Patient Medication Information: uses, side effects, how to take - Alburex - 25
What is Alburex® 5 / Alburex® 25 used for?
Alburex® 5 / Alburex® 25 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.
How does Alburex® 5 / Alburex® 25 work?
Alburex® 5 / Alburex® 25 contain albumin that stabilises the circulating blood volume. Albumin is a carrier of hormones, enzymes, medicines, and toxins. The albumin protein in Alburex® 5 / Alburex® 25 is isolated from human blood plasma. Therefore, the albumin works exactly as if it was your own protein.
What are the ingredients in Alburex® 5 / Alburex® 25?
Medicinal ingredients:
- Either Alburex® 5 or Alburex® 25 contains 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).
Non-medicinal ingredients:
- Sodium caprylate
- Sodium chloride
- Sodium N-acetyltryptophanate
- Water for injection
For a full listing of nonmedicinal ingredients, see PART I: HEALTH PROFESSIONAL INFORMATION of the product monograph.
Serious Warnings and Precautions
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Alburex® 5 / Alburex® 25 comes in the following dosage forms:
Alburex® 5 is provided as 5% (50 g/L) solution for infusion in 250 mL and 500 mL bottles.
Alburex® 25 is provided as 25% (250 g/L) solution for infusion in 50 mL and 100 mL bottles.
Do not use Alburex® 5 / Alburex® 25 if:
- If you are allergic to any of albumin preparations or any of the other ingredients or component of the container of the products.
- If you suffer from severe anemia;
- If you suffer from heart failure.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Alburex® 5 / Alburex® 25. Talk about any health conditions or problems you may have, including if you:
- Suffer from heart problems;
- Suffer from high blood pressure;
- Suffer from bleeding or blood clotting disorders;
- Suffer from gullet varices;
- Suffer from water in your lungs;
- Suffer from kidney disease;
- Suffer from severe anaemia.
Other warnings you should know about:
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.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with Alburex® 5 / Alburex® 25:
No specific interaction of human albumin with other drugs medicinal product are known. However, infusing albumin may affect the medicines that bind to albumin.
How to take Alburex® 5 / Alburex® 25:
- Alburex® 5 / Alburex® 25 solutions can be infused directly into a vein and Alburex® 25 can also 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 bottle has been opened, the content should be used immediately. Any unused product should be thrown away.
Usual dose:
Your doctor will adjust the infusion rate for your individual needs. Normally, the rate is less than 5 mL/min for Alburex® 5 and 1-2 mL/min for Alburex® 25 respectively. For plasma-exchange, 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.
Alburex® 5 / Alburex® 25 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® 5 / Alburex® 25 solutions are given to you.
If you have any questions about the dose, please ask your doctor.
Overdose:
If large volumes of Alburex® 5 / Alburex® 25 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.
| If you think you, or a person you are caring for, have taken too much Alburex® 5 / Alburex® 25, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
Not applicable.
What are possible side effects from using Alburex® 5 / Alburex® 25?
These are not all the possible side effects you may have when taking Alburex® 5 / Alburex® 25. If you experience any side effects not listed here, tell your healthcare professional.
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® 5 / Alburex® 25 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 and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| RARE | |||
| Shock* | √ | ||
| Flush | √ | ||
| Hives | √ | ||
| Fever | √ | ||
| Nausea | √ | ||
* Anaphylactic reaction.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
We recommend that CSL Behring Canada, Inc. be copied when reporting suspected side effects, at the following address:
AdverseReporting@CSLBehring.com
Storage:
Alburex® 5 / Alburex® 25 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.
Keep out of reach and sight of children.
If you want more information about Alburex® 5 / Alburex® 25:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.cslbehring.ca), or by calling 1-866-773-7721.