ГиперХАЕС

General characteristics. Structure:

Active ingredients: 60 g hydroxyethylstarch 200/0.5 *, 72 g of sodium.

Electrolytes: Na + 1232 mmol, Cl-of 1232 mmol, рН 3.5-6.0, theoretical osmolarity of 2464 ¼Äß¼/l, titrable acidity <1 mmol of NaOH/l.

* extent of molar substitution 0.5, average molecular weight 200 000 Yes.

Excipients: Acidum hydrochloricum of 25% - q.s. for correction рН, sodium hydroxide - q.s. for correction рН, water for injections.

Pharmacological properties:

Pharmacodynamics. Plasma substituting drug. ГиперХАЕС represents hypertonic isooncotic salt solution. Thanks to high osmolarity of drug of GIPERKHAYES, liquid (generally from intercellular space) quickly moves to blood vessels, as a result of this ABP and cordial emission quickly increase depending on a dose and the speed of infusion of drug. After administration of drug of GIPERKHAYES increase in OTsK continues within a short period of time and has to be stabilized by immediate introduction of sufficient volume of liquid (including saline and colloidal solutions).

Pharmacokinetics. Distribution and metabolism. Hydroxyethylated starch (GEK) is exposed to zymolysis blood α-amylase that leads to education oligo-and polysaccharides of various molecular weight.

Removal. GEK has T1/2 is brought about 4 h GEK out of a blood channel generally by kidneys, 50% of the received dose are removed with urine less than for 24 h. A small amount of substance is temporarily deposited in fabrics.

In 30 min. after administration of sodium chloride is evenly distributed on all extracellular space. Sodium chloride is removed preferential by kidneys, a small amount is removed with then through skin.

Pharmacokinetics in special clinical cases. In case of use of drug of GIPERKHAYES for patients with a renal failure of GEK it can be brought out of blood by a diafiltration, but not by dialysis. In this case T1/2 and time of deduction of substance in blood are proportional to weight of a renal failure.

Indications to use:

— initial treatment at a pre-hospital stage of an acute hypovolemia and shock by single introduction of one dose of drug ("small-volume resuscitation").

Solution is intended for substitution of volume of blood and cannot be used as blood substitute or a blood plasma.

Route of administration and doses:

ГиперХАЕС enter by single in a bolyusny injection within 2-5 min. in a dose about 4 ml/kg of body weight - 250 ml for the patient with the body weight of 60-70 kg. Despite very high osmolarity, the drug it is possible to administer in a peripheral vein. If there is an opportunity, it is preferable to administer the drug in the central vein though it is not obligatory.

ГиперХАЕС it is intended only for single introduction. Repeated infusions are not recommended. Right after administration of drug of GIPERKHAYES it is necessary to carry out standard plasma substituting therapy (including saline and colloidal solutions) which doses select according to a condition of the patient. If the subsequent standard plasma substituting therapy includes GEK, then it is necessary to include GEK in the total received dose of GEK, contained in earlier administered drug of GIPERKHAYES.

Features of use:

Use at pregnancy and feeding by a breast. Clinical experience of use of drug of GIPERKHAYES at pregnancy and in the period of a lactation is absent.

Drug should not be used at the time of delivery for prevention of the arterial hypotension caused by epidural anesthesia since there is a risk of development in the woman in labor of anaphylactic or anaphylactoid reaction.

Use at abnormal liver functions. With care use drug at a heavy liver failure.

Use at renal failures. Drug is contraindicated to use at a renal failure of heavy degree with an anury.

Special instructions. It is necessary to pay special attention to increase in osmolarity of a blood plasma, especially at patients with a diabetes mellitus.

It is regularly necessary to check concentration of electrolytes, osmolarity of a blood plasma and balance of liquid.

It is necessary to pay special attention to a possibility of the bleedings connected with intensive administration of the solutions increasing intravascular pressure and also the hemodilution caused by drug of GIPERKHAYES.

During infusion it is necessary to control a condition of the patient carefully. As well as in case of use of other colloidal plasma substituting solutions, there is a risk of development of anaphylactic reaction which pathogeny is still unknown. However introduction of GEK usually is not followed by formation of specific antibodies.

In order to avoid risk of development of a hypervolemia it is necessary to control hemodynamics indicators.

If the first minutes of infusion there are any abnormal symptoms and signs, including a fever, a small tortoiseshell, reddening, rush of blood to the person or falling of the ABP, then infusion should be stopped immediately.

If the drug is administered in the absence of the expressed hypovolemic shock, then passing arterial hypotension or symptoms of an overload the volume (a left ventricular failure, arrhythmia, pulmonary hypertensia) can develop, especially patients with reduced function have hearts or a limited coronary blood-groove (including at cardiac operations).

Side effects:

Allergic reactions: seldom - skin rash, anaphylactoid reactions up to disturbances of blood circulation, shock, bronchospasm and cardiac standstill. In case of intolerance of drug infusion it is necessary to stop and hold the relevant emergency medical activities immediately.

From respiratory system: are possible from slight to heavy and life-threatening - a fluid lungs, a bronchospasm and an apnoea. Careful observation of patients is required, the appropriate resuscitation means have to be on call.

From cardiovascular system: often - arterial hypotension, a left ventricular failure, arrhythmia, pulmonary hypertensia at the patients who do not have the expressed hypovolemic shock; are possible from slight to heavy and life-threatening - bradycardia, tachycardia, usually weak, but can be and expressed and life-threatening if develop a fluid lungs and, seldom, arterial hypotension with the subsequent cardiac standstill. Careful observation of patients is required, and the appropriate resuscitation means have to be on call. If hypertonic salt solutions enter in the absence of the expressed hypovolemic shock, then development of passing arterial hypotension is possible.

From a metabolism: very often - a hypernatremia and a hyperchloremia; dehydration is possible.

From coagulant system of blood: perhaps - blood coagulation disturbances

From a nervous system: perhaps - caused by dehydration миелинолиз a brainstem, intracerebral bleeding owing to compression and a rupture of a meningeal cover.

From laboratory indicators: often - increase in level of amylase in a blood plasma (that can complicate diagnosis of pancreatitis).

Local reactions: thrombophlebitis (at introduction to peripheral veins).

Interaction with other medicines:

At simultaneous administration of drug with heparin lengthening of a bleeding time is possible.

It is necessary to avoid mixing with other drugs.

Contraindications:

— a renal failure of heavy degree with an anury;

— pregnancy (until the birth of the child or extraction of a fruit at operational delivery);

— dehydration;

— hypervolemia;

— dekompensirovanny chronic heart failure;

— the confirmed hypersensitivity to hydroxyethylated starches.

With care appoint at the following diseases and states: the compensated congestive heart failure, the confirmed blood coagulation disturbances, the hyper osmolarity of blood expressed hyper - or the hyponatremia expressed hyper - or a hypochloraemia, a heavy liver failure.

Overdose:

Symptoms: hypernatremia.

Treatment: it is necessary to carry out compensation administration of liquid and an artificial diuresis in the presence of a hypervolemia.

Storage conditions:

Drug should be stored in the unavailable to children, protected from light place at a temperature not above 25 °C; not to freeze. A period of validity - 3 years. After opening of a bag drug should be used immediately. The remains of unused solution should be destroyed. It is impossible to combine solutions from partially used bags.

Issue conditions:

According to the recipe

Packaging:

250 ml - containers the polyolefin "фрифлекс" (20) - boxes cardboard.
250 ml - containers the polyolefin "фрифлекс" (30) - boxes cardboard.