Zenalb 4.5, Human Albumin 4.5% Solution

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

ALBUMIN, HUMAN

Disponibil de la:

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

Codul ATC:

B05AA01

INN (nume internaţional):

ALBUMIN, HUMAN

Forma farmaceutică:

SOLUTION FOR INFUSION

Compoziție:

ALBUMIN, HUMAN 4.5 percent weight/volume

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2006-03-24

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB
®
4.5
4.5% W/V SOLUTION FOR INFUSION
HUMAN ALBUMIN SOLUTION
ADL 18
REDE DESIGN LTD. 
Tel: [phone]
JOB NO. 
CLIENT:
CONTACT:
PROJECT NAME:
CLIENT ORDER NO.
DATE: 
PROOF NO.
OPERATOR:
DOC. SIZE:
7754
BPL
Chidi Wek
Zenalb 4.5 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
®
4.5 IS AND WHAT IT IS USED FOR
2. BEFORE YOU ARE GIVEN ZENALB
®
4.5 
3. HOW YOU WILL BE GIVEN ZENALB
®
4.5
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZENALB
®
4.5
6. FURTHER INFORMATION
1. WHAT ZENALB
®
4.5 IS AND WHAT IT IS USED FOR
Zenalb 4.5
®
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 4.5
®
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 a similar
amount of albumin as normal blood. 
The product is given by injection into a vein (intravenous
infusion). 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
®
4.5
DO NOT ALLOW ZENALB
®
4.5 TO BE GIVEN TO YOU IF YOU:
•
are allergic to albumin or any of the other ingredients of
Zenalb
®
4.5 

Caracteristicilor produsului

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1. 
NAME OF MEDICINAL PRODUCT 

Zenalb

 4.5, a Human Albumin 4.5% 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

 4.5 is a clear, yellow to green, sterilised solution. It is a solution containing         40 
- 50 g/L of plasma protein of which not less than 95% is albumin. Zenalb


4.5 is free from 
the  plasma  proteins  associated  with  the  blood  clotting  mechanism  and  blood  group 
antibodies. 
Zenalb


4.5 contains 100 - 160 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

  4.5  is  an  isotonic  (and  isooncotic)  solution  ready  to  be  administered  as  an 
intravenous infusion only. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 
Zenalb

  4.5  is  used  for  restoration  and  maintenance  of  circulating  blood  volume  where 
volume  deficiency  has  been  demonstrated  and  use  of  a  colloid,  such  as  albumin,  is 
appropriate. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Zenalb

  4.5  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