Uman Albumin 200 g/L

Human albumin from human plasma.

See Table 1.

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Excipient with known effect: This medicinal product contains 123.5-136.5 mmoles/liter sodium. To be taken into consideration by patients on a controlled sodium diet.
Excipients/Inactive Ingredients: 1 litre of solution for infusion contains: UMAN ALBUMIN 200 g/l: Sodium chloride 4.52 g/l, Sodium caprylate 2.660 g/l (16 mmoles/l), Acetyltryptophan 3.940 g/l (16 mmoles/l), Water for injections up to 1000 ml, Total concentration of sodium 123.5-136.5 mmoles/l.
UMAN ALBUMIN 250 g/l: Sodium chloride 3.52 g/l, Sodium caprylate 3.325 g/l (20 mmoles/l), Acetyltryptophan 4.925 g/l (20 mmoles/l), Water for injections up to 1000 ml, Total concentration of sodium 123.5-136.5 mmoles/l.

Pharmacotherapeutic Group: Plasma substitutes and plasma protein fractions. ATC Code: B05AA01.
Pharmacology: Pharmacodynamics: 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.
Physicochemical data: UMAN ALBUMIN 200 g/l or 250 g/l has a corresponding hyperoncotic effect.
The most important physiological function 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.
Paediatric population: No specific studies of efficacy and safety are available on paediatric population.
Pharmacokinetics: 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 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 feed-back 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 a 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.
Paediatric population: No specific studies of efficacy and safety are available on paediatric population.
Toxicology: 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.

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.

The concentration of the albumin preparation, dosage and the infusion-rate must be adjusted to the patient's individual requirements.
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 must be used to determine the dose required.
If human albumin is to be administered, haemodynamic performance must 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 safety and efficacy of UMAN ALBUMIN in children have not been established by controlled clinical trials and its use in paediatric population is based only on established medical practice. For this reason, UMAN ALBUMIN must be used in children only if clearly necessary. UMAN ALBUMIN can be administered to premature infants.
Patients with renal impairment: UMAN ALBUMIN can be administered to dialysis patients as the aluminium content of the finished product is not more than 200 μg/l.
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 must be adjusted according to the individual circumstances and the indication. In Plasma exchange the infusion-rate must be adjusted to the rate of removal.

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 must be stopped immediately and the patient's haemodynamic parameters carefully monitored, Additionally, diuresis or cardiac output must be increased in accordance to the severity of the clinical situation.

Hypersensitivity to the active substance or to any of the excipients listed in Description.

Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. In case of shock, standard medical treatment for shock must be implemented.
Albumin must 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 or 250 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 must 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 electrolytes status of the patients must be monitored (see Dosage & Administration) 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).
If the haematocrit drops below 30%, packed red cells should be given in order to maintain the oxygen transport capacity of the blood.
Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patients 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.
Viral safety: 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 UMAN ALBUMIN 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.
Effects on ability to drive and use machines: UMAN ALBUMIN has no or negligible influence on the ability to drive and use machines.
Fertility: No animal reproduction studies have been conducted with UMAN ALBUMIN.
However human albumin is a normal constituent of human blood.
Use in Children: Although no specific data are available for paediatric population, the clinical experience on the use of Human Albumin in children suggests that no differences between adults and children are to be expected, provided that a careful attention to the dosage has been observed in order to avoid circulatory overload.

Pregnancy: The safety of UMAN ALBUMIN 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.
In general, particular attention must be paid when a substitution of volume is effected in a pregnant patient.
Breast-feeding: Since human albumin is a normal constituent of human blood, treatment of the nursing mother with UMAN ALBUMIN is not expected to present a risk to the breast-fed newborn/infant.

Summary of safety profile: Severe reactions, such as shock, may occur very rarely with human albumin solutions. In these cases, the infusion must be stopped and an appropriate treatment must be initiated.
Mild undesirable effects, which may occur rarely with the use of human albumin solutions, are flush, urticaria, fever, and nausea.
These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped.
For safety information with respect to transmissible agents, see Precautions.
Tabulated list of adverse reactions: The table presented as follows is according to the MedDRA System Organ Classification (SOC) and Preferred Term Level (PT) and it includes undesirable effects occurring with the use of human albumin solutions.
Frequencies have been evaluated according to the following convention: 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); very rare (<1/10,000), not known (cannot be estimated from the available data).
There are no robust data on the frequency of undesirable effects from clinical trials.
The following data is in line with the safety profile of human albumin solutions, and confirmed by the post marketing experience; as the post marketing 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: See Table 2.

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Paediatric population: No specific data are available on paediatric population.
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 national reporting system.

No interaction studies have been performed.

Special precautions for disposal and other handling: 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 must 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 container has been opened, the contents must be used immediately.
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Incompatibilities: This medicinal product must not be mixed with other medicinal products (except those mentioned in Description), whole blood and packed red cells.

Do not store above 30˚C.
Protect from light.
Do not freeze.
The storage conditions must be strictly followed.
Shelf-Life: In its intact packaging and if the storage instructions have been fully followed, UMAN ALBUMIN has a validity of 3 years from the date of production.

Intravenous & Other Sterile Solutions

B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.

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