国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
IMMUNOGLOBULIN HUMAN
台灣綠十字股份有限公司 台北市大同區承德路三段二四四號六樓 (71621557)
J06BA02
注射劑
IMMUNOGLOBULIN HUMAN (8004000603) 0.05GM
瓶裝;;盒裝
菌 疫
限由醫師使用
INSTITUTO GRIFOLS S.A. POLIGONO LEVANTE C/CAN GUASCH 2, 08150 PARETS DEL VALLES BARCELONA SPAIN ES
immunoglobulins, normal human, for intravascular adm.
免疫球蛋白缺乏症、原發性血小板減少紫瘢症。川崎氏症(KAWASAKI DISEASE)。
有效日期: 2026/06/26; 英文品名: FLEBOGAMMA 5% DIF
2001-06-26
Incompatibilities Flebogamma ® 5% DIF should not be mixed with any other drugs or intravenous solutions. It should be administered by a separate intravenous line. WARNINGS Pregnancy and lactation The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given if clearly indicated to pregnant women and breast-feeding mothers. Long lasting clinical experience with immunoglobulins, indicates that no harmful effects on the course of pregnancy, on the foetus and the neonate are to be expected. Effects on ability to drive Not applicable. POSOLOGY The dose and dosage regimen is dependent on the indication. In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline: Replacement therapy in primary immunodeficiency syndromes The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4 - 6 g/l. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4 - 0.8 g/kg followed by at least 0.2 g/kg every three weeks. The dose required to achieve a trough level of 6 g/l is of the order of 0.2 - 0.8 g/kg/month. The dosage interval when steady state has been reached varies from 2 - 4 weeks. Trough levels should be measured in order to adjust the dose and dosage interval. Idiopathic Thrombocytopenic Purpura For the treatment of an acute episode, 0.8 - 1 g/kg on day one, which may be repeated once within 3 days, or 0.4 g/kg daily for two to five days. The treatment can be repeated if relapse occurs. Kawasaki Disease 1.6 - 2.0 g/kg should be administered in divided doses over two to five days or 2.0 g/kg as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid. The dosage recommendations are summarised in the following table: INDICATION DOSE FREQUENCY Replacement therap 阅读完整的文件