Consumer medicine information

Alburex 20 AU

Albumin, human

BRAND INFORMATION

Brand name

Alburex 20 AU

Active ingredient

Albumin, human

Schedule

Unscheduled

SUMMARY CMI

Alburex^® 20 AU

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor.

1. Why am I being given Alburex^® 20 AU?

Your healthcare provider has decided Alburex^® 20 AU is appropriate for you. Alburex^® 20 AU contains the active ingredient human albumin. Alburex^® 20 AU is used to restore and maintain circulating blood volume where volume deficiency has been demonstrated.

For more information, see Section 1. Why am I being given Alburex^® 20 AU? in the full CMI.

2. What should I know before I am given Alburex^® 20 AU?

Do not use if you have ever had an allergic reaction to Alburex^® 20 AU or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding or are on a sodium controlled diet.

For more information, see Section 2. What should I know before I am given Alburex^® 20 AU? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Alburex^® 20 AU and affect how it works.

For more information see Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given Alburex^® 20 AU?

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.
Follow the instructions provided by your doctor.

More instructions can be found in Section 4. How will I be given Alburex^® 20 AU? in the full CMI.

5. What should I know after I am given Alburex^® 20 AU?

Things you should do	Remind any doctor or dentist you visit that you are using Alburex^® 20 AU. Notice any signs of a serious side effect – this may indicate that the administration of Alburex^® 20 AU should be stopped.
Driving or using machines	Alburex^® 20 AU does not affect your ability to drive and use machines.
Looking after your medicine	Store below 30°C. Do not freeze. Protect from light. Do not use after the expiry date.

For more information, see Section 5. What should I know after I am given Alburex^® 20 AU? in the full CMI.

6. Are there any side effects?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Alburex^® 20 AU

Active ingredient: human albumin

Consumer Medicine Information (CMI)

This leaflet provides important information about using Alburex^® 20 AU. You should also speak to your doctor if you would like further information or if you have any concerns or questions about using Alburex^® 20 AU.

Where to find information in this leaflet:

1. Why am I being given Alburex^® 20 AU?
2. What should I know before I am given Alburex^® 20 AU?
3. What if I am taking other medicines?
4. How will I be given Alburex^® 20 AU?
5. What should I know after I am given Alburex^® 20 AU?
6. Are there any side effects?
7. Product details

1. Why am I being given Alburex^® 20 AU?

Your healthcare provider has decided Alburex^® 20 AU is appropriate for you.

Alburex^® 20 AU contains human albumin as the active ingredient.

Alburex^® 20 AU is made from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood.

Alburex^® 20 AU solution for intravenous infusion is used under medical supervision to restore and maintain blood volume in situations when your blood volume has or is at risk of critical decrease.

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.

Alburex^® 20 AU 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.

2. What should I know before I am given Alburex^® 20 AU?

Warnings

You must not be given Alburex^® 20 AU if:

you are allergic to human albumin, or any of the ingredients listed at the end of this leaflet.

Check with your doctor if you currently have or had in the past, at least one of these conditions:

are on a sodium controlled diet
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).

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will decide whether you can receive Alburex^® 20 AU during your pregnancy or while you are breastfeeding.

Virus safety

Alburex^® 20 AU is made 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 certain viruses known as enveloped viruses such as HIV, hepatitis B and hepatitis C viruses, and the non-enveloped viruses, hepatitis A and parvovirus B19.

Despite these measures, the risk of viral and other agents' infectivity cannot be totally eliminated.

Alburex^® 20 AU contains sodium

Alburex^® 20 AU contains approximately 3.2 mg sodium per 1 mL. Please take this into account if you are on a sodium controlled diet.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Alburex^® 20 AU.

4. How will I be given Alburex^® 20 AU?

How much will I be 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 will Alburex^® 20 AU be given

Alburex^® 20 AU should be used to restore and stabilise the circulating blood volume. It is normally used under intensive care situations, when your blood volume has decreased critically.

If too much Alburex^® 20 AU is given

Alburex^® 20 AU is administered under medical supervision only. An overdosage is therefore very unlikely to occur. 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.

5. What should I know after I am given Alburex^® 20 AU?

Things you should do

Call your doctor straight away if you:

notice signs of an allergic reaction (hypersensitivity reaction). These may occur and may very rarely be severe enough to cause shock (see Side effects) Your doctor will decide to stop the infusion completely and start the appropriate treatment.
notice signs of an abnormal increase in blood volume (hypervolaemia). This may occur if the dosage and infusion rate are not 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 (jugular vein congestion). Your doctor will stop the infusion and monitor your circulation as necessary.
notice signs of an abnormal increase in body water content (hyperhydration). This 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. Your doctor will stop the infusion and monitor your fluid status as necessary.

Remind any doctor or dentist you visit that you are using Alburex^® 20 AU.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Alburex^® 20 AU affects you.

Alburex^® 20 AU does not affect your ability to drive and use machines.

Looking after your medicine

Store below 30°C.
Do not freeze.
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date
Keep the vial in the outer carton in order to protect from light.
Do not use this medicine if you notice that the solution is cloudy or has particles.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
flushing itchy rash (urticaria) fever nausea. They will normally disappear rapidly when the infusion is slowed down or the infusion is stopped.	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Symptoms of an allergic reaction may include any, some or many of the following:

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, stomach ache, nausea, vomiting or diarrhoea.

Tell your doctor immediately if you notice any of these serious symptoms which may be signs of serious allergy, as the infusion of Alburex^® 20 AU should be stopped.

Tell your doctor if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

Alburex^® 20 AU is usually given in a hospital.

What Alburex^® 20 AU contains

Active ingredient (main ingredient)	Human albumin
Other ingredients (inactive ingredients)	sodium acetyltryptophanate sodium octanoate sodium chloride

Do not take this medicine if you are allergic to any of these ingredients.

What Alburex^® 20 AU looks like

Alburex^® 20 AU is a solution for infusion. It is a clear, slightly viscous liquid. It is almost colourless, yellow, amber or green.

Alburex^® 20 AU is issued in glass vials in two sizes:

The 50 mL vial contains 10 g of human albumin.

The 100 mL vial contains 20 g of human albumin.

50 mL AUST R 327952

100 mL AUST R 327953

Who distributes Alburex^® 20 AU

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

This leaflet was prepared in August 2024

® Registered trademark of CSL Behring AG

Published by MIMS October 2024

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.

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Consumer medicine information

Alburex 20 AU

Albumin, human

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