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Highly concentrated pharmaceutical formulations comprising anti - cd20 antibody
专利权人:
F. HOFFMANN-LA ROCHE AG
发明人:
STAUCH OLIVER BORIS,ADLER MICHAEL,MAHLER HANNS-CHRISTIAN
申请号:
NZ62144810
公开号:
NZ621448A
申请日:
2010.09.10
申请国别(地区):
NZ
年份:
2015
代理人:
摘要:
Discloses a pharmaceutical kit comprising in separate containers: (i) a first highly concentrated, stable pharmaceutical formulation for subcutaneous administration of a pharmaceutically active anti-CD20 antibody comprising: a) about 50 to 350 mg/ml anti-CD20 antibody; b) about 1 to 100 mM of a buffering agent providing a pH of 5.5 ± 2.0; c) about 1 to 500 mM of a stabiliser or a mixture of two or more stabilisers; d) about 0.01 to 0.1 % of a nonionic surfactant; and (ii) a second pharmaceutical formulation for subcutaneous administration, comprising about 1,000 to about 16,000 U/ml of a hyaluronidase enzyme.
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