Human Albumin Grifols 200g/l Solution for Infusion

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Human albumin

Доступно од:

Instituto Grifols S.A.

АТЦ код:

B05AA; B05AA01

INN (Међународно име):

Human albumin

Дозирање:

200 gram(s)/litre

Фармацеутски облик:

Solution for infusion

Тип рецептора:

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

Терапеутска област:

Blood substitutes and plasma protein fractions; albumin

Статус ауторизације:

Not marketed

Датум одобрења:

2001-10-19

Информативни летак

150 mm
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, 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, 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 Human Albumin Grifols
®
200 g/l is and what it is used for
2. What you need to know before you use Human Albumin Grifols
®
200 g/l
3. How to use Human Albumin Grifols
®
200 g/l
4. Possible side effects
5. How to store Human Albumin Grifols
®
200 g/l
6. Contents of the pack and other information
1. WHAT HUMAN ALBUMIN GRIFOLS
® 200 G/L IS AND WHAT IT IS USED FOR
Human Albumin Grifols
®
200 g/l is a solution for intravenous infusion containing proteins
extracted from human plasma, which is the
liquid part of the blood. Each bottle contains a solution of 200 g
plasma protein/litre of which at least 95% is human albumin protein.
This medicinal product belongs to a group of medicines known as plasma
substitutes and plasma protein fractions.
Human Albumin Grifols
®
200 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.
If you have any questions about the use of Human Albumin Grifols
®
200 g/l please ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HUMAN ALBUMIN GRIFOLS
® 200 G/L
DO NOT USE HUMAN ALBUMIN GRIFOLS
® 200 G/L
If you are allergic (hypersensitive) to human albumin protein or any
of the other ingredients of this medicine (listed in section 6)
(see “Important information about some of the ingredients of Human
Albumin Grifols
®
200 g/l” at the end of this section).
WARNINGS AND PRECAUTIONS
Talk

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Human Albumin Grifols 200g/l Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin
Human Albumin Grifols 200g/l is a solution containing 200 g/l of total
protein of which at least 95% is human
albumin.
A vial of 10 ml contains at least 1.9 g of human albumin.
A vial of 50 ml contains at least 9.5 g of human albumin.
A vial of 100 ml contains at least 19 g of human albumin.
Human Albumin Grifols 200g/l has a hyperoncotic effect.
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_
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