ALBUMIN 20%W/V (BUMINATE 20%W/V)
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
HUMAN ALBUMIN
Available from:
Baxter Healthcare Limited
Dosage:
20 %w/v %w/v
Pharmaceutical form:
Solution for Infusion
Authorization date:
1977-04-01
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Albumin 20 % w/v (Buminate 20% w/v) Human Albumin Solution,
Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin.
Solution containing 20 % of protein of which at least 96
% is human albumin.
Each 100 ml contains at least 19.2g of human albumin.
The effective oncotic pressure of the solution is approximately
four times that of blood plasma.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Glass (Type I Ph. Eur.) bottle, effectively sealed, containing 100
ml or 50 ml of a clear, colourless, sterile, buffered
solution for infusion.
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 ADMINSTRATION
The concentration of the albumin preparation, dosage and
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
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 24/10/2005_
_CRN 2016038_
_page number: 1_
METHOD
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