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  • Human Albumin 20% Behring
    / Gemedix


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Solution for Infusion

    50 ml

    partial basket chart 65224

    Solution for Infusion

    100 ml

    partial basket chart 16762

    Dosage

    The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient’s individual requirements.
    Posology: The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and 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
    – haematocrit/haemoglobin
    Method of administration: Human albumin can be administered by the intravenous route, either undiluted or after dilution in an isotonic solution (e.g. 5 % glucose or 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.


    Indications

    – Hypoalbuminemia (liver cirrhosis, nephrosis)
    – Toxic processes ( pregnancy toxicosis, hyperbilirubinemia )
    – Volume substitution therapy


    Contra-Indications

    Hypersensitivity to albumin preparations or to any of the excipients of the product.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    The following adverse reactions are based on post marketing experience and were observed very rarely (< 1/10,000 including reported single cases):
    – General disorders and administration site conditions: Chills, fever, nausea, vomiting, headache, malaise and flush.
    – Immune system disorders: Hypersensitivity reactions or allergic-anaphylactic reactions such as rash, itching, urticaria, dyspnoea, tachycardia, bradycardia, hypotension. These reactions might in single cases be reaching as far as life-threatening shock.
    Mild reactions normally disappear rapidly after the infusion rate has been slowed down or the infusion stopped. In case of severe reactions (e.g. anaphylactic shock) the infusion has to be stopped immediately and appropriate treatment instituted.


    Drug interactions

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


    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.


    Overdose

    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 or pulmonary oedema, the infusion should be stopped immediately and the patient’s haemodynamic parameters carefully monitored.


    Manufacturer
    CSL Behring
    Licence holder
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