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HUMAN ALBUMIN BAXALTA 50 G/L SOLUTION FOR INFUSION

Active substance(s): HUMAN ALBUMIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Human Albumin Baxalta 50 g/l
Solution for Infusion

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin Baxalta 50 g/l is a solution containing 50 g/l of total protein of
which at least 95% is human albumin.
A vial of 250 ml contains 12.5 g of human albumin.
A vial of 500 ml contains 25 g of human albumin.
Human albumin 50 g/l is mildly hypooncotic.
Excipients with known effect:
Sodium 130-160 mmol
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 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 concentration
- haematocrit/haemoglobin
- clinical signs of cardiac/respiratory failure (e.g., dyspnoea)
- clinical signs of increasing intra-cranial pressure (e.g., headache)
Method of administration
Human Albumin Baxalta 50 g/l can be directly administered by the intravenous route.
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 injection. 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
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.
Human Albumin Baxalta 50 g/l contains 130-160 mmol/l sodium. This is to be taken
into consideration by patients on a controlled sodium diet.
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 rate of infusion 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
central venous pressure and pulmonary oedema, the infusion is to be stopped
immediately.
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 Human Albumin Baxalta 50 g/l 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 interaction

No interaction studies of Human Albumin Baxalta 50 g/l with other medicinal
products have been performed.

4.6

Fertility, pregnancy and lactation
The safety of Human Albumin Baxalta 50 g/l for use in human pregnancy has not
been established in controlled clinical trials. 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.
The effects of human albumin on fertility have not been established in controlled
clinical trials.
No animal reproduction studies have been performed with Human Albumin Baxalta
50 g/l.
Experimental animal studies are insufficient to assess the safety with respect to
reproduction, development of the embryo or foetus, the course of gestation and periand postnatal development.
However, human albumin is a normal constituent of human blood.

4.7

Effects on ability to drive and use machines
Human Albumin Baxalta 50 g/l has no influence on the ability to drive and use
machines.

4.8

Undesirable effects
Frequency has been evaluated using the following criteria: very common
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare
(≥1/10,000 to <1/1,000), and very rare (<1/10,000), not known (cannot be
estimated from the available data).
Very
Common

Common

Uncommon

Rare

Immune system disorders
Gastrointestinal disorders
Skin and subcutaneous
tissue disorders
General disorders and
administration site

Very rare
anaphylactic
shock

nausea
flushing,
skin rash
fever

conditions
In cases of severe reactions, the infusion should be stopped and an appropriate
treatment should be initiated.
In post-marketing surveillance the following adverse events have been
reported. These events are listed by MedDRA System Organ Class, then by
Preferred Term in order of severity.
Immune System Disorders: Anaphylactic reaction, Hypersensitivity/Allergic
reactions
Nervous System Disorders: Headache, Dysguesia
Cardiac Disorders: Myocardial infarction, Atrial fibrillation, Tachycardia
Vascular Disorders: Hypotension
Respiratory, Thoracic, and Mediastinal Disorders: Pulmonary edema, Dyspnea
Gastrointestinal Disorders: Vomiting
Skin and Subcutaneous Tissue Disorders: Urticaria, Pruritis
General Disorders and Administration Site Conditions: Chills
There are no data available on adverse reactions from Baxter-sponsored
clinical trials conducted with Albumin (Human).
For safety with respect to transmissible agents, see section 4.4.
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 reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

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 Baxalta 50 g/l is mildly hypooncotic to
normal plasma.
The most important physiological functions of albumin result from its contribution to
the oncotic pressure of the blood and its transport function. Albumin stabilizes
circulating blood volume and is a carrier of hormones, enzymes, medicinal products
and toxins.

5.2

Pharmacokinetic properties
Under normal conditions the total exchangeable albumin pool is 4 - 5
g/kg bodyweight, of which 40 to 45 % is present intravascularly and 55
to 60 % 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.
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 two 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 Caprylate

4 mmol/l (0.7 g/l)

Sodium N-Acetyltryptophanate

4 mmol/l (1.1 g/l)

Sodium Chloride

7.5 g/l

Water for Injection

ad 1 l

6.2

Incompatibilities
This medicinal product must not be mixed with other medicinal products,
whole blood and packed red cells. Further human albumin should not be
mixed with protein hydrolysates (e.g. parenteral nutrition) or solutions
containing alcohol since these combinations may cause the proteins to
precipitate.

6.3

Shelf life
36 months
After opening the product should be used immediately.

6.4

Special precautions for storage
Do not store above 25°C
Do not freeze.
Store in the original package in order to protect from light.

6.5

Nature and contents of container
250 ml of solution in a vial (type II glass) with a bromobutyl rubber stopper –
pack size of 1 or 24.
500 ml of solution in a vial (type II glass) with a bromobutyl rubber stopper –
pack size of 1 or 10.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal
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 that are cloudy or have deposits. This may indicate that
the protein is unstable or that the solution has become contaminated.
Do not use unless seal is intact. If leaks are found, discard.
Once the container 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
Baxalta Innovations GmbH
Industriestrasse 67
A-1221 Vienna
Austria

8

MARKETING AUTHORISATION NUMBER(S)
PL 34078/0007

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/12/2010

10

DATE OF REVISION OF THE TEXT

08/06/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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