Den Europæiske Union - engelsk - EMA (European Medicines Agency)

takeda manufacturing austria ag - human normal immunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - immune sera and immunoglobulins, - replacement therapy in adults, and children and adolescents (0-18 years) in:primary immunodeficiency syndromes with impaired antibody production;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;hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (hsct);congenital aids and recurrent bacterial infections.immunomodulation 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;multifocal motor neuropathy (mmn).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 40 g - injection, solution - excipient ingredients: water for injections; proline - replacement therapy for primary immunodeficiency diseases (pid), myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy for idiopathic thrombocytopenic purpura (itp) in patients at high risk of bleeding or prior to surgery to correct the platelet count, guillain-barr syndrome (gbs), kawasaki disease, chronic inflammatory demyelinating polyneuropathy (cidp), multifocal motor neuropathy (mmn), myasthenia gravis (mg) exacerbations, lambert-eaton myasthenic syndrome (lems), stiff person syndrome (sps).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 20 g - injection, solution - excipient ingredients: water for injections; proline - replacement therapy for primary immunodeficiency diseases (pid), myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy for idiopathic thrombocytopenic purpura (itp) in patients at high risk of bleeding or prior to surgery to correct the platelet count, guillain-barr syndrome (gbs), kawasaki disease, chronic inflammatory demyelinating polyneuropathy (cidp), multifocal motor neuropathy (mmn), myasthenia gravis (mg) exacerbations, lambert-eaton myasthenic syndrome (lems), stiff person syndrome (sps).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 10 g - injection, solution - excipient ingredients: proline; water for injections - replacement therapy for primary immunodeficiency diseases (pid), myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy for idiopathic thrombocytopenic purpura (itp) in patients at high risk of bleeding or prior to surgery to correct the platelet count, guillain-barr syndrome (gbs), kawasaki disease, chronic inflammatory demyelinating polyneuropathy (cidp), multifocal motor neuropathy (mmn), myasthenia gravis (mg) exacerbations, lambert-eaton myasthenic syndrome (lems), stiff person syndrome (sps).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 5 g - injection, solution - excipient ingredients: proline; water for injections - replacement therapy for primary immunodeficiency diseases (pid), myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy for idiopathic thrombocytopenic purpura (itp) in patients at high risk of bleeding or prior to surgery to correct the platelet count, guillain-barr syndrome (gbs), kawasaki disease, chronic inflammatory demyelinating polyneuropathy (cidp), multifocal motor neuropathy (mmn), myasthenia gravis (mg) exacerbations, lambert-eaton myasthenic syndrome (lems), stiff person syndrome (sps).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - normal immunoglobulin, quantity: 100 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - kiovig administered intravenously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid);,? symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,2. immunomodulation indications,? idiopathic thrombocytopenia purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;,? guillain barr? syndrome;,? kawasaki disease;,? chronic inflammatory demyelinating polyradiculoneuropathy (cidp) in adults.,? multifocal motor neuropathy (mmn).,kiovig administered subcutaneously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - normal immunoglobulin, quantity: 100 mg/ml - injection, solution - excipient ingredients: water for injections; glycine; human immunoglobulin a - kiovig administered intravenously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid);,? symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,2. immunomodulation indications,? idiopathic thrombocytopenia purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;,? guillain barr? syndrome;,? kawasaki disease;,? chronic inflammatory demyelinating polyradiculoneuropathy (cidp) in adults.,? multifocal motor neuropathy (mmn).,kiovig administered subcutaneously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - normal immunoglobulin, quantity: 100 mg/ml - injection, solution - excipient ingredients: water for injections; human immunoglobulin a; glycine - kiovig administered intravenously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid);,? symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,2. immunomodulation indications,? idiopathic thrombocytopenia purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;,? guillain barr? syndrome;,? kawasaki disease;,? chronic inflammatory demyelinating polyradiculoneuropathy (cidp) in adults.,? multifocal motor neuropathy (mmn).,kiovig administered subcutaneously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - normal immunoglobulin, quantity: 100 mg/ml - injection, solution - excipient ingredients: human immunoglobulin a; water for injections; glycine - kiovig administered intravenously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid);,? symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,2. immunomodulation indications,? idiopathic thrombocytopenia purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;,? guillain barr? syndrome;,? kawasaki disease;,? chronic inflammatory demyelinating polyradiculoneuropathy (cidp) in adults.,? multifocal motor neuropathy (mmn).,kiovig administered subcutaneously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - normal immunoglobulin, quantity: 1 g - solution - excipient ingredients: glycine; water for injections - cuvitru is indicated as replacement therapy in adult and paediatric patients for,? primary immunodeficiency diseases (pid) and,? symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.