G.P.O. (Pasteurised Plasma-protein Solution)

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

HUMAN PLASMA, PROTEIN

Dostupné z:

Sanquin Plesmanlaan 125, 1066 CX Amsterdam, Netherlands

ATC kód:

B05AA01

INN (Medzinárodný Name):

HUMAN PLASMA PROTEIN 40 g/l

Forma lieku:

SOLUTION FOR INFUSION

Zloženie:

HUMAN PLASMA PROTEIN 40 g/l

Typ predpisu:

POM

Terapeutické oblasti:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2007-01-29

Príbalový leták

INFORMATION FOR THE PATIENT
READ THIS PACKAGE LEAFLET CAREFULLY WHEN YOU
HAVE SOME TIME TO YOURSELF. IF YOU HAVE FURTHER
QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR PHAR-
MACIST.
GENERAL CHARACTERISTICS
The name under which the product will be brought to market
is G.P.O. (’Gepasteuriseerde Plasma-eiwit Oplossing’, pasteuri-
sed plasma-protein solution).
The commercial packing of G.P.O. consists of:
• A vial of G.P.O. of 100 ml or 250 ml.
The product is delivered as a solution for infusion for intrave-
nous use.
The active substance is albumin. The product contains 40
grams of protein per litre, at least 95% of which is albumin.
The product contains other proteins besides albumin, such as
pre-albumin and haptoglobin.
The product also contains the following other ingredients:
sodium chloride, sodium caprylate and water for injections.
G.P.O. is a protein purified from donor blood. This donor
blood is obtained from healthy, voluntary, non-remunerated
donors. These individuals satisfy the requirements imposed on
blood donors in the Netherlands.
All blood donors are tested for several pathogens, such as:
• the AIDS virus;
• the hepatitis B and C viruses (which cause jaundice);
• Treponema pallidum (the causative agent of syphillis).
These pathogens could not be detected in the donors.
Furthermore, this product has undergone a ”virus reducing
treatment”. This “virus reducing treatment” kills or eliminates
as many as possible of the viruses still present, thus making
the risk of virus transfer exceptionally small.
Albumin is an important protein in the blood. Albumin provi-
des for the transport of endogenous substances as well as cer-
tain medicinal products. Furthermore, albumin is important
in the regulation of the blood volume through the mainte-
nance of the so-called colloid osmotic pressure, because albu-
min has a powerfully hydrophilic effect upon the surrounding
tissue fluid. With a shortage of albumin, fluid goes from the
blood circulation to the surrounding tissue, and tissue swel-
lin

Súhrn charakteristických

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. TRADE NAME OF THE MEDICINAL PRODUCT 

The trade name of the product is G.P.O. ('Gepasteuriseerde
Plasma-eiwit Oplossing', pasteurised 
plasma protein solution). 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

2.1 ACTIVE INGREDIENT 

G.P.O. consists of a protein fraction prepared from human venous
plasma. The product is delivered 
as a sterile and pyrogen-free solution and has a
protein concentration of 40 g/l, of which at least 
95% is albumin. 

2.2 VIRAL SAFETY 

G.P.O. is prepared from venous plasma by means of ethanol
fractionation. The plasma has to be 
derived from voluntary, nonremunerated donors who satisfy the
requirements of the Blood 
Transfusion Council of the Netherlands Red Cross. This means, among
other things, that every 
individual donation has been tested and found negative for
hepatitis B surface antigen (HBsAg), for 
antibodies against human immunodeficiency viruses 1 and 2 (HIV-1
and HIV-2, the inducers of 
AIDS) and for antibodies against hepatitis C virus. 
 Manufacturing by means of ethanol fractionation and the
pasteurisation of G.P.O. (heating of the 
infusion solution at 60
°C during 10 hours) ensure that the risk of
transmission of viral diseases, in 
particular, AIDS, hepatitis B and hepatitis non-A, non-B
(including hepatitis C) will be extremely 
small. 

3. PHARMACEUTICAL FORM 

G.P.O. is delivered as a solution for infusion for intravenous use. 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

G.P.O. is indicated in the following situations: 
- imminent or existing cases of shock such as during
severe bleeding and burns 
- extracorporeal circulation 
- sepsis or serious infections accompanied by severe protein loss
(peritonitis, mediastinitis) 
- temporary arterial hypotension during haemodialysis 
- plasmapheresis and plasma exchange 

4.2 POSOLOGY AND METHOD OF ADMINISTRATI