抗人體血清

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)

可用日期:

雄恆行股份有限公司 台北巿民權東路三段５８號八樓 (03413602)

药物剂型:

試劑

类:

試劑體外用

处方类型:

由醫師或檢驗師使用

厂商:

HYLAND DIVISION OF TRAVENOL LAB. INC. 3300 HYLAND AVENUE COSTA MESE. CALIFORNIA 92626 US

產品總結:

註銷日期: 2006/08/23; 註銷理由: 有效期限已屆; 有效日期: 1985/12/08; 英文品名: ANTI-RH SERUM (RABBIT)

授权状态:

已註銷

授权日期:

1972-12-08

资料单张

1
SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
2
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
3
1.
NAME OF THE MEDICINAL PRODUCT
NORMOSANG 25 mg/ml, concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human hemin
........................................................................................................................................
25 mg/ml.
One ampoule of 10 ml contains 250 mg of human hemin.
After dilution of one 10 ml ampoule in 100 ml of 0.9% Na Cl solution,
the diluted solution contains
2273 micrograms per ml of human hemin.
Excipient with known effect: ethanol 96% (1 g / 10 ml) (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
NORMOSANG is a dark coloured concentrate for solution for infusion.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of acute attacks of hepatic porphyria (acute intermittent
porphyria, porphyria variegata,
hereditary coproporphyria).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dose is 3 mg/kg once daily for four days,
diluted in 100 ml of 0.9% sodium
chloride in a glass bottle and infused intravenously over at least 30
minutes into a large antebrachial or
central vein using an inline filter.
The dose should not exceed 250 mg (1 ampoule) per day.
Exceptionally, the course of the treatment may be repeated under
strict biochemical surveillance if
there is inadequate response after the first course of treatment.
_Elderly patients_
No dose adjustment is required.
_Children and adolescents _
Attacks of porphyria are rare in children but limited experience in
tyrosinaemia suggests that it is safe
to use a dose of not more than 3 mg/kg daily for 4 days, administered
with the same precautions as for
adults.
Method of administration
4
The infusions should be administered in a large antebrachial or
central vein over a period of at least 30
minutes. After the infusion, the vein should be rinsed with 100 ml o