Human Albumin 50g per l Baxter

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

albumin, human 50 g/l

Dostupné z:

Baxter Healthcare Limited

ATC kód:

B05AA01

INN (Medzinárodný Name):

albumin, human

Forma lieku:

solution for infusion

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2007-07-10

Príbalový leták

1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

HUMAN ALBUMIN 50 G/L BAXTER 
SOLUTION FOR INFUSION 

Human albumin 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your doctor, pharmacist or
nurse. 
- 
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, pharmacist or
nurse. This includes any possible side 
effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET 
1. 
What Human Albumin 50 g/l Baxter is and what it is used for 
2. 
What you need to know before you use Human Albumin 50 g/l Baxter 
3. 
How to use Human Albumin 50 g/l Baxter 
4. 
Possible side effects 
5. 
How to store Human Albumin 50 g/l Baxter 
6. 
Contents of the pack and other information 

1. WHAT HUMAN ALBUMIN 50 G/L BAXTER IS AND WHAT IT IS USED FOR 

This product contains a protein called albumin found in the
liquid component of the blood (the plasma) and 
belongs to the group of medical products called “plasma
substitutes and plasma protein fractions”. It is made 
from human blood collected from blood donors. 

A vial of 250 ml contains 12.5 g of human albumin. 
A vial of 500 ml contains 25 g of human albumin. 

Human albumin is used to restore and maintain blood volume in patients
who have lost blood or fluid due to 
certain medical conditions. The choice of albumin rather than an
artificial substitute and the dose needed will 
depend on the clinical situation of the individual patient. 

2. WHAT YOU NEED TO KNOW BEFORE YOU USE HUMAN ALBUMIN 50 G/L BAXTER 

DO NOT USE HUMAN ALBUMIN 50 G/L BAXTER: 
- 
if you are allergic (hypersensitive ) to human albumin or any of
the other ingredients (listed in

Súhrn charakteristických

1 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Human Albumin 50 g/l Baxter 
Solution for Infusion 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Human Albumin 50 g/l Baxter is a solution containing 50 g/l
of total protein of which at least 95% is 
human albumin. 

A vial of 250 ml contains 12.5 g of human albumin. 
A vial of 500 ml contains 25 g of human albumin. 

Human albumin 50 g/l is mildly hypooncotic and contains
130 – 160 mmol/l of total sodium. 

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. 
The choice of albumin rather than artificial colloid will depend
on the clinical situation of the individual 
patient, based on official recommendations._ _

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 
2 

- electrolyte concentration 
- haematocrit/haemoglobin 
- clinical signs of cardiac/respiratory failure (e.g., dyspnoea) 
- clinical signs of increasing intra-cranial pr