Human Albumin Grifols 50 g/l solution for infusion

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Human plasma protein

MAH:

Instituto Grifols S.A.

ATC_code:

B05AA; B05AA01

INN:

Human plasma protein

dosage:

50 gram(s)/litre

pharmaceutical_form:

Solution for infusion

prescription_type:

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

therapeutic_area:

Blood substitutes and plasma protein fractions; albumin

authorization_status:

Not marketed

authorization_date:

2007-01-26

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMAN ALBUMIN GRIFOLS
® 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 nurse.
-
If you get any side effects, talk to your doctor 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
® 50 g/l is and what it is used for
2.
What you need to know before you use Human Albumin Grifols
®
50 g/l
3.
How to use Human Albumin Grifols
®
50 g/l
4.
Possible side effects
5.
How to store Human Albumin Grifols
®
50 g/l
6.
Contents of the pack and other information
1.
WHAT HUMAN ALBUMIN GRIFOLS
® 50 G/L IS AND WHAT IT IS USED FOR
Human Albumin Grifols
®
50 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 50 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
®
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. The choice of an albumin solution rather than an
artificial plasma
substitute will depend on the clinical situation of the individual
patient, based on official
recommendations.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HUMAN ALBUMIN GRIFOLS
® 50 G/L
DO NOT USE HUMAN ALBUMIN GRIFOLS
® 50 G/L
If you are allergic 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
®
50 g/l at the end of this

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Human Albumin Grifols 50 g/l solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin
Human Albumin Grifols 50 g/l is a solution containing 50 g/l of total
protein of which at least 95% is human albumin.
A bottle of 250 ml contains at least 11.87 g of human albumin.
Human Albumin Grifols 50 g/l is mildly hypooncotic to normal plasma.
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
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