Zenalb 20, a Human Albumin 20% Solution

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

ALBUMIN, HUMAN

Tilgængelig fra:

Bio Products Laboratory Limited Dagger Lane, Elstree Hertfordshire, WD6 3BX, United Kingdom

ATC-kode:

B05AA01

INN (International Name):

ALBUMIN, HUMAN

Lægemiddelform:

SOLUTION FOR INFUSION

Sammensætning:

ALBUMIN, HUMAN 20 percent weight/volume

Recept type:

POM

Terapeutisk område:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Autorisation status:

Authorised

Autorisation dato:

2006-03-24

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB
®
20
20% W/V SOLUTION FOR INFUSION
HUMAN ALBUMIN SOLUTION
ABL 25
REDE DESIGN LTD. 
Tel: [phone]
JOB NO. 
CLIENT:
CONTACT:
PROJECT NAME:
CLIENT ORDER NO.
DATE: 
PROOF NO.
OPERATOR:
DOC. SIZE:
7753
BPL
Chidi Wek
Zenalb 20 PIL UK Leaflet UK
BPL233413
8/1/2008
7
Hema Joshi
150 x 220mm
PROOF APPROVED
PROOF UNAPPROVED
SIGNED
PLEASE READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you. Do not pass it 
on to others. It may harm them, even if their symptoms are 
the same as yours.
- If any of the side effects become serious, or if you 
notice any side effects not listed in this leaflet, please tell 
your doctor.
IN THIS LEAFLET: 
1. WHAT ZENALB
®
20 IS AND WHAT IT IS USED FOR
2. BEFORE YOU ARE GIVEN ZENALB
®
20 
3. HOW YOU WILL BE GIVEN ZENALB
®
20
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZENALB
®
20
6. FURTHER INFORMATION
1. WHAT ZENALB
®
20 IS AND WHAT IT IS USED FOR
Zenalb 20
®
is a solution containing the active substance
called human albumin (a protein found naturally in your
blood which is needed for many different functions). Human
albumin is obtained from blood plasma from screened
donors selected from the USA. 
Zenalb 20
®
is used to replace the blood or body fluids that
you have lost because of bleeding, surgery, or kidney
dialysis (blood “cleaning” by a machine). It contains four
times the amount of albumin as normal blood.
The product is given by injection into a vein (intravenous
infusion) either undiluted or in a solution containing 5%
glucose or 0.9% sodium chloride. It is only available on a
doctor’s prescription.
This medicine is also suitable for premature babies and
patients on kidney dialysis as it contains only very small
quantities of aluminium.
2. BEFORE YOU ARE GIVEN ZENALB
®
20
DO NOT ALLOW ZENALB
®
20 TO BE GIVEN TO YOU IF YOU:
• are aller

Produktets egenskaber

Page 1 of 5 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF MEDICINAL PRODUCT 

Zenalb

20, a Human Albumin 20% Solution 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

2.1 
ACTIVE INGREDIENTS 
Human  albumin  is  prepared  from  plasma  from  screened  donors.  Donors  are  selected  from 
the USA. 

2.2 
QUANTITATIVE COMPOSITION 
Zenalb

20 is a clear, yellow to green, sterilised solution. It is a low salt solution containing 
190 - 210 g/L of plasma protein of which not less than 95% is albumin. The residual proteins 
are heat stable alpha- and beta- globulins. Zenalb

20 is free from plasma proteins associated 
with the blood clotting mechanism and blood group antibodies. 
Zenalb

20 contains 50 - 120 mmol/L sodium. The assayed sodium content is stated on the 
label of the bottle. For excipients see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Zenalb

20  is  a  low  salt  solution  (hypotonic,  but  hyperoncotic)  of  albumin  ready  to  be 
administered as an intravenous infusion only. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Zenalb

20  is  used  for  restoration  and  maintenance  of  circulating  blood  volume  where 
volume  deficiency  has  been  demonstrated,  use  of  a  colloid  such  as  albumin  is  appropriate, 
and where electrolyte or fluid load requires careful monitoring. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Zenalb

20 is given by intravenous infusion. In general the dosage and the infusion-rate 
should be adjusted to the patient’s individual requirements. 
In  anaphylactic  reactions,  treatment  should  follow  the  current  recommendations  for  shock 
therapy. 

4.2.1  POSOLOGY 
The dose required depends on