VOLULYTE SOLUTION FOR INFUSION 6% [SIN13893P]

Product Info

VOLULYTE SOLUTION FOR INFUSION 6%

[SIN13893P]

4.1 Therapeutic indications
Volulyte 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
Volulyte is administered by intravenous infusion only.
The daily dose and rate of infusion depends on the patient's blood loss, on the maintenance or restoration of haemodynamics and on the haemodilution (dilution effect). Volulyte 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:
Up to 50 ml of Volulyte per kg of body weight per day (equivalent to 3.0 g hydroxyethyl starch, 6.85 mEq sodium and 0.2 mEq potassium per kg of body weight). This dose is equivalent to 3,500 mL Volulyte for a 70 kg patient.

Paediatric dose:
The dosage in children should be adapted to the individual patient colloid needs, taking into account the basic disease state, as well as the haemodynamics and hydration status (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications
Do not use HES products in:

• patients with known hypersensitivity to hydroxyethyl starch

• patients with sepsis

• patients with renal failure with oliguria or anuria not related to hypovolaemia

• patients receiving dialysis treatment

• patients with intracranial bleeding

• clinical conditions where volume overload (hyperhydration) is a potential problem, especially in cases of pulmonary oedema and congestive cardiac failure

• patients with severe hyperkalaemia, severe hypernatraemia or severe hyperchloraemia

• patients with severe liver disease

• patients with pre-existing coagulation or bleeding disorders