5% Biotest isotonic/20 % Biotest low salt content
Human Albumin
Composition: 1,000 ml solution contain: HA 5% Biotest isotonic: human plasma proteins 50 g (of which albumin at least 95%). Further constituents: caprylate (4 mmol/l), N-acetyl-DL-trytophanate 4 mmol/l), water for injection ad 1.000ml.
HA 20% Biotest low salt content: Human plasma proteins 200 g (of which albumin at least 95%). Further constituents (16 mmol/l), sodium ions (122 mmol/l), chloride ions (110 mmol/l), water for injection ad 1,000 ml.
Indications: albumin replacement in patients with albumin and blood volume deficiency (HA 5%). Albumin replacement in patients with major albumin deficiency (HA 20%).
Contra-Indication: Hypersensitive to albumin preparations or to any of the excipients.
Special precautions for use: If allergic or anaphylactic-type reactions occur, the infusion should be stopped immediately and appropriate treatment instituted. In case of shock, the current medical standards for shock-treatment should be observed.
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 anamie, Renal and post-renal anuria.
The colloid-osmotic effect of human albumin 20% is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.
Dosage instructions and duration of application: The dosage required depends on the size of the patients, the severity of trauma or illness 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.
Instructions with other medicinal products: No specific interactions of human albumin with other products are known.
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. 0.9 % sodium chloride).
The infusion rate should be adjusted according to the individual circumstances and the indication, but should normally be set up to 5 ml/min (HA 5%) and to 1-2 ml/min (HA 20%), Respectively.
Special Precautions for storage: Store at 2% oC to 8 oC. Do not freeze. Keep the container in the outer carton in order to protect from light.
Presentation: Human albumin 5% Biotest isotonic is a solution for intravenous administration: Vial with 50 ml, vial with 250 ml, vial with 500 ml. Human albumin 20% Biotest is a concentrated solution for intravenous administration: vial with 50 ml, vial with 100 ml.