Albunorm 20%, 200g/l, solution for infusion

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Human plasma protein not containing less than 96% human albumin

Beschikbaar vanaf:

Octapharma (IP) SPRL

ATC-code:

B05AA; B05AA01

INN (Algemene Internationale Benaming):

Human plasma protein not containing less than 96% human albumin

Dosering:

200 gram(s)/litre

farmaceutische vorm:

Solution for infusion

Prescription-type:

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

Therapeutisch gebied:

Blood substitutes and plasma protein fractions; albumin

Autorisatie-status:

Marketed

Autorisatie datum:

2009-06-25

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUNORM 20%
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 or pharmacist.
-
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.
IN THIS LEAFLET:
1.
What Albunorm 20% is and what it is used for
2.
What you need to know before you use Albunorm 20%
3.
How to use Albunorm 20%
4.
Possible side effects
5.
How to store Albunorm 20%
6.
Contents of the pack and other information
1.
WHAT ALBUNORM 20% IS AND WHAT IT IS USED FOR
Albunorm 20% belongs to the pharmacotherapeutic group: blood
substitutes and plasma protein
fractions.
The product is given to patients to restore and maintain circulating
blood volume where a
deficiency in volume has been demonstrated.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALBUNORM 20%
DO NOT USE ALBUNORM 20%
if you are allergic to human albumin preparations or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
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Talk to your doctor, pharmacist or nurse before using Albunorm 20%.
Take special care with Albunorm 20%
-
if you are at special risk from increased blood volume e.g. in case of
severe heart disorders,
high blood pressure, dilated veins of the oesophagus, fluid in the
lung, bleeding disorders,
severely lowered
red blood cell count or without urine output.
-
when there are signs for increased blood volume (headache, breathing
disorder, jugular vein
congestion) or increased blood pressure. The infusion should be
stopped immediately.
-
when there are signs of

Productkenmerken

Health Products Regulatory Authority
29 January 2021
CRN00C4RJ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Albunorm 20%, 200g/l, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Albunorm 20% is a solution containing 200 g/l of total protein of
which at least 96% is human albumin.
A bottle of 50 ml contains 10 g of human albumin.
A bottle of 100 ml contains 20 g of human albumin.
Albunorm 20% is a hyperoncotic solution.
Excipients with known effect:
Sodium (144-160 mmol/l)
For a 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.
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

haematocrit/haemoglobin
PAEDIATRIC POPULATION
Data on the use of Albunorm 20% in children are limited; therefore,
the product should only be administered to these
individuals if the benefits clearly outweigh potential risks.
Health Products Regulatory Authority
29 January 2021
CRN00C4RJ
Page 2 of 5
METHOD OF ADMINISTRATION
Human albumin can be directly administered by the intravenous route,
or it can be diluted in an isotonic solution (e.g. 5%
glucose