ORGALUTRAN SOLUTION FOR INJECTION 0.25 mg0.5 ml

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

GANIRELIX

متاح من:

ORGANON SINGAPORE PTE. LTD.

ATC رمز:

H01CC01

جرعة:

0.25 mg/0.5 ml

الشكل الصيدلاني:

INJECTION

تركيب:

GANIRELIX 0.25 mg/0.5 ml

طريقة التعاطي:

SUBCUTANEOUS

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

VETTER PHARMA-FERTIGUNG GMBH & CO KG

الوضع إذن:

ACTIVE

تاريخ الترخيص:

2003-01-07

نشرة المعلومات

CCDS-MK-8761-INJ-052012_SIN 
1. 
NAME OF THE MEDICINAL PRODUCT 
Orgalutran 0.25 mg/0.5 ml solution for injection 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each pre-filled syringe contains 0.25 mg of ganirelix (INN) in 0.5
ml aqueous 
solution. The active substance ganirelix is a synthetic
decapeptide with high 
antagonistic activity to the naturally occurring gonadotrophin
releasing 
hormone (GnRH). The amino acids at positions 1, 2, 3, 6, 8 and
10 of the 
natural GnRH decapeptide have been substituted resulting in
N-Ac-D-Nal(2)
1
, 
D-pClPhe
2
, D-Pal(3)
3
, D-hArg(Et2)
6
, L-hArg(Et2)
8
, D-Ala
10
]-GnRH with a 
molecular weight of 1570.4.  
For a full list of excipients, see 6.1. 

3. PHARMACEUTICAL 
FORM 
Solution for injection. 
Clear and colorless aqueous solution. 

4. CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
The prevention of premature luteinizing hormone (LH) surges in
women 
undergoing controlled ovarian hyperstimulation (COH) for assisted 
reproduction techniques (ART). 
In clinical trials Orgalutran was used with recombinant
follicle stimulating 
hormone (FSH). 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Orgalutran should only be prescribed by a specialist
experienced in the 
treatment of infertility. 
_Posology _
Orgalutran is used to prevent premature LH surges
in patients undergoing 
COH. Controlled ovarian hyperstimulation with FSH may start at
day 2 or 3 of 
menses. Orgalutran (0.25 mg) should be injected
subcutaneously once daily, 
starting in general on day 6 of FSH administration. In high
responders an 
CCDS-MK-8761-INJ-052012_SIN 
early LH rise may be prevented by starting Orgalutran treatment
on day 5. 
The start of Orgalutran may be delayed in absence of follicular
growth.  
Orgalutran and FSH should be administered approximately at the same
time. 
However, the preparations should not be mixed and different
injection sites 
are to be used.  
FSH dose adjustments�

خصائص المنتج

CCDS-MK-8761-INJ-082020_SIN
1.
NAME OF THE MEDICINAL PRODUCT
Orgalutran® 0.25 mg/0.5 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 0.25 mg of ganirelix (INN) in 0.5 ml
aqueous
solution. The active substance ganirelix is a synthetic decapeptide
with high
antagonistic activity to the naturally occurring gonadotrophin
releasing
hormone (GnRH). The amino acids at positions 1, 2, 3, 6, 8 and 10 of
the
natural GnRH decapeptide have been substituted resulting in
N-Ac-D-Nal(2)
1
,
D-pClPhe
2
, D-Pal(3)
3
, D-hArg(Et2)
6
, L-hArg(Et2)
8
, D-Ala
10
]-GnRH with a
molecular weight of 1570.4.
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colorless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
The prevention of premature luteinizing hormone (LH) surges in women
undergoing controlled ovarian hyperstimulation (COH) for assisted
reproduction techniques (ART).
In clinical trials Orgalutran was used with recombinant follicle
stimulating
hormone (FSH).
4.2
Posology and method of administration
Orgalutran should only be prescribed by a specialist experienced in
the
treatment of infertility.
Posology
Orgalutran is used to prevent premature LH surges in patients
undergoing
COH. Controlled ovarian hyperstimulation with FSH may start at day 2
or 3 of
menses. Orgalutran (0.25 mg) should be injected subcutaneously once
daily,
starting in general on day 6 of FSH administration. In high responders
an
early LH rise may be prevented by starting Orgalutran treatment on day
5.
The start of Orgalutran may be delayed in absence of follicular
growth.
Orgalutran and FSH should be administered approximately at the same
time.
However, the preparations should not be mixed and different injection
sites
are to be used.
FSH dose adjustments should be based on the number and size of growing
follicles, rather than on the amount of circulating oestradiol (see
section 5.1
Pharmacodynamic properties). Daily treatment with Orgalut