Human Albumin 200g per l Baxter

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

albumin, human 200 g/l

Mevcut itibaren:

Baxter Healthcare Limited

ATC kodu:

B05AA01

INN (International Adı):

albumin, human

Farmasötik formu:

solution for infusion

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2007-07-10

Bilgilendirme broşürü

1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

HUMAN ALBUMIN 200 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 200 g/l Baxter is and what it is used for 
2. 
What you need to know before you use Human Albumin 200 g/l Baxter 
3. 
How to use Human Albumin 200 g/l Baxter 
4. 
Possible side effects 
5. 
How to store Human Albumin 200 g/l Baxter 
6. 
Contents of the pack and other information 

1. WHAT HUMAN ALBUMIN 200 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 50 ml contains 10 g of human albumin. 
A vial of 100 ml contains 20 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 200 G/L BAXTER 

DO NOT USE HUMAN ALBUMIN 200 G/L BAXTER: 
- 
if you are allergic (hypersensitive ) to human albumin or any of the
other ingredients (listed in section 
6) of Human A

Ürün özellikleri

1 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Human Albumin 200 g/l Baxter 
Solution for Infusion 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Human Albumin 200 g/l Baxter is a solution containing 200 g/l of total
protein of which at least 95% 
is human albumin. 

A vial of 100 ml contains 20 g of human albumin. 
A vial of 50 ml contains 10 g of human albumin. 

The solution is hyperoncotic and contains 100 – 130 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 
- electrolyte concentration 
- haematocrit/haemoglobin 
2 

- clinical signs of cardiac/respiratory failure (e.g., dyspnoea) 
- clinical signs of increasing intra-cranial pressure (e.g.,
headache) 

Method of administ