〝基立福〞人免疫球蛋白靜脈注射液５％ DIF

Country: Тајван

Језик: Кинески

Извор: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Активни састојак:

IMMUNOGLOBULIN HUMAN

Доступно од:

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)

АТЦ код:

J06BA02

Фармацеутски облик:

注射劑

Састав:

IMMUNOGLOBULIN HUMAN (8004000603) 0.05GM

Јединице у пакету:

瓶裝;;盒裝

Класа:

菌　疫

Тип рецептора:

限由醫師使用

Произведен од:

INSTITUTO GRIFOLS S.A. POLIGONO LEVANTE C/CAN GUASCH 2, 08150 PARETS DEL VALLES BARCELONA SPAIN ES

Терапеутска област:

immunoglobulins, normal human, for intravascular adm.

Терапеутске индикације:

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)。

Резиме производа:

有效日期: 2026/06/26; 英文品名: FLEBOGAMMA 5% DIF

Датум одобрења:

2001-06-26

Информативни летак

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