Plasmasol IV Infusion

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. This solution is used for the treatment and prevention of low blood volumes (hypovolaemia) in adults and children.

1000 ml solution for infusion contain the active substances are:

• Poly (O-2-hydroxyethyl) starch: 60.00 g
• Sodium acetate trihydrate: 4.63 g
• Sodium chloride: 6.02 g
• Potassium chloride: 0.30 g
• Magnesium chloride hexahydrate: 0.30 g

This solution will be given to you by, or under the direct supervision of, your physician, who will closely control the amount of this solution given to you.

Mode of administration: You will receive this medicine by infusion into a vein (intravenous drip). The speed of infusion, along with the amount of solution infused, will depend on your specific requirements, the disease for which the product is being used, and by reference to the maximum daily dose.

Dosage: Your doctor will decide on the correct dose for you to receive. The recommended maximum daily dose is up to 50 ml of this solution per kg of body weight.

Use in children and adolescents: Your doctor may give the product to children after careful evaluation of advantages and disadvantages.

If you have received more of this solution than you should: Your doctor will ensure that you receive the right amount of this solution. However, different people need different doses, and if the dose does prove too much for you, your doctor may stop this solution immediately and, if necessary, administer medicine that removes water from the body (diuretic). If you have any further questions on the use of this product, please ask your doctor or pharmacist

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.

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.

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.

Plasma expanders

Keep this medicine out of the sight and reach of children. Do not freeze. Do not store above 25°C.