Composition comprising immunoglobulin

A - Human Necessities – 61 – K

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Details

A61K 39/395 (2006.01) C07K 16/06 (2006.01)

Patent

CA 2283965

The present invention relates to a liquid composition for intravenous administration which comprises an aqueous solution of immunoglobulin and to its preparation. The liquid composition is formulated so as to be stable upon storage such that the immunoglobulin does not substantially aggregate nor degrade and maintains acceptable levels of anti-complementary activity, PKA activity and kallikrein activity during storage for an extended period at a temperature in the range of 4 ~C to 25 ~C.

La présente invention concerne une composition liquide s'administrant par voie intraveineuse et sa préparation. Ladite composition contient une solution aqueuse d'immunoglobuline et elle est formulée de telle manière qu'elle reste stable lorsqu'elle est entreposée, et que son immunoglobuline ne s'agrège pas sensiblement ni ne se dégrade, mais conserve des niveaux acceptables d'activité anticomplémentaire, d'activité pré-kallikréinique (PKA) ou kallikréinique quand elle est entreposée pendant un laps de temps prolongé dans une plage de température comprise entre 4 et 25 ·C.

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