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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 g - injection, solution - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - 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. - guillain barr? syndrome - kawasaki disease.

Malta - engelsk - 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 - engelsk - Medicines Authority

kedrion s.p.a loc. ai conti, 55051 castelvecchio pascoli, barga - lucca, italy - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 g/l - immune sera and immunoglobulins

Malta - engelsk - Medicines Authority

kedrion s.p.a loc. ai conti, 55051 castelvecchio pascoli, barga - lucca, italy - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 g/l - immune sera and immunoglobulins

Malta - engelsk - Medicines Authority

kedrion s.p.a loc. ai conti, 55051 castelvecchio pascoli, barga - lucca, italy - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 g/l - immune sera and immunoglobulins

Singapore - engelsk - HSA (Health Sciences Authority)

wellchem pharmaceuticals pte ltd - immunoglobulin (human) (normal) - injection - 50 mg/ml - immunoglobulin (human) (normal) 50 mg/ml

Singapore - engelsk - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - human normal immunoglobulin (human plasma protein containing at least 96% immunoglobulin) - infusion, solution - 50 mg/ml - human normal immunoglobulin (human plasma protein containing at least 96% immunoglobulin) 50 mg/ml

Den europeiske union - engelsk - 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 - engelsk - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; human immunoglobulin a - 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. hepatitis a-routine passive protection is recommended in persons exposed less than one week previously for the following categories of individuals, household contacts of an index case, who have not already had hepatitis a or have no serological evidence of immunity to the virus. common source exposures. when a vehicle such as food or water is identified as a common source of infection for multiple hepatitis cases, administration of normal immunoglobulin-vf should be considered for all those exposed to the source. institutional contacts. staff in institutions where hepatitis is endemic. routine prophylaxis is not recommended for school, office, factory or hospital contacts. rubella, although normal immunoglobulin-vf can prevent or modify the clinical disease in susceptible rubella contacts if given within 72 hours of exposure, it does not prevent viraemia in such patients. it should, therefore, not be relied upon to prevent congenital malformations due to rubella if given to susceptible pregnant women during the first trimester. measles (morbilli), normal immunoglobulin-vf is indicated for protection against measles in persons exposed less than one week previously. it is recommended in children under six months of age whose mothers have not had the disease, in children between six months and three years of age who have not been actively immunised and in immunosuppressed contacts of the index case. poliomyelitis, normal immunoglobulin-vf is recommended for susceptible contacts who have not been immunised against poliomyelitis.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 320 mg - injection, solution - excipient ingredients: glycine; human immunoglobulin a - 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. hepatitis a-routine passive protection is recommended in persons exposed less than one week previously for the following categories of individuals, household contacts of an index case, who have not already had hepatitis a or have no serological evidence of immunity to the virus. common source exposures. when a vehicle such as food or water is identified as a common source of infection for multiple hepatitis cases, administration of normal immunoglobulin-vf should be considered for all those exposed to the source. institutional contacts. staff in institutions where hepatitis is endemic. routine prophylaxis is not recommended for school, office, factory or hospital contacts. rubella, although normal immunoglobulin-vf can prevent or modify the clinical disease in susceptible rubella contacts if given within 72 hours of exposure, it does not prevent viraemia in such patients. it should, therefore, not be relied upon to prevent congenital malformations due to rubella if given to susceptible pregnant women during the first trimester. measles (morbilli), normal immunoglobulin-vf is indicated for protection against measles in persons exposed less than one week previously. it is recommended in children under six months of age whose mothers have not had the disease, in children between six months and three years of age who have not been actively immunised and in immunosuppressed contacts of the index case. poliomyelitis, normal immunoglobulin-vf is recommended for susceptible contacts who have not been immunised against poliomyelitis.