Israel - English - Ministry of Health

kamada ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 5 g / 100 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents in:- primary immunodeficiency 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- congenital aids with recurrent bacterial infectionsimmunomodulation in adults, and children and adolescents 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

Israel - English - Ministry of Health

medici medical ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 0.5 g / 10 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 syndromemyeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.children with congenital aids and recurrent infections.immunomodulation :idiopathic thrombocytopenic purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.guillain barré syndrome.kawasaki disease.allogeneic bone marrow transplantation

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >90% gamma globulin - powder and solvent for solution for infusion - 0.5 g/30 m gram(s)/millilitre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration - primary immunodeficiency syndromes (pid): congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeficiencies severe combined immunodeficiencies wiskott aldrich syndrome myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections children with congenital aids and recurrent infections

United States - English - NLM (National Library of Medicine)

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 0.05 g in 1 ml - flebogamma 5% dif is an immune globulin intravenous (human) solution indicated in adults and pediatric patients 2 years of age and older for the treatment of primary immunodeficiency (pi), including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and wiskott-aldrich syndrome. - flebogamma 5% dif is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. - flebogamma 5% dif is contraindicated in iga-deficient patients with antibodies to iga and a history of hypersensitivity. (see warnings and precautions [5.1] ) risk summary there are no studies of flebogamma 5% dif use in pregnant women. animal reproduction studies have not been performed with flebogamma 5% dif. it is also not known whether flebogamma 5% dif can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. flebogamma 5% dif should be given to a pregnant woman only if clearly needed. risk summary there is no information regarding the presence of flebogamma 5% dif in human milk, its effects on the breastfed infant, or its effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for flebogamma 5% dif and any potential adverse effects on the breastfed infant from flebogamma 5% dif or from the underlying maternal condition. flebogamma 5% dif was studied in a multicenter clinical trial for the treatment of pi in 24 subjects aged 2-16 years (seven were 2-5 years of age, seven were 6-11 years, and ten were 12-16 years), and found to be efficacious for the prevention of acute serious bacterial infections. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. twenty subjects (83.3%) had at least one adverse reaction at some time during the study that was considered product-related. there were no deaths or serious adverse reactions. treatment-related adverse reactions that occurred with an incidence of at least 5% on a per-subject basis included headache (42%), pyrexia (29%), hypotension (25%), tachycardia (25%), diastolic hypotension (21%), nausea (8%), abdominal pain (8%), diarrhea (8%), pain (8%), and vomiting (8%). safety and efficacy of flebogamma 5% dif in pediatric patients below the age of 2 years have not been established. limited information is available for the geriatric use of flebogamma 5% dif. clinical studies of flebogamma 5% dif did not include sufficient numbers of subjects over the age of 65 to determine whether they respond differently from younger subjects. use caution when administering flebogamma 5% dif to patients age 65 and over who are judged to be at increased risk for developing thrombosis or renal insufficiency. do not exceed recommended dose, and administer flebogamma 5% dif at the minimum dose and infusion rate practicable, and at less than 0.06 ml per kg per minute (3 mg per kg per min). (see boxed warning, warning and precautions [5.2, 5.4], and dosage and administration [2.3] )

United States - English - NLM (National Library of Medicine)

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 5 g in 50 ml - flebogamma 10% dif is an immune globulin intravenous (human) solution indicated for the treatment of: flebogamma 10% dif is indicated as replacement therapy in primary immunodeficiency (pi) including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and wiskott-aldrich syndrome. flebogamma 10% dif is indicated for the treatment of patients 2 years of age and older with chronic primary immune thrombocytopenia to raise platelet count. - flebogamma 10% dif is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. - flebogamma 10% dif is contraindicated in iga deficient patients with antibodies to iga and a history of hypersensitivity. (see warnings and precautions (5.1)) risk summary there are no studies of flebogamma 10% dif use in pregnant women. animal reproduction studies have not been performed with flebogamma 10% dif. it is

Israel - English - 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

European Union - English - EMA (European Medicines Agency)

instituto grifols s.a. - human normal immunoglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immune sera and immunoglobulins, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, 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.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 5 g - injection, solution - excipient ingredients: sorbitol; human immunoglobulin a; water for injections - 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.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 20 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.

Australia - English - 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.