Human Albumin 20% Behring (Low Salt) Solution for Infusion

Human Albumin 20% Behring (Low Salt) Solution for Infusion Special Precautions

human albumin


CSL Behring


Full Prescribing Info
Special Precautions
Suspicion of allergic or anaphylactic type reactions (reaction like an allergic shock) 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 (oversized blood volume) and its consequences or haemodilution (dilution of the blood) could represent a special risk for the patient. Examples of such conditions are: decompensated cardiac insufficiency (severe heart muscle deficiency), hypertension (increased blood pressure), oesophageal varices (disease of the gullet vessels), pulmonary oedema, haemorrhagic diathesis (increased tendency to bleeding), severe anaemia (severe red blood cell deficiency), renal and post-renal anuria (kidney failure).
The colloid-osmotic effect of human albumin 200 or 250 g/l is approximately four times that of blood plasma. Therefore, when highly concentrated albumin is administered, care must be taken to assure adequate hydration (fluid supply) of the patient. Patients should be monitored carefully to guard against circulatory overload or hyperhydration (increased volume of total body water).
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 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 (destruction of red cells) 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 situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea [difficulty in breathing], jugular vein congestion), or increased blood pressure, raised venous pressure or pulmonary oedema, the infusion is to be stopped immediately.
Human Albumin 20% Behring, low salt contains 125 mmol sodium per litre. To be taken into consideration by patients on a controlled sodium diet.
Pathogen Safety: This product is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically Creutzfeldt-Jakob Disease (CJD) agents, that can cause disease. The risk that such product will transmit an infectious agent has been reduced by measures put in place to prevent infections being passed on to patients. These include careful 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 signs of virus infections.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses and remove CJD agents. 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 20% Behring, low salt, the name and batch number of the product are recorded in order to maintain a record of the batches used.
Pregnancy and lactation: The safety of Human Albumin 20% Behring, low salt, 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, particularly since human albumin is a normal constituent of human blood. No animal reproduction studies have been conducted with Human Albumin 20% Behring, low salt.
Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development.
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