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  • Gammaplex
    / Kamada


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    10 g / 200 ml

    partial basket chart 27942 7856

    Vial

    5 g / 100 ml

    partial basket chart 27940 7855

    Vial

    2.5 g / 50 ml

    partial basket chart 54574

    Related information


    Dosage

    The dose and dose regimen is dependent on the indication.
    In replacement therapy the dose may need to be individualised for each patient
    dependent on the pharmacokinetic and clinical response. The following dose
    regimens are given as a guideline.
    Replacement therapy in primary immunodeficiency syndromes: The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/L. Three to six months are required after the
    initiation of therapy for equilibration to occur. The recommended starting
    dose is 0.4 – 0.8 g/kg given once, followed by at least 0.2 g/kg given every
    three to four weeks.
    The dose required to achieve a trough level of 5-6 g/L is of the order of 0.2 – 0.8 g/kg/month. The dosage interval when steady state has been reached varies from 3 – 4 weeks.
    Trough levels should be measured and assessed in conjunction with the
    incidence of infection. To reduce the rate of infection, it may be necessary to
    increase the dosage and aim for higher trough levels.
    Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; congenital AIDS with recurrent bacterial infections: The recommended dose is 0.2 – 0.4 g/kg every three to four weeks.
    Primary immune thrombocytopenia: There are two alternative treatment schedules:
    – 0.8 – 1 g/kg given on day one; this dose may be repeated once within 3 days
    – 0.4 g/kg given daily for two to five days.
    The treatment can be repeated if relapse occurs.
    Guillain Barré syndrome: 0.4 g/kg/day over 5 days.
    Kawasaki Disease: 1.6 – 2.0 g/kg should be administered in divided doses over two to five days or 2.0 g/kg as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
    See prescribing information for full details.


    Indications

    Replacement therapy in: Primary immunodeficiency syndromes such as: congenital agammaglobulinemia and hypogammaglobulinemia; common variable immunodeficiency; severe combined immunodeficiency; Wiskott Aldrich syndrome.Myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections. Children with congenital AIDS and recurrent infections.


    Contra-Indications

    Hypersensitivity to any of the components. Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. Fructose intolerance.


    Special Precautions

    The recommended infusion rate must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Certain adverse reactions may occur more frequently in case of high infusion rate; in patients with hypo- or agammaglobulinemia with or without IgA deficiency; in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion. See prescribing information for full details.Pregnancy and lactation: The safety of this product has not been established in controlled clinical trials and therefore should only be given with caution in pregnancy and lactation. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected. Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
    See prescribing information for full details.


    Side Effects

    Adverse reactions are experienced by almost 50% of the patients. The most frequent adverse reaction is headache.
    See prescribing information for full details.


    Manufacturer
    BPL, Bio Products Laboratory
    Licence holder
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