Flexbumin 200 g/l solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human plasma protein

Available from:

Baxalta Innovations GmbH

ATC code:

B05AA; B05AA01

INN (International Name):

Human plasma protein

Dosage:

200 gram(s)/litre

Pharmaceutical form:

Solution for infusion

Administration route:

intravenous route

Units in package:

50 or 100 ml in single units

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic group:

plasma substitutes and plasma protein fractions

Therapeutic area:

Blood substitutes and plasma protein fractions; albumin

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.

Authorization status:

Marketed

Authorization date:

2007-08-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLEXBUMIN 200 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 Flexbumin 200 g/l is and what it is used for
2.
What you need to know before you use Flexbumin 200 g/l
3.
How to use Flexbumin 200 g/l
4.
Possible side effects
5.
How to store Flexbumin 200 g/l
6.
Contents of the pack and other information
1.
WHAT FLEXBUMIN 200 G/L IS AND WHAT IT IS USED FOR
Flexbumin 200 g/l is a solution of plasma protein and belongs to the
pharmacotherapeutic group of plasma
substitutes and plasma protein fractions. Plasma is the fluid in which
blood cells are suspended.
This medicine is used for restoration and maintenance of circulating
blood volume when there is not enough
blood volume.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLEXBUMIN 200 G/L
DO NOT USE FLEXBUMIN 200 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 Flexbumin 200
g/l.
-
If you get headache, difficulties in breathing or feeling faint during
the treatment please tell your doctor or
nurse. It can be an allergic reaction.
-
If you have:
– decompensated heart failure
– high blood pressure
– oesophageal varices (swelled veins in the oesophagus)
– pulmonary oedema (fluid in the lungs)
– a tendency to spontaneous bleeding
– severe anemia (lack of red blood cells)
– decreased urine formation
inform your

Summary of Product characteristics

Health Products Regulatory Authority
09 November 2023
CRN00DQJ4
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flexbumin 200 g/l solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Flexbumin 200 g/lis a solution containing 200 g/l (20%) of total
protein of which at least 95% is human albumin.
A bag of 100 ml contains 20 g of human albumin.
A bag of 50 ml contains 10 g of human albumin
The solution is hyperoncotic.
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 (PCW-pressure)
- urine output
- electrolyte
- haematocrit/haemoglobin
- clinical signs of cardiac/respiratory failure (e.g.dyspnoea)
- clinical signs of increasing intra-cranial pressure (e.g. headache)
Paediatric population
The safety and efficacy of the use of Albumin (Human) solution in
paediatric patients have not been established in
company-sponsored