HUMAN ALBUMIN TAKEDA 200 MGML SOLUTION FOR INFUSION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALBUMIN HUMAN

Available from:

TAKEDA ISRAEL LTD

ATC code:

B05AA01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

ALBUMIN HUMAN 200 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BAXTER AG, AUSTRIA

Therapeutic area:

ALBUMIN

Therapeutic indications:

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

Authorization date:

2021-07-20

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Human Albumin Takeda 200 mg/ml Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin Takeda 200 mg/ml is a solution containing 200 mg/ml of
total 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.
Excipients with known effect:
Sodium
100-130 mmol/l
For the 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.
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
2
-
urine output
-
electrolyte concentration
-
haematocrit/haemoglobin
Method of administration
Human Albumin Takeda 200 mg/ml can be directly administered by the
intravenous route, or
it can also be diluted in an isotonic solution (e.g. 5 % glucose or
0.9 % sodium chloride).
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 excipients
listed