Albumin (Human) U.S.P. Albutein® 20% Solution for Infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Albumin (human), USP

Available from:

GRIFOLS MALAYSIA SDN. BHD.

INN (International Name):

Albumin (human), USP

Units in package:

50 ml; 100 ml

Manufactured by:

Grifols Biologicals LLC

Summary of Product characteristics

Albumin (Human) U.S.P.
Albutein
®
20%
Solution for Infusion
1. NAME OF THE MEDICINAL PRODUCT
Albumin (Human) U.S.P., Albutein
®
20%, Solution for Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Albutein
®
20% is human albumin
Albutein
®
20% is a solution containing 200 g/l of total
protein of which at least 95% is human albumin.
A vial of 50 ml contains 10 g of human albumin.
A vial of 100 ml contains 20 g of human albumin.
Albutein
®
20% has a hyperoncotic effect.
The solution contains between 130 - 160 mmol/l of sodium
and not more than 2 mmol/l of potassium.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
A clear, slightly viscous liquid; it is almost colourless,
yellow, amber or green.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Restoration and maintenance of circulating blood volume
where volume deficiency has been demonstrated, and use
of a colloid is appropriate.
The choice of albumin rather than artificial colloid will
depend on the clinical situation of the individual patient,
based on official recommendations.
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
This product is suitable for premature infants and dialysis
patients.
METHOD OF ADMINISTRATION
Human
albumin
can
be
directly
administered
by
the
intravenous route, or it can also be diluted in an isotonic
solut