Human Albumin 20% Biotest Low Salt Content
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
HUMAN PLASMA, PROTEIN
Available from:
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
ATC code:
B05AA01
INN (International Name):
HUMAN PLASMA PROTEIN 200 g/l
Pharmaceutical form:
SOLUTION FOR INFUSION
Composition:
HUMAN PLASMA PROTEIN 200 g/l
Prescription type:
POM
Therapeutic area:
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorization status:
Withdrawn
Authorization date:
2005-10-04
Patient Information leaflet
INSTRUCTIONS FOR USE
HUMAN ALBUMIN 20 % BIOTEST LOW SALT CONTENT
Active ingredient: Human albumin
COMPOSITION
1000 ml solution contain:
- ACTIVE INGREDIENTS:
Human plasma protein
200 g
of which albumin
at least 96 %
- EXCIPIENTS:
Caprylate*
2.31 g (16 mmol)
N-Acetyl-DL-tryptophanate*
3.94 g (16 mmol)
Sodium
2.80 g (122 mmol)
Chloride
≤
3.90 g (
≤ 110 mmol)
Water for injections
ad
1000 ml
_*Stabilizer_
PRESENTATION
Solution for intravenous infusion.
Vial with 50 ml
Vial with 100 ml
PHARMACOTHERAPEUTIC GROUP / MODE OF ACTION
Plasma protein fraction, plasma substitute
The most important physiological functions of albumin result
from its contribution to oncotic
pressure of the blood and transport function. Albumin stabilises
circulating blood volume and is
a carrier of hormones, enzymes, medicinal products and toxins.
NAME AND ADDRESS OF AUTHORIZATION HOLDER AND MANUFACTURER
Biotest Pharma GmbH
Landsteinerstraße 5
63303 Dreieich
Germany
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.
CONTRAINDICATIONS
Hypersensitivity to albumin preparations or to any of the
excipients.
PREGNANCY AND LACTATION
The safety of Human Albumin 20 % Biotest low salt content for
use in human pregnancy has not
been established in controlled clinical trials. However, clinical
experience with albumin suggests
that no harmful effects on the course of pregnancy, or on the
foetus and the neonate are to be
expected.
Experimental animal studies are insufficient to assess the safety
with respect to reproduction,
development of the embryo or foetus,
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Summary of Product characteristics
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Human Albumin 20 % Biotest low salt content
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin
1000 ml solution contain 200 g human plasma protein of which at
least 96 % is human albumin
The product has a hyperoncotic effect.
For excipients, see 6.1.
3. PHARMACEUTICAL
FORM
Solution for infusion.
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 or 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
− haemaotcrit / haemoglobin
Human Albumin 20% Biotest low salt content is suitable for use in
dialysis patients and premature
infants.
Page 2 of 5
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. 0.9 % sodium chloride).
The infusion rate should be adjusted according to the individual
circumstances and the indication.
4.3
CONTRAINDI
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