Israel - English - Ministry of Health

medici medical ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 0.5 g / 10 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in: primary immunodeficiency syndromes such as:- congenital agammaglobulinaemia and hypogammaglobulinaemia- common variable immunodeficiency- severe combined immunodeficiency- wiskott aldrich syndromemyeloma 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

Israel - English - Ministry of Health

kamada ltd, israel - human hepatitis b immunoglobulin - solution for infusion - human hepatitis b immunoglobulin 50 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - prophylaxis against hepatitis b in adults and children over 2 years of age who have not been vaccinated against hepatitis b (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis b by accidental contact with hepatitis b virus containing material following: - percutaneous exposure (e.g. accidental needle stick). - direct mucous membrane contact. when the administration of an intramuscular hepatitis b immunoglobulin is not possible. the immunoglobulin should be administered in association with hepatitis b vaccine. prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis b virus. immunoprophylaxis of hepatitis b in the newborn of a hepatitis b virus carrier mother.

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

immunoglobulin - cytomegalovirus; immunoglobulin g - human; human cytomegalovirus immunoglobulin -

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

plasvacc pty ltd - equine gamma globulins - parenteral liquid/solution/suspension - equine gamma globulins vaccine active 22.0 g/l - immunotherapy - horse foal - increase gamma globulin levels of foals

Malta - English - Medicines Authority

octapharma (ip) limited - immunoglobulin g, human - solution for injection - immunoglobulin g, human 165 mg/ml - immune sera and immunoglobulins

Malta - English - Medicines Authority

octapharma (ip) limited - immunoglobulin g, human - solution for infusion - immunoglobulin g, human 100 mg i/ml - immune sera and immunoglobulins

European Union - English - EMA (European Medicines Agency)

cangene europe limited - human hepatitis b immunoglobulin - immunization, passive; hepatitis b - specific immunoglobulins - immunoprophylaxis of hepatitis b - in case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown).- in haemodialysed patients, until vaccination has become effective.- in the newborn of a hepatitis b virus carrier-mother.- in subjects who did not show an immune response (no measurable hepatitis b antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis b.consideration should also be given to other official guidance on the appropriate use of human hepatitis b immunoglobulin for intramuscular use.

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

takeda pharmaceuticals australia pty ltd - normal immunoglobulin, quantity: 30 g - injection, solution - excipient ingredients: glycine; water for injections - 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).

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

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: octoxinol 10; maltose; tributyl phosphate; water for injections; human immunoglobulin a - replacement therapy in: 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; immunomodulation: 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.

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

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: maltose; octoxinol 10; tributyl phosphate; water for injections; human immunoglobulin a - replacement therapy in: 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; immunomodulation: 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.