Human Albumin CSL Behring, 200 g/l, solution for infusion

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Human albumin solution

可用日期:

CSL Behring GmbH

ATC代码:

B05AA01

INN（国际名称）:

Human albumin solution

剂量:

20, 200 gram(s)/litre

药物剂型:

Solution for infusion

治疗领域:

albumin

授权状态:

Not marketed

授权日期:

2020-07-31

资料单张

CSL BEHRING
HUMAN ALBUMIN CSL BEHRING
PIL/IE/ENGLISH, REV.:18-SEP-2020/RMS DAY 20 POSITION
CSL Behring
Page 2 of 8
Human Albumin CSL Behring -IE-PIL_18-SEP-2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMAN ALBUMIN CSL BEHRING, 200 G/L, SOLUTION FOR INFUSION
Active substance: human albumin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your doctor or pharmacist.

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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Human Albumin CSL Behring is and what it is used for
2.
What you need to know before you are given Human Albumin CSL Behring
3.
How to use Human Albumin CSL Behring
4.
Possible side effects
5.
How to store Human Albumin CSL Behring
6.
Contents of the pack and other information
1.
WHAT _HUMAN ALBUMIN CSL BEHRING_ IS AND WHAT IT IS USED FOR
_WHAT IS HUMAN ALBUMIN CSL BEHRING_
Human Albumin CSL Behring is a plasma substitute.
_HOW HUMAN ALBUMIN CSL BEHRING WORKS_
Albumin stabilises the circulating blood volume. It is a carrier of
hormones, enzymes, medicinal
products and toxins. The albumin protein in Human Albumin CSL Behring
is taken from human
blood plasma. Therefore the albumin works exactly as if it was your
own protein.
_WHAT HUMAN ALBUMIN CSL BEHRING IS USED FOR_
Human Albumin CSL Behring is used to restore and stabilize the
circulating blood volume. It is
normally used under intensive care situations, when your blood volume
has decreased critically.
This may be the case e.g.:

due to severe loss of blood after an injury _or_

due to a large surface burn
The choice of using Human Albumin CSL Behring will be made by your
doctor. It will depend on
you

产品特点

Health Products Regulatory Authority
21 February 2022
CRN009XRV
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Human Albumin CSL Behring, 200 g/l, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin CSL Behring is a solution containing 200 g/l of total
protein of which at least 96 % is human albumin.
A vial of 100 ml contains at least 19.2 g of human albumin.
A vial of 50 ml contains at least 9.6 g of human albumin.
The solution is hyperoncotic.
Excipients with known effect:
Sodium 125 mmol per litre.
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.
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_
The posology in children and adolescents (0-18 years) is not expected
to be different from that of adults.
Method of administration
Human Albumin CSL Behring can be directly administered by the
intravenous route, or it can also be diluted in an isotonic
solution (e.g. 5 % glucose or 0.9 % sodium chloride). For instructions
on dilution of the medicinal product before
administrati