Restoring and maintaining circulating blood volume when the loss of volume has been demonstrated and the use of a colloid is appropriate.


The concentration, albumin preparation, dosage and infusion rate must be individually tailored to the needs of the patient

Dosage

The dose required depends on the size of the patient, the severity of the trauma or pathology, and the extent of fluid and protein loss. The appropriate measure of the circulating volume and not the albuminemia should be taken into account in determining the dosage.

If the administration of human albumin is necessary, the hemodynamic parameters of the patient should be monitored regularly, especially
· Blood pressure and pulse

· Central venous pressure

· Pulmonary artery occlusion pressure

· Urinary flow

· Electrolytes

· Hematocrit / hemoglobinemia

Mode of administration

Human albumin can be administered directly intravenously or diluted in an isotonic solution (eg, 5% glucose or 0.9% sodium chloride).
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The infusion rate shall be adapted to each particular case and to the indication

In the case of plasma exchange, the infusion rate must be adjusted to the rate of elimination.
The solution is clear, slightly viscous, yellow, amber or green.
Pharmacotherapeutic group, blood substitute and plasma protein fractions ATC code: B05AA01

Human albumin accounts for quantitatively more than half of the total plasma proteins and about 10% of the protein synthesis activity of the liver. >
Physico-chemical data

Human albumin at 200 or 250 g / l has corresponding hyper-oncotic effects.
The major physiological function of albumin lies in its contribution to blood pressure and on its role as a carrier .An albumin stabilizes the circulating blood volume and transports hormones, enzymes, drugs and toxins .

No effect on the ability to drive and use machines has been observed.
Hypersensitivity to the active substance or to any of the excipients.
Therefore, if an allergic or anaphylactic reaction is suspected, the injection should be immediately discontinued. In the event of a shock, standard shock treatment shall be initiated.

Albumin should be administered with caution in situations where hypervolemia and its consequences or hemodilution may present a risk peculiar to the patient. These situations can be

· Decompensated heart failure

· Hypertension

· Oesophageal varices

· Pulmonary edema

· Haemorrhagic terrain

· Severe anemia

· Renal and post-renal anuria.

In post-hoc follow-up studies of patients with cranial trauma and in critical condition, resuscitation with albumin has been associated with a higher mortality rate than resuscitation with a solution Saline.

Although the mechanisms related to the difference in the mortality rate are not clearly identified, it is advisable to administer the albumin with caution in patients with severe cranial trauma. >

The colloido-osmotic effect of human albumin at 200 or 250 g / l is approximately four times that of blood plasma. Therefore, adequate hydration of the patient should be ensured during the administration of concentrated albumin. Patients should be closely monitored to prevent vascular overload or hyperhydration.

Human albumin solutions at 200-250 g / l are relatively poor in electrolytes, compared to human albumin solutions at 40-50 g / l. When administering albumin, the electrolyte balance should therefore be followed (see Dosage and Mode of Administration) and appropriate measures should be taken to restore or maintain the electrolyte balance. Code>
The solutions of albumin should not be diluted in water for preparations injections because of the risk of haemolysis in the patient

If exchange volumes are relatively large, coagulation and hematocrit checks are necessary, Ensure adequate replacement of other blood components (coagulation factors, electrolytes, platelets and erythrocytes). Code>
Hypervolemia may occur if the dosage and infusion rate are not adjusted to the vascular condition of the patient From the first clinical signs of cardiovascular overload (headache, dyspnea, jugular vein congestion) Elevation of arterial or venous pressure or pulmonary edema, the infusion should be immediately interrupted.

Data on the use of Albunorm 20%, 200 g / l in children are limited. The product should therefore be administered to the child only in cases where the benefit / risk ratio is clearly positive.

This specialty contains 7.2 - 8 mmol / 14.4 - 16 mmol / l of sodium per 50 ml vial / 100 ml of albumin solution, which should be taken into consideration in patients controlling their sodium dietary intake.

This specialty contains at most 1 mmol of potassium per vial of 100 ml of albumin solution. This is to be taken into consideration in patients with reduced renal function or patients controlling their potassium dietary intake.
Standard measures for preventing infections resulting from the use of drugs prepared from human blood or plasma include the selection of donors, the search for specific markers of infection on individual donations and mixtures of Plasma and inclusion; effective manufacturing steps for viral inactivation / elimination

However, when drugs prepared from human blood or plasma are administered, the possibility of transmission of infectious agents can not be totally ruled out. This also applies to unknown or emerging viruses and other pathogens

No virus transmission has been reported with the albumin manufactured in accordance with the specifications of the European Pharmacopoeia according to established procedures

No specific interaction of human albumin with other drugs is known

The human albumin solution should not be mixed with other medicines, whole blood, red blood cell concentrates and water, for injections because of risk, hemolysis in recipients

The solution may be administered directly by the intravenous route or diluted in an isotonic solution (eg glucose, 5% sodium chloride or 0.9% sodium chloride).

Do not use cloudy or deposited solution. This may indicate that the protein is unstable or that the solution has been contaminated.





The safety of Albunorm 20%, 200 g / l, during pregnancy has not been established, by controlled clinical trials. However, clinical experience with albumin suggests that no deleterious effects on the course of pregnancy, the fetus and the newborn are expected.
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No animal reproduction studies were conducted with Albunorm 20%, 200 g / l.
However, human albumin is a normal constituent of human blood.

Mild, puff, vasomotor, urticaria, fever and nausea reactions occur in rare cases. Normally, these reactions disappear rapidly when the perfusion rate is reduced or the infusion is interrupted. Very rarely, severe shock-like reactions can occur. In the case of severe reactions, the infusion should be discontinued and appropriate treatment should be initiated.


Class of organ systems

Reactions

(Frequency not known) *

Immune system disorders

Anaphylactic reaction, anaphylactic reaction

Hypersensitivity

Psychiatric disorders

State of confusion

Disorders of the nervous system

Headache

Cardiac disorders

Tachycardia

Bradycardie

Affections, vascular

Hypotension

Hypertension

Flushing

Respiratory, thoracic and mediastinal disorders

Dyspnea

Gastrointestinal disorders

Nausea

Skin and subcutaneous tissue disorders

Urticaria

Edema of Quincke

Erythematous rash

Hyperhidrosis

Disorders, General and Site Anomalies, Administration

Pyrexia

Thrills

* Can not be estimated from the data available

For information on the safety of transmissible infectious agents see Warnings and Precautions for Use

Restoration and maintenance of circulating blood volume when loss of volume has been demonstrated and the use of a colloid is appropriate The choice of an albumin rather than a synthetic colloid depends on the situation; Clinic of each patient, based on official recommendations.