Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva b.v. - sugammadex sodium 108,8 mg/ml - eq. sugammadex 100 mg/ml - solution for injection - 100 mg/ml - sugammadex sodium 108.8 mg/ml - sugammadex

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - sugammadex sodium (unii: erj6x2mxv7) (sugammadex - unii:361lpm2t56) - sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.  pediatric use information is approved for merck sharp & dohme corp., a subsidiary of merck & co. inc.’s bridion ® (sugammadex injection). however, due to merck sharp & dohme corp., a subsidiary of merck & co. inc.’s marketing exclusivity rights, this drug product is not labeled with that information. sugammadex is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex [see warnings and precautions (5.1), adverse reactions (6)].  risk summary  there are no clinical trial data on sugammadex use in pregnant women to inform any drug-associated risks. the available data from

Israel - English - Ministry of Health

takeda israel ltd - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 100 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - ivig can be used in all age ranges, unless otherwise specified below.replacement therapy 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.children and adolescents (age 0-18) with congenital aids and recurrent bacterial infections.hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (hsct).immunomodulationprimary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count.guillain barré syndrome.kawasaki disease.

Israel - English - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 100 g/l - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in• primary immunodeficiency syndromes (pid) 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 infectionsimmunomodulation• immune thrombocytopenic purpura (itp) in children or adults at high risk of bleeding or prior to surgical interventions to correct the platelet count• guillain-barré syndrome• kawasaki disease• chronic inflammatory demyelinating polyneuropathy (cidp)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: sorbitol water for injection - 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. - guillan barre syndrome. - kawasaki disease.

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

teva pharma australia pty ltd - sugammadex sodium, quantity: 217.6 mg (equivalent: sugammadex, qty 200 mg) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - gamma globulin electrolytes nos - 100 millilitre

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 60 mg/ml - injection, solution - excipient ingredients: maltose; water for injections; human immunoglobulin a - intragam p is indicated in replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. indications as at 21 july 2000: replacement igg therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; kawasaki disease. indications as at 25 february 2003: for replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; congenital acquired immune deficiency syndrome with recurrent infections. for immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogeneic bone marrow transplantation; kawasaki disease, and; guillain-barre syndrome (gbs).

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 60 mg/ml - injection, solution - excipient ingredients: maltose; human immunoglobulin a; water for injections - intragam p is indicated in replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. indications as at 21 july 2000: replacement igg therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; kawasaki disease. indications as at 25 february 2003: for replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; congenital acquired immune deficiency syndrome with recurrent infections. for immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogeneic bone marrow transplantation; kawasaki disease, and; guillain-barre syndrome (gbs).

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 60 mg/ml - injection, solution - excipient ingredients: water for injections; human immunoglobulin a; maltose - intragam p is indicated in replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. indications as at 21 july 2000: replacement igg therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; kawasaki disease. indications as at 25 february 2003: for replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; congenital acquired immune deficiency syndrome with recurrent infections. for immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogeneic bone marrow transplantation; kawasaki disease, and; guillain-barre syndrome (gbs).