Alburex 5, 50 g/l, solution for infusion

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Human albumin

Mevcut itibaren:

CSL Behring GmbH

ATC kodu:

B05AA; B05AA01

INN (International Adı):

Human albumin

Doz:

50 gram(s)/litre

Farmasötik formu:

Solution for infusion

Reçete türü:

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

Terapötik alanı:

Blood substitutes and plasma protein fractions; albumin

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2014-06-13

Bilgilendirme broşürü

Alburex-PIL-IE
1
CSL BEHRING
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUREX
® 5, 50 G/L, SOLUTION FOR INFUSION &
ALBUREX
® 20, 200 G/L, SOLUTION FOR INFUSION
Human albumin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 healthcare
professional.
•
If you get any side effects, talk to your doctor or healthcare
professional. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Alburex is and what it is used for
2.
What you need to know before you are given Alburex
3.
How to use Alburex
4.
Possible side effects
5.
How to store Alburex
6.
Contents of the pack and other information
1.
WHAT ALBUREX IS AND WHAT IT IS USED FOR
WHAT ALBUREX IS
Alburex is a plasma substitute.
HOW ALBUREX WORKS
Albumin stabilises the circulating blood volume. It is a carrier of
hormones, enzymes, medicines
and toxins. The albumin protein in Alburex is isolated from human
blood plasma. Therefore the
albumin works exactly as if it was your own protein.
WHAT ALBUREX IS USED FOR
Alburex is used to restore and stabilise the circulating blood volume.
It is normally used under
intensive care situations, when your blood volume has decreased
critically. This may be the case
e.g.:
•
due to severe loss of blood after an injury,
_or_
•
due to a large surface burn
The choice of using Alburex will be made by your doctor. It will
depend on your individual
clinical situation.
Alburex-PIL-IE
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALBUREX
➔
Read this section carefully. The information given should be taken
into consideration by
you and your doctor before you are given Alburex.
DO NOT USE ALBUREX
•
If you are allergic (hypersensitive) to human albumin or any of the
other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
➔
Talk to your doctor or healthcare professional before you

Ürün özellikleri

Health Products Regulatory Authority
19 December 2023
CRN00DY56
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alburex 5, 50 g/l, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alburex 5 is a solution containing 50 g/l of total protein of which at
least 96% is human albumin.
One vial of 250 ml contains 12.5 g of human albumin
One vial of 500 ml contains 25 g of human albumin
Alburex 5 is mildly hypooncotic to normal plasma.
Excipient with known effect:
Alburex 5 contains approximately 3.2 mg sodium per ml of solution (140
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

urine output

electrolyte

haematocrit / haemoglobin
_Paediatric population_
The posology in children and adolescents (0-18 years) should be
adjusted to the patient’s individual requirements.
Health Products Regulatory Authority
19 December 2023
CRN00DY56
Page 2 of