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Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases.

Abstract：

:Subjects with primary immune deficiency diseases treated with intravenous immunoglobulin (n=42) received intravenous infusions of Carimune NF Liquid every 3-4 weeks for 6 months without routine premedication. The mean dose/patient/infusion was 278.5-800.7 mg/kg. Also, 80.4% of infusions achieved maximum rates of >or=3.5 mg/kg/min; 32% of infusions were associated with adverse events during or within 48 h of their end (upper 95% confidence interval was 39.4%, meeting the Food and Drug Administration (FDA) criterion for acceptable tolerability), and 54.8% of subjects had at least one temporally associated adverse event considered at least possibly drug-related (headache: 35.7% of subjects, 12.4% of infusions; nausea: 14.3%, 3.5%; myalgia: 14.3%, 3.2%; fatigue: 11.9%, 5.7%). The frequencies of these were highest after the first infusion. There were no serious drug-related adverse events or acute serious bacterial infections. Serum IgG trough levels were unchanged from baseline. Carimune NF Liquid, a ready-to-use, high-concentration, liquid immunoglobulin preparation is safe and effective.

journal_name

J Clin Immunol

journal_title

Journal of clinical immunology

authors

Berger M,Cunningham-Rundles C,Bonilla FA,Melamed I,Bichler J,Zenker O,Ballow M

doi

10.1007/s10875-007-9096-9

subject

Has Abstract

pub_date

2007-09-01 00:00:00

pages

503-9

issue

5

eissn

0271-9142

issn

1573-2592

journal_volume

27

pub_type

临床试验,杂志文章,多中心研究

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