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HUMAN ALBUMIN BAXALTA 200 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 200 g/l
Solution for Infusion

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin Baxalta 200 g/l is a solution containing 200 g/l of total protein of
which at least 95% is human albumin.
A vial of 100 ml contains 20 g of human albumin.
A vial of 50 ml contains 10 g of human albumin.
The solution is hyperoncotic.
Excipients with known effect:
Sodium 100-130 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 200 g/l can be directly administered by the intravenous
route, or it can also be diluted in an isotonic solution (e.g. 5 % glucose or 0.9 %
sodium chloride).
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
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) and appropriate steps taken to
restore or maintain the electrolyte balance. Human Albumin Baxalta 200 g/l contains
100-130 mmol/l sodium. This is to be taken into consideration by patients on a
controlled sodium diet.
Albumin solutions 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 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 200 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 200 g/l with other medicinal
products have been performed.

4.6

Fertility, pregnancy and lactation
The safety of Human Albumin Baxalta 200 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 conducted with Human Albumin Baxalta
200 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 200 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
conditions

anaphylactic
shock
nausea
flushing,
skin rash
fever

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 company-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

Very rare

Overdose
Hypervolaemia may occur if the dosage and rate of infusion 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 200 g/l has a corresponding
hyperoncotic effect.
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 embryofoetal toxicity, oncogenic or mutagenic potential.
No signs of acute toxicity have been described in animals models.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sodium Caprylate

16 mmol/l (2.7 g/l)

Sodium N-Acetyltryptophanate

16 mmol/l (4.3 g/l)

Sodium Chloride

3.0 g/l

Water for Injection

ad 1 l

6.2

Incompatibilities
This medicinal product must not be mixed with other medicinal products
(except the recommended diluents mentioned in section 6.6), 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
50 ml of solution in a vial (type II glass) with a bromobutyl rubber stopper –
pack size of 1 or 70.

100 ml of solution in a vial (type II glass) with a bromobutyl rubber stopper –
pack size of 1 or 56.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
The solution can be directly administered by the intravenous route or it can
also be diluted in an isotonic solution (e.g. 5 % glucose or 0.9% sodium
chloride).
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.
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 34078/0008

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
05/10/2006

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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