ישראל - אנגלית - Ministry of Health

omrix biopharmaceuticals - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 50 mg/ml mg/ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy * primary immunodeficiency (patients with primary defective antibody synthesis such as agammaglobulinemia or hypogammaglobulinemia) * myeloma or chronic lymphocytic leukemia (cll) with severe secondary hypogammaglobulinemia and recurrent infections. * children with congenital aids and recurrent infections - immunomodulation * idiopathic thrombocytopenic purpura (itp) * guillain barre syndrome * kawasaki disease - allogenic bone marrow transplantation

ישראל - אנגלית - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for injection - immunoglobulins, normal human 160 mg/ml - immunoglobulins, normal human, for extravascular adm. - immunoglobulins, normal human, for extravascular adm. - substitution in - primary antibody deficiency syndromes resulting from defective antibody synthesis. - protracted transitory hypogammaglobulinaemia especially in premature infants .prophylaxis of hepatitis a- before exposure- within 2 weeks after exposure בקשה לתוספת התוויה 28/4/2019indications for subcutaneous administration (scig)replacement therapy in adults, children and adolescents (0-18 years) in: • primary immunodeficiency syndromes with impaired antibody production (see section 4.4).• hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (cll), in whom prophylactic antibiotics have failed or are contra-indicated.• hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (mm) patients • hypogammaglobulinaemia in patients pre- and post- allogeneic haematopoietic stem cell transplantation (hsct)indications for intramuscular administration (imig)hepatitis a prophylaxisin adults and children and adolescents (0-18 years)• pre-exposure prophylaxis, preferably in combination with vaccination, in unvaccinated individuals travelling in less than 2 weeks to areas of hepatitis a risk.• post-exposure prophylaxis in unvaccinated individuals within 2 weeks of hepatitis a virus (hav) exposure.consideration should also be given to other official guidance on the appropriate use in hepatitis a prophylaxis. for long term hepatitis a prophylaxis, vaccination is recommended. הערה: הבקשה הינה בהתאם לנוהל ema (25.2.15)- guideline on core smpc for human normal immunoglobulin for subcutaneous and intramuscular administration

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - hepatitis b immunoglobulin, quantity: 400 iu; human immunoglobulin g, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - 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.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - anti-d rho immunoglobulin, quantity: 250 iu; anti-d rho immunoglobulin, quantity: 10 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - rh(d) immunoglobulin is indicated for the prevention of rh sensitisation in rh(d)negative females at or below child bearing age.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - anti-d rho immunoglobulin, quantity: 625 iu; anti-d rho immunoglobulin, quantity: 30 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 6 august 2002 : rh(d) immunoglobulin is indicated for the prevention of rh sensitisation in rh(d) negative females at or below child bearing age.

אוסטרליה - אנגלית - 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).

אוסטרליה - אנגלית - 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).

אוסטרליה - אנגלית - 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).

ישראל - אנגלית - Ministry of Health

kamada ltd, israel - cytomegalovirus antibody; human plasma protein; immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 96 %; human plasma protein 50 mg/ml; cytomegalovirus antibody 100 u/ml - cytomegalovirus immunoglobulin - prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.the concomitant use of adequate virostatic agents should be considered for cmv-prophylaxis.

ישראל - אנגלית - Ministry of Health

dover medical & scientific equipment ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 50 mg/ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in: • primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - wiskott aldrich syndrome. • children with congenital aids and recurrent bacterial infections. immunomodulatory effect: • idiopathic thrombocytopenic purpura (itp) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. • guillain barre syndrome. • kawasaki disease. allogeneic bone marrow transplantation.• myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.