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HUMAN ALBUMIN BIOTEST 20% SOLUTION FOR INFUSION

Active substance: HUMAN ALBUMIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Solution for infusion
Human albumin

Read this entire leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Human Albumin Biotest 20% is and what it is used for
2. Before you are given Human Albumin Biotest 20%
3. How you are given Human Albumin Biotest 20%
4. Possible side effects
5. How to store Human Albumin Biotest 20%
6. Further information
1. WHAT HUMAN ALBUMIN BIOTEST 20% IS AND WHAT IT IS USED FOR
Human Albumin Biotest 20% is a solution for infusion (into a vein).
1000 ml solution contains 200 g human plasma protein of which at least
95% is human albumin.
Human Albumin Biotest 20% 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. BEFORE YOU ARE GIVEN HUMAN ALBUMIN BIOTEST 20%
You will not receive Human Albumin Biotest 20% if:
• you are allergic (hypersensitive) to albumin preparations or to any of the
other ingredients (these are listed in section 6 of this leaflet).
Special care will be taken with Human Albumin Biotest 20%:
Suspicion of allergic or anaphylactic type reactions requires immediate
stopping of the injection. In case of shock, standard medical treatment for
shock should be applied.
185909 001

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)
You should tell your doctor if you suffer from any of the following conditions:
– Decompensated cardiac insufficiency (heart failure)
– Hypertension (high blood pressure)
– Oesophageal varices (enlarged veins in the gullet)
– Pulmonary oedema (water on the lungs)
– Haemorrhagic diathesis (tendency to abnormal or spontaneous bleeding)
– Severe anaemia (reduced red blood cells)
– Renal and post-renal anuria (decreased or absent urine production)
He/She will take the appropriate precautions. You will also be monitored by your
doctor to check your circulatory situation with the electrolyte balance and blood
volume.
When medicines are made from human blood or plasma, certain measures are put
in place to prevent infections being passed on to patients. These include careful
selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for
signs of virus/infections. Manufacturers of these products also include steps in the
processing of the blood or plasma that can inactivate or remove viruses. Despite
these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This
also applies to any unknown or emerging viruses or other types of infections.
There are no reports of virus infections with albumin manufactured to European
Pharmacopoeia specifications by established processes.
It is strongly recommended that every time you receive a dose of Human Albumin
Biotest 20% the name and batch number of the product are recorded in order to
maintain a record of the batches used.
Taking other medicines
Please tell your doctor if you are taking, or have recently taken, any other medicines
including any that you may have bought without a prescription from a chemist or
supermarket.

Pregnancy and breast-feeding
If you are pregnant, planning a family, or breast-feeding ask your doctor or pharmacist for advice before taking any medicine. If you have already told your doctor then
follow any instructions that may have been given to you.
Driving and using machines
Human Albumin Biotest 20% has no known effects on the ability to drive or use
machines.
3. HOW YOU ARE GIVEN HUMAN ALBUMIN BIOTEST 20%
Human Albumin Biotest 20% treatment will usually be given in hospital by a doctor
or a nurse.
Human albumin can be given directly into a vein or diluted in 0.9% sodium chloride.
Dosage and Frequency of Administration
The amount of Human Albumin Biotest 20% you receive depends on your size, the
illness, and on fluid or protein losses.
Your doctor will calculate the dose of Human Albumin Biotest 20% and how often
you will receive it to obtain the correct levels in your blood.
If you are given more Human Albumin Biotest 20% than you should
This is very unlikely but your doctor will know what to do if this happens.If you have
any further questions on the use of the product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Human Albumin Biotest 20% can cause side effects, although
not everybody gets them.
The following side effects have been reported:
• flush,
• urticaria (nettle rash),
• fever and nausea (feeling sick).
These occur rarely.
Very rarely, severe reactions such as shock may occur. If this happens the infusion
will be stopped and the appropriate treatment will be started.
If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE HUMAN ALBUMIN BIOTEST 20%
Human Albumin Biotest 20% should be kept in the outer carton to protect it from
light.
Human Albumin Biotest 20% should not be stored above 25ºC.
Do not freeze. Keep out of the reach and sight of children.
Do not use Human Albumin Biotest 20% after the expiry date which is stated on
label and outer carton. The expiry date refers to the last day of that month.
The product, once opened, should be used immediately.
Immediately before administration, check that the solution is clear. The product
must not be used if any cloudiness or particles are visible.
Medicines should not be disposed of via wastewater or household water. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Human Albumin Biotest 20% contains:
Each vial with 50 ml solution contains 10 g of human plasma protein.
Each vial with 100 ml solution contains 20 g of human plasma protein.
It also contains the other ingredients caprylate, N-acetyl-DL-tryptophanate, sodium
ions, and water for injections.
What Human Albumin Biotest 20% looks like and contents of the pack
A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.
Glass vial with 50 ml
Glass vial with 100 ml

Marketing Authorisation Holder and Manufacturer
Biotest Pharma GmbH
Landsteinerstraße 5
63303 Dreieich
Germany
Tel.: +49 6103 801-0
Fax: +49 6103 801-150 und -727
mail@biotest.de
For any information about this medicine, please contact your local representative of the Marketing Authorisation Holder:
Biotest (UK) Ltd.
28 Monkspath Business Park
Highlands Road
Shirley
Solihull
West Midlands B90 4NZ
Tel: +44(0)121 733 3393
Fax: +44(0)121 733 3066
biotestuk@biotestuk.com
PL 04500/0012
POM
This medicinal product is authorised in the Member States of the EU under the
following trade names:
Austria: Albiomin® 200 g/l
Bulgaria: Albiomin® 20% (200 g/l)
Germany: Albiomin® 20% (200 g/l)
Greece: Albiomin® 20% (200 g/l)
Hungary: Human Albumin Biotest 200 g/l
Italy:
Albiomin® 20% (200 g/l)
Malta:
Albiomin® 20% (200 g/l)
Poland: Albiomin® 20% (200 g/l)
Portugal: Albiomin® 20% (200 g/l)
Romania: Albiomin® 20% (200 g/l)
Spain
Albiomin® 20% (200 g/l)
UK:
Human Albumin Biotest 20%
This leaflet was last approved in February 2009.

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE
PROFESSIONALS ONLY:
Special warnings and special precautions for use
The colloid-osmotic effect of human albumin 200 g/l is approximately four times
that of blood plasma. Therefore, when concentrated albumin is administered, care
must be taken to ensure adequate hydration of the patient. Patients should be
monitored carefully to guard against circulatory overload and hyperhydration.
Albumin solutions must not be diluted with water for injections as this may cause
haemolysis in recipients.
If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).
Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the
patient‘s circulatory situation.
There are no reports of virus infections with albumin manufactured to European
Pharmacopoeia specifications by established processes.
It is strongly recommended that every time a dose of Human Albumin Biotest 20%
is administered the name and batch number of the product are recorded in order
to maintain a record of the batches used.
Interactions with other medicinal products and other forms of interactions
No specific interactions of human albumin with other products are known.
Dosage instructions and mode of administration
Dosage
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
Mode of administration
In plasma exchange the infusion-rate should be adjusted to the rate of removal.
Storage and notes for the handling
If large volumes are administered, the product should be warmed to room or body
temperature before use.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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