HUMAN ALBUMIN TAKEDA 50 MGML SOLUTION FOR INFUSION

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

ALBUMIN HUMAN

Disponibil de la:

TAKEDA ISRAEL LTD

Codul ATC:

B05AA01

Forma farmaceutică:

SOLUTION FOR INFUSION

Compoziție:

ALBUMIN HUMAN 50 MG / 1 ML

Calea de administrare:

I.V

Tip de prescriptie medicala:

Required

Produs de:

BAXTER AG, AUSTRIA

Zonă Terapeutică:

ALBUMIN

Indicații terapeutice:

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

Data de autorizare:

2021-07-20

Caracteristicilor produsului

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Human Albumin Takeda 50 mg/ml Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin Takeda 50 mg/ml is a solution containing 50 mg/ml of
total protein of which
at least 95% is human albumin.
A vial of 250 ml contains 12.5 g of human albumin.
A vial of 500 ml contains 25 g of human albumin.
Human albumin 50 mg/ml is mildly hypooncotic.
Excipients with known effect:
Sodium
130-160 mmol/l
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion, I.V.
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 50 mg/ml can be directly administered by the
intravenous route.
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 in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Suspicion of a