ALBUNORM 5 %

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ALBUMIN HUMAN; PLASMA PROTEIN FRACTION

Fáanlegur frá:

DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL

ATC númer:

B05AA01

Lyfjaform:

SOLUTION FOR INFUSION

Samsetning:

ALBUMIN HUMAN 50 G / 1000 ML; PLASMA PROTEIN FRACTION 96 %

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

OCTAPHARMA AG, SWITZERLAND

Meðferðarhópur:

ALBUMIN

Lækningarsvæði:

ALBUMIN

Ábendingar:

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 the official recommendations

Leyfisdagur:

2018-06-30

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Albunorm 5%
_, _
50 g/l,
_ _
solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Albunorm 5% is a solution containing 50 g/l of total protein of which
at least 96% is human
albumin.
A bottle of 100 ml contains 5 g of human albumin.
A bottle of 250 ml contains 12.5 g of human albumin.
A bottle of 500 ml contains 25 g of human albumin.
Excipients:
Sodium (144-160 mmol/l)
Albunorm 5% is a mildly hypooncotic solution.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
The solution is a clear, slightly viscous liquid; it is 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
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 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