- Approval Id
- 6d1d8a1d04bd0ea1
- Drug Name
- VOLUVEN SOLUTION FOR INFUSION 6%
- Product Name
- VOLUVEN SOLUTION FOR INFUSION 6%
- Approval Number
- SIN12297P
- Approval Date
- 2003-05-16
- Registrant
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Licence Holder
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- General Sale List
- Dosage Form
- INJECTION
- Dosage
- **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.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **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.
- Contraindications
- **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
- Atc Code
- B05AA07, B05AA07
- Atc Item Name
- xb 05 aa 07, b 05 aa 07
- Pharma Manufacturer Name
- FRESENIUS KABI (SINGAPORE) PTE LTD
- Company Detail Path
- /organization/fresenius-kabi-singapore-pte-ltd
