Albumeon 20, 200 g/l solution for infusion (50ml vial)

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

HUMAN ALBUMIN, SOLUTION

Mevcut itibaren:

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

ATC kodu:

B05AA01

INN (International Adı):

HUMAN ALBUMIN SOLUTION 200 g/l

Farmasötik formu:

SOLUTION FOR INFUSION

Kompozisyon:

HUMAN ALBUMIN SOLUTION 200 g/l

Reçete türü:

POM

Terapötik alanı:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Ürün özeti:

Licence number in the source country: NOT APPLICAPABLE

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2020-06-26

Bilgilendirme broşürü

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUMEON 20, 200 G/L, SOLUTION FOR INFUSION
Active substance: human albumin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Albumeon is and what it is used for
2.
What you need to know before you are given Albumeon
3.
How to use Albumeon
4.
Possible side effects
5.
How to store Albumeon
6.
Contents of the pack and other information
1.
WHAT ALBUMEON IS AND WHAT IT IS USED FOR
_WHAT IS ALBUMEON _
Albumeon is a plasma substitute.
_HOW ALBUMEON_
_WORKS _
Albumin stabilises the circulating blood volume. It is a carrier of
hormones, enzymes, medicinal
products and toxins. The albumin protein in Albumeon is taken from
human blood plasma.
Therefore the albumin works exactly as if it was your own protein.
_WHAT ALBUMEON_
_IS USED FOR _
Albumeon is used to restore and stabilize the circulating blood
volume. It is normally used under
intensive care situations, when your blood volume has decreased
critically. This may be the case
e.g.:
•
due to severe loss of blood after an injury
_or_
•
due to a large surface burn
The choice of using Albumeon will be made by your doctor. It will
depend on your individual
clinical situation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALBUMEON
Read this section carefully. The information given should be taken
into consideration by you and
your doctor before you are given Albumeon.
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DO NOT USE
Albumeon
•
if you are allergic (hypersensitive) to human albumin or any of the
other ingredients of this
medi

Ürün özellikleri

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1.
NAME OF THE MEDICINAL PRODUCT
Albumeon 20, 200 g/l, solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Albumeon is a solution containing 200 g/l of total protein of which at
least 96 % is human
albumin.
A vial of 100 ml contains at least 19.2 g of human albumin.
A vial of 50 ml contains at least 9.6 g of human albumin.
The solution is hyperoncotic.
Excipients with known effect:
Sodium 125 mmol per litre.
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
−
urine output
−
electrolyte
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−
haematocrit / haemoglobin
_Paediatric Population _
The posology in children and adolescents (0-18 years) is not expected
to be different from that
of adults.
Method of administration
Albumeon 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). For
instructions on dilution of
the medicinal product before administration, see section 6.6.
The infusion rate should be adjusted according to the individual
circumstances and th