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VOLUVEN SOLUTION FOR INFUSION 6% [SIN12297P]
Active ingredients: VOLUVEN SOLUTION FOR INFUSION 6%
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Product Info
VOLUVEN SOLUTION FOR INFUSION 6%
[SIN12297P]
Product information
Active Ingredient and Strength | POLY (O-2-HYDROXYETHYL) STARCH - 60 G/L |
Dosage Form | INJECTION |
Manufacturer and Country | FRESENIUS KABI DEUTSCHLAND GMBH - GERMANY |
Registration Number | SIN12297P |
Licence Holder | FRESENIUS KABI (SINGAPORE) PTE LTD |
Forensic Classification | GENERAL SALE LIST |
Anatomical Therapeutic Chemical (ATC) code | B05AA07 |
4.1 Therapeutic indications
Voluven 6% is indicated for the treatment and prophylaxis of hypovolaemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma.
4.2 Posology and method of administration
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). Voluven can be administered repetitively over several days.
The initial 10 to 20 ml should be infused slowly, keeping the patient under close observation due to possible anaphylactic/anaphylactoid reactions.
Adult dose:
The maximum daily dose is 45 ml/kg b.w./day.
There is currently limited experience with repetitive dosing up to 4 days. The duration of treatment depends on the duration and extent of hypovolaemia, the haemodynamics and on the haemodilution.
There is currently no clinical experience with this maximum daily dose of 45 ml/kg b.w./day given for prolonged periods.
Paediatric dose:
The dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the haemodynamic and hydration status (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Geriatric Use:
No overall differences in safety or effectiveness were observed between subjects ≥ 65 years of age and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
4.3 Contra-indications
Do not use HES products in:
patients with sepsis
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 failure with oliguria or anuria not related to hypovolaemia
patients receiving dialysis treatment
patients with severe hypernatraemia or severe hyperchloraemia
patients with intracranial bleeding
