Human Albumin Baxalta 200g/l, 100ml vial

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

ALBUMIN, HUMAN

可用日期:

Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria

ATC代码:

B05AA01

INN（国际名称）:

ALBUMIN, HUMAN 200 g/l

药物剂型:

SOLUTION FOR INFUSION

组成:

ALBUMIN, HUMAN 200 g/l

处方类型:

POM

治疗领域:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

授权状态:

Authorised

授权日期:

2007-07-10

资料单张

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.
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产品特点

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Human Albumin 200 g/l Baxalta
Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin 200 g/l Baxter/Baxalta 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
Page 3 of 8
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urine output
-
electrolyte concentration
-
haematocrit/haemoglobin
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clinical signs of cardiac/respiratory failure (e.g., dyspnoea)
-
clinical signs of increasing intra-cranial pressure (e.g., headache)
Method of administration
Human Albumin 200 g/l Baxter/Baxalta can be directly administered by
the intravenous
route, or it can also be diluted in an isotoni