Sanbe Hest 130/Sanbe Hest 200

Sanbe Hest 130/Sanbe Hest 200

Manufacturer:

PT Sanbe Farma

Distributor:

Caledan
Full Prescribing Info
Contents
Sanbe Hest 130: Hydroxyethyl starch (HES 130/0.4), sodium chloride.
Sanbe Hest 200: Hydroxyethyl starch (HES 200/0.5), sodium chloride.
Description
Each 500 mL contains: Poly (O-2-hydroxyethyl) starch 30.0 g.
(Hydroxyethyl starch: HES).
(Molar substitution: Sanbe Hest 130: 0.40-0.44; Sanbe Hest 200: 0.40-0.55).
(Average molecular weight: Mw: Sanbe Hest 130: 130,000; Sanbe Hest 200: 200,000).
Sodium Chloride 4.5 g.
Water for injection ad 500 mL.
Na+ 154 mEq/L. Cl- 154 mEq/L.
Osmolarity 308 mOsm/L.
Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200) (6% hydroxyethyl starch 130/0.42 (or 200/0.5) in 0.9% sodium chloride injection) is a clear solution, colorless yellowish, practically free from particle, sterile, non-pyrogenic, isotonic solution for intravenous administration using sterile equipment.
Each 100 mL of the solution contains: 6 g of Hydroxyethyl Starch 130/0.42 (or 200/0.5) and 900 mg of Sodium Chloride in Water for Injection.
In addition, sodium hydroxide, USP, or Hydrochloric acid, USP, has been added to adjust the final pH so the final solution pH is 3.5 to 6.5.
The electrolyte composition is as follows (mEq/L): Sodium 154, Chloride 154.
The calculated osmolarity is 308 mOsmol/L.
The hydroxyethyl starch contained in Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200) is a synthetic colloid for use in plasma volume replacement. The chemical name of hydroxyethyl starch is poly(O-2-hydroxyethyl) starch.
Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200) is supplied in clear plastic bag double wound medical film M312A 135 mm width 500 mL. The primary packaging is a clear plastic bag double wound medical film 135 mm width (500 mL) contain some polymer with co-extrusion process each have characteristic physical. As secondary packaging dispatch labeled, and accompanied by package insert.
Action
Pharmacology: Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200) contains Hydroxyethyl Starch (Hetastarch) in a colloidal solution which expands plasma volume when administered intravenously. Hetastarch produces a plasma volume expansion slightly in excess of the volume of Hetastarch solution infused. Maximum plasma volume expansion in hypovolemic patients is reached within a few minutes after the end on infusion. The extent and duration of the expansion in plasma volume vary with the volume of solution infused and depend on the pre administration plasma volume, the distribution of Hetastarch through body water, and the rate of renal clearance of the drug; effective plasma volume expansion may persist for 24 hours or longer. In hypovolemic patients, Hetastarch causes a temporary increase in arterial and venous pressure, cardiac index, stroke work index and pulmonary wedge pressure. When added to whole blood, Hetastarch molecules with a molecular weight of less than 50.000 are rapidly excreted by the kidney, presumably via glomerular filtration. The large unexcreted molecules with a molecular weight of 50.000 or greater are slowly degraded enzymatically to molecules small enough to be excreted.
Indications/Uses
Sanbe Hest 130: Therapy and prophylaxis of hypovolemia and acute normovolemic hemodilution technique (ANH).
Sanbe Hest 200: Therapy and prophylaxis of hypovolemia and shock in connection with surgery (hemorrhagic shock), trauma (traumatic shock, injuries), infections (septic shock), burns (burn shock).
Dosage/Direction for Use
Sanbe Hest 130: Hydroxyethyl starch + Sodium chloride (SANBE HEST 130) is administered by intravenous infusion only. The daily dose and rate of infusion depend on the patient's blood loss, on the maintenance or restoration of hemodynamics and on the hemodilution (dilution effect). Hydroxyethyl starch + Sodium chloride (SANBE HEST 130) can be administered repetitively over several days (see Precautions), according to the patient's needs. The duration of treatment depends on the duration and extent of hypovolemia, the hemodynamics and on the hemodilution.
The initial 10 to 20 mL are be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions (see Precautions).
The maximum daily dose is 50 mL/kg body weight/day. There is currently limited experience with this maximum daily dose given for prolonged periods.
Direction for use: The mixing with other drugs should be avoided. If in exceptional cases, a mixture with other drugs is required care should be taken with the compatibility (clouding or precipitation) hygienic injection and a good admixture.
Sanbe Hest 200: Application as intravenous infusion: The daily dose and rate of infusion are to be determined according to blood loss on the maintenance or restoration of hemodynamics and hemodilution (dilution effect). The therapeutic limit is based on the hemodilution effects. In younger patients without cardiovascular or pulmonary risk, a hematocrit value of 30% is regarded as borderline for the use of colloidal volume substitutes.
Recommended dosage for the therapy and prophylaxis of volume deficiency and shock (volume substitution therapy) - unless otherwise prescribed - daily dose up to 20 mL/kg body weight/day (= 1500 mL/75 kg body weight/day = 2.0 g HES/kg body weight/day). Normally 500 to 1000 mL/day.
Rates of infusion: In hemorrhagic shock up to 20 mL/kg body weight/hour (= 0.33 mL/kg body weight/minute = 1500 mL/75 kg body weight/hour = 25 mL/75 kg body weight/minute).
In septic and burn shock lower rates of infusion.
For continuous infusion: The initial 10-20 mL are to be infused slowly, keeping the patient under close observation (due to possible anaphylactoid reaction). The daily dose and rate of infusion depend on the patient's blood loss, on the maintenance or restoration of hemodynamic and the hemodilution (dilution effect).
Duration of application: There is no pharmacological or clinical evidence to give cause for concern with regard to a repeated application. The duration and extent of the treatment are to be determined according to the duration and extent of the hypovolemia.
Recommended dosage for hemodilution therapy - unless otherwise prescribed - daily dose: 500 mL/day (medium dose); 2 x 500 mL (high dose).
The maximum daily dose is 50 mL/kg body weight/day. Hydroxyethyl Starch 200 can be administered repetitively over several days according to patient's needs. The duration of treatment depends on the duration and extent of hypovolemia, the hemodynamics and on the hemodilution. There is currently limited experience with this maximum daily dose given for prolonged periods.
Overdosage
(Symptoms, emergency procedure, antidotes).
As with all volume substitutes, overdose can lead to overloading of the circulatory system (e.g. pulmonary oedema). In this case the infusion should be stopped immediately and if necessary, a diuretic should be administered.
Contraindications
Do not use hydroxyethyl starch (HES) products, including Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200), in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (RRT).
Do not use HES products, including Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200), in patients with severe liver disease.
Do not use HES products, including Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200), in patients with known hypersensitivity to hydroxyethyl starch.
Do not use HES products in clinical conditions with volume overload.
Do not use HES products in patients with pre-existing coagulation or bleeding disorders.
Do not use HES products in patients with renal failure with oliguria or anuria not related to hypovolemia.
Do not use HES products in patients receiving dialysis treatment.
Do not use HES products in patients with severe hypernatremia or severe hyperchloremia.
Do not use HES products in patients with intracranial bleeding.
Special Precautions
Anaphylactoid Reactions: Anaphylactoid reactions (mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch. If a hypersensitivity reaction occurs, administration of the drug should be discontinued immediately and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved.
Renal Dysfunction: Avoid use in patients with pre-existing renal dysfunction. Discontinue use of Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200) at the first sign of renal injury.
Continue to monitor renal function in hospitalized patients for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products.
Coagulopathy: Monitor the coagulation status of patients undergoing open heart surgery in association with cardio-pulmonary bypass as excess bleeding has been reported with HES solutions in this population. Discontinue use of Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200) at the first sign of coagulopathy.
Fluid Equilibrium: Avoid fluid overload; adjust dosage in patients with cardiac or renal dysfunction. Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with cardiac insufficiency or severe kidney dysfunction.
In cases of severe dehydration, a crystalloid solution should be given first. Generally, sufficient fluid should be administered in order to avoid dehydration.
Monitoring: Laboratory Tests: Clinical evaluation and periodic laboratory determinations are necessary to monitor fluid balance, serum electrolyte concentrations, kidney function, acid-base balance, and coagulation parameters during prolonged parenteral therapy or whenever the patient's condition warrants such evaluation. Monitor liver function in patients receiving HES products, including Hydroxyethyl starch + Sodium chloride (SANBE HEST 130/SANBE HEST 200).
Interference with Laboratory Tests: Elevated serum amylase levels may be observed temporarily following administration of the product and can interfere with the diagnosis of pancreatitis.
At high dosages the dilutional effects may result in decreased levels of coagulation factors and other plasma proteins and a decrease in hematocrit.
Adverse Reactions
Hypersensitivity, mild influenza like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary oedema.
Skin and subcutaneous tissue disorders: Pruritus (itching).
Disturbances of blood coagulation can occur depending on the dosage.
In the event of an intolerance reaction occurring the infusion should be discontinued immediately and the appropriate emergency medical treatment initiated.
The concentration of serum amylase can rise during administration of hydroxyethyl starch and can interfere with the diagnosis of pancreatitis. (See table.)

Click on icon to see table/diagram/image
Drug Interactions
Sanbe Hest 130: No interactions with other drugs or nutritional products are known.
Sanbe Hest 200: If a mixture with other drugs is necessary, hygienic injection, complete mixing and compatibility has to be taken care of. The results of compatibility tests are provided on request.
Caution For Usage
Do not use if the solution is cloudy, changes colour, containing visible solid particles, also if the container is damaged and leaking.
Single dose container.
Storage
Store at temperature not exceeding 30°C. Do not refrigerate or freeze.
Shelf-Life: 24 months.
ATC Classification
B05AA07 - hydroxyethylstarch ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.
Presentation/Packing
Sanbe Hest 130: Soln for IV infusion (clear, colorless, yellowish, practically free from particle, sterile, non-pyrogenic, isotonic solution) 500 mL.
Sanbe Hest 200: Soln for IV infusion (clear, colorless, yellowish, practically free from particle, sterile, non-pyrogenic, isotonic solution) 500 mL.
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