HUMAN ALBUMIN 20% BEHRING

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALBUMIN HUMAN

Available from:

CSL BEHRING LTD., ISRAEL

ATC code:

B05AA01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

ALBUMIN HUMAN 200 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

CSL BEHRING GMBH, GERMANY

Therapeutic group:

ALBUMIN

Therapeutic area:

ALBUMIN

Therapeutic indications:

Hypoalbuminemia (liver cirrhosis nephrosis) toxic processes ( pregnancy toxicosis, hyperbilirubinemia ) ,volume substitution therapy.

Authorization date:

2019-02-28

Summary of Product characteristics

HUMAN ALBUMIN 20 % BEHRING
1.
NAME OF THE MEDICINAL PRODUCT
Human Albumin 20 % Behring
Solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin 20 % Behring, low salt, 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
•
Hypoalbuminemia (liver cirrhosis, nephrosis)
•
Toxic processes ( pregnancy toxicosis, hyperbilirubinemia ) ,
•
Volume substitution therapy.
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 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 infusion rate should be adjusted according to the individual
circumstances and the
indication.
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