欧州連合 - 英語 - 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.

イギリス - 英語 - MHRA (Medicines & Healthcare Products Regulatory Agency)

takeda uk ltd - normal immunoglobulin human - powder and solvent for solution for injection - 5gram

イギリス - 英語 - MHRA (Medicines & Healthcare Products Regulatory Agency)

takeda uk ltd - normal immunoglobulin human - powder and solvent for solution for injection - 10gram

オーストラリア - 英語 - 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).

オーストラリア - 英語 - 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).

オーストラリア - 英語 - 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).

ニュージーランド - 英語 - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - hepatitis b immunoglobulin, human 220 iu/ml (from us plasma) - solution for injection - 220 iu/ml - active: hepatitis b immunoglobulin, human 220 iu/ml (from us plasma) excipient: glycine water for injection - hepatitis b immunoglobulin (human) is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete or when the antibody level is inadequate i.e. (human) with hepatitis b vaccine will provide both short and long-term protection. this post exposure prophylaxis should be considered following either parenteral exposure, direct mucous membrane contact, oral ingestion, sexual exposure to an hbsag-positive person and for infants hepatitis b immunoglobulin (human) can also be considered for haemodialysis patients and receptors of certain blood products unable to develop adequate immune protection.

ニュージーランド - 英語 - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - zoster immunoglobulin, human 100 iu/ml (immunoglobulin ex nz) - granules for injection - 200 iu/2ml - active: zoster immunoglobulin, human 100 iu/ml (immunoglobulin ex nz) excipient: glycine - zoster immunoglobulin-vf 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 prior history of chickenpox. 4. if zoster immunoglobulin-vf can be administered within 96 hours after exposure. zoster immunoglobulin-vf, normal immunoglobulin-vf (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-vf 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.

マルタ - 英語 - 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

マルタ - 英語 - 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