Albunorm 5% Solution for Infusion 50g/l (500ml)

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

HUMAN ALBUMIN, SOLUTION

Mevcut itibaren:

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

ATC kodu:

B05AA01

INN (International Adı):

HUMAN ALBUMIN SOLUTION 50 g/l

Farmasötik formu:

SOLUTION FOR INFUSION

Kompozisyon:

HUMAN ALBUMIN SOLUTION 50 g/l

Reçete türü:

POM

Terapötik alanı:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2010-05-17

Bilgilendirme broşürü

_Page 1 of 5 _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUNORM 5%
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 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 5% is and what it is used for
2.
What you need to know before you use Albunorm 5%
3.
How to use Albunorm 5%
4.
Possible side effects
5.
How to store Albunorm 5%
6.
Contents of the pack and other information
1.
WHAT ALBUNORM 5% IS AND WHAT IT IS USED FOR
Albunorm 5% 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 5%
DO NOT USE ALBUNORM 5%
-
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 5%.
Take special care with Albunorm 5%
_Page 2 of 5 _
_ _
-
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 should be
s

Ürün özellikleri

_Page 1 of 7 _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Albunorm 5%
_, _
50 g/l,
_ _
solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Albunorm 5% is a solution containing 50 g/l of total protein of which
at least 96% is human
albumin.
A bottle of 100 ml contains 5 g of human albumin.
A bottle of 250 ml contains 12.5 g of human albumin.
A bottle of 500 ml contains 25 g of human albumin.
Albunorm 5% is a mildly hypooncotic solution.
Excipients with known effect:
Sodium (144-160 mmol/l)
For 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
_Page 2 of 7 _
_ _
-
central venous pressure
-
pulmonary artery wedge pressure
-
urine output
-
electrolyte
-
haematocrit/haemoglobin
_Paediatric population _
Data on the use of Albunorm 5% 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.
The infusion rate should be adjusted according to the individual
circumstances and the indication.
In plasma exchange the infusio