Consumer medicine information

Alburex 20 AU

Albumin, human

BRAND INFORMATION

Brand name

Alburex 20 AU

Active ingredient

Albumin, human

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Alburex 20 AU.

What is in this leaflet

This leaflet answers some common questions about Alburex® 20 AU. It does not contain all the available information about Alburex® 20 AU. It does not take the place of talking to your doctor.

All medicines have benefits and risks. Your doctor has weighed the benefits that Alburex® 20 AU will have for you against the risks.

If you have any concerns about using this medicine, ask your doctor. Follow your doctor's advice even if it is different from what this leaflet says.

Please read this leaflet carefully and keep it for future reference. The information in this leaflet is subject to change. Please check with your doctor whether there is any new information about this medicine that you should know since you were last treated with this medicine.

What Alburex® 20 AU is used for

Alburex® 20 AU is used to restore and stabilise the circulating blood volume. It is normally used under intensive care situations, when your blood volume has decreased critically. This may be the case, for example:

  • due to severe loss of blood after an injury or
  • due to a large surface burn.

The choice of using Alburex® 20 AU will be made by your doctor. It will depend on your individual clinical situation.

Ask your doctor if you have any questions about why Alburex® 20 AU has been prescribed for you.

How Alburex® 20 AU works

Albumin stabilises the circulating blood volume. It is a carrier of hormones, enzymes, medicines and toxins. The albumin protein in Alburex® 20 AU is isolated from human blood plasma. Therefore the albumin works exactly as if it was your own protein.

Before you are given Alburex® 20 AU

When you must not receive it

Do not receive Alburex® 20 AU if you are allergic to:

  • human albumin
  • any of the ingredients listed at the end of this leaflet.

Before you are given it

Tell your doctor before treatment if you currently have or had in the past, at least one of these conditions:

  • allergies to any food or medicine
  • heart insufficiency which needs to be treated with medicines (decompensated cardiac insufficiency)
  • high blood pressure (hypertension)
  • expansion of the gullet vein (oesophageal varices)
  • abnormal accumulation of liquid in the lung (pulmonary oedema)
  • predisposition for bleeding (haemorrhagic diathesis)
  • severe decrease of red blood cells (severe anaemia)
  • severe decrease of urine excretion because of kidney disease or outflow impairment (renal and post-renal anuria).

Tell your doctor if you are pregnant, plan to become pregnant or are breastfeeding. Your doctor will decide whether you can receive Alburex® 20 AU during your pregnancy or while you are breast-feeding.

Tell your doctor if you are on a sodium controlled diet. This medicine contains sodium which should be taken into consideration.

Taking other medicines

No specific interactions of Alburex® 20 AU with other medicines are known.

However tell your doctor before treatment if you are taking, have recently taken or might take any other medicines.

About blood products

Alburex® 20 AU is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. When medicines are made from human blood and injected into you, it is possible that viruses or other substances could be present in the medicine and cause an illness. These could be viruses such as hepatitis, human immunodeficiency virus (HIV), or parvovirus B19 and theoretically Creutzfeldt-Jakob Disease (CJD) agent. There could also be other infectious agents, some of which may not yet have been discovered.

To reduce the risk of this happening, extra steps are taken when manufacturing this medicine. Strict controls are applied when selecting blood donors and donations. The medicine is specially treated to remove or kill certain viruses. This special treatment is considered effective against viruses known as enveloped viruses such as HIV, and hepatitis B and C viruses, and the non-enveloped virus, hepatitis A and parvovirus B19. Despite the measures taken, the risk of viral and other agents’ infectivity cannot be totally eliminated.

Vaccines are available against some of these viruses and your doctor will be able to help you decide whether it is worthwhile having any of those vaccines.

Please discuss the risks and benefits of this medicine with your doctor.

How Alburex® 20 AU is given

Your doctor will be responsible for determining the amount and infusion rate of Alburex® 20 AU that you are to receive, as appropriate for your condition. Your doctor will give you Alburex® 20 AU as an infusion, that is, an injection given slowly into the vein.

Your doctor will regularly monitor important blood flow values like:

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

These values are monitored to determine the right dose and infusion rate.

When stopping the infusion may be required?

Allergic reactions (hypersensitivity reactions) may occur and may very rarely be severe enough to cause shock (see Side effects).

Tell your doctor immediately if you notice such reactions during the infusion. Your doctor will decide to stop the infusion completely and start the appropriate treatment.

An abnormal increase in blood volume (hypervolaemia) may occur if the dosage and infusion rate are not adequately adjusted to your condition. This may lead to an overload of the heart and circulatory system (cardiovascular overload). First signs of such an overload are headache, breathing difficulty or swelling of your neck veins (jugular vein congestion).

Tell your doctor immediately if you notice such signs. Your doctor will stop the infusion and monitor your circulation as necessary.

An abnormal increase in body water content (hyperhydration) may occur if you are not appropriately hydrated for the dosage and infusion rate given. Your doctor will monitor this closely. First signs of body water overload are headache, confusion, irritability and drowsiness.

Tell your doctor immediately if you notice such signs. Your doctor will stop the infusion and monitor your fluid status as necessary.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Such side effects may occur even when you have previously received Alburex® 20 AU and had tolerated it well.

Tell your doctor as soon as possible if you do not feel well while you are being given Alburex® 20 AU.

Severe allergic reactions (hypersensitivity reactions) may occur very rarely. Tell your doctor immediately if you notice any of the following symptoms which may be signs of serious allergy or anaphylaxis, as the infusion of Alburex® 20 AU should be stopped:

  • feeling faint (fall in blood pressure)
  • dizziness
  • irregular or faster heart beat
  • skin reactions, e.g. redness, itching, swelling, blistering, rash or hives (itchy bumps)
  • difficulty breathing, e.g. wheezing, chest tightness, 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, stomachache, nausea, vomiting or diarrhoea.

Tell your doctor if you notice any of the following and they worry you:

  • flushing
  • itchy rash (urticarial)
  • fever
  • nausea.

They will normally disappear rapidly when the infusion is slowed down or the infusion is stopped.

Talk to your doctor if you get any side effects. This includes any possible side effects not listed in this leaflet.

Do not be alarmed by this list of possible side effects.

Overdose

An abnormal increase in blood volume (hypervolaemia) may occur if the dosage and infusion rate are too high. This may lead to an overload of the heart and circulatory system (cardiovascular overload).

Tell your doctor if you notice the following symptoms of an overdose:

  • headache
  • breathing difficulty
  • swelling of your neck veins (jugular vein congestion).

Your doctor may also detect signs like:

  • an increased blood pressure
  • a raised central venous pressure
  • an abnormal accumulation of liquid in the lung (pulmonary oedema).

In all these cases, your doctor will stop the infusion and monitor your circulation as necessary.

How to store Alburex® 20 AU

Store below 25°C. Do not freeze. Protect from light. Do not use after the expiry date. Keep out of reach of children.

Further information

Alburex® 20 AU can only be obtained on a doctor's prescription. This leaflet does not contain all the available information about Alburex® 20 AU. If you need more information about Alburex® 20 AU and your treatment in general, or if you have any questions or are not sure about something in this leaflet, ask your doctor.

Product description

What it looks like

Alburex® 20 AU is a clear and slightly viscous liquid. It is almost colourless, yellow, amber or green.

Ingredients

The 50 mL vial contains 10 g of human albumin.

The 100 mL vial contains 20 g of human albumin.

Alburex® 20 AU also contains sodium acetyltryptophanate, sodium octanoate and sodium chloride.

Manufacturer

Alburex® 20 AU is manufactured in Australia by:

CSL Behring (Australia) Pty Ltd
ABN 48 160 734 761
189–209 Camp Road
Broadmeadows VIC 3047

Distributor

Australian Red Cross Lifeblood

Date of revision

November 2022

® Registered trademark of CSL Behring AG

Published by MIMS March 2023

BRAND INFORMATION

Brand name

Alburex 20 AU

Active ingredient

Albumin, human

Schedule

Unscheduled

 

Notes

Distributed by Australian Red Cross Lifeblood

1 Name of Medicine

Human albumin.

2 Qualitative and Quantitative Composition

Human albumin 20% (200 g/L).
Alburex 20 AU is a solution containing 200 g/L of total protein of which at least 96% is human albumin. Alburex 20 AU is hyperoncotic to normal plasma. It has a nominal osmolality of 258 mOsm/kg, is isotonic and the pH is 6.7-7.3.
Alburex 20 AU is manufactured from human plasma collected in Australia by Australian Red Cross Lifeblood.
One litre of Alburex 20 AU also contains 16 mmol of sodium acetyltryptophanate and 16 mmol of sodium octanoate. Sodium chloride is added to give a sodium content of 140 mmol/L.
Alburex 20 AU also contains water for injections.

3 Pharmaceutical Form

Solution for intravenous infusion.
Alburex 20 AU is a clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.

4 Clinical Particulars

4.1 Therapeutic Indications

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.
The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient.

4.2 Dose and Method of Administration

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient's individual requirements.

Dosage.

The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. Infusion rate and volume need to be adapted according to clinical conditions, most notably in the elderly or in the paediatric population.

Paediatric population.

The dosage in children and adolescents (0-18 years) should be adjusted to the patient's individual requirements.

Monitoring advice.

If Alburex 20 AU 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.

Method of administration.

Note.

Alburex 20 AU contains no antimicrobial preservative. It must, therefore, be used immediately after opening the vial. Use in one patient on one occasion only. Any unused solution should be discarded appropriately.
Alburex 20 AU is a clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. Do not use solutions which are cloudy or have deposits. This may indicate that the protein is unstable or that the solution has become contaminated. The vial should be returned unopened to Australian Red Cross Lifeblood.
Alburex 20 AU can be directly administered by the intravenous route, or it can also be diluted in a suitable crystalloid solution.
Alburex 20 AU can be diluted to a mildly hypooncotic solution to normal plasma (4-5% albumin) prior to administration, in the proportion of 1 mL of Alburex 20 AU to 4 mL of suitable crystalloid solution and administered by the usual intravenous technique. Alburex 20 AU is packaged in a glass vial that must be vented during use.
Alburex 20 AU must not be diluted with water for injections as this may cause haemolysis in recipients.
The infusion rate should be adjusted according to the individual circumstances and the indication.
In plasma exchange the infusion rate should be adjusted to the rate of removal.
If large volumes are administered, the product should be warmed to room or body temperature before use. Do not use if the solution has been frozen.

4.3 Contraindications

Hypersensitivity to albumin preparations or to any of the excipients.

4.4 Special Warnings and Precautions for Use

Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. In case of shock, standard medical treatment for shock should be implemented.
Albumin should be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are: decompensated cardiac insufficiency, hypertension, oesophageal varices, pulmonary oedema, haemorrhagic diathesis, severe anaemia, renal and post-renal anuria.
The colloid-osmotic effect of human albumin 200 g/L is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.
200-250 g/L human albumin solutions are relatively low in electrolytes compared to the 40-50 g/L human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see Section 4.2 Dose and Method of Administration) and appropriate steps taken to restore or maintain the electrolyte balance.
Alburex 20 AU 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 haematocrit 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 infusion rate are not adjusted to the patient's circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.
Alburex 20 AU contains approximately 3.2 mg sodium per mL of solution (140 mmol/L). This should be noted when the product is used in patients requiring sodium restriction.

Pathogen safety.

This product is made from human plasma. Products made from human plasma may contain infectious agents such as viruses and theoretically Creutzfeldt-Jakob disease (CJD) agents, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain infectious agents and by testing for the presence of certain viral markers.
In addition, the Alburex 20 AU manufacturing process includes pasteurisation (60°C for 10 hours) and multiple steps involving ethanol fractionation and depth filtration in the presence of filter aids which contribute to the reduction of pathogens should they be present. The current process and procedures applied in the manufacture of this product are effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and the non-enveloped virus, hepatitis A virus (HAV) and human parvovirus B19.
Despite these measures, such products may still potentially transmit disease. There is also the possibility that other known or unknown infectious agents may be present in such products.
Vaccination for patients in receipt of medicinal products from human plasma should be considered where appropriate.
It is strongly recommended that every time that Alburex 20 AU is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Use in the elderly.

There have been no specific clinical studies of Alburex 20 AU in the elderly.

Paediatric use.

There have been no specific clinical studies of Alburex 20 AU in children.

Effects on laboratory tests.

Human albumin is an endogenous plasma protein so no specific effects on laboratory tests are anticipated.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No specific interactions of human albumin with other medicinal products are known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies examining the effect of Alburex 20 AU on fertility have been conducted.
Reproductive toxicity studies with Alburex 20 AU in animals have not been conducted.
The use of Alburex 20 AU in human pregnancy has not been established in controlled clinical trials; therefore, use in pregnant women only if benefits outweigh risk.
 Like endogenous serum albumin, Alburex 20 AU may be excreted in milk. No safety information is available.

4.7 Effects on Ability to Drive and Use Machines

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

4.8 Adverse Effects (Undesirable Effects)

Summary of the safety profile.

Mild reactions with human albumin solutions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe allergic reactions such as anaphylactic shock may occur. In these cases, the infusion should be stopped immediately and an appropriate treatment should be initiated.

Tabulated list of adverse reactions.

Table 1 presents the adverse reactions which have been observed with CSL Behring human albumin solutions during the post-marketing phase, according to the MedDRA system organ class and preferred term level. As the post-marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions. Hence the frequency category 'not known (cannot be estimated from the available data)' is used.
For safety information with respect to transmissible agents, see Section 4.4 Special Warnings and Precautions for Use, Pathogen safety.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Hypervolaemia may occur if the dosage and infusion rate are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion) or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion should be stopped immediately and the patient's haemodynamic parameters carefully monitored.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Human albumin accounts quantitatively for more than half of the total protein in the plasma and represents about 10% of the protein synthesis activity of the liver.
Physico-chemical data: human albumin 200 g/L has a hyperoncotic effect.
The most important physiological functions of albumin results from its contribution to oncotic pressure of the blood and transport function. Albumin stabilises circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins.

Clinical trials.

There have been no company sponsored clinical trials conducted using Alburex 20 AU.

5.2 Pharmacokinetic Properties

Distribution.

Under normal conditions, the total exchangeable albumin pool is 4-5 g/kg body weight, of which 40-45% is present intravascularly and 55-60% is in the extravascular space. Increased capillary permeability will alter albumin kinetics and abnormal distribution may occur in conditions such as severe burns or septic shock.

Excretion.

Under normal conditions, the average half-life of albumin is about 19 days. The balance between synthesis and breakdown is normally achieved by feedback regulation. Elimination is predominantly intracellular and due to lysosome proteases.
In healthy subjects, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. There is considerable individual variation in the effect on plasma volume. In some patients the plasma volume can remain increased for some hours. However, in critically ill patients, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.

5.3 Preclinical Safety Data

Genotoxicity.

No genotoxicity studies have been conducted with Alburex 20 AU.

Carcinogenicity.

No carcinogenicity studies have been conducted with Alburex 20 AU.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Alburex 20 AU must not be mixed with any other medicinal products, including whole blood, packed red cells, or other albumins.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C (Do not freeze). Protect from light. Do not use after the expiry date.

6.5 Nature and Contents of Container

Alburex 20 AU is issued in glass vials in two sizes:
One vial of 50 mL contains 10 g of human albumin.
One vial of 100 mL contains 20 g of human albumin.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Not applicable.

CAS number.

9048-49-1.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes