2010/06/23

Haes-Steril

Composition, structure and packing

Solution for infusion of 6% 1 l starch 200/0.5 60 g osmolarity of 308 mOsm / l pH 3.5-6.0. Excipients: sodium chloride, water, d / and.

Solution for infusion 10% 1 l starch 200/0.5 100 g osmolarity 308 mOsm / l pH 3.5-6.0. Excipients: sodium chloride, water, d / and.

Clinico-pharmacological group: Plazmozameschayuschy drug.

Mechanism of action Plazmozameschayuschy drug. It is a 6% or 10% isotonic solution of starch (derived from amylopectin) with an average molecular weight of 200,000 daltons and the degree of substitution of about 0.5, which means that 10 glucose residues of amylopectin are 5 gidroksietilovyh groups.

The action of the drug due to the ability to bind and retain water in the intravascular space, thus decreasing swelling of tissues. The drug improves blood rheology and microcirculation, and cerebral and utero-placental blood flow (including through the reduction in the hematocrit). This leads to improved blood supply to tissues, reduce plasma viscosity, platelet aggregation and prevents the aggregation of red blood cells. Starch structurally related glycogen, which explains its high tolerance and a low risk of anaphylactoid reactions.

Infusion Haese-ters (500 ml per 15 min), volunteers with hypovolemia leads to increased plasma volume by approximately 100% of the administered volume (for infusion of 6% solution) or 145% (with the infusion of 10% solution) for 3-4 PM Haese-ters is highly stable solution and does not give flocculation temperature fluctuations.

Pharmacokinetics

Metabolism and excretion

Hydrolyzed serum amylase. About 47% incorporated into starch excreted in the urine within 24 h and only 10% continued to circulate in the blood serum.

Statement
treatment and prevention of hypovolemia and shock in surgical interventions (hemorrhagic shock), traumatic injuries (traumatic shock), infections (septic shock), burns (burn shock);
normovolemicheskaya acute hemodilution to reduce the introduction of donor blood during surgery;
therapeutic hemodilution.

Dosage regimen

For the treatment and prevention of hypovolemia and shock, the maximum daily dose of 6% solution for infusion is 33 ml / kg body weight (2500 ml/75 kg body weight) (1.2 g starch / kg body weight). Maximum speed in / infusion - 20 ml / kg body weight / h (1500 ml/75 kg body weight / h) (2 g starch / kg body weight / h). The maximum daily dose of 10% solution for infusion of 20 ml / kg body weight (1500 ml/75 kg body weight) (2 g starch / kg body weight). Maximum speed in / infusion - 20 ml / kg body weight / h (1500 ml/75 kg body weight / h) (2 g starch / kg body weight / h).

The first 10-20 ml of solution should pour slowly, with careful monitoring of the patient in connection with the risk of anaphylactoid reactions. Duration of Haese-ters determined by the degree and duration of hypovolemia.

To minimize the introduction of donor blood during surgery before the surgery recommended single dose of 6% solution Haese-ters in the ratio 1:1 (to target hematocrit not lower than 30%). Producing 2-3-fold selection of 500 ml of his own blood and 2-3 injections of 500 ml 6% solution Haese sr. Speed of blood collection - 1000 ml for 15-30 min, the rate of introduction of 6% solution Haese ste - 1000 ml for 15-30 min. Repeated administration of the drug is possible with normal values of hematocrit (not below 30%).

In the conduct of therapeutic hemodilution criterion for selection of doses is a reduction in the hematocrit, determined for each patient. Infusion Haese-ters can be Isovolemic (with simultaneous selection of his own blood), or hypervolemic (without selection of his own blood) in small (250 ml for 0.5-2 h), medium (500 ml for 4-6 h) or high doses (twice at 500 ml for 8-24 h). The maximum daily dose is 1.2 g / kg body weight. The drug is introduced within 10 days.

Side effect

Allergic reactions: skin rash, bronchospasm, anaphylactoid reactions (tachycardia, hypotension, dizziness, nausea, vomiting), the shock until the cessation of breathing and cardiac activity. Skin reactions: with prolonged daily use in middle and high doses often - itchy skin, are difficult to therapy (reduction in the maximum recommended daily dose of up to 250 ml). Other: rarely - pain in the kidneys when used in high doses - increase in bleeding time, increased concentration of serum amylase.

Contraindications
Chronic heart failure stage IIB-III;
renal insufficiency (serum creatinine> 2 mg / dl or more than 177 mmol / l);
expressed disorders of blood coagulation (except for life threatening conditions);
hyperhydration;
marked dehydration;
intracranial bleeding
sensitivity to starch.

Pregnancy and lactation

Data on the feasibility and safety of the drug Haese-ters during pregnancy and lactation no. Use of the drug in early pregnancy is only possible to survive.

Application for violations of renal function

Contraindicated in renal insufficiency (serum creatinine> 2 mg / dl or more than 177 mmol / l). Before therapy with Haese-ters needed to control the content of creatinine in serum. In terms creatinine 1.2-2 mg / dL (106-177 micromol / l) should be conducted daily monitoring of fluid balance and renal excretory function.

Cautions

Before therapy with Haese-ters necessary to control the content of creatinine in serum.
In terms creatinine 1.2-2 mg / dL (106-177 micromol / l) should be conducted daily monitoring of fluid balance and renal excretory function.
If you have allergic reactions during infusion Haese-ters of the drug should be stopped immediately and initiate an Antiallergic therapy (antihistamines, prednisolone 120 mg IV); during resuscitation prescribe adrenaline 0.05-0.1 mg / in the SCS in / in 5% albumin solution.
If you experience pain in the kidneys infusion of the drug should be discontinued to ensure plenty of fluids and frequent monitoring of serum creatinine.
If you want to mix with other drugs should comply with the rules of asepsis and ensure interoperability of solutions.

Overdose

Cases of overdose are not currently registered.

Drug Interactions

Currently, drug interactions drug Haese-ters not described.

Terms and Conditions of storage

The drug should be stored at a temperature not above 25 ° C; not freeze. Shelf life - 5 years.