European Union - English - EMA (European Medicines Agency)

piramal critical care b.v. - sugammadex sodium - neuromuscular blockade - sugammadex - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.

Ireland - English - HPRA (Health Products Regulatory Authority)

bio products laboratory limited - human normal immunoglobulin - solution for infusion - 100 milligram(s)/millilitre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.

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: 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).

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 20 g - injection, solution - excipient ingredients: glycine; water for injections - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 10 g - injection, solution - excipient ingredients: water for injections; glycine - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 5 g - injection, solution - excipient ingredients: water for injections; glycine - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 2.5 g - injection, solution - excipient ingredients: glycine; water for injections - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

Australia - English - 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).

Australia - English - 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).