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.

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).

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; zoster immunoglobulin, quantity: 200 iu - injection, solution - excipient ingredients: water for injections; glycine; human immunoglobulin a - indications as at 8 august 2002 : zoster immunoglobulin is indicated for prophylaxis against varicella in patients who meet all four of the criteria listed below: 1. one of the following underlying illnesses or conditions: a. neoplastic disease (leukaemia or lymphoma); b. congenital or acquired immunodeficiency; c. immunosuppressive therapy with steroids or antimetabolites. 2. one of the following types of exposure to chickenpox or shingles patients: a. household contact; b. playmate contact (>1 hour play indoors); c. hospital contact (in same 2 to 4 bedroom or adjacent beds in a large ward); d. newborn contact (newborn of mother who had onset of chickenpox <5 days before delivery or within 48 hours after delivery); e. premature infant (>= 28 weeks gestation) whose mother lacks a prior history of chickenpox; f. premature infant (< 28 weeks gestation or <= 1000g) regardless of maternal history. 3. negative or unknown history of chickenpox. 4. if zoster immunoglobulin can be administered within 96 hours after exposure. zoster immunoglobulin, normal immunoglobulin (immunoglobulin for intramuscular use) or plasma are of no value in the treatment of established varicella or zoster infection. high levels of circulating antibody do not prevent dissemination of infection. zoster immunoglobulin is not indicated for prophylactic use in immunodeficient children or adults when there is a history of varicella, unless the patient's immunosuppressed status is that which is associated with bone marrow transplantation.

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 - human immunoglobulin g, quantity: 20 g - injection, solution - excipient ingredients: human immunoglobulin a; glycine - intragam 10 is indicated for replacement igg therapy in: - primary immunodeficiency disease (pid) - myeloma and chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections - congenital or acquired immune deficiency syndrome with recurrent infections. intragam 10 is indicated for immunomodulatory therapy in: - immune thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count - allogeneic bone marrow transplantation - kawasaki disease - guillain-barr? 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 - human immunoglobulin g, quantity: 10 g - injection, solution - excipient ingredients: glycine; human immunoglobulin a - intragam 10 is indicated for replacement igg therapy in: - primary immunodeficiency disease (pid) - myeloma and chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections - congenital or acquired immune deficiency syndrome with recurrent infections. intragam 10 is indicated for immunomodulatory therapy in: - immune thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count - allogeneic bone marrow transplantation - kawasaki disease - guillain-barr? 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 - human immunoglobulin g, quantity: 5 g - injection, solution - excipient ingredients: human immunoglobulin a; glycine - intragam 10 is indicated for replacement igg therapy in: - primary immunodeficiency disease (pid) - myeloma and chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections - congenital or acquired immune deficiency syndrome with recurrent infections. intragam 10 is indicated for immunomodulatory therapy in: - immune thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count - allogeneic bone marrow transplantation - kawasaki disease - guillain-barr? 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: 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)

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; hepatitis b immunoglobulin, quantity: 100 iu - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 8 august 2002 : hepatitis b immunoglobulin is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive material or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin is also indicated for prophylaxis in infants born to hbsag-positive mothers. hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

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.