Composition, form of production and packaging
Solution for infusions 6% colorless or slightly yellowish, transparent or slightly opalescent.
1 l
hydroxyethyl starch 200 / 0.5 60 g
Including: Na + 154 mmol / l Cl - 154 mmol / l pH 3.5-6.0 titratable acidity less than 1 mmol NaOH / l theoretical osmolarity 308 mOsm / l
Excipients: sodium chloride - 9 g, water d / and - up to 1 l, sodium hydroxide - qs for pH correction.
250 ml - glass bottles (10) - cardboard boxes.
250 ml - glass bottles with holders for droppers (10) - cardboard boxes.
250 ml - plastic bottles with a loop-holder for droppers (10) - cardboard boxes.
250 ml - plastic bottles with a loop-holder for droppers (20) - cardboard boxes.
250 ml - polyolefin "friffex" containers (1) - plastic bags (10) - cardboard boxes.
250 ml - polyolefin "friffex" containers (1) - plastic bags (15) - cardboard boxes.
250 ml - polyolefin "friffex" containers (1) - plastic bags (20) - cardboard boxes.
250 ml - polyolefin "friffex" containers (1) - plastic bags (30) - cardboard boxes.
500 ml - glass bottles (10) - cardboard boxes.
500 ml - glass bottles with holders for droppers (10) - cardboard boxes.
500 ml - plastic bottles with loop-holder for dropper (10) - cardboard boxes.
500 ml - plastic bottles with loop-holder for dropper (20) - cardboard boxes.
500 ml - polyolefin "friffex" containers (1) - plastic bags (10) - cardboard boxes.
500 ml - polyolefin "friffex" containers (1) - plastic bags (15) - cardboard boxes.
500 ml - polyolefin "friffex" containers (1) - plastic bags (20) - cardboard boxes.
500 ml - polyolefin "friffex" containers (1) - plastic bags (30) - cardboard boxes.
Solution for infusions 10% colorless or slightly yellowish, transparent or slightly opalescent.
1 l
hydroxyethyl starch 200 / 0.5 100 g
Including: Na + 154 mmol / l Cl - 154 mmol / l pH 3.5-6.0 titratable acidity less than 1 mmol NaOH / l theoretical osmolarity 308 mOsm / l
Excipients: sodium chloride - 9 g, water d / and - up to 1 l, sodium hydroxide - qs for pH correction.
250 ml - glass bottles (10) - cardboard boxes.
250 ml - glass bottles with holders for droppers (10) - cardboard boxes.
250 ml - plastic bottles with a loop-holder for droppers (10) - cardboard boxes.
250 ml - plastic bottles with a loop-holder for droppers (20) - cardboard boxes.
250 ml - polyolefin "friffex" containers (1) - plastic bags (10) - cardboard boxes.
250 ml - polyolefin "friffex" containers (1) - plastic bags (15) - cardboard boxes.
250 ml - polyolefin "friffex" containers (1) - plastic bags (20) - cardboard boxes.
250 ml - polyolefin "friffex" containers (1) - plastic bags (30) - cardboard boxes.
500 ml - glass bottles (10) - cardboard boxes.
500 ml - glass bottles with holders for droppers (10) - cardboard boxes.
500 ml - plastic bottles with loop-holder for dropper (10) - cardboard boxes.
500 ml - plastic bottles with loop-holder for dropper (20) - cardboard boxes.
500 ml - polyolefin "friffex" containers (1) - plastic bags (10) - cardboard boxes.
500 ml - polyolefin "friffex" containers (1) - plastic bags (15) - cardboard boxes.
500 ml - polyolefin "friffex" containers (1) - plastic bags (20) - cardboard boxes.
500 ml - polyolefin "friffex" containers (1) - plastic bags (30) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Plasmo-replacing drug.
Hydroxyethyl starch (HES) is derived from amylopectin and is characterized by its molecular weight and degree of substitution. For Hayes steril, the average molecular weight of HES is 200,000 Da, and the degree of substitution is about 0.5, which means that there are 5 hydroxyethyl groups per 10 glucose residues of amylopectin. HES is structurally related to glycogen, which explains its high tolerance and low risk of anaphylactic reactions. Hayes-steril is characterized by high stability of the solution and does not give flocculation due to temperature fluctuations.
Infusion of the Haes steril preparation (500 ml for 15 min) to the test with hypovolemia leads to an increase in the plasma volume by approximately 100% of the administered volume (with a 6% Hayes infusion) or 145% (in the case of 10% Haes steril infusion) within 3-4 hours, Hayes-steril provides improvement of hemodynamics and microcirculation for 3-4 hours.
PHARMACOKINETICS
Metabolism and excretion
HES is subjected to enzymatic digestion with alpha-amylase of blood, which leads to the formation of oligo- and polysaccharides of different molecular weights.
HES has T 1/2 of the bloodstream about 4 hours. It 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 drug is temporarily deposited in the tissues, and only 10% continues to circulate in the blood serum. Sodium chloride is excreted mainly through the kidneys, and a small amount is removed with sweat through the skin.
INDICATIONS
- treatment and prevention of hypovolemia and shock during surgical interventions (hemorrhagic shock), traumatic lesions (traumatic shock), infections (septic shock), burns (burn shock);
- acute normovolemic hemodilution to reduce the introduction of donor blood during surgical interventions;
- therapeutic hemodilution.
DOSING MODE
Hayes steril 6%, 10% is administered intravenously in adults and children older than 3 years.
The doses used to treat and prevent hypovolemia and shock .
The maximum daily dose:
6% solution: 33 ml / kg / day (= 2500 ml per 75 kg body weight per day or = 2 g HES / kg / day).
10% solution: 20 ml / kg / day (= 1500 ml per 75 kg body weight per day or = 2 g HES / kg / day).
Maximum infusion rate:
6% solution: 20 ml / kg / hour (= 1500 ml per 75 kg body weight per hour or = 1.2 g HES / kg / h).
10% solution: 20 ml / kg / hour (= 1500 ml per 75 kg body weight per hour or 2 g HES / kg / hour).
In children under 10 years of age, the infusion rate should not exceed 15 ml / kg / h.
Children older than 12 years: the average daily dose is 33 ml / kg, the maximum daily dose is 33 ml / kg (2 g of hydroxyethyl starch per kg / day); children from 3 to 12 years , respectively - 15-20 ml / kg and 33 ml / kg.
Doses used to reduce the amount of donor blood during surgical operations (acute normovolemic hemodilution).
Simultaneous administration of Hayes sterile 6% in a ratio of 1: 1 (up to a hematocrit of at least 30%) is recommended for direct preoperative replacement of one's own blood.
Blood sampling: 2-3 times with 500 ml of own blood.
Daily dose: 2-3 infusions of 500 ml of Hayes sterile 6%.
The rate of blood sampling is 1000 ml for 15-30 min.
The rate of administration of Hayes sterile is 6% -1000 ml for 15-30 min.
Recommended doses for hemodilution therapy .
The criterion is the decrease in the hematocrit indicator, determined for each patient. Infusion of Hayes sterile 6%, 10% can be carried out isovolemically (with simultaneous selection of own blood) or hypervolemically (without selection of own blood) in small (250 ml), medium (500 ml) or high doses (twice 500 ml). Avoid hypervolemia with too rapid administration and too large doses of the drug, the limiting dose is 1.2 g HES / kg / day.
The following daily doses and rate of administration are used:
Daily dose:
- 250 ml (low dose)
- 500 ml (medium dose)
- 2 times 500 ml per day (high dose)
Infusion rate:
- 250 ml for 0.5-2 hours
- 500 ml in 4-6 hours
- 2 times 500 ml for 8-24 hours.
Duration of use.
Treatment and prevention of hypovolemia and shock:
The degree and duration of hypovolemia determine the daily dose and duration of application of Hayes sterile.
Reduction of the use of donor blood during surgical interventions (acute normovolemic hemodilution ).
Acute normovolemic hemodilution is used once in surgical interventions. Repeated application of Hayes sterile is possible at normal hematocrit values ​​(not lower than 30%).
Therapeutic hemodilution.
The use of Hayes sterile for hemodilution therapy is recommended for 10 days.
SIDE EFFECT
Rarely - allergic reactions of varying severity: skin rash, tachycardia, a sharp decrease in blood pressure, dizziness, nausea, vomiting, bronchospasm, anaphylactic shock until the stop of breathing and cardiac activity. When allergic reactions occur, the solution should be immediately discontinued, and immediate emergency measures are initiated, depending on the clinical symptoms and severity. It is necessary to prescribe antihistamines and other drugs, glucocorticosteroids (prednisolone 120 mg intravenously), epinephrine 0.05-0.1 mg intravenously, administration of albumin 5%.
Prolonged daily use of Hayes sterile in moderate to high doses often causes difficult to treat itching. In these cases, it is recommended to reduce the maximum daily dose to 250 ml per day.
Occasionally - pain in the lumbar region. In this case, the infusion of the drug should be discontinued, provide abundant fluid administration and frequent monitoring of serum creatinine. High doses of Hayes sterile as a result of the dilution effect can cause an increase in bleeding time, but the infusion of Hayes sterile does not cause clinically significant bleeding. One should pay attention to the possible decrease in hematocrit and the development of hypoproteinemia. When using Hayes steril, serum amylase activity may increase, which can interfere with the diagnosis of pancreatitis.
CONTRAINDICATIONS
- intracranial hypertension;
- arterial hypertension;
- intracranial bleeding;
Decompensated chronic heart failure;
- acute renal failure (oligonuria, anuria);
- severe hemorrhagic diathesis;
- cardiogenic pulmonary edema;
- hypocoagulation;
- coagulopathy;
- hyperhydration;
- hypervolemia;
- Dehydration (if necessary, correction of electrolyte exchange);
- hypofibrinogenemia;
- severe thrombocytopenia;
- Hypernatremia;
- hemodialysis;
- Children's age up to 3 years;
- hypersensitivity (including to starch).
With caution: lactation period, compensated chronic heart failure, chronic renal failure, chronic liver disease, von Willebrand's disease, hemorrhagic diathesis.
PREGNANCY AND LACTATION
There are no data on the use of Hayes sterile in pregnant and lactating mothers.
Use of the drug during pregnancy and during lactation is possible only for life indications.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in acute renal failure (oligonuria, anuria).
With caution: chronic renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution: chronic liver disease
APPLICATION FOR CHILDREN
Contraindicated in children under 3 years.
SPECIAL INSTRUCTIONS
At the beginning of treatment, it is necessary to monitor the serum creatinine concentration.
At boundary values ​​of creatinine content (106-177 μmol / l - compensated renal failure), daily monitoring of intracellular and extracellular fluid balance and excretory function of kidneys is necessary.
When mixing with other medicinal products is necessary, a complete asepsis should be observed. It is necessary to ensure the compatibility of drugs and their good mixing.
Because of possible anaphylactic reactions, the first 10-20 ml of Hayes sterile should be infused slowly and with careful monitoring of the patient's condition.
When using the drug, regular monitoring of the water-electrolyte balance and the number of leukocytes and platelets is necessary.
OVERDOSE
No cases of drug overdose have been registered at the moment.
DRUG INTERACTION
The simultaneous use of hydroxyethyl starch with heparin or oral anti-coagulants and may increase bleeding time.
Particular attention should be paid to patients taking other medications, especially when taking beta-blockers and vasodilators, as changes in systemic BP and heart rate may not be detected despite volume-substituting therapy.
It should be borne in mind that HES can affect clinical and chemical indices (glucose, protein, ESR, fatty acid, cholesterol, sorbitol dehydrogenase, specific gravity of urine).
There are no data on the interaction of hydroxyethyl starch with food.
TERMS OF RELEASE FROM PHARMACY
For hospitals.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at a temperature of no higher than 25 В° C, in a place protected from light. Freezing is not allowed. Keep out of the reach of children. Shelf life - 5 years in glass or plastic bottles; 3 years - in containers "friffex".
