Human Albumin Solution for Infusion 20% Behring

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Human Albumin

Tilgængelig fra:

CSL BEHRING PTE. LTD.

ATC-kode:

B05AA01

Dosering:

200g/L

Lægemiddelform:

INFUSION, SOLUTION

Sammensætning:

Human Albumin 200g/L

Indgivelsesvej:

INTRAVENOUS DRIP

Recept type:

Prescription Only

Fremstillet af:

CSL Behring GmbH

Autorisation status:

ACTIVE

Autorisation dato:

2012-01-20

Indlægsseddel

1. NAME OF THE MEDICINAL PRODUCT
Human Albumin solution for infusion 20 % Behring
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin solution for infusion 20 % Behring is a
solution containing 200 g/l of total protein of which at 
least 96 % is human albumin.
100 ml contain at least 19.2 g of human albumin.
50 ml contain at least 9.6 g of human albumin.
The solution is hyperoncotic.
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
infusionrate 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 administered by the intravenous 
route, either undiluted or after dilution in an isotonic solution
(e.g. 5 % glucose or 0.9 % sodium chloride). See section 3
"Pharmaceutical Form" and 6.6 "Special precautions for 
disposal and other handling".
The infusionrate should be adjusted according to the 
individual circumstances and

Produktets egenskaber

1.
NAME OF THE MEDICINAL PRODUCT
Human Albumin solution for infusion 20 % Behring
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin solution for infusion 20 % Behring is a
solution containing 200 g/l of total protein of which at
least 96 % is human albumin.
100 ml contain at least 19.2 g of human albumin.
50 ml contain at least 9.6 g of human albumin.
The solution is hyperoncotic.
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
infusionrate 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 administered by the intravenous
route, either undiluted or after dilution in an isotonic solution
(e.g. 5 % glucose or 0.9 % sodium chloride). See section 3
"Pharmaceutical Form" and 6.6 "Special precautions for
disposal and other handling".
The
infusionrate
should
be
adjusted
according
to
the
individual circumstances and the indication.
In plasma exchange the in