Human Albumin Baxalta 200 g/l Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
18-01-2022
Summary of Product characteristics
(SPC)
18-11-2020
Active ingredient:
Plasma protein containing at least 95% human albumin
Available from:
Baxalta Innovations GmbH
ATC code:
B05AA; B05AA01
INN (International Name):
Plasma protein containing at least 95% human albumin
Dosage:
200 gram(s)/litre
Pharmaceutical form:
Solution for infusion
Administration route:
intravenous route
Units in package:
50 ml of solution in a vial, pack size of 1 or 70. 100 ml of solution in a vial, pack size of 1 or 56
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic group:
plasma substitutes and plasma protein fractions
Therapeutic area:
Blood substitutes and plasma protein fractions; albumin
Therapeutic indications:
Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate
Authorization status:
Not marketed
Authorization date:
2006-12-21
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMAN ALBUMIN BAXALTA 200 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, 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 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 Human Albumin Baxalta 200 g/l is and what it is used for
2.
What you need to know before you use Human Albumin Baxalta 200 g/l
3.
How to use Human Albumin Baxalta 200 g/l
4.
Possible side effects
5.
How to store Human Albumin Baxalta 200 g/l
6.
Contents of the pack and other information
1. WHAT HUMAN ALBUMIN BAXALTA 200 G/L IS AND WHAT IT IS USED FOR
Human Albumin Baxalta 200 g/l contains a protein called albumin found
in the liquid component of
the blood (the plasma) and belongs to the group of medical products
called “plasma substitutes and
plasma protein fractions”. It is made from human blood collected
from blood donors.
A vial of 50 ml contains 10 g of human albumin.
A vial of 100 ml contains 20 g of human albumin.
Human albumin is used to restore and maintain blood volume in patients
who have lost blood or fluid
due to certain medical conditions. The choice of albumin rather than
an artificial substitute and the
dose needed will depend on the clinical situation of the individual
patient.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HUMAN ALBUMIN BAXALTA 200 G/L
DO NOT USE HUMAN ALBUMIN BAXALTA 200 G/L:
-
if you are allergic to human albumin 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 Human Albumin
Baxalta 200 g/l.
-
i
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
17 November 2020
CRN00C1DR
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Human Albumin Baxalta 200 g/l Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin Baxalta 200 g/l is a solution containing 200 g/l of
total protein of which at least 95% is human albumin.
A vial of 100 ml contains 20 g of human albumin.
A vial of 50 ml contains 10 g of human albumin.
The solution is hyperoncotic.
Excipients with known effect:
Sodium 100-130 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 concentration
- haematocrit/haemoglobin
- clinical signs of cardiac/respiratory failure (e.g., dyspnoea)
- clinical signs of increasing intra-cranial pressure (e.g., headache)
Method of administration
Health Products Regulatory Authority
17 November 2020
CRN00C1DR
Page 2 of 6
Human Albumin Baxalta 200 g/l
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