Consumer Information for: ALBUREX - 25

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Alburex® solutions are medications used to restore and maintain the circulating blood volume in critical clinical situations such as: shock, burns and hypoproteinemia with or without edema.

What it does

Alburex® solutions are medications used to restore and maintain the circulating blood volume in critical clinical situations such as: shock, burns and hypoproteinemia with or without edema.

When it should not be used

Alburex® solutions should not be used if any of the following situations apply to you:

  • If you are allergic to any of the components of the product (the following two subsections address the medication composition);
  • If you suffer from severe anemia;
  • If you suffer from heart failure
What the medicinal ingredient is

The solutions contain either 5% or 25% protein extracted from human plasma, which is the liquid part of the blood.

Alburex® 5 contains 5% (50 g/L) of protein of which at least 96% is Albumin (Human). Alburex® 25 contains 25% (250 g/L) of protein of which at least 96% is Albumin (Human)

What the non-medicinal ingredients are

Sodium N-acetyltryptophanate, Sodium caprylate, Sodium chloride, Water for injection

For a full listing of nonmedicinal ingredients, see Part 1 of the product monograph.

What dosage form it comes in

Alburex® 5 is provided as 5% (50 g/L) solution for infusion in 100 mL, 250 mL and 500 mL vials. Alburex® 25 is provided as 25% (250 g/L) solution for infusion in 50 mL and 100 mL vials.

Warnings and precautions

Serious Warnings and Precautions

Alburex® is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Alburex® is made from human blood, there may be a risk of transmission of infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob Disease (vCJD) agent.

Developing allergic reactions which may include flush, hives, fever, and nausea is possible. On rare occasions these reactions may lead to shock.

BEFORE you use Alburex® talk to your doctor or pharmacist if:

  • you suffer from heart problems
  • you suffer from high blood pressure
  • you suffer from bleeding or blood clotting disorders
  • you suffer from gullet varices
  • you suffer from water in your lungs
  • you suffer from kidney disease
  • you suffer from severe anaemia
Interactions with this medication

Tell your doctor if you are taking other drugs. No specific interaction of human albumin with other drugs medicinal product are known. However, infusing albumin may affect the medicines that bind to albumin.

Proper use of this medication

Alburex® solutions can be infused directly into a vein or can be first diluted in an isotonic solution. Your doctor will decide which is the correct mode of administration and how much you should be given.

The product should be warmed to room temperature before use

The solution should be clear or slightly opalescent. Solutions which are cloudy or have deposits should not be used. This may indicate that the protein is unstable or that the solution has become infected.

Once the vial has been opened, the content should be used immediately. Any unused product should be thrown away

Your doctor will adjust the infusion rate for your individual needs. Normally, the rate is less than 5 mL/min for Alburex® 5 and 1-2mL/min for Alburex® 25 respectively. For plasmaexchange, your doctor will adjust the infusion rate to match the removal rate.

Your doctor will determine your dose based on your size, the severity of your injury or illness and on your fluid and protein losses. To determine the dose required, your doctor may monitor your circulating volume, which may include measurement of:

  • blood pressures and pulse rate
  • lung artery pressure
  • urine production
  • presence of salt and minerals
  • amount of red blood cells and red blood cell protein

If allergic reactions occur, the infusion should be stopped immediately and your doctor should treat you for these reactions. In case of shock, your doctor should treat you according to the current guidelines for the management of shock.

If large volumes of Alburex® solutions are given, your blood clotting and red blood cell levels will be tested. As needed, other blood components (blood clotting factors, salts and minerals, blood platelets and red blood cells) may be given to you. Your doctor will adjust the dose and infusion rate to avoid increasing the volume of circulating blood too much. If there is any sign that this is happening (headache, uncomfortable awareness of your breathing, strong heartbeat in the throat, increased blood pressure or water in the lungs), your doctor must immediately stop the infusion

Alburex® contains approximately 3.2 mg sodium per ml of solution (0.14 M), which should be taken into consideration for patients on a controlled sodium diet.

Your name and the batch number will usually be recorded whenever Alburex® solutions are given to you.

If you have any questions about the dose please ask your doctor

Side effects and what to do about them

If you notice any side effects not mentioned in this leaflet, please inform your doctor

In rare cases flushing, hives, fever and sickness may occur. These reactions normally disappear quickly when the infusion rate is slowed down or the infusion is stopped. In very rare cases severe reactions such as shock may occur. If this happens, the infusion should be stopped and your doctor should treat you for shock.

An excessive increase in the volume of circulating blood may occur if the dose and infusion rate are too high. If there is any sign that this is happening (headache, uncomfortable awareness of your breathing, strong heartbeat in the throat, increased blood pressure or water in the lungs), your doctor must immediately stop the infusion and check your blood circulation.

Human blood may contain certain infective agents, such as viruses, including agents of until-now unknown nature. The risk of viral infection after receiving Alburex® solutions is however reduced by careful selection of donors, blood tests for viruses and by virus removal/inactivation procedures in the production process.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and call your doctor or pharmacist
Common
Incidence of untoward reactions is low - - -
Uncommon
Shock *   ✔  
Flush   ✔  
Hives   ✔  
Fever   ✔  
Nausea   ✔  
* Anaphylactic reaction.

This is not a complete list of side effects. For any unexpected effects while taking Alburex solutions, contact your doctor or pharmacist.

How to store

Alburex® solutions must be kept out of reach and sight of children.

It can be stored either in the refrigerator or at room temperature (at +2°C to +30°C), and should be protected from light. Do not freeze.

It must be stored in the original container and must not be used after the expiry date on the carton.

Use only clear or slightly opalescent solutions.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document, plus the full Product Monograph, prepared for health professionals can be found at:

http://www.cslbehring.ca
or for more information you may communicate with the sponsor, CSL Behring Canada, Inc. at: 1-613-783-1892 This leaflet was prepared by CSL Behring Canada, Inc.

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