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Package leaflet: Information forthe user

Human Albumin Biotest 20%, solution for infusion

What is in this leaflet:

1.    What Human Albumin Biotest 20% is and what it is used for

2.    Whatyou need to know before you are given Human Albumin Biotest 20%

3.    Howyou are given Human Albumin Biotest 20%

4.    Possible side effects

5.    Howto store Human Albumin Biotest 20%

6.    Contents of the pack and other 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. Whatyou need to know before you are given Human Albumin Biotest 20%

You will not receive Human Albumin Biotest 20% 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 ofthe injection. In case of shock, standard medical treatment for shock should be applied.

The infusion will also be stopped if you develop any ofthe following conditions as a sign of cardiovascular overload (hypervolaemia):

•    headache

•    dyspnoea (difficulties in breathing)

•    jugularvein 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 checkyour 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 ofthe 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% thenameand batch number of the product are recorded in order to maintain a record ofthe batches used.

Other medicines and Human Albumin Biotest 20%

Tell your doctor or pharmacist ifyou are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

Ifyou are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Ifyou 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.

Human Albumin Biotest 20% contains sodium

This medicinal product contains 122 mmol sodium per litre.To be taken into consideration by patients on a controlled sodium diet.

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.

Ifyou 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.

Ifyou have any further questions on the use of the medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 numberofthe product are recorded in order to maintain a record ofthe batches used.

Interactions with other medicinal products and otherforms of interactions

No specific interactions of human albumin with other products are known.

Posology and method of administration Posology

Measuresofadequacy of circulatingvolume 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

Method of administration

In plasma exchange the infusion-rate should be adjusted to the rate of removal. Notes for handling

The solution can be directly administered by the intravenous route, or it can be diluted in an isotonic solution (e.g. 0.9% sodium chloride).

Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If large volumes are administered, the product should be warmed to room or body temperature before use.

The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or have deposits.This may indicate that the protein is unstable or that the solution has become contaminated.

Once the container has been opened, the contents should be used immediately. Any unused product should be disposed of in accordance with local requirements.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via

Yellow Card Scheme

Website: www.mhra.gov.uk/vellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on label and outer carton.

Keep the container in the outer carton, in order to protect from light.

Do not store above 25°C.

Do not freeze.

The product, once opened, should be used immediately.

Immediately before administration, check thatthe solution is clear.The product must not be used if any cloudiness or particles are visible.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist howto throwaway medicinesyou no longer use.These measures will help protect the environment.

6. Contents of the pack and other information What Human Albumin Biotest 20% contains

Each vial with 50 ml solution contains 10 g of human plasma protein of which at least 95% is human albumin.

Each vial with 100 ml solution contains 20 g of human plasma protein of which at least 95% is human albumin.

The other ingredients are: sodium caprylate (16 mmol/l), sodium chloride (63 mmol/l), N-acetyltryptophanate (l6 mmol/l), water for injections.

What Human Albumin Biotest 20% looks like and contents of the pack

A clear, slightly viscous liquid; it is almost colour less, yellow, amber or green.

Glass vial with 50 ml Glass vial with 100 ml

Marketing Authorisation Holder and Manufacturer

Biotest Pharma GmbH Landsteinerstra(5e 5 63303 Dreieich Germany

Tel.: +49 6103 801-0 Fax:+49 6103 801-150 mail@biotest.de

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% (200g/l)

Denmark    Human Albumin Biotest    200g/l

Finland    Albiomin 200g/l

Germany    Albiomin 20% (200g/l)

Greece    Albiomin 20% (200 g/l)

Hungaria    Human Albumin Biotest 20% oldatos infuzio

Italy    Albiomin 20% (200g/l)

Malta    Albiomin 20% (200 g/l)

Norway    Human Albumin Biotest    200 g/l

Poland    Albiomin 20%

Portugal    Albiomin 20% (200 g/l)

Romania    Albiomin 200g/l

Spain    Albiomin 20% (200g/l)

Sweden    Albumin Biotest 200 g/l

United Kingdom Human Albumin Biotest    20%

29.09.15 10:11