50 g / l and 200 g / l infusion solution, human albumin solution

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects , talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Alburex is and what it is used for 
2. What you need to know before you use Alburex 
3. How to get Alburex 
4. Possible side effects 
5. How to store Alburex 
6. Contents of the packaging and other information 

1. What Alburex is and what it is used for

What Alburex is

Alburex is a plasma substitute (replaces blood plasma).

How Alburex works

Albumin stabilizes the circulating blood volume. It is a carrier of hormones, enzymes, drugs, and toxic substances in the blood. Protein et albumin in Alburex is extracted from human blood plasma. Therefore, the albumin works just as if it were your own protein .

What Alburex is used for

Alburex is used to restore and stabilize the circulating blood volume. It is usually used in acute situations when the blood volume is critically low. This may be the case, for example:

  • due to large blood losses after an injury or
  • due to large burns

The choice to use Alburex will be made by your doctor. It depends on your medical condition.

2. What you need to know before using Alburex

Do not use Alburex

→ Read this section carefully. You and your doctor should consider the information before receiving Alburex.

DO NOT use Alburex

if you are allergic (hypersensitive) to human albumin or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

→ Talk to your doctor or nurse before receiving Alburex.

What circumstances increase the risk of side effects?

Your doctor or nurse will pay special attention to whether an abnormal increase in blood volume ( hypervolemia ) or dilution of the blood (hemodilution) may be dangerous for you. Examples of such conditions are:

  • heart failure requiring treatment with medication (decompensated heart failure )
  • high blood pressure ( hypertension )
  • dilated blood vessels in the esophagus (esophageal varices)
  • abnormal accumulation of fluid in the lungs ( pulmonary edema )
  • tendency to bleeding
  • severe decrease in red blood cell count (severe anemia )
  • severe decrease in urinary excretion due to kidney disease or problems with urine flow ( renal and postrenal anuria ) 
    → Tell your doctor or nurse before treatment if at least one of these conditions affects you.

When can it be appropriate to stop infusion one?

  • Allergic reactions ( hypersensitivity reactions ) may occur and in very rare cases may be severe enough to cause shock (see also section 4 “Possible side effects”).→ Tell your doctor or nurse immediately if you notice any such reactions during infusion of Alburex. He or she will decide to stop the infusion completely and begin appropriate treatment.
  • An abnormal increase in blood volume ( hypervolemia ) may occur if the dosageand infusion rate is not adjusted sufficiently according to your condition. This can lead to congestion of the heart and circulation ( cardiovascular congestion). The first signs of such congestion are headaches, difficulty breathing, or congestion in the jugular vein (jugular vein stasis).→ Tell your doctor or nurse immediately if you notice such signs. He or she will stop the infusion one and monitor your blood circulation appropriately.

Information on safety with respect to infections you

When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes:

  • a careful selection of blood and plasma donors to ensure that people at risk of being infected are excluded;
  • testing of individual donations and plasma pools for signs of virus/infection
  • steps in the management of blood and plasma that can inactivate or secrete any viruses.

Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to unknown or new viruses and other types of infection.

There are no reports of virus transmission with albumin manufactured according to European Pharmacopoeia requirements and established procedures.

It is strongly recommended that the name and batch number of the product be noted each time you are given Alburex to have a list of used batches.

Other medicines and Alburex

No specific interaction ( interaction ) between Alburex and other drugs is known.

→ However, tell your doctor or healthcare professional if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

→ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine. Your doctor will decide if you can get Alburex during your pregnancy or while you are breast-feeding.

The use of Alburex in pregnant or lactating women has not been studied separately. However, drugs containing human albumin have been used in pregnant or lactating women. Experience shows that no harmful effects are to be expected either during pregnancy or on the fetus or the newborn baby.

Driving and using machines

No effects on the ability to drive and use machines have been observed with Alburex.

Alburex contains sodium

This medicine contains approximately 3.2 mg sodium per ml solution (140 mmol / l). Doctors or healthcare professionals will take this into account if you have been prescribed a low-salt diet.

3. How to get Alburex

Alburex is given to you by your doctor or nurse.

It should only be given as an infusion into a vein ( intravenous infusion ). The product should be warmed to room or body temperature before use.

Your doctor will decide how much Alburex to give you. The amount and rate of infusion depend on your individual needs.

Your doctor or nurse will regularly monitor important blood measurements, such as:

  • your blood pressure
  • your heart rate
  • your urine output
  • your blood tests.

These values ​​are checked to determine the correct dose and infusion rate.

Alburex 50 g / l must not be mixed with other medicines or blood products.

Alburex 200 g / l must not be mixed with other medicinal products (other than diluents such as 50 mg/ml (5%) glucose solution or 9 mg/ml (0.9%) sodium chloride solution) or blood products.

If you take more Alburex than you should

Alburex is given only under medical supervision. Therefore, an overdose is unlikely to occur. An abnormal increase in blood volume ( hypervolemia ) may occur if the dosage and infusion rate are too high. This can lead to congestion of the heart and circulation ( cardiovascular congestion).

The first signs of such an overload include:

  • headache
  • breathing difficulties
  • congestion of the jugular vein (throat vein stasis) 
    → Tell your doctor or nurse immediately if you notice such symptoms.

Your doctor or nurse may also detect signs such as

  • increased blood pressure
  • increased central venous pressure
  • an abnormal accumulation of fluid in the lungs ( pulmonary edema ).

In all such situations, he or she will discontinue the infusion and monitor your blood circulation.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Such side effects may occur even if you have previously used Alburex and then tolerated it well.

The general experience with human albumin solutions shows that the following side effects can be observed.

Allergic reactions ( hypersensitivity reactions ) can occur and in very rare cases (less than 1 in 10,000 patients treated) can be severe enough to cause shock.

Symptoms of an allergic reaction may include one or more of the following:

  • skin reactions, e.g. redness, itching, swelling, blisters, rash or hives (itchy blisters)
  • difficulty breathing, e.g. wheezing, tightness of the chest, shortness of breath or cough
  • swelling of the face, eyelids, lips, tongue or throat
  • cold-like symptoms, e.g. stuffy or runny nose, sneezing, red, itchy, swollen, or watery eyes
  • headache, stomach pain, nausea, vomiting, or diarrhea. 
    → Tell your doctor or nurse immediately if you notice such reactions during infusion with Alburex. At such times, he or she will stop the infusion and begin appropriate treatment.

The following mild side effects may occur in rare cases (between 1 in 1,000 and 1 in 10,000 patients treated):

  • redness
  • itchy rash ( urticaria )
  • fever
  • nausea

They usually disappear quickly when the infusion rate is reduced or the infusion is stopped.

The same side effects have been observed with Alburex after market introduction. However, the exact frequency of these side effects is not known.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Alburex

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and label of the vial after the abbreviation “EXP” The expiry date refers to the last day of that month.
  • Once the vial has been opened, the contents should be used immediately.
  • Do not store above 25 ° C.
  • Do not freeze.
  • Keep the vial in the outer carton. Sensitive to light.
  • Do not use this medicine if you notice that the solution is cloudy or contains particles.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is human albumin. 
    Alburex is a solution that contains a total of 50 g / l or 200 g / l protein of which at least 96% is human albumin. 

    One vial of Alburex 50 g / l with 100 ml contains 5 g of human albumin.One vial of Alburex 50 g / l with 250 ml contains 12.5 g of human albumin.A vial Alburex 50 g / l with 500 ml containing 25 g of human albumin.One vial of Alburex 200 g / l with 50 ml contains 10 g of human albumin.One vial of Alburex 200 g / l with 100 ml contains 20 g of human albumin.

  • The other ingredients are N-acetyltryptophan, sodium salt, sodium caprylate, sodium chloride, water for injections.

What the medicine looks like and the contents of the pack

Alburex is a solution for infusion . The solution is clear and slightly viscous. It is almost colorless or yellow, amber or green.

Pack sizes:

One vial per pack

Alburex 50 g / l: 5 g / 100 ml, 12.5 g / 250 ml, 25 g / 500 ml.

Alburex 200 g / l: 10 g / 50 ml, 20 g / 100 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behringstrasse 76

D-35041 Marburg

Germany

This medicinal product is authorized under the European Economic Area under the names:

Belgium, Luxembourg, Netherlands: Alburex 5, 50 g / l and Alburex 20, 200 g / l, Solution for infusion, Solution for perfusion , Infusion solution

Bulgaria: Albureks 5, 50 g / l and Albureks 20, 200 g / l Infusion infusion

Cyprus: Alburex 5, 50 g / l, ιάλυμα για έγχυση

Cyprus, Greece: Alburex 20, 200 g / l, ιάλυμα για έγχυση

Slovakia: Alburex 5, 50 g / l and Alburex 20, 200 g / l, infused roztok / infúzny roztok

Denmark: Human Albumin CSL Behring 5% and 20%

France: Alburex 50 g / l and Alburex 200 g / l, perfusion solution

Austria, Germany: Alburex 5, 50 g / l and Alburex 20, 200 g / l, Infusion solution

Hungary: Alburex 50g / l and Alburex 200 g / l oldatos infusion

Italy: Alburex 5%, 50 g / l and Alburex 20%, 200 g / l, infusion solution

Finland, Norway, Iceland, Alburex 50 g / l and Alburex 200 g / l, infusion test, liquid / infusion solution, solution / for intravenous / infusion use only , solution.

Poland: Alburex 5, 50g / l and Alburex 20, 200 g / l, roztwór do infusion

Portugal: Alburex 5, 50 g / l and Alburex 20, 200 g / l, perfusion solution

Romania: Alburex 50 g / l and Alburex 200 g / l, perfusion solution

Slovenia: Alburex 50 g / l and Alburex 200 g / l infusion solution

Spain: Alburex 50 g / l and Alburex 200 g / l, perfusion solution

United Kingdom, Ireland: Alburex 5, 50 g / l and Alburex 200, 200 g / l, solution for infusion

Muhammad Nadeem

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