Description

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AIZEN ® is a solution for infusion (into a vein). 100ml solution contains 20 g human plasma protein of which at least 95% is human albumin.

AIZEN ® 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.

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BEFORE YOU ARE GIVEN AIZEN ®

Do not receive AIZEN ® 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 AIZEN ®

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.

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 buildup 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)
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• Renal and post-renal anuria

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 AIZEN ® 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

AIZEN ® has no known effects on the ability to drive or use machines.

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HOW YOU ARE GIVEN AIZEN ®

AIZEN ® 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 AIZEN ® you receive depends on your size, the illness, and on fluid or protein losses.

Your doctor will calculate the dose of AIZEN ® and how often you will receive it to obtain the correct levels in your blood.

If you are given more AIZEN ® 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.

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POSSIBLE SIDE EFFECTS

Like all medicines, AIZEN ® can cause side effects although not everybody gets them.

Very rarely, severe reactions such as shock may occur. If this happens the infusion will be stopped and the appropriate treatment will be started.

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HOW TO STORE AIZEN

AIZEN ® should be kept in the outer carton to protect it from light. AIZEN ® should not be stored above 25ºC.

Do not freeze. Keep out of the reach and sight of children.

Do not use AIZEN ® 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.

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FURTHER INFORMATION

What AIZEN ® contains:

Each vial with 100 ml solution contains 20 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 injection
The solution is clear, yellow, amber or green
Also available in
Solution for infusion in a bottle (250 ml – pack size of 1 and 10)
Solution for infusion in a bottle (500 ml – pack size of 1)