Albutein, 50 gram(s)/litre, solution for infusion

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Human albumin solution

Доступна з:

Instituto Grifols S.A.

Код атс:

B05AA01

ІПН (Міжнародна Ім'я):

Human albumin solution

Дозування:

50 gram(s)/litre

Фармацевтична форма:

Solution for infusion

Терапевтична области:

albumin

Статус Авторизація:

Not marketed

Дата Авторизація:

2021-10-08

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUTEIN 50 G/L, SOLUTION FOR INFUSION
human albumin
READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE;
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 symptoms are the same as yours.
-
If you get any side effects tell your doctor, pharmacist or nurse.
This includes any side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Albutein 50 g/l is and what it is used for
2.
What you need to know before you use Albutein 50 g/l
3.
How to use Albutein 50 g/l
4.
Possible side effects
5.
How to store Albutein 50 g/l
6.
Contents of the pack and other information
1.
WHAT ALBUTEIN 50 G/L IS AND WHAT IT IS USED FOR
Albutein 50 g/l is a solution for intravenous infusion containing
proteins extracted from human plasma
(plasma proteins), which is the liquid part of the blood. Each
bottle/bag contains a solution of 50 g
plasma protein/litre of which at least 95% is human albumin.
This medicinal product belongs to a group of medicines known as plasma
substitutes and plasma
protein fractions.
Albutein 50 g/l is used to restore and maintain the circulating blood
volume where volume deficiency
has been demonstrated and use of a plasma substitute is appropriate.
Albutein can be used for all age groups. For children, see section 4.
If you have any questions about the use of Albutein 50 g/l please ask
your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALBUTEIN 50 G/L
DO NOT USE ALBUTEIN 50 G/L
-
If you are allergic (hypersensitive) to the active ingredient or to
any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you start using
Albutein 50 g/l.
Special care should be taken with Albutein 50 g/l
•
If you have a special risk

Характеристики продукта

Health Products Regulatory Authority
16 January 2024
CRN00DJ8Z
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Albutein, 50 gram(s)/litre, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Albutein 50 g/l is a solution containing 50 g/l (5%) of total protein
of which at least 95% 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.
A bag of 100 ml contains 5 g of human albumin.
A bag of 250 ml contains 12.5 g of human albumin.
A bag of 500 ml contains 25 g of human albumin.
Albutein 50 g/l has a mildly hypooncotic effect to normal plasma.
Excipient(s) with known effect
The solution contains between 130 - 160 mmol/l of sodium and less than
2 mmol/l of potassium.
Produced from the plasma of human donors.
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.
Albutein can be used for all age groups. For paediatric population,
see section 4.4.
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
Health Products Regulatory Authority
16 January 202