or on 1 bottle in a pack.