果納芬75國際單位(5.5微克)

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)

资料单张 资料单张 (PIL)
03-09-2021
公众评估报告 公众评估报告 (PAR)
13-04-2020

有效成分:

FOLLITROPIN ALFA(r-hFSH)

可用日期:

台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)

ATC代码:

G03GA05

药物剂型:

凍晶乾燥注射劑

组成:

FOLLITROPIN ALFA(r-hFSH) (6818000500) I.U.

每包单位数:

小瓶;;針筒裝附溶劑

类:

菌 疫

处方类型:

限由醫師使用

厂商:

MERCK SERONO S.P.A. VIA DELLE MAGNOLIE 15, ZONA INDUSTRIALE DI MODUGNO, 70026 MODUGNO, ITALY IT

治疗领域:

follitropin alfa

疗效迹象:

(1)婦女經CLOMIPHENE CITRATE治療,仍無法排卵者(含多囊性卵巢症,PCOD)。(2)對於實施人工生殖協助技術(ART),如體外受精(IVF),配子輸卵管植入(GIFT),合子輸卵管植入(ZIFT)的病人,可刺激其多濾泡發育。(3)Gonal-F®併用人類絨毛膜性腺刺激素(hCG),用於治療患有先天或後天性腺刺激素不足之性腺功能低下症之男性患者,以刺激精子生成。

產品總結:

有效日期: 2028/06/03; 英文品名: GONAL-F 75IU(5.5MCG)

授权日期:

2003-04-08

资料单张

                                PAGE 1
N1973801G
•
Unexplained vaginal bleeding (gynaecological haemorrhages
of unknown aetiology)
•
Cancer in the ovaries, uterus or breasts
Gonal-f must not be used when an effective response cannot
be obtained, such as:
•
Primary ovarian failure
•
Malformations
of
sexual
organs
incompatible
with
pregnancy
•
Fibroid tumours of the uterus incompatible with pregnancy
•
Primary testicular insufficiency
Do not use GONAL-f if any of the above applies to you. If you
are not sure, talk to your doctor or pharmacist before using this
medicine.
SPECIAL WARNINGS AND PRECAUTIONS
GONAL-F is a potent ganadotrophic substance capable of
causing mild to severe adverse reactions, and should only be
used by physicians who are thoroughly familiar with infertility
problems and their management.
Gonadotropin therapy requires a certain time commitment by
physicians and supportive health professionals, as well as the
availability of appropriate monitoring facilities. In women, safe
and effective use of GONAL-f calls for monitoring of ovarian
response with ultrasound, alone or preferably in combination
with measurement of serum oestradiol levels, on a regular basis.
There may be a degree of interpatient variability in response to
FSH administration, with a poor response to FSH in some patients
and exaggerated response in others. The lowest effective dose
in relation to the treatment objective should be used in both
men and women.
PORPHYRIA
Tell your doctor before you start treatment, if you or any member of
your family have porphyria (an inability to break down porphyrins
that may be passed on from parents to children) as GONAL-f may
increase the risk of an acute attack. Patients with porphyria or a
family history of porphyria should be closely monitored during
treatment with GONAL-f. Deterioration or a first appearance of
this condition may require cessation of treatment.
Tell your doctor straight away if:
•
your skin becomes fragile and easily blistered, especially skin
that has been frequently in the sun, and/or
•
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