Albiomin 20 %

/ Kamada

The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid or 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
– haemaotcrit / haemoglobin
Method of administration
Intravenous use
Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 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.

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 recommendation.

Hypersensitivity to albumin preparations or to any of the excipients.

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Transmissible agents
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 Pharma-copoeia specifications by established processes.
Precautions for use
Suspicion of allergic or anaphylactic-type reactions requires immediate discontinuation of the infusion .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 is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to ensure adequate hydration of the patient. Patients should 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 electrolyte status of the patient should be monitored 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 patient’s 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. See prescribing information for full details.

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. See prescribing information for full details.

No specific interactions of human albumin with other products are known.

Pregnancy
The safety of this medicinal product 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 fetus and the neonate are to be expected.
Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or fetus, the course of gestation and peri- and postnatal development.
However, human albumin is a normal constituent of human blood.

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 should be stopped immediately and the patient’s haemodynamic parameters carefully monitored.

Store below 25°C. Do not freeze.
Keep the container in the outer carton in order to protect from light.
Once the container has been opened, the contents should be used immediately. Any unused product should be disposed of in accordance with local requirements.