Cealb

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

ALBUMIN, HUMAN

Dostupné z:

Sanquin Plesmanlaan 125, 1066 CX Amsterdam, Netherlands

ATC kód:

B05AA01

INN (Medzinárodný Name):

ALBUMIN, HUMAN 200 g/l

Forma lieku:

SOLUTION FOR INFUSION

Zloženie:

ALBUMIN, HUMAN 200 g/l

Typ predpisu:

POM

Terapeutické oblasti:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2007-01-29

Príbalový leták

I B2.4. Design of the Patient Information Leaflet for Cealb
® 

INFORMATION FOR THE PATIENT: 

Read this package leaflet carefully when you have some
time to yourself. 
If
you have further questions, please ask your physician or your pharmacist. 

GENERAL CHARACTERISTICS 

The product is marketed under the name of Cealb®. 
The commercial packing of Cealb® consists of: 
* 
A vial with 10 ml, 20 ml, 50 ml or 100 ml of Cealb®. 
The product is delivered as a solution for infusion for
intravenous use. 
The active substance is albumin. The product contains 200 grams
of protein per litre, of which at least 95% 
is albumin. 
Along with albumin, the product contains other proteins, such as
pre-albumin and haptoglobin. 
The product also contains the following other ingredients: sodium chloride, sodium caprylate, mandelic acid 
and water for injections. 
Cealb® 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 provides for the
transport of endogenous substances 
as well as certain medicinal
products. In addition, albumin is important
in the regulation of the blood volume 
through maintenance of the so-called c

Súhrn charakteristických

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.    
NAME OF THE PRODUCT 

The trade name of the product is Cealb®. 

2.    
QUALITATIVE AND QUANTITATIVE COMPOSITION 

2.1     ACTIVE INGREDIENT 

Cealb® consists of a protein fraction prepared from human venous
plasma. The preparation 
is delivered as a sterile and pyrogen-free solution and has a
protein concentration of 200 g/l, 
of which at least 95% is albumin. 

2.2  
VIRAL SAFETY 

Cealb® 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 Cealb® (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 

Cealb® is delivered as a solution for infusion for intravenous
use. 

4.    
CLINICAL PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Cealb® is indicated especially for application in clinical
situations where large amounts of 
plasma protein with low sodium levels must be administered. 
After dilution to an iso-oncotic solution Cealb® can be applied in
cases of volume deficit. 
Cealb® is indicated in the following situations: 
- imminent or existing cases of shock such as during severe bleeding
and burns 
- extracorporeal circulation 
- sepsis or s