Malta - Englisch - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - immunoglobulin g, human - solution for injection - immunoglobulin g, human 165 mg/ml - immune sera and immunoglobulins

Israel - Englisch - Ministry of Health

kamada ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 100 mg/ml - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents (0-18 years) in: - primary immunodeficiency syndromes (pid) with impaired antibody production - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of <4 g/l * psaf= failure to mount at least a 2-fold rise in igg antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccinesimmunomodulation 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 (in conjunction with acetylsalicylic acid) - chronic inflammatory demyelinating polyradiculoneuropathy (cidp) - multifocal motor neuropathy (mmn)

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - human immunoglobulin g, quantity: 50 mg/ml - injection - excipient ingredients: octoxinol 10; water for injections; tributyl phosphate; maltose; human immunoglobulin a - 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.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - human immunoglobulin g, quantity: 50 mg/ml - injection - excipient ingredients: maltose; human immunoglobulin a; octoxinol 10; water for injections; tributyl phosphate - 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.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - human immunoglobulin g, quantity: 50 mg/ml - injection - excipient ingredients: water for injections; octoxinol 10; human immunoglobulin a; tributyl phosphate; maltose - 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.

Australien - Englisch - 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.

Australien - Englisch - 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.

Australien - Englisch - 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.

Israel - Englisch - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 200 mg / 1 ml - immunoglobulins, normal human, for extravascular adm. - replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency and wiskott-aldrich syndrome - igg subclass deficiencies with recurrent infectionsreplacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Singapur - Englisch - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - human normal immunoglobulin - infusion, solution - 50 mg/ml - human normal immunoglobulin 50 mg/ml