HUMAN ALBUMIN 200gl BAXTER

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

HUMAN ALBUMIN

Fáanlegur frá:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC númer:

B05AA01

Skammtar:

200 mg/ml

Lyfjaform:

SOLUTION, STERILE

Samsetning:

HUMAN ALBUMIN 200 mg/ml

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

Prescription Only

Framleitt af:

BAXTER AG

Leyfisstaða:

ACTIVE

Leyfisdagur:

2004-07-30

Upplýsingar fylgiseðill

1 

HUMAN ALBUMIN 200G/L BAXTER 
20% SOLUTION FOR INFUSION 
HUMAN ALBUMIN 

NAME OF THE MEDICINAL PRODUCT 
HUMAN ALBUMIN 200g/l BAXTER 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Human Albumin 200 g/l Baxter is a solution containing 20% of protein
of which at least 95% is human 
albumin. 

A vial of 100 ml contains 20 g of human albumin. 
A vial of 50 ml contains 10 g of human albumin. 
The solution is hyperoncotic and contains 100 – 130 mmol/l of
total sodium. 
For full list of excipients, see ‘LIST OF EXCIPIENTS’ 
PHARMACEUTICAL FORM 
Solution for infusion 
A clear, slightly viscous solution; it is almost colourless, yellow
to brown or green. 
CLINICAL PARTICULARS: 
THERAPEUTIC INDICATIONS 
Restoration and maintenance of circulating blood volume where volume
deficiency has been 
demonstrated, and use of 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. 
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 
2 

  electrolyte concentration 
  haematocrit/haemoglobin 
  clinical signs of cardiac/respiratory failure (e.g.,
dyspnoea) 
  clinical signs of increasing intra-cranial pressure (e.g.
headache) 
This product is suitable for premature infa

Vara einkenni

1
HUMAN ALBUMIN 200G/L BAXTER
20% SOLUTION FOR INFUSION
HUMAN ALBUMIN
NAME OF THE MEDICINAL PRODUCT
HUMAN ALBUMIN 200g/l BAXTER
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin 200 g/l Baxter is a solution containing 20% of protein
of which at least 95% is human
albumin.
A vial of 100 ml contains 20 g of human albumin.
A vial of 50 ml contains 10 g of human albumin.
The solution is hyperoncotic and contains 100 – 130 mmol/l of total
sodium.
For full list of excipients, see ‘LIST OF EXCIPIENTS’
PHARMACEUTICAL FORM
Solution for infusion
A clear, slightly viscous solution; it is almost colourless, yellow to
brown or green.
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS
Restoration and maintenance of circulating blood volume where volume
deficiency has been
demonstrated, and use of 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.
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
2

electrolyte concentration

haematocrit/haemoglobin

clinical signs of cardiac/respiratory failure (e.g., dyspnoea)

clinical signs of increasing intra-cranial pressure (e.g. headache)
This product is suitable for premature infants and dialysis patients.
METHOD OF ADMINISTRATION
Human Albumin 200g/l BAXTER can be directly administered by the
intravenous route, or it can be
dilute