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Package leaflet: Information for the user

HUMAN ALBUMIN 200 g/l BAXTER

Solution for Infusion

Human albumin

Baxter

0001853

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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 200 g/l Baxter is and what it is used for

2.    What you need to know before you use Human Albumin 200 g/l Baxter

3.    How to use Human Albumin 200 g/l Baxter

4.    Possible side effects

5.    How to store Human Albumin 200 g/l Baxter

6.    Contents of the pack and other information

1.    What Human Albumin 200 g/l Baxter is and what it is used for

Human Albumin 200 g/l Baxter 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 200 g/l Baxter

Do not use Human Albumin 200 g/l Baxter:

-    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 200 g/l Baxter.

-    if you think you have an allergic reaction during the treatment, with difficulty breathing, feeling faint or other symptoms. If this happens, tell your doctor or nurse immediately because the infusion will have to be stopped and medical treatment for shock may need to be implemented.

-    if you have:

-    uncontrolled heart failure

-    high blood pressure

-    oesophageal varices (swollen veins in the oesophagus)

-    pulmonary oedema (fluid on the lungs)

-    a tendency to spontaneous bleeding

-    severe anemia (lack of red blood cells)

-    no urine formation.

If you think any of these applies to you, inform your doctor so that he/she can take appropriate precautions.

When medicines are made from human blood or plasma, certain steps 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 200 g/l Baxter the name and batch number of the product are recorded in order to maintain a record of the batches used.

Other medicines and Human Albumin 200 g/l Baxter

-    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

-    No specific complications of taking human albumin with other medicinal products are known.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby ask your doctor or pharmacist before taking this medicine . Your doctor will decide if you can use Human Albumin 200 g/l Baxter during pregnancy or breast-feeding.

Driving and using machines

No effect on the ability to drive or use machines has been observed.

Human Albumin 200 g/l Baxter contains sodium

Human Albumin 200 g/l Baxter contains 100 - 130 mmol/l sodium. This is to be taken into consideration by patients on a controlled sodium diet.

3. How to use Human Albumin 200 g/l Baxter

Human Albumin 200 g/l Baxter is a medicine for hospital use. It will therefore be administered in a hospital by appropriate health care personnel. Your doctor will establish the amount of product to be administered, the frequency of dosing and the duration of treatment based on your specific condition. He/she will monitor your condition,

Perforation

The following information is intended for healthcare professionals only:

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-    Human Albumin Solution 200 g/l should be administered by the intravenous route, infusing the package contents directly or it can also be diluted in an isotonic solution (e.g. 5 % glucose or 0.9% sodium chloride).

-    Human Albumin Solution 200 g/l should not be diluted with water for injection, since this could cause hemolysis in the recipient of the product.

-    Do not use unless seal is intact. If leaks are found, discard.

- Solutions should be clear, slightly viscous, almost colourless, yellow, amber or green.. Solutions that are turbid or showing sediments should not be used, since this could be an indication that the protein is unstable or the solution has been contaminated. Once the package has been opened, its contents must be used immediately.

-    Infusion is performed by the intravenous route using a disposable sterile and pyrogen-free infusion set. Before inserting the infusion set in the cap, this should be disinfected with an appropriate antiseptic. Once the infusion set is attached to the vial, the contents should be perfused immediately. Unused solutions should be adequately discarded.

-    The infusion rate should be adjusted according to the individual circumstances and the indication.

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

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

-    When concentrated albumin is administered, adequate hydration of the patient must be ensured. Patients should be adequately monitored to prevent circulatory overload and overhydration.

Perforation