Human Albumin Biotest 5% Solution For Infusion
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PACKAGE LEAFLET: INFORMATION FOR THE USER
(50 g/l)
Solution for infusion
Human albumin
A Biotest
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Albiomin 5% (50 g/l) is and what it is used for
2. Before you are given Albiomin 5% (50 g/l)
3. How you are given Albiomin 5% (50 g/l)
4. Possible side effects
5. How to store Albiomin 5% (50 g/l)
6. Further information
1. WHAT ALBIOMIN 5% (50 g/l) IS AND WHAT IT IS USED FOR
Albiomin 5% (50 g/l) is a solution for infusion (into a vein). 1000 ml solution contains 50 g human plasma protein of which at least 95 % is human albumin.
Albiomin 5% (50 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. BEFORE YOU ARE GIVEN ALBIOMIN 5% (50 g/l)
You will not receive Albiomin 5% (50 g/l) 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 Albiomin 5% (50 g/l):
Suspicion of allergic or anaphylactic type reactions requires an immediate stop 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 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 Albiomin 5% (50 g/l) 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
Albiomin 5% (50 g/l) has no known effects on the ability to drive or use machines.
3. HOW YOU ARE GIVEN ALBIOMIN 5% (50 g/l)
Albiomin 5% (50 g/l) treatment will usually be given in hospital by a doctor or a nurse.
Human albumin can be given directly into a vein.
Dosage and Frequency of Administration
The amount of Albiomin 5% (50 g/l) you receive depends on your size, the illness, and on fluid or protein losses.
Your doctor will calculate the dose of Albiomin 5% (50 g/l) and how often you will receive it to obtain the correct levels in your blood.
If you are given more Albiomin 5% (50 g/l) 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, Albiomin 5% (50 g/l) 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.
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 the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ALBIOMIN 5% (50 g/l)
Albiomin 5% (50 g/l) should be kept in the outer carton to protect it from light. Albiomin 5% (50 g/l) should not be stored above 25°C.
Do not freeze. Keep out of the reach and sight of children.
Do not use Albiomin 5% (50 g/l) 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 Albiomin 5% (50 g/l) contains
Each vial with 250 ml solution contains 12.5 g of human plasma protein.
It also contains the other ingredients caprylate, N-acetyl-DL-tryptophanate, sodium ions, and water for injections.
What Albiomin 5% (50 g/l) looks like and contents of the pack
A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.
Glass vial with 250 ml
Marketing Authorisation Holder and Manufacturer
Biotest Pharma GmbH Landsteinerstrafte 5 63303 Dreieich Germany
Tel.: +49 6103 801-0
Fax: +49 6103 801-150 und -727
This medicinal product is authorised in the Member States of the EU under the following trade names:
Germany: Albiomin 5%
This leaflet was last approved in {month YYYY}
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:
Special warnings and special precautions for use
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 hae-matocrit 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 Albiomin 5% (50 g/l) 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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