Albumex 4

Main information

  • Trade name:
  • Albumex 4 4% w/v Solution for infusion
  • Dosage:
  • 4% w/v
  • Pharmaceutical form:
  • Solution for infusion
  • Units in package:
  • Vial, glass, bottle, 50 mL
  • Class:
  • General sale
  • Prescription type:
  • General sale
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • CSL Behring (Australia) Pty Ltd

Documents

Localization

  • Available in:
  • Albumex 4 4% w/v Solution for infusion
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Hypovolaemia/shock; Preservation of an adequate circulating blood volume should be the primary aim of therapy. Albumex® 4 may be the initial plasma expander of choice if shock is associated with significant hypoalbuminaemia (albumin concentration less than 25 g/Litre), or if it is clinically desirable to avoid the infusion of large volumes of crystalloid solutions. Albumex® 4 may also be useful following initial resuscitation with crystalloid or synthetic colloid solutions in patients in whom extended support of the intravascular volume is required, such as seriously ill patients with multiple organ failure or the systemic capillary leak syndrome.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 7572
  • Authorization date:
  • 14-06-1995
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

Albumex 4 NZ DS 13.00

Page 1 of 9

New Zealand Data Sheet

Albumex

®

4

Human Albumin 4% (40 g/L)

NAME OF THE MEDICINE

Human albumin, solution for intravenous infusion.

DESCRIPTION

Albumex

4 is manufactured from human plasma donated by New Zealand’s voluntary and

non-remunerated donors. Albumex

4 is a clear, slightly viscous liquid; it is almost

colourless, yellow, amber or green. It is prepared by a combination of the Cohn cold-ethanol

fractionation process and chromatographic techniques. It is a sterile, preservative free 4% w/v

human albumin solution which is iso-oncotic with human serum. It has a nominal osmolality

of 260 mOsm/kg, is approximately isotonic and the pH is 6.7 to 7.3. The manufacturing

process for Albumex

4 contains dedicated steps to reduce the possibility of virus

transmission including pasteurisation (heating at 60°C for 10 hours) and incubation at low pH

to inactivate viruses. The nominal composition of Albumex

4 is as follows:

Human Albumin

40 g/Litre

Sodium

140 mmol/Litre

Chloride

128 mmol/Litre

Octanoate

6.4 mmol/Litre

PHARMACOLOGY

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. The metabolic half-life of

albumin

in vivo

is about 19 days and the turnover in an adult is approximately 15 g per day.

There is rapid interchange of albumin between the intra- and extravascular spaces.

Albumex

4 is iso-oncotic with human serum. When infused into adequately hydrated

patients its effect is to expand the circulating blood volume by an amount approximately

equal to the volume of Albumex

4 infused.

CLINICAL TRIALS

A large multicentre, double blind, randomised controlled trial was conducted to determine the

effect of fluid resuscitation with either albumin or saline on mortality in a heterogeneous

Albumex 4 NZ DS 13.00

Page 2 of 9

population of patients in the ICU. This Saline versus Albumin Fluid Evaluation (SAFE) study

was a collaboration of the Australian and New Zealand Intensive Care Society Clinical Trials

Group, the Australian Red Cross Blood Service and the George Institute for International

Health.

The trial randomised 6997 patients to receive either albumin 4% (Albumex

4)(n = 3497) or

normal (0.9%) saline (n = 3500). The two groups had similar baseline characteristics with

randomisation stratified at each centre to ensure each institution enrolled equal numbers of

patients for each treatment. Death from any cause during the 28 days after randomisation was

the primary outcome measure. There were 726 deaths in the albumin group and 729 deaths in

the saline group (relative risk of death 0.99, 95% confidence interval 0.91 to 1.09, p = 0.87).

The proportion of patients with new single or multiple organ failure was similar in the two

groups (p = 0.85). There were also no statistically significant differences between the two

groups in the secondary outcomes measured: mean (

SD) number of days spent in ICU

(6.5

6.6 in the albumin group and 6.2

6.2 in the saline group, p = 0.44), days spent in

hospital (15.3

9.6 and 15.6

9.6 respectively, p = 0.30), days of mechanical ventilation

(4.5

6.1 and 4.3

5.7, respectively, p = 0.74) or days of renal replacement therapy (0.5

and 0.4

2.0, respectively, p = 0.41).

This study concluded that in patients in the ICU, use of either 4% albumin or normal (0.9%)

saline for fluid resuscitation results in similar mortality at 28 days.

INDICATIONS

Hypovolaemia/shock

Preservation of an adequate circulating blood volume should be the primary aim of therapy.

Albumex

4 may be the initial plasma expander of choice if shock is associated with

significant hypoalbuminaemia (albumin concentration less than 25 g/Litre), or if it is

clinically desirable to avoid the infusion of large volumes of crystalloid solutions.

Albumex

4 may also be useful following initial resuscitation with crystalloid or synthetic

colloid solutions in patients in whom extended support of the intravascular volume is

required, such as seriously ill patients with multiple organ failure or the systemic capillary

leak syndrome.

Cardiopulmonary bypass

Albumex

4 may be used for priming the pump for cardiopulmonary bypass surgery for

patients with poor left ventricular function, and other complicating factors such as long

Albumex 4 NZ DS 13.00

Page 3 of 9

bypass time, anaemia or repeat surgery. For post-operative hypovolaemia Albumex

4 may

be used if further colloid is required after a moderate amount of synthetic colloid (1–2 L) has

been given or there is ongoing bleeding or anaemia until cross-matched blood is available.

Plasma exchange

Albumex

4 is indicated as a replacement solution in plasma exchange procedures,

particularly when the volume exchanged exceeds 20 mL/kg body weight. In patients with

thrombotic thrombocytopenic purpura, fresh frozen plasma may be a preferred replacement.

CONTRAINDICATIONS

Albumex

4 must not be used if there is a history of allergy to this product. Albumin is

contraindicated in patients with cardiac failure, pulmonary oedema or severe anaemia.

PRECAUTIONS

Patients with cardiac failure, renal insufficiency, stabilised chronic anaemia or on

cardiopulmonary bypass are at special risk of developing circulatory overload. When being

infused with Albumex

4 they should be carefully monitored for this potential complication.

Two potential risks when using plasma volume expanders are allergic reactions and the risk

of circulatory overload. Hypersensitivity is rare when human albumin solution is used

because of the human origin of the product, and circulatory overload can be avoided by

monitoring the rate and volume of infusion. Should an anaphylactic reaction to Albumex

develop, the infusion should be stopped and treatment instituted with adrenaline,

hydrocortisone and antihistamines, as appropriate. Circulatory overload can be avoided by

monitoring the rate and volume of infusion. Hypotension and rigors have been associated

with human albumin solutions. Administration of albumin can aggravate myocardial

depression when present in patients with shock.

No comparative clinical study with Albumex

4 has been carried out. However such data

exists for a similar product, Albumex

5 which has been compared with 5% NSA in an open

apheresis study carried out in five Australian apheresis clinics. Adverse experiences noted in

that study are set out below as a guide to users of this product (Albumex

The rise in blood pressure which may follow rapid administration of albumin necessitates

observation of the injured patient to detect bleeding points which failed to bleed at the lower

blood pressure; otherwise, new haemorrhage and shock may occur.

Albumex 4 NZ DS 13.00

Page 4 of 9

The use of albumin for fluid resuscitation of patients with traumatic brain injury is not

recommended.

Hypotension:

Hypotension has been associated with human albumin solutions. Hypotension

following administration of albumin can aggravate myocardial depression when present in

patients with shock.

Albumex

4 contains trace amounts of aluminium (≤200 µg/L). Accumulation of aluminium

in patients with chronic renal insufficiency has led to toxic manifestations such as

hypercalcaemia, vitamin D-refractory osteodystrophy, anaemia and severe progressive

encephalopathy. Therefore, when large volumes of albumin are contemplated for

administration to such patients, serious consideration of these potential risks relative to the

anticipated benefits should be given.

The addition of other medicines to Albumex

4 has not been evaluated (See

Compatibility

with other fluids

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, virus inactivation/removal procedures are included in the manufacturing process.

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).

These procedures may be of limited value against the non-enveloped virus, 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.

Effects on fertility

No studies examining the effect of Albumex

4 on fertility have been conducted.

Albumex 4 NZ DS 13.00

Page 5 of 9

Use in pregnancy

The safety of this medicinal product for use in human pregnancy has not been established in

controlled clinical trials; therefore, it should be given to pregnant women only if clearly

needed.

Use in lactation

No information available.

Paediatric use

There have been no specific clinical studies of Albumex

4 in children.

Use in the elderly

There have been no specific clinical studies of Albumex

4 in the elderly.

Genotoxicity

No genotoxicity studies have been conducted with Albumex

Carcinogenicity

No carcinogenicity studies have been conducted with Albumex

Effect on laboratory tests

Albumin is an endogenous plasma protein so no specific effects on laboratory tests are

anticipated. However, administration of Albumex

4 which may contain some bound

bilirubin has been shown to result in elevated serum bilirubin in some patients.

INTERACTIONS WITH OTHER MEDICINES

Hypotension has been reported in patients given albumin who are on Angiotensin Converting

Enzyme (ACE) inhibitors, (see also

Compatibility with other fluids

ADVERSE EFFECTS

Adverse reactions reported with albumin solutions in general may include chills, fever,

flushing, headache, dyspnoea, nausea, vomiting, increased salivation and allergic reactions

(hypotension, urticaria, skin rashes, anaphylaxis).

Albumex 4 NZ DS 13.00

Page 6 of 9

Adverse reactions to albumin solutions are uncommon and are usually mild and transient.

More serious events may include rigors, hypotension, lowered serum electrolyte levels

(potassium, calcium, bicarbonate), lowered total serum protein levels, low platelet count and

increased prothrombin time.

DOSAGE AND ADMINISTRATION

Dosage

Hypovolaemia/shock

The management of hypovolaemic shock usually requires the intravenous (IV) infusion of at

least one litre of Albumex

4 into an average adult patient.

The total volume required cannot be accurately predicted, since it depends on such factors as

the initial extracellular fluid volume deficit and the continuing rate of fluid loss.

Monitoring advice

It is recommended that blood pressure is monitored during administration of Albumex

To avoid circulatory overload the rate and volume of infusion should be monitored

frequently.

Myocardial function should also be monitored e.g. central venous pressure, arterial pressure

and pulse rate.

Myocardial function (in shock), serum potassium (when pretreatment concentrations are

low), platelet count (when pretreatment values are low) and prothrombin times (when these

are prolonged before exchange) should also be monitored.

Albumex 4 NZ DS 13.00

Page 7 of 9

Administration

CAUTION: Albumex

®

4 contains no antimicrobial preservative. It must, therefore, be

used immediately after opening the bottle. Any unused solution should be discarded

appropriately. Use in one patient on one occasion only.

Albumex

4 is normally clear or slightly opalescent. If it appears to be turbid by transmitted

light, it must not be used and the bottle should be returned unopened to the New Zealand

Blood Service.

Albumex

4 should always be administered by intravenous infusion through a standard IV

infusion giving set.

If the product was stored in the refrigerator it should be allowed to reach room temperature or

body temperature before administration. Do not use if the solution has been frozen.

The following procedure is recommended:

Remove the plastic cover from the seal.

Apply a suitable antiseptic to the exposed part of the rubber stopper and allow to dry.

Stand the bottle upright and insert the air vent needle vertically in one of the indentations

of the stopper. It is preferable to use a long airway needle fitted with a filter. If not

available, a short needle attached to a non-wettable filter may be used.

Clamp the tubing of the giving set and insert the perforator vertically through one of the

other indentations of the stopper.

Should the stopper become dislodged, do not use this

bottle and discard the solution appropriately.

Invert the bottle and attach the hanger to a support approximately one metre above the

patient.

Allow the tubing to fill by adjusting the clamp. Insert the giving set needle into a vein and

adjust the rate of flow.

When the bottle is empty, clamp the tubing and transfer the air vent needle and the needle

at the upper end of the giving set to a further bottle of Albumex

4 or to a bottle

containing a crystalloid solution, according to requirements.

Should leakage become evident during administration, cease the infusion and

discard the solution appropriately. Recommence the infusion with a new bottle and

giving set.

Albumex 4 NZ DS 13.00

Page 8 of 9

Compatibility with other fluids

Albumex

4 should not be mixed with protein hydrolysates, amino acid solutions, solutions

containing alcohol, or solutions containing drugs that bind to albumin e.g. calcium channel

blockers.

OVERDOSAGE

Excess human albumin may lead to circulatory overload (see

PRECAUTIONS

PRESENTATION AND STORAGE CONDITIONS

Albumex

4 is issued in three sizes:

2 g of human albumin in 50 mL of electrolyte solution

10 g of human albumin in 250 mL of electrolyte solution

20 g of human albumin in 500 mL of electrolyte solution.

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

NAME AND ADDRESS OF THE SPONSOR

CSL Behring (NZ) Ltd

666 Great South Road

Penrose

Auckland

New Zealand

NAME AND ADDRESS OF THE MANUFACTURER

CSL Behring (Australia) Pty Ltd

189–209 Camp Road

Broadmeadows VIC 3047

Australia

NAME AND ADDRESS OF THE DISTRIBUTOR

New Zealand Blood Service

71 Great South Road

Epsom

Auckland

New Zealand

Albumex 4 NZ DS 13.00

Page 9 of 9

MEDICINE CLASSIFICATION

General Sale Medicine

DATE OF PREPARATION

09 May 2014

Albumex

is the registered trademark of CSL Limited

For Medical/Technical Enquiries

+61 3 9389 1932

For Customer Service Enquiries

+61 3 9246 5231

customerservice@cslbehring.com.au

www.cslbehring.com.au

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Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Europe - EMA - European Medicines Agency

6-12-2018


Ex ante publicity of a negotiated procedure: bank accounts for the deposit of surplus funds in euro

Ex ante publicity of a negotiated procedure: bank accounts for the deposit of surplus funds in euro

Ex ante publicity of a negotiated procedure: bank accounts for the deposit of surplus funds in euro

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Active substance: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor) - Orphan designation - Commission Decision (2018)7798 of Wed, 21 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Active substance: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast) - Orphan designation - Commission Decision (2018)7797 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/134/18

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

13-8-2018

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Active substance: Ex-vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast) - Orphan designation - Commission Decision (2018)5277 of Mon, 13 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/028/18

Europe -DG Health and Food Safety

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

2-8-2018

EU/3/18/2044 (medac Gesellschaft fUr klinische SpezialprAparate mbH)

EU/3/18/2044 (medac Gesellschaft fUr klinische SpezialprAparate mbH)

EU/3/18/2044 (Active substance: Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded) - Orphan designation - Commission Decision (2018)5276 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/023/18

Europe -DG Health and Food Safety

11-6-2018

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Active substance: idelalisib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3765 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3843/T/40

Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1817 (IQVIA RDS Ireland Limited)

EU/3/16/1817 (IQVIA RDS Ireland Limited)

EU/3/16/1817 (Active substance: Human donor haematopoietic stem and progenitor cells that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor) - Transfer of orphan designation - Commission Decision (2018)3143 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/191/16/T/01

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1382 (Novartis Europharm Limited)

EU/3/14/1382 (Novartis Europharm Limited)

EU/3/14/1382 (Active substance: Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist) - Transfer of orphan designation - Commission Decision (2018)3044 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/120/14/T/01

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

17-4-2018

Autologous skeletal myoblasts expanded ex vivo (Assistance Publique - Hopitaux de Paris (APHP))

Autologous skeletal myoblasts expanded ex vivo (Assistance Publique - Hopitaux de Paris (APHP))

Autologous skeletal myoblasts expanded ex vivo (Active substance: Autologous skeletal myoblasts expanded ex vivo) - Refusal of orphan designation - Commission Decision (2018)2354 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/144/17

Europe -DG Health and Food Safety