New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - immunoglobulin g 160 mg/ml (immunoglobulin ex nz 16% igg) - solution for injection - 160 mg/ml - active: immunoglobulin g 160 mg/ml (immunoglobulin ex nz 16% igg) excipient: glycine - normal immunoglobulin-vf is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. it may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. in susceptible contacts of hepatitis a, measles and poliomyelitis, normal immunoglobulin-vf may be of value in preventing or modifying the disease. in general, the earlier in the incubation period of these diseases normal immunoglobulin-vf is given, the greater its effectiveness.

European Union - English - EMA (European Medicines Agency)

csl behring gmbh - human normal immunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - immune sera and immunoglobulins, - replacement therapy in adults, and children and adolescents (0-18 years) in:primary immunodeficiency (pid) 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;hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (hsct);congenital aids with recurrent bacterial infections.immunomodulation 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;chronic inflammatory demyelinating polyneuropathy (cidp). only limited experience is available of use of intravenous immunoglobulins in children with cidp.

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

takeda pharmaceuticals australia pty ltd - normal immunoglobulin, quantity: 100 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; normal immunoglobulin - 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: 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).

Malta - English - Medicines Authority

kedrion s.p.a loc. ai conti, 55051 castelvecchio pascoli, barga - lucca, italy - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 0.550 g/l - immune sera and immunoglobulins

Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg/ml - immune sera and immunoglobulins

Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg/ml - immune sera and immunoglobulins