果納芬注射劑 450 國際單位/0.75公撮

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)

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:

凍晶注射劑

组成:

FOLLITROPIN ALFA(r-hFSH) (6818000500) (33MCG)I.U.

每包单位数:

小瓶裝(每單瓶附等支數1公撮溶劑與6支含針注射筒)

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:

註銷日期: 2020/04/06; 註銷理由: 許可證已逾有效期; 有效日期: 2018/10/09; 英文品名: GONAL-F 450IU/0.75ML

授权状态:

已註銷

授权日期:

2003-10-09

资料单张

450 IU POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION
INGREDIENT:
Active ingredient: follitropin alfa
Follitropin alfa is recombinant human follicle stimulating hormone
(r-hFSH)
produced in Chinese Hamster Ovary cells by recombinant DNA technology.
COMPOSITION
_GONAL-f 450 IU powder and solvent for solution for injection: _
Each vial contains 44 micrograms of follitropin alfa equivalent to 600
IU
(International Units) to deliver 33 mcg (450 IU). Each ml of the
reconstituted
solution contains 600 IU.
CLINICAL PROPERTIES
INDICATIONS
Women
Anovulation including polycystic ovarian syndrome in women who have
been
unresponsive to treatment with clomiphene citrate.
Stimulation of multifollicular development in women undergoing
superovulation
for assisted reproductive technologies (ART) such as
_in vitro_
fertilisation (IVF),
gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian
transfer (ZIFT).
Men
Stimulation
of
spermatogenesis
in
men
who
have
congenital
or
acquired
hypogonadotrophic
hypogonadism
with
concomitant
human
Chorionic
Gonadotropin (hCG) therapy.
DOSAGE AND ADMINISTRATION
Treatment with GONAL-f should be initiated under the supervision of a
physician
experienced in the treatment of fertility disorders.
POSOLOGY
The dose recommendations given for GONAL-f are those in use for
urinary FSH.
Clinical assessment of GONAL-f indicates that its daily doses,
regimens of
administration, and treatment monitoring procedures should not be
different from
those currently used for urinary FSH-containing medicinal products. It
is advised
to adhere to the recommended starting doses indicated below.
Comparative clinical studies have shown that on average patients
require a lower
cumulative dose and shorter treatment duration with GONAL-f compared
with
urinary FSH. Therefore, it is considered appropriate to give a lower
total dose of
GONAL-f than generally used for urinary FSH, not only in order to
optimise
follicular
development
but
also
to
minimise
the
risk
of
unwanted
ovarian
hyperstimulation.
Bioequivalence has bee