Alburex 5, 50 g/l, solution for infusion

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Human albumin
Available from:
CSL Behring GmbH
ATC code:
B05AA; B05AA01
INN (International Name):
Human albumin
Dosage:
50 gram(s)/litre
Pharmaceutical form:
Solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Blood substitutes and plasma protein fractions; albumin
Authorization status:
Not marketed
Authorization number:
PA0800/008/001
Authorization date:
2014-06-13

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CSL Behring

Package leaflet: Information for the user

Alburex

®

5, 50 g/l, solution for infusion &

Alburex

®

20, 200 g/l, solution for infusion

Human albumin

Read all of this leaflet carefully before you are given this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or healthcare professional.

If you get any side effects, talk to your doctor or healthcare professional. This includes any

possible side effects not listed in this leaflet.

What is in this leaflet:

What Alburex is and what it is used for

What you need to know before you are given Alburex

How to use Alburex

Possible side effects

How to store Alburex

Contents of the pack and other information

1.

What Alburex is and what it is used for

What Alburex is

Alburex is a plasma substitute.

How Alburex works

Albumin stabilises the circulating blood volume. It is a carrier of hormones, enzymes, medicines

and toxins. The albumin protein in Alburex is isolated from human blood plasma. Therefore the

albumin works exactly as if it was your own protein.

What Alburex is used for

Alburex 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

e.g.:

due to severe loss of blood after an injury, or

due to a large surface burn

The choice of using Alburex will be made by your doctor. It will depend on your individual

clinical situation.

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2.

What you need to know before you are given Alburex

Read this section carefully. The information given should be taken into consideration by

you and your doctor before you are given 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 precautions

Talk to your doctor or healthcare professional before you are given Alburex.

Which circumstances increase the risk of having side effects?

Your doctor or healthcare professional will take special care if an abnormal increase in blood

volume (hypervolaemia) or blood dilution (haemodilution) could be dangerous for you.

Examples of such conditions are:

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 renal impairment or outflow impairment

(renal and post-renal anuria)

Tell your doctor or healthcare professional before treatment if at least one of these

conditions applies to you.

When stopping the infusion may be required?

Allergic reactions (hypersensitivity reactions) may occur and may very rarely be severe

enough to cause shock (see also section 4 ‘Possible side effects’).

Tell your doctor or healthcare professional immediately if you notice such reactions

during the infusion of Alburex. He or she 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 or healthcare professional immediately if you notice such signs. He or

she will stop the infusion and monitor your circulation as necessary

Information on safety with respect to infections

When medicines are made from human blood or plasma, certain measures are put in place to

prevent infections being passed on to patients. These include:

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careful selection of blood and plasma donors to make sure those at risk of carrying

infections are excluded,

the testing of each donation and pools of plasma for signs of virus/infections.

The inclusion of steps in the processing of the blood or plasma that can inactivate or remove

viruses.

Despite these measures, when medicines prepared from human blood or plasma are administered,

the possibility of passing on infection cannot be totally excluded. This also applies to any

unknown or emerging viruses and other types of infections.

There are no reports of virus infections with albumin manufactured to European Pharmacopoeia

requirements by established processes.

It is strongly recommended that every time you are given a dose of Alburex the name and batch

number of the product are recorded, in order to maintain a record of the batches used.

Other medicines and Alburex

No specific interactions of Alburex with other medicines are known.

However, always tell your doctor or healthcare professional before treatment if you are taking,

have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

Tell your doctor or healthcare professional if you are pregnant, plan to become pregnant or are

breast-feeding. Your doctor will decide whether you can receive Alburex during your

pregnancy or while you are breast-feeding.

The use of Alburex in pregnant or breast-feeding women has not been studied separately.

Nevertheless, medicines containing human albumin have been used in pregnant or breast-feeding

women. The experience showed that no harmful effects on the course of pregnancy, or on the

foetus and the newborn are to be expected.

Driving and using machines

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

Alburex contains sodium

This medicine contains approximately 3.2 mg sodium per ml of solution (140 mmol/l).

Your doctor or healthcare professional will take that into consideration if you are on a controlled

sodium diet.

3.

How to use Alburex

Alburex is given to you by your doctor or healthcare professional.

It is intended only for infusion into your veins (intravenous infusion). The product should be

warmed to room or body temperature before it is given.

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Your doctor decides how much Alburex you will receive. The amount and infusion rate depends

on your individual requirements.

Your doctor or healthcare professional 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.

Alburex 5 must not be mixed with other medicinal products or blood-derived products.

Alburex 20 must not be mixed with other medicinal products (except dilution solvents such as 5%

glucose and 0.9% sodium chloride) and blood-derived products.

If you are given more Alburex than you should

Alburex 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).

First signs of such an overload include:

headache,

breathing difficulty,

swelling of your neck veins (jugular vein congestion).

Tell your doctor or healthcare professional immediately if you notice such symptoms.

Your doctor or healthcare professional 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, he or she will stop the infusion and monitor your circulation as necessary.

4.

Possible 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 and had tolerated it

well.

General experience with human albumin solutions showed that the following side effects may be

observed.

Allergic reactions (hypersensitivity reactions) may occur and may very rarely (less than 1 in

10,000 persons treated) be severe enough to cause shock.

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

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 or healthcare professional immediately if you notice such reactions

during the infusion of Alburex. In this case, he or she will stop the infusion and start the

appropriate treatment.

The following mild side effects may occur rarely (between 1 in 1,000 and 1 in 10,000 persons

treated):

flushing

itchy rash (urticaria)

fever

nausea

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

The same side effects have been observed with Alburex since the product is on the market.

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 or healthcare professional. This includes any

possible side effects not listed in this leaflet.

You can also report side effects directly via:

UK:

Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card

in the Google Play or Apple App Store

Ireland:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

Email: medsafety@hpra.ie

Malta:

ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

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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 outer carton and the vial

label 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 in order to protect from light.

Do not use this medicine if you notice that the solution is cloudy or has particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6.

Contents of the pack and other information

What Alburex contains

The active substance is human albumin.

Alburex 5 is a solution containing 50 g/l of total protein, of which at least 96% is human

albumin.

One vial of 100 ml containing 5 g of human albumin.

One vial of 250 ml containing 12.5 g of human albumin.

One vial of 500 ml containing 25 g of human albumin.

Alburex 20 is a solution containing 200 g/l of total protein, of which at least 96% is human

albumin.

One vial of 50 ml contains 10 g of human albumin.

One vial of 100 ml contains 20 g of human albumin.

The other ingredients are sodium N-acetyltryptophanate, sodium caprylate, sodium chloride,

and water for injections.

What Alburex looks like and contents of the pack

Alburex is a solution for infusion. The solution is clear and slightly viscous. It may be almost

colourless or yellow, amber or green.

Pack sizes:

Alburex 5: 1 vial per pack (5 g/100 ml, 12.5 g/250 ml, 25 g/500 ml)

Alburex 20: 1 vial per pack (10 g/50 ml, 20 g/100 ml)

Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

United Kingdom

CSL Behring UK Ltd.

Tel: +44 (0)1444 447405

Ireland

CSL Behring GmbH

Tel: +49 69 30517254

Malta

AM Mangion Ltd.

Tel: +356 2397 6333

This leaflet was last revised in 01/2019

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Alburex5, 50 g/l, solution for infusion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Alburex 5 is a solution containing 50 g/l of total protein of which at least 96% is

human albumin.

One vial of 100 ml contains 5 g of human albumin

One vial of 250 ml contains 12.5 g of human albumin

One vial of 500 ml contains 25 g of human albumin

Alburex 5 is mildly hypooncotic to normal plasma.

Excipient with known effect:

Alburex 5 contains approximately 3.2 mg sodium per ml of solution (140 mmol/l).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Solution for infusion.

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, based on official recommendations.

4.2 Posology and method of administration

The concentration of the albumin preparation, dosage and the infusion rate should

be adjusted to the patient’s individual requirements.

Posology

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

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circulating volume and not plasma albumin levels should be used to determine the

dose required.

If human albumin 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

Paediatric population

The posology in children and adolescents (0-18 years) should be adjusted to the

patient’s individual requirements.

Method of administration

Human albumin should be administered by the intravenous route only.

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.

4.3 Contraindications

Hypersensitivity to albumin preparations or to any of the excipients listed in section

6.1.

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, standardmedical 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

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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) and appropriate steps taken to

restore or maintain the electrolyte balance.

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 5 contains approximately 3.2 mg sodium per ml of solution (140 mmol/l).

That should be taken into consideration for patients on a controlled sodium diet.

Transmissible agents

Standard measures to prevent infections resulting from the use of medicinal

products prepared from human blood or plasma include selection of donors,

screening of individual donations and plasma pools for specific markers of infection

and the inclusion of effective manufacturing steps for the inactivation/removal of

viruses. Despite this, when medicinal products prepared from human blood or

plasma are administered, the possibility of transmitting infective agents cannot be

totally excluded. This also applies to unknown or emerging viruses and other

pathogens.

There are no reports of virus transmissions with albumin manufactured to European

Pharmacopoeia specifications by established processes.

It is strongly recommended that every time that Alburex 5 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.

4.5 Interaction with other medicinal products and other forms of interactions

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

4.6 Fertility, pregnancy and lactation

Pregnancy

No animal reproduction studies have been conducted with Alburex 5

Its safety for use in human pregnancy has not been established in controlled clinical

trials and therefore it should only be given with caution to pregnant women.

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However, clinical experience with albumin suggests that no harmful effects on the

course of pregnancy, or on the foetus and the neonate are to be expected.

Breast-feeding

It is unknown whether Alburex 5 is excreted in human milk. Since human albumin is a

normal constituent of human blood, treatment of the nursing mother with Alburex 5

is not expected to present a risk to the breastfed newborn/infant.

Fertility

No animal reproduction studies have been conducted with Alburex 5. However,

human albumin is a normal constituent of human blood and harmful effects on

fertility are not expected.

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 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

The summary table below presents the adverse reactions which have been observed

with Alburex during the post-marketing phase, according to the MedDRA system

organ classification (SOC and Preferred Term Level).

As the postmarketing 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.

MedDRA System Organ Class

(SOC)

Adverse Reaction

Frequency

Immune system disorders

Hypersensitivity reactions (including

anaphylaxis and shock)

Not known

Gastrointestinal disorders

Nausea

Not known

Skin and subcutaneous tissue

disorders

Flush, urticaria

Not known

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MedDRA System Organ Class

(SOC)

Adverse Reaction

Frequency

General disorders and

administration site conditions

Fever

Not known

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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

reactionsvia HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1

6764971; Fax: +353 1 6762517. Website: www.hpra.ie; Email: medsafety@hpra.ie

For safety information with respect to transmissible agents, see section 4.4.

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: plasma substitutes and plasma protein fractions, ATC

code: B05AA01.

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 50 g/l is mildly hypooncotic to normal

plasma.

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.

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% in the extravascular

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space. Increased capillary permeability will alter albumin kinetics and abnormal

distribution may occur in conditions such as severe burns or septic shock.

Elimination

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

Human albumin is a normal constituent of human plasma and acts like physiological

albumin.

In animals, single dose toxicity testing is of little relevance and does not permit the

evaluation of toxic or lethal doses or of a dose-effect relationship. Repeated dose

toxicity testing is impracticable due to the development of antibodies to

heterologous protein in animal models.

To date, human albumin has not been reported to be associated with embryo-foetal

toxicity, oncogenic or mutagenic potential. No signs of acute toxicity have been

described in animal models.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium N-acetyltryptophanate 4 mmol/l

Sodium caprylate 4 mmol/l

Sodium chloride q.s. to a sodium content of 140 mmol/l

Water for injections q.s. to 1 liter

6.2 Incompatibilities

Human albumin must not be mixed with other medicinal products, whole blood and

packed red cells.

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6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25 °C. Do not freeze. Keep the vial in the outer carton in order to

protect from light.

6.5 Nature and contents of container

100 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic

elastomer).

250 ml of solution in a single vial (glass type II) with a stopper ( halogenated

synthetic elastomer).

500 ml of solution in a single vial (glass type II) with a stopper ( halogenated

synthetic elastomer).

1 vial per pack (5 g/100 ml, 12.5 g/250 ml, 25 g/500 ml).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

The solution can be directly administered by the intravenous route.

Albumin solutions must not be diluted with water for injections as this may cause

haemolysis in recipients.

If large volumes are administered, the product should be warmed to room or body

temperature before use.

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.

Once the vial has been opened, the contents should be used immediately

Any unused medicinal product or waste material should be disposed of in

accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

CSL Behring GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

8 MARKETING AUTHORISATION NUMBER

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PA0800/008/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13

June 2014

Date of last renewal: 30

January 2019

10 DATE OF REVISION OF THE TEXT

September 2018

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