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Combinations and methods for subcutaneous administration of immunoglobulin and hyaluronidase
专利权人:
Baxalta Incorporated;Baxalta GmbH
发明人:
SCHIFF, Richard,LEIBL, Heinz,FROST, Gregory
申请号:
ES09721669
公开号:
ES2633295T3
申请日:
2009.03.16
申请国别(地区):
ES
年份:
2017
代理人:
摘要:
A combination of immunoglobulin (IG) compositions and a soluble hyaluronidase for use to treat a disease or condition treatable with GI in a subject, wherein: GI and soluble hyaluronidase are formulated separately for subcutaneous administration; IG and soluble hyaluronidase are formulated for single dose administration once a month; soluble hyaluronidase is administered separately from the GI before administration of the GI and at the same site as the GI; the concentration of GI is 5 to 15% w / v and the amount of GI in the composition is 0.5 grams (g) to 70 g; the GI is formulated in a volume of liquid that is 50 mL to 700 mL; The soluble hyaluronidase is formulated for administration as a ratio of hyaluronidase to IG of 10 U / gram (g) at 500 U / g of IG, whereby the amount of hyaluronidase in the composition is sufficient to effect the increased bioavailability of the GI when administered in combination with GI up to at least 90% of the bioavailability of the same single dose of GI administered through intravenous administration for the treatment of the same disease or condition treatable with GI; soluble hyaluronidase is formulated in a volume of liquid that is 5 to 30 mL; and the disease or condition treatable with GI are selected from immunodeficiency; Acquired hypogammaglobulinemia secondary to hematologic malignancies; Kawasaki disease; chronic inflammatory demyelinating polyneuropathy (PDIC); Guillain Barre syndrome; Idiopathic thrombocytopenic purpura; inflammatory myopathies; Myasthenic Lambert-Eaton syndrome; multifocal motor neuropathy; Myasthenia gravis; Moersch-Woltmann syndrome; secondary hypogammaglobulinemia, including iatrogenic immunodeficiency; specific antibody deficiency; Acute disseminated encephalomyelitis; positive systemic necrotizing vasculitis for ANCA; Autoimmune hemolytic anemia; Bullous Pemphigoid; Scarring pemphigoid; Evans syndrome, including autoimmune hemolytic anemia with immune thrombocytopenia; Feto-maternal / neonatal alloimm
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