ZENALB 4.5 HUMAN ALBUMIN SOLUTION 4.5% W/V [SIN07170P]

Product Info

ZENALB 4.5 HUMAN ALBUMIN SOLUTION 4.5% W/V

[SIN07170P]

4.1 Therapeutic indications
Zenalb 4.5 is indicated in all patients for the restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

4.2 Posology and method of administration
The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient’s individual requirements.

Posology
The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume, and not plasma albumin levels, should be used to determine the dose required.

If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:

• arterial blood pressure and pulse rate

• central venous pressure

• pulmonary artery wedge pressure

• urine output

• electrolyte

• haematocrit/haemoglobin

Method of administration
Human albumin can be directly administered by the intravenous route.
The infusion rate should be adjusted according to the individual circumstances and the indication.

The recommended rate of administration for patients with normal blood volume should be 1–2ml/minute (60–120ml/hour). In patients with greatly reduced blood volume and/or shock, infusion of Zenalb 4.5 may be as rapid as necessary, e.g. up to 1L/hour.

In plasma exchange the infusion rate should be adjusted to the rate of removal.

4.3 Contraindications
Hypersensitivity to albumin preparations or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Patients with severe anaemia and patients with cardiac failure.