Albiomin 20% (200 g/l), solution for infusion
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
01-05-2020
Summary of Product characteristics
(SPC)
01-05-2020
Active ingredient:
ALBUMIN, HUMAN
Available from:
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
ATC code:
B05AA01
INN (International Name):
ALBUMIN, HUMAN 20 % (W/V)
Pharmaceutical form:
SOLUTION FOR INFUSION
Composition:
ALBUMIN, HUMAN 20 % (W/V)
Prescription type:
POM
Therapeutic area:
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorization status:
Authorised
Authorization date:
2011-06-08
Patient Information leaflet
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBIOMIN 20% (200 G/L), SOLUTION FOR INFUSION
Human albumin
READ ALL OF THE 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 Albiomin 20% (200 g/l) is and what it is used for
2. What you need to know before you use Albiomin 20% (200 g/l)
3. How to use Albiomin 20% (200 g/l)
4. Possible side effects
5. How to store Albiomin 20% (200 g/l)
6. Contents of the pack and other information
1. WHAT ALBIOMIN 20% (200 G/L)
IS AND WHAT IT IS USED FOR
Albiomin 20% (200 g/l) is a solution for infusion (into a vein). 1
litre solution contains 200 g
human plasma protein of which at least 96% is human albumin.
Albiomin 20% (200 g/l) is used to restore and maintain circulating
blood volume where there is a
low blood volume and the use of a colloid, such as albumin, is
required.
_ _
_ _
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALBIOMIN 20% (200 G/L)
DO NOT USE ALBIOMIN 20% (200 G/L):
•
if you are allergic to albumin preparations or to any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Suspicion of allergic or anaphylactic type reactions requires an
immediate stop of the infusion. In
case of shock, standard medical treatment for shock should be applied.
The infusion will also be stopped if you develop any of the following
conditions as a sign of
cardiovascular overload (hypervolaemia):
•
headache
•
dyspnoea (difficulties in breathing)
•
jugular vein congestion (a build up of fluid in a neck vein)
•
increased blood pressure
•
raised venous pressure (increased pressure in the veins)
•
pulmonary oedema (water on the lungs)
Page 2 of 6
TALK TO YOUR DOCTOR IF YOU SUFFER FROM ANY
Read the complete document
Summary of Product characteristics
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Albiomin 20% (200 g/l), solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin
Albiomin 20% (200 g/l) is a solution containing 200 g/l of total
protein of which at least 96% is
human albumin.
Each vial of 50 ml contains 10 g of human plasma protein of which at
least 96% is human albumin.
Each vial of 100 ml contains 20 g of human plasma protein of which at
least 96% is human albumin.
The product has a hyperoncotic effect.
Excipients with known effect:
One vial of 50 ml Albiomin 20% (200 g/l) contains approximately 140 mg
sodium (6.1 mmol).
One vial of 100 ml Albiomin 20% (200 g/l) contains approximately 280
mg sodium (12.2 mmol).
For the full list of excipients, see 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 or 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
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•
electrolyte
•
haemaotcrit / haemoglobin
METHOD OF ADMINISTRATION
Intravenous use
Human albumin can be directly administered by the intravenous route,
or it can also be diluted in an
isotonic solution (e.g. 0.9% sodium chloride).
The infusion rate s
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