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HUMAN ALBUMIN 200 G/L SOLUTION FOR INFUSION

Active substance(s): HUMAN ALBUMIN

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HUMAN BioPlazma
Manufacturing and Trading Limited Liability Company
Táncsics M. út 80., H-2100 Gödöllő, Hungary
PACKAGE LEAFLET: INFORMATION FOR THE
PRESCRIBERS
1. NAME OF THE MEDICINAL PRODUCT
Human Albumin 200 g/l solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin 200 g/l solution for infusion is a solution containing 200 g/l of total protein of which at
least 95% is human albumin.
Each vial of 50 ml contains 10 g of human albumin.
Each vial of 100 ml contains 20 g of human albumin.
Excipient(s):
This medicinal product contains 138-152 mmol
sodium per litre. To be taken into consideration by
patients on a controlled sodium diet.
For a 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
continuity of 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
- haematocrit/haemoglobin

Method of administration
Human albumin 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.
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 solution for infusion 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 solution are relatively
low in electrolytes compared to the 4 - 5% 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.
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 patients circulatory

HUMAN BioPlazma
Manufacturing and Trading Limited Liability Company
Táncsics M. út 80., H-2100 Gödöllő, Hungary
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.
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 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 200 g/l solution for infusion 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 specific interactions of human albumin with
other medicinal products are known.
4.6 Pregnancy and lactation
The safety of Human Albumin 200 g/l solution for
infusion 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.
No animal reproduction studies have been conducted with Human Albumin 200 g/l solution for infusion.
However, human albumin is a normal constituent of
human blood.
4.7 Effects on ability to drive and use machines
No effects on ability to drive and use machines have
been observed.
4.8 Undesirable effects
Mild reactions 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
reactions such as shock may occur. In these cases,
the infusion should be stopped and an appropriate
treatment should be initiated.
For safety with respect to transmissible agents, see
section 4.4.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Human Albumin 200 g/l solution for infusion
Human Albumin
Read all of this leaflet carefully before you start using 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 pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Human Albumin 200 g/l solution for infusion is and what it is used for
2. What you need to know before you use Human Albumin 200 g/l solution for
infusion
3. How to use Human Albumin 200 g/l solution for infusion
4. Possible side effects
5. How to store Human Albumin 200 g/l solution for infusion
6. Contents of the pack and other information
1. What Human Albumin 200 g/l solution for infusion is and what it is used
for
Your medicine has been made from blood plasma originating from screened donors. The product contains proteins, which are substances that occur naturally
in your body and are needed for several different functions. The sterilised liquid
in the glass vials contains approximately 200 grams per litre (200 g/l) of protein,
of which at least 95% is human albumin (the active substance), stabilised with
sodium caprylate and N-acetyl-DL-tryptophan.
Each vial contains 50 ml or 100 ml of a 200 g/l solution of human albumin.
The medicine is used for the restoration and maintenance of circulating blood
volume (if you lose a lot of fluid, you will need to have this replaced, which is
what this medicine is intended for).
The product is an intravenous infusion (an injection given slowly into a vein) and
is only available on a doctor’s prescription.
2. What you need to know before you use Human Albumin 200 g/l
solution for infusion
Do not use Human Albumin 200 g/l solution for infusion
- if you are allergic (hypersensitive) to albumin preparation or any of the other
ingredients of this medicine (listed in section 6).
Take special care with Human Albumin 200 g/l solution for infusion
Tell your doctor if you
- have allergic or violent reaction to Human Albumin 200 g/l solution for infusion
when injected. Treatment should be stopped immediately.
- high blood pressure (hypertension)
- heart problem when the heart is not pumping properly (heart failure)
- enlarged veins in the oesophagus (oesophageal varices)
- fluid accumulation in the lungs
- have blood problems, especially anaemia, or a tendency to spontaneous
bleeding
- have severe kidney problems or a chronic liver condition

- are breast feeding your baby
- know that you are, or you think you might be pregnant
- are taking other medicine (although other medicines are unlikely to affect your
treatment)
Other medicines and Human Albumin 200 g/l solution for infusion
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Human Albumin
200 g/l solution for infusion
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
selection of blood and plasma donors to make sure those at risk of carrying
infections are excluded, and the testing of each donation and pools of plasma
for sign of viral infections. Manufacturers of these products are also include
steps in the processing of the blood or plasma that can inactive 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 or other
types of infections.
There are no reports of virus infections with albumin manufactured to European
Pharmacopoeia specifications by established processes.
It is strongly recommended that every time you receive a dose of Human Albumin 200 g/l solution for infusion the name and batch number of the product are
recorded in order to maintain a record of the batches used.
3. How to use Human Albumin 200 g/l solution for infusion
Your medicine will be given to you in hospital as an infusion (an injection given
slowly into a vein). The product will be warmed to room temperature before it
is given.
The amount needed will depend on the reason the medicine is being given and
on how well you respond to the treatment. The dose will be calculated by your
doctor. Tests will probably be carried out on your blood to check when the right
amounts of protein are present and treatment can stop.
Children: The amount given will depend on the age of your child. Your doctor
will take this into account when working out the amount of medicine to give.
During and after treatment with Human Albumin 200 g/l solution for infusion,
your doctor will check how well the medicine is working by taking your pulse
and blood pressure and by testing your blood. Your heart and breathing will
be checked regularly as these are a good indication of whether you have too
much fluid, particularly if you are elderly or very young. This checking may be
continued even after the treatment has finished.
When large quantities of fluid are needed, the amounts of important substances
normally found in blood may go down too far. In this case, other types of fluid,
such as plasma or red blood cells, may also be needed.

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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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