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  • Flebogamma 5% DIF
    / Medici


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    100 ml

    partial basket chart 74378 6558

    Vial

    200 ml

    partial basket chart 74379 6559

    Related information


    Dosage

    Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
    The dose and dosage regimen is dependent on the indication.
    In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline.
    Replacement therapy in primary immunodeficiency syndromes: The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 – 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 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 Thrombocytopenic: There are two alternative treatment schedules:
    0.8 – 1 g/kg given on day one, which may be repeated once within 3 days, or 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.
    Allogeneic Bone Marrow Transplantation: Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplant.
    For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. The starting dose is normally 0.5 g/kg/week, starting seven days before transplantation and for up to 3 months after transplantation.
    See prescribing information for full details.


    Indications

    Replacement therapy in:
    Primary immunodeficiency syndromes such as:
    – congenital agammaglobulinaemia and hypogammaglobulinaemia
    – common variable immunodeficiency
    – severe combined immunodeficiency
    – Wiskott Aldrich syndrome
    Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
    Children with congenital AIDS and recurrent infections.
    Immunomodulation: Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.
    Guillain Barré Syndrome.
    Kawasaki disease.
    Allogeneic bone marrow transplantation.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients listed in section List of excipients (see section Special warnings and precautions for use).
    Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA.
    Fructose intolerance (see section Special warnings and precautions for use).
    In babies and young children (aged 0 – 2 years) hereditary fructose intolerance (HFI) may not yet be diagnosed and may be fatal, thus, they must not receive this medicinal product.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    Adverse reactions such as headache, chills, dizziness, fever, nausea, vomiting, allergic reactions, arthralgia, low blood presure and moderate low back pain may occur occasionally.
    See prescribing information for full details.


    Drug interactions

    Live attenuated virus vaccines: Flebogamma® 5% DIF administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
    After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore patients receiving measles vaccine should have their antibody status checked.
    Paediatric population: It is expected that the same interactions than those mentioned for the adults may be presented by the paediatric population.


    Pregnancy and Lactation

    Pregnancy: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. IVIg products have been shown to cross the placenta, increasingly after the third trimester.
    Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or the foetus and neonate are to be expected to either the mother or the offspring.
    Breast-feeding: Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.


    Overdose

    Overdose may lead to fluid overload and hyper viscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.
    Paediatric population: Information on overdose in children has not been established with Flebogamma® DIF.
    However, as in adult population, overdose may lead to fluid overload and hyperviscosity as with any other intravenous immunoglobulins.


    Manufacturer
    Instituto Grifols, S.A.
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