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

csl behring australia pty ltd - human immunoglobulin g, quantity: 5 g - injection, intravenous infusion - excipient ingredients: proline - privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of the following conditions. 1.1 primary humoral immunodeficiency privigen indicated as replacement therapy for primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. 1.2 chronic immune thrombocytopenic purpura privigen is indicated for the treatment of patients with chronic immune thrombocytopenic purpura (itp) to raise platelet counts. 1.3 chronic inflammatory demyelinating polyneuropathy privigen is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (cidp) to improve neuromuscular disability and impairment. limitation of use: privigen maintenance therapy in cidp has not been studied for periods longer than 6 months. after responding during an initial treatment period, not all patients require indefinite maintenance therapy with privigen in order to remain free of cidp symptoms. individualize the duration of any treatment beyond 6 months based upon the patient?s response and demonstrated need for continued therapy.

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 20 g - injection, intravenous infusion - excipient ingredients: proline - privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of the following conditions. 1.1 primary humoral immunodeficiency privigen is indicated as replacement therapy for primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. 1.2 chronic immune thrombocytopenic purpura privigen is indicated for the treatment of patients with chronic immune thrombocytopenic purpura (itp) to raise platelet counts. 1.3 chronic inflammatory demyelinating polyneuropathy privigen is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (cidp) to improve neuromuscular disability and impairment. limitation of use: privigen maintenance therapy in cidp has not been studied for periods longer than 6 months. after responding during an initial treatment period, not all patients require indefinite maintenance therapy with privigen in order to remain free of cidp symptoms. individualize the duration of any treatment beyond 6 months based upon the patient?s response and demonstrated need for continued therapy.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 0.8 g - injection, solution - excipient ingredients: glycine; human immunoglobulin a; water for injections - evogam is indicated in adults and children for replacement therapy in: primary immunodeficiency disease (pid) and symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 60 g/l - injection, solution - excipient ingredients: maltose - tbsf human immunoglobulin for intravenous use is indicated for replacement igg therapy in: * primary immunodeficiency (pid) * symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. tbsf human immunoglobulin for intravenous use is indicated for immunomodulatory therapy in: * idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count * allogeneic bone marrow transplantation * kawasaki disease * guillain-barre syndrome (gbs).

Malta - engelsk - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin antihepatitis - solution for injection - immunoglobulin antihepatitis b 100 iu/ml - immune sera and immunoglobulins

Malta - engelsk - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin rabies, human - solution for injection - immunoglobulin rabies, human 150 iu/ml - immune sera and immunoglobulins

USA - engelsk - NLM (National Library of Medicine)

csl behring ag - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 6 g - carimune® nf is indicated for the maintenance treatment of patients with primary immunodeficiencies (pid), e.g., common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency.30,32-34 carimune® nf is preferable to intramuscular immune globulin (human) preparations in treating patients who require an immediate and large increase in the intravascular immunoglobulin level28 , in patients with limited muscle mass, and in patients with bleeding tendencies for whom intramuscular injections are contraindicated. the infusions must be repeated at regular intervals. please see dosage and administration section. a controlled study was performed in children in which carimune® was compared with steroids for the treatment of acute (defined as less than 6 months duration) itp. in this study sequential platelet levels of 30,000, 100,000, and 150,000/µl were all achieved faster with carimune® than with steroids and without any of the side effects associated with steroids.29,35 howeve

USA - engelsk - NLM (National Library of Medicine)

adma biologics, inc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 5 g in 50 ml - bivigam is an immune globulin intravenous (human), 10% liquid, indicated for the treatment of patients with primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. - bivigam is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. - bivigam is contraindicated in iga deficiency patients with antibodies to iga and a history of hypersensitivity. pregnancy category c. animal reproduction studies have not been conducted with bivigam. it is not known whether bivigam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. bivigam should be given to pregnant women only if clearly needed.17,18 use of bivigam in nursing mothers has not been evaluated. bivigam should be giv

USA - engelsk - NLM (National Library of Medicine)

kedrion biopharma, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 1 g in 10 ml - bivigam is an immune globulin intravenous (human), 10% liquid, indicated for the treatment of patients with primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. - bivigam is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. - bivigam is contraindicated in iga deficiency patients with antibodies to iga and a history of hypersensitivity. pregnancy category c. animal reproduction studies have not been conducted with bivigam. it is not known whether bivigam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. bivigam should be given to pregnant women only if clearly needed.17,18 use of bivigam in nursing mothers has not been evaluated. bivigam should be given to nursing m

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 2.5 g - injection, solution - excipient ingredients: glycine; water for injections - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.