Human Albumin Baxalta 50g/l, 250ml vial

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALBUMIN, HUMAN

Available from:

Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria

ATC code:

B05AA01

INN (International Name):

ALBUMIN, HUMAN 50 g/l

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

ALBUMIN, HUMAN 50 g/l

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2007-07-10

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMAN ALBUMIN BAXALTA 50 G/L
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Human Albumin Baxalta 50 g/l is and what it is used for
2.
What you need to know before you use Human Albumin Baxalta 50 g/l
3.
How to use Human Albumin Baxalta 50 g/l
4.
Possible side effects
5.
How to store Human Albumin Baxalta 50 g/l
6.
Contents of the pack and other information
1.
WHAT HUMAN ALBUMIN BAXALTA 50 G/L IS AND WHAT IT IS USED FOR
Human Albumin Baxalta 50 g/l 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 BAXALTA 50 G/L
DO NOT USE HUMAN ALBUMIN BAXALTA 50 G/L:
-
if you are allergic to human albumin or any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Human Albumin
Baxalta 50 g/l.
-
if you t

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Human Albumin 50 g/l Baxalta
Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin 50 g/l Baxter/Baxalta 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.
Excipients with known effect:
Sodium
130-160 mmol/l
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
Page 3 of 8
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urine output
-
electrolyte concentration
-
haematocrit/haemoglobin
-
clinical signs of cardiac/respiratory failure (e.g., dyspnoea)
-
clinical signs of increasing intra-cranial pressure (e.g., headache)
Method of administration
Human Albumin 50 g/l Baxter/Baxalta can be directly administered by
the intravenous route.
The infusion rate should b