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

octapharma australia pty ltd - human immunoglobulin g, quantity: 50 mg/ml - injection - excipient ingredients: human immunoglobulin a; octoxinol 10; tributyl phosphate; maltose; water for injections - replacement therapy: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulatory effect: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - normal immunoglobulin 100 mg/ml - solution for infusion - 100 g/l - active: normal immunoglobulin 100 mg/ml excipient: glycine water for injection - replacement therapy indications: - primary immunodeficiency (pi) diseases - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

Israel - English - Ministry of Health

takeda israel ltd - human normal immunoglobulin - solution for infusion - human normal immunoglobulin 100 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, 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 (cll), in whom prophylactic antibiotics have failed or are contra-indicated.• hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (mm) patients.• hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (hsct).

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.

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.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 2 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.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 1 g - injection, solution - excipient ingredients: water for injections; proline; polysorbate 80 - 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.

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - human normal immunoglobulin - immunologic deficiency syndromes - immune sera and immunoglobulins, - replacement therapy in adults, 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 (cll), in whom prophylactic antibiotics have failed or are contra‑indicated.hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (mm) patients.hypogammaglobulinaemia in patients pre‑ and post‑allogeneic hematopoietic stem cell transplantation (hsct).

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)

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

csl behring ag - human normal immunoglobulin - solution for infusion - 100mg/ml