The active ingredient is human albumin.
Excipients/Inactive Ingredients: sodium chloride, sodium caprylate and water for injections.
Pharmacotherapeutic class: Volume Substitute / Protide Provision Product (BO5AA01, Albumin).
First line treatment: For the treatment of serious hypoalbuminaemia except during the early stage of cardiovascular resuscitation in hypovolaemic patients with hydrous inflation with or without hyponatraemia.
During chronic exudative enteropathy and graft-versus-host reaction.
During cirrhosis with refractory ascites, specially around transplantation.
For the treatment of hypovolaemia in pregnancy, childhood and in case of known allergy to artificial colloids.
Second line treatment: When synthetic colloids have been used at their maximal doses.
In prevention of nuclear jaundice of the newborn.
The treatment of hypovolaemia and hypoalbuminaemia in newborns and infants, use the "Newborn and Infant" presentation.
Posology: The posology should be adapted to each individual case. It is determined by clinical parameters, in particular age and weight, haemodynamics (blood pressure, central venous pressure), diuresis (amount of hourly urine output) and common biochemical parameters (total proteins or albumin levels).
When hypovolaemia (decrease in volume of blood circulating) is accompanied by hyponatraemia (abnormally low level of protein in the blood), the level of total protein resulting from the infusion must be monitored.
In the treatment of hypovolaemia (decrease in volume of blood circulating) in children, the dosage is usually 1 or 2 g/kg. It is preferable to administer the product as 10% albumin (dilution to ½ in 5% glucose isotonic solution or 0.9% sodium chloride solution) according to sodium level in the child's blood.
If the patient feels the effect of Normal Serum Albumin Soln-LFB 20% is too strong or too weak, ask the doctor or pharmacist.
Method and route of administration: The solution is intended for intravenous use only.
If necessary, the solution should be brought to room temperature before infusion.
Respect usual rules of asepsis: The solution is colourless, yellow, brown or green. It is normally clear or slightly opalescent. When a vial is open, its content should be used instantly.
The rate of administration must be adapted to each individual case and to the indication.
Any unused or wasted product should be discarded according to current regulations.
Symptoms and instructions in case of overdose: Hypervolaemia (increase in volume of blood circulation) may occur if the dosage is too high and the rate of administration too fast. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), increased blood pressure, central venous pressure or pulmonary oedema (infiltration of liquid in the lungs), infusion must be stopped immediately.
Do not use Normal Serum Albumin Soln-LFB 20%: If the patient is allergic to albumin or to any of the excipients included in Normal Serum Albumin Soln-LFB 20%.
If allergy or anaphylactic reaction occurs, administration should be stopped immediately. In the event of shock, treatment should follow the current recommendations for treatment of shock.
Whenever hypervolaemia (increase of volume of blood circulating), and its consequences (for example raised cardiac output and high blood pressure and haemodilution (dilution of the blood) may present a particular risk for the patient. Careful clinical and biological monitoring should be provided. Such conditions are, for instance, coagulation disorders, serious anaemia (decrease in the number of red cells in the blood), anuria (absence of urine in the bladder).
The interpretation of blood concentrations of albumin and total proteins is impossible during the early stage of caring of patient in a severe stage in an emergency care unit.
In actual fact: 1. Most of the time these patients have received large amounts of artificial colloids and/or crystalloids, which artificially decrease the albuminaemia figures.
2. It is difficult to make a comparison between albuminaemia measures performed with different techniques, so that it is impossible to determine a threshold criteria to define serious hypoalbuminaemia.
3. The published data do not allow to define a threshold valve of serious hypoalbuminaemia.
If a large volume is administered, coagulation parameters and haematocrit should be controlled.
When drugs are prepared with human blood or human plasma, the risk of transmission of infectious agents cannot be definitely excluded; this applies to agents that might breed an illness and which nature is so far unknown as well.
The risk is limited by: stricter controls performed when donations are selected by means of a medical interview with donors and of the performance of screening tests for the main virus markers on every donation.
The manufacturing process for this product, which includes stages of elimination and/or inactivation of viruses, which effectiveness was established by means of virus validation studies.
However the effectiveness of elimination and/or inactivation of viruses remains limited towards a number of specially resistant viruses (viruses that are not enveloped).
To date, in case of viral contamination linked with the administration of human albumin has been reported.
When concentrated albumin is administered, care must be taken to ensure adequate hydration of the patient. Patients should be monitored carefully to prevent circulation overload and dehydration.
When high volume of human albumin 20% is administered, it is recommended to administer additional solutions of mineral salts to maintain balance of mineral salt level. Alternatively, therapy may be continued with albumin 4%.
Normal Serum Albumin Soln-LFB 20% contains 280 mg sodium per 100 ml vial and 140 mg per 50 ml vial.
This should be taken into account in case of salt-free diet.
List of excipients with known effects: Sodium salts (sodium chloride, sodium caprylate).
Effects on ability to drive and use machines: There are no indications that human albumin may impair the ability to operate motor vehicles or machinery.
Pregnancy: The safety of albumin during pregnancy and lactation has not been established by controlled clinical trials.
Animal experiments are insufficient to assess safety regarding reproduction, progress of pregnancy, development of embryo or foetus and peri- and postnatal development.
Ask the doctor or pharmacist before any medicine.
Lactation: Albumin is a normal constituent of blood and so it may be used during pregnancy and lactation if necessity has been clearly established.
Ask the doctor or pharmacist before any medicine.
As any medicine, Normal Serum Albumin Soln-LFB 20% may have undesirable effects.
Side effects after administration of human albumin are rare.
Mild reaction such as flush (redness and warmth of the body), urticaria, shivering, feeling of warmth, nausea, disappear rapidly when infusion rate is slowed or infusion is stopped. In very rare cases, severe reaction leading to shock may occur. In such, administration should be stopped and the appropriate treatment initiated.
Inform the doctor or pharmacist of any undesirable effect not mentioned.
No interaction between human albumin and other medicines has been reported at date.
Store at a temperature under 25°C. Do not freeze.
Keep the primary packaging in the outer package in other to protect the drug against light.
If necessary, visible signs of deterioration is a warning.
Do not use any solution which is cloudy or in which a deposit has formed.
B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.
Soln for inj 20% (colourless, yellow, brown or green, normally clear or slightly opalescent) x 50 mL.