果納芬注射筆300國際單位/0.5毫升

Land: Taiwan

Sprache: Chinesisch

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

Wirkstoff:

FOLLITROPIN ALFA(r-hFSH)

Verfügbar ab:

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-Code:

G03GA05

Darreichungsform:

注射劑

Zusammensetzung:

FOLLITROPIN ALFA(r-hFSH) (6818000500) MCG

Einheiten im Paket:

注射匣;;注射器;;盒裝

Klasse:

菌　疫

Verschreibungstyp:

限由醫師使用

Hergestellt von:

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

Therapiebereich:

follitropin alfa

Anwendungsgebiete:

女性患者(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)與黃體刺激素(LH)併用，使用於嚴重缺乏黃體刺激激素與濾泡刺激激素患者的濾泡刺激成長。男性患者治療男性對於患有先天或後天性腺刺激素不足之性腺功能低下症，併用人類絨毛膜性腺刺激素(hCG)，刺激精子生成。

Produktbesonderheiten:

有效日期: 2025/05/04; 英文品名: GONAL-F 300IU/0.5ML solution for injection in pre-filled pen

Berechtigungsdatum:

2005-05-04

Gebrauchsinformation

300 IU
SOLUTION
FOR
INJECTION IN PRE-FILLED PEN
450 IU
SOLUTION
FOR
INJECTION IN PRE-FILLED PEN
900 IU
SOLUTION
FOR
INJECTION IN PRE-FILLED PEN
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 300 IU_
_solution for injection in pre-filled _
_pen: _
Each ml of the solution contains 600 IU (International
Units)
of
follitropin
alfa,
(equivalent
to 44
micrograms). Each pre-filled multidose pen delivers
300 IU (equivalent to 22 micrograms) in 0.5 ml.
_GONAL-f 450 IU solution for injection in pre-filled _
_pen: _
Each ml of the solution contains 600 IU (International
Units)
of
follitropin
alfa,
(equivalent
to
44 micrograms).
Each
pre-filled
multidose
pen
delivers
450 IU
(equivalent
to
33 micrograms)
in
0.75 ml.
_GONAL-f 900 IU solution for injection in pre-filled _
_pen: _
Each ml of the solution contains 600 IU (International
Units)
of
follitropin
alfa,
(equivalent
to
44 micrograms).
Each
pre-filled
multidose
pen
delivers
900 IU
(equivalent
to
66 micrograms)
in
1.5 ml.
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).
GONAL-f in association with a luteinising hormone
(LH) preparation is recommended for the stimulation
of follicular development in women with severe LH
and FSH deficiency. In clinical trials these patients
were
defined
by
an
endogenous
serum
LH
level
< 1.2 IU/l.
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 initia