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Solution for Infusion
Polyolefine bag: 250 ml, 500 ml
Solution for Infusion
Glass bottle: 250 ml, 500 ml
For continuous intravenous infusion. The initial 10-20 ml are to be infused slowly, keeping the patient under close observation (due to possible anaphylactoid reactions). The daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of haemodynamics and on the haemodilution (dilution effect). The maximum daily dose is 33 ml / kg b.w. / day. The duration of treatment depends on the duration and extent of hypovolaemia, the haemodynamics and on the haemodilution. There is currently no clinical experience for application lasting several days.
Dosage in renal failure: dosage reductions are recommended in patients with impaired renal function. In patients with severe renal impairment, the initial administration of Voluven should be pursued as in patients with normal renal function (initial intravenous infusion at recommended dosage). However, subsequent volumes should be reduced by 20% to 50% of the normal requirements.
Treatment of children: Limited clinical data on use of Voluven in children is available. In 41 children including newborns to infants (<2 years), a mean dose of 169 ml/kg was used safely and was well tolerated for stabilization of haemodynamics.
The dosage in children should be adapted to the individual patient colloid needs, taking into account basic disease, haemodynimics, and hydration status.
Therapy and prophylaxis of hypovolemia, acute normovolemic hemodilution technique (ANH).
Fluid overload (hyperhydration), starch allergy, renal failure with oliguria or anuria, patients receiving dialysis treatment, intracranial bleeding, hypervolemia, congestive heart failure, severe hypernatremia or severe hyperchloremia.
Fluid overload caused by overdose should be avoided in general. Particularly for patients with cardiac insufficiency or severe kidney dysfunctions, the increased risk of hyperhydration must be taken into consideration, posology must be adapted. In cases of severe dehydration, a crystalloid solution should first be given. Pulmonary edema, severe liver disease, severe bleeding disorders. Serum electrolytes should be monitored.
Children: May be given only after careful risk/benefit evaluation.
Administration of large volumes. Periodic laboratory determinations are necessary. See prescribing information for full details.
Pregnancy and lactation: Should be administered in pregnancy only if the potential benefit justifies the potential risk to the fetus. Exercise caution when administering to a nursing woman.
Medicinal products containing hydroxyethyl starch may lead to anaphylactoid reactions (hypersensitivity, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary oedema) in very rare cases. 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.
Pruritus (itching) after prolonged administration of high dosages is a known undesirable effect of hydroxyethyl starches. At high dosages the dilution effects may result in a corresponding dilution of blood components such as coagulation factors and other plasma proteins and in a decrease of hematocrit. With the administration of hydroxyethyl starches disturbances of blood coagulation can occur depending on the dosage. Additional undesirable effects: headache and vomiting.
No interactions with other drugs are known to date.
Pregnancy and Lactation
For Voluven no clinical data on exposed pregnancies are currently available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or postnatal development. No evidence of teratogenicity was seen. Voluven should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
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.