Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 4 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

Israel - English - Ministry of Health

kamada ltd, israel - human normal immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents (0-18 years) in:- primary immunodeficiency syndromes (pid) with impaired antibody production- secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of <4 g/l* psaf= failure to mount at least a 2-fold rise in igg antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccinesimmunomodulation in adults, and children and adolescents (0-18 years) in:- primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count- guillain barré syndrome- kawasaki disease (in conjunction with acetylsalicylic acid)- chronic inflammatory demyelinating polyradiculoneuropathy (cidp)- multifocal motor neuropathy (mmn)

Australia - English - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - normal immunoglobulin, quantity: 3300 mg - injection, solution - excipient ingredients: tributyl phosphate; sodium chloride; water for injections; human immunoglobulin a; glycine; polysorbate 80; sodium acetate - replacement therapy in adults and children in primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency (cvid), severe combined immunodeficiencies, igg subclass deficiencies with recurrent infections. replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Australia - English - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - normal immunoglobulin, quantity: 1650 mg - injection, solution - excipient ingredients: polysorbate 80; water for injections; glycine; tributyl phosphate; human immunoglobulin a; sodium acetate; sodium chloride - replacement therapy in adults and children in primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency (cvid), severe combined immunodeficiencies, igg subclass deficiencies with recurrent infections. replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Australia - English - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 5 g - injection, solution - excipient ingredients: sorbitol; human immunoglobulin a; water for injections - replacement therapy indications: - primary immunodeficiency (pi) diseases - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,immunomodulation indications: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - guillain barr? syndrome - kawasaki disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 20 g - injection, solution - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - replacement therapy indications: - primary immunodeficiency (pi) diseases - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,immunomodulation indications: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - guillain barr? syndrome - kawasaki disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 g - injection, solution - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - replacement therapy indications: - primary immunodeficiency (pi) diseases - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,immunomodulation indications: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - guillain barr? syndrome - kawasaki disease.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >90% gamma globulin - powder and solvent for solution for infusion - 0.5 g/30 m gram(s)/millilitre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration - primary immunodeficiency syndromes (pid): congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeficiencies severe combined immunodeficiencies wiskott aldrich syndrome myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections children with congenital aids and recurrent infections

Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg/ml - immune sera and immunoglobulins

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 4 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.