Voluven

Hydroxyethyl starch (HES 130/0.4), sodium chloride.

1000 mL solution for infusion contains Poly (O-2-hydroxyethyl) starch 60.00 g (Molar substitution: 0.38-0.45, mean molecular weight: 130,000 Da) and sodium chloride 9 g (Na⁺=154 mmol/L; Cl^-=154 mmol/L).
The solution has a theoretical osmolarity of 308 mOsmol/l, pH 4.0-5.5 and titratable acidity of <1.0 mmol NaOH/L.
Excipients/Inactive Ingredients: Sodium hydroxide, hydrochloric acid, water for injection.

Treatment of hypovolaemia caused by acute blood loss.
For use in elective surgery patients, trauma patients, patients undergoing open-heart surgery in association with cardiopulmonary bypass, where alternative infusion solutions are not considered to be sufficient.
Kidney function should be monitored at least 90 days and blood coagulation parameter should be closely monitored.

Voluven 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 haemodynamics and on the haemodilution (dilution effect). Use at the lowest effective dose for the shortest period of time. Should not be used for more than 24 hours.
The initial 10-20 ml should be infused slowly, keeping the patient under close observation (due to possible anaphylactic/anaphylactoid reactions).
Adult dose: Up to 50 ml of Voluven per kg of body weight per day (equivalent to 3.0 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3,500 ml Voluven for a 70 kg patient.
Paediatric dose: The dosage in children should be adapted to the individual patient colloid needs, taking into account basic disease, haemodynamics, and hydration status.
In 41 newborns to infants (< 2 years), a mean dose of 16±9 ml/kg was administered. In 31 children from 2 - 12 years of age a mean dose of 36 ± 11 ml/kg was administered. The dose in adolescents > 12 is the same as the adult dose.

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.

Do not use HES products in: Patients with severe sepsis; critically ill patients; patients with severe liver disease; patients with known hypersensitivity to hydroxyethyl starch; clinical conditions where volume overload is a potential problem, especially in cases of pulmonary oedema and congestive cardiac failure; patients with pre-existing coagulation or bleeding disorders; patients with renal impairment; patients receiving dialysis treatment; patients with severe hypernatraemia or severe hyperchloraemia; patients with intracranial bleeding; patients with blood coagulation disorders; patients with burns, scalds.

(Based on Notification of the Ministry of Public Health)
Do not use in patients with severe sepsis, critically ill patients, patients with renal impairment, patients with blood coagulation disorders and patients with burns, scalds.
Use with caution in elective surgery patients, trauma patients, patients undergoing open heart surgery in association with cardiopulmonary bypass.
Use at the lowest effective dose for the shortest period of time. Should not use for more than 24 hours.

Use with caution in elective surgery patients, trauma patients, patients undergoing open heart surgery in association with cardiopulmonary bypass.
Anaphylactic/anaphylactoid reactions (hypersensitivity, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary oedema) 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.
Avoid use in patients with pre-existing renal dysfunction.
Discontinue use of Voluven at the first sign of clinically relevant renal injury.
Continue to monitor renal function in hospitalised patients for at least 90 days as use of renal replacement therapy has been recorded up to 90 days after administration of HES products.
Monitor the coagulation status in patients undergoing open heart surgery in association with cardiopulmonary bypass as excess bleeding has been reported with other HES solutions in this population. Discontinue the use of Voluven at the first sign of clinically relevant coagulopathy.
Avoid fluid overload; adjust dosage in patients with cardiac dysfunction. Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with cardiac insufficiency.
In cases of severe dehydration a crystalloid solution should be given first. Generally, sufficient fluid should be administered in order to avoid dehydration.
Particular care must be taken in patients with electrolyte abnormalities.
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 Voluven.

There are limited clinical study data available from the use of a single dose of Voluven in pregnant women undergoing caesarean section with spinal anesthesia. No negative influence of Voluven on patient safety could be detected; a negative influence on the neonate could also not be detected.
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.
Information on the use of Voluven during labour or delivery is unknown with the exception of caesarean section. Use if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Voluven is administered to a nursing woman.

The undesirable effects are defined as follows: See Table.

Click on icon to see table/diagram/image

Blood and lymphatic system disorders: Rare (in high doses): With the administration of hydroxyethyl starch disturbances of blood coagulation beyond dilution effects can occur depending on the dosage.
Immune system disorders: Rare: Medicinal products containing hydroxyethyl starch may lead to anaphylactic/anaphylactoid reactions (hypersensitivity, mild influenza like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary oedema). 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.
Skin and subcutaneous tissue disorders: Common (dose dependent): Prolonged administration of high dosages of hydroxyethyl starch may cause pruritus (itching) which is a known undesirable effect of hydroxyethyl starches.
Investigations: Common (dose dependent): The concentration of serum amylase level can rise during administration of hydroxyethyl starch and can interfere with the diagnosis of pancreatitis. The elevated amylase is due to the formation of an enzyme-substrate complex of amylase and hydroxyethyl starch subject to slow elimination and must not be considered diagnostic of pancreatitis.
Common (dose dependent): 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 haematocrit.

No interactions with other drugs or nutritional products are known to date. 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 haematocrit.

Special precautions for disposal and other handling: For single use only.
To be used immediately after the bottle or bag is opened.
Any unused solution should be discarded. Any unused solution should be disposed of in accordance with local requirements.
Use only clear, particle-free solutions and undamaged containers.
Remove the overwrap from the Polyolefine (freeflex) bag and PVC bag prior to use.
Incompatibilities: 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.

Do not freeze. Store below 25°C.

Intravenous & Other Sterile Solutions

B05AA07 - hydroxyethylstarch ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.

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