ZENALB 20

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALBUMIN HUMAN

Available from:

KAMADA 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:

BIO PRODUCTS LABORATORY LIMITED, UK

Therapeutic group:

ALBUMIN

Therapeutic area:

ALBUMIN

Therapeutic indications:

For restoration and maintenance of circulation blood volume where volume deficiency has been demonstrated and use of a colloid, is appropriate.

Authorization date:

2022-12-31

Summary of Product characteristics

_Page 1 of 7 _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
ZENALB
 20
1.
NAME OF THE MEDICINAL PRODUCT
Zenalb 20
Human albumin 20%, solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zenalb 20 is a solution containing 200 g/l (20%) of total protein of
which at least 95%
is human albumin.
A vial of 100 ml contains 20 g of human albumin.
Zenalb 20 has a mildly hyperoncotic effect.
Excipient with known effect:
Zenalb 20 contains approximately 50 - 120 mmol/l sodium.
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
_Page 2 of 7 _
_ _
-
urine output
-
electrolyte
-
haematocrit/haemoglobin METHOD OF ADMINISTRATION
Human albumin 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