Hydroxyethyl starch (HES 130/0.4) in an isotonic electrolyte solution for intravenous infusion. It belongs to a group of medicines known as plasma volume substitutes. They work by increasing and maintaining the circulating blood volume for several hours. This helps to keep your blood pressure stable ... Read moreHydroxyethyl starch (HES 130/0.4) in an isotonic electrolyte solution for intravenous infusion. It belongs to a group of medicines known as plasma volume substitutes. They work by increasing and maintaining the circulating blood volume for several hours. This helps to keep your blood pressure stable. This solution is used for the treatment and prevention of low blood volumes (hypovolaemia) in adults and children.
Plasma expanders
Colloidal solution volume expander that contains hydroxyethyl starch.
Adult: Dose Up to 50 mL of (hydroxyethyl starch in sodium chloride injection) per kg of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3500 mL of (hydroxyethyl starch in sodium chloride injection) for a 70 kg patient.Pediatric Dose: Dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration statusNewborns and infants: 2-12 years: Mean dose of 36 mL/kg IVGive initial 10-20 mL by slow IV infusion and monitor for anaphylactoid reaction
The safety and compatibility of other additives, other than citrate anticoagulant, have not been established. Incompatibilities: In the absence of incompatibility studies this medicinal product must not be mixed with other medicinal products.
Do not use this solution if you:
suffer from severe generalized infection (sepsis)
have a severe liver disease
have a known allergy (hypersensitivity) to hydroxyethyl starch
have a clinical condition where too much fluid in your body is a potential problem, especially if you have too much fluid in your lungs (pulmonary edema) or if you suffer from a condition in which your heart cannot pump enough blood to other organs of your body (congestive heart failure)
have pre-existing blood clotting (coagulation) or bleeding disorders
suffer from kidney failure and you produce little or no urine if this is not caused by low blood volumes (hypovolaemia)
receive dialysis treatment
have a severe increase of potassium, sodium or chloride levels in your blood (severe hyperkalaemia, severe hypernatraemia or severe hyperchloraemia)
suffer from bleeding in the brain (intracranial bleeding).
Common (may affect up to 1 in 10 people):
Itching is a known side effect of hydroxyethyl starches when used over long periods of time and at high doses.
Other effects are associated with the dilution of the blood, which occurs at high dosages, such as prolonged blood clotting time.
The level of the enzyme serum amylase can arise during the administration of hydroxyethyl starch and can interfere with the diagnosis of inflammation of the pancreas (pancreatitis). However, this solution does not cause pancreatitis.
Use in pregnancy: Animal reproduction studies have not been conducted with Hydroxyethyl Starch in Sodium Chloride infusion and it is also not known whether it can cause fetal harm or affect reproductive capacity when administered during pregnancy. This infusion should be given during pregnancy only if clearly needed Use during lactation: It is not known whether Hydroxyethyl starch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hydroxyethyl Starch in Sodium Chloride infusion is administered to a nursing woman.
It is important to tell your doctor if you have:
impairment of your liver function
problems with your heart or circulation
blood clotting (coagulation) disorders
problems with your kidneys
In case of certain serious diseases, your doctor will consider using salt solutions instead of this solution. This solution should be avoided if you have kidney disease and must not be used if you are treated with dialysis.
Keep this medicine out of the sight and reach of children. Do not freeze. Do not store above 25°C.
Plasma expanders
For this solution, no clinical data on exposed pregnancies are available. Your doctor will only give this solution after having weighed the benefits versus the potential risk to the baby. It is not known whether this drug is excreted in human milk. Your doctor will advise you whether to interrupt breastfeeding or not.
