Albunorm 20% Solution for Infusion 200g/l (100ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HUMAN ALBUMIN, SOLUTION

Available from:

Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium

ATC code:

B05AA01

INN (International Name):

HUMAN ALBUMIN SOLUTION 200 g/l

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

HUMAN ALBUMIN SOLUTION 200 g/l

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2010-05-17

Patient Information leaflet

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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. WHAT IS 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
Talk to your doctor, pharmacist or nurse before using Albunorm 20%.
Take special care with Albunorm 20%
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_ _
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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 an allergic reaction. The infusion

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Albunorm 20%
_,_
200 g/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.
Aclear, 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
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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.
Method of administration
Human albumin can be directly administered by the intravenous route,
or it can also be diluted in an
isotonic solution (e.g. 5% glucose or 0.9% sodium chloride).
The infusion rate should be adjusted according to the individual
circumstances