HyperHAES - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsp

solution for infusions

Composition:

1000 ml of solution contains:

Active substances:

Hydroxyethyl starch (200 / 0.5) - 60.0 g

(with the degree of molar substitution 0.5

average molecular weight of 200,000 Da)

Sodium chloride - 72.0 g

Excipients:

Hydrochloric acid 25% (for pH correction) - q.s.

Sodium hydroxide (for pH correction) - q.s.

Water for injections - up to 1000 ml

Electrolytes:

Na + - 1232 mmol / l

Cl- 1232 mmol / L

pH 3.5-6.0

Theoretical osmolarity - 2464 mOsm / l

Titrated acidity - <1 mmol NaOH / L

Description:Transparent or slightly opalescent, colorless or slightly yellowish solution.

Pharmacotherapeutic group:Plasmasuberant

ATX: & nbsp

Blood plasma preparations and plasma-substituting drugs

Pharmacodynamics:The drug HyperHAES is a hypertonic isononic solution. Due to the high osmolarity of the HyperHAES preparation, the liquid (mainly from the intercellular space) quickly moves to the blood vessels, as a result of which the blood pressure and the volume of cardiac output rapidly increase depending on the dose and the rate of infusion of the drug. After the administration of the HyperHAES preparation, the increase in the volume of circulating blood lasts a short time and should be stabilized by the immediate introduction of a sufficient volume of fluid (including saline and colloidal solutions).

Pharmacokinetics:

Hydroxyethyl starch (HES) undergoes enzymatic digestion with blood alpha-amylase, which leads to the formation of oligo- and polysaccharides of different molecular weights. HES has a half-life from the bloodstream for about 4 hours. HES is excreted mainly through the kidneys, 50% of the administered dose is excreted in the urine in less than 24 hours. A small amount of the substance is temporarily deposited in the tissues. In the case of using the drug HyperHAES in patients with renal insufficiency, HES can be excreted from the blood by diafiltration, but not by dialysis. In this case, the half-life and the retention time of the substance in the blood are proportional to the severity of renal failure.

After 30 minutes. after the introduction sodium chloride evenly distributed throughout the extracellular space. Sodium chloride is excreted primarily through the kidneys, and a small amount is removed with sweat through the skin.

Indications:Initial treatment at the prehospital stage of acute hypovolemia and shock by a single dose of the drug ("low volume resuscitation").

Contraindications:

- confirmed hypersensitivity to hydroxyethyl starches,

- severe renal failure with anuria,

- Pregnancy (before the birth of the child or fetal extraction during operative delivery)

- dehydration,

- hypervolemia,

- decompensated chronic heart failure.

Carefully:

- compensated chronic heart failure,

- confirmed violations of blood clotting,

- hyperosmolarity of blood,

- pronounced hyper- or hyponatremia,

- pronounced hyper- or hypochloraemia,

- severe hepatic insufficiency.

Pregnancy and lactation:The clinical experience of using the drug HyperHAES during pregnancy and during lactation is absent.

Dosing and Administration:

Intravenously.

The maximum dose:

HyperHAES is administered by a single intravenous bolus injection (for 2-5 minutes) at a dose of approximately 4 ml / kg body weight (250 ml for a patient weighing 60- TO kg).

Despite the very high osmolarity, the drug can be injected into the peripheral vein. If possible, it is preferable to administer the drug into the central vein, although this is not necessary.

Duration of treatment:

The preparation HyperHAES is intended only for single administration.Repeated infusions are not recommended.

Immediately after the administration of the HyperHAES preparation, standard plasma replacement therapy (including saline and colloidal solutions) should be performed, the doses of which are selected in accordance with the patient's condition. In case the subsequent standard plasma replacement therapy includes HES, then the total dose of HES to be taken should include HES contained in the previously introduced HyperHAES preparation.

Side effects:

Anaphylactoid reactions - from a simple skin rash to circulatory disorders, shock, bronchospasm and cardiac arrest. In case of intolerance of the drug, the infusion should be stopped immediately and appropriate emergency medical measures carried out.

From the respiratory system - from mild reactions to life-threatening and life-threatening (pulmonary edema, bronchospasm, respiratory arrest). Careful observation and the possibility of using resuscitation facilities are necessary.

From the side of the cardiovascular system - from mild reactions, including bradycardia and tachycardia, to life-threatening and life-threatening (pulmonary edema, lowering of blood pressure followed by cardiac arrest).Careful observation and the possibility of using resuscitation facilities are necessary.

With the introduction of hypertonic solutions in the absence of pronounced hypovolemic shock, it is possible to develop a transient decrease in blood pressure.

Dehydrated myelinolysis of the brainstem, intracerebral bleeding due to compression and rupture of the meningeal membrane.

Reactions at the site of administration: thrombophlebitis and phlebothrombosis (when injected into the peripheral veins).

Increased activity of alpha-amylase in blood plasma, which can make it difficult to diagnose pancreatitis.

Dose-dependent disruption of blood clotting.

The frequency of adverse reactions listed below is set out in accordance with the following gradation: Often (>1/10), often (>1/100, ≤1/10); infrequently (>1/1000, ≤1/100); rarely (>1/10000, ≤1/1000); rarely (≤1/10000), including single messages.

Vascular disorders

Often: decrease in blood pressure, in patients who do not have pronounced hypovolemic shock.

Heart Disease

Often: left ventricular failure, arrhythmia, pulmonary hypertension in patients without pronounced hypovolemic shock.

Laboratory and instrumental data

Often: increased activity of plasma alpha-amylase.

Immune system disorders

Rarely: anaphylactoid reactions

Disorders from the metabolism and nutrition

Often. So far, it has not been observed, but it is considered possible: Hypernatremia and hyperchloremia, dehydration.

Violations of the blood and lymphatic system

Until now, it has not been observed, but it is considered possible: a clotting disorder.

Disturbances from the nervous system

Until now, it has not been observed, but it is considered possible: myelinolysis of the brain stem

Disturbances from the respiratory system, chest and mediastinal organs

Until now, it has not been observed, but it is considered possible: a breathing disorder

General disorders and disorders at the site of administration

So far, it has not been observed, but it is considered possible: local reactions of intolerance.

Overdose:

Symptoms: hypernatremia.

Treatment: it is necessary to perform compensatory fluid administration and forced diuresis in the presence of hypervolemia.

Interaction:The administration of the drug together with heparin can prolong bleeding time. Avoid mixing with other drugs.

Special instructions:

Precautions for use

Special attention should be given to increasing the osmolarity of blood plasma, especially in patients with diabetes mellitus.

The concentration of electrolytes, the osmolarity of the blood plasma and the fluid balance should be checked regularly.

Special attention should be given to the possibility of bleeding associated with the intensive administration of solutions that increase intravascular pressure, as well as hemodilution caused by the HyperHAES preparation.

During the infusion, the patient should be closely monitored. As with other colloidal plasma-substitution solutions, there is a risk of developing an anaphylactic reaction, the pathogenesis of which is still unknown. However, the introduction of HES is usually not accompanied by the formation of specific antibodies.

To avoid the risk of developing hypervolemia, you should monitor the parameters of hemodynamics.

If any abnormal symptoms and signs appear during the first minutes of the infusion, including chills, urticaria, redness, "flushing" of blood to the face or a drop in blood pressure, the infusion should be stopped immediately.

If the drug is administered in the absence of expressed hypovolemic shock, a transient decrease in blood pressure or symptoms of volume overload (left ventricular failure, arrhythmia, pulmonary hypertension) may develop, especially in patients with reduced cardiac function or limited coronary blood flow (including cardiosurgery operations).

Special Precautions

Only for single use. The solution should be used immediately after opening the package. Do not combine solutions from partially used bags. Use only clear solution from intact packaging. Dispose of unused solution.

Form release / dosage:

Solution for infusion.

Packaging:

250 ml in a polyolefin container "friffex". The container consists of two bags. The primary bag with the solution of the preparation contained in it is made of a special polymer equipped with two ports. The outer protective bag is made of a polymer film.

For 20 or 30 containers, along with the instructions for use are placed in a cardboard box (for hospitals).

Storage conditions:

Store at a temperature of no higher than 25 ° C in a dark place.

Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:LS-001399

Date of registration:10.06.2011

Expiration Date:Unlimited

The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany

Manufacturer: & nbsp

FRESENIUS KABI DEUTSCHLAND, GmbH Germany

Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany

Information update date: & nbsp17.04.2017

Illustrated instructions

Instructions

HyperHAES (HyperHAES)