MENOPUR 75 IU

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

MENOTROPHIN

Disponible des:

FERRING PHARMACEUTICALS LTD

Codi ATC:

G03GA02

formulario farmacéutico:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composición:

MENOTROPHIN 75 IU/DOSE

Vía de administración:

S.C, I.M

tipo de receta:

Required

Fabricat per:

FERRING GmbH ,GERMANY

Área terapéutica:

HUMAN MENOPAUSAL GONADOTROPHIN

indicaciones terapéuticas:

Sterility in females with hypo or normogonadotropic ovarian insufficiency : stimulation of follicle growth. Sterility in males with hypo or normogonadotropic hypogonadism: In combination with HCG to spermatogenesis.

Data d'autorització:

2021-11-30

Informació per a l'usuari

يدؤت دق ةوطخلا هذه نلأ ،زهلا زوجي لا
.لولحملا طلخا ،قوحسملا ةباذإ ىلع
ةدعاسملل نمضتي ناك اذإ وأ ايفاص نكي مل اذإ
لولحملا لامعتسا زوجي لا !ءاوه تاعاقف ن
ّ
وكت ىلإ
.تائيزج
.ةنقحملا لخاد ىلإ ةيناث لولحملا بحسا
،ةنقحملا لخاد ىلإ اددجم )روپونيمل لوأ
طلخ( لولحملا بحس نكمي ،ةنقح لك يف ةدحاو
ةروراق نم رثكأ كل ف
ِ
ص
ُ
و اذإ
كاصوأ اذإ طقف نكلو - لمجملاب قوحسم
تاروراق ثلاث ىتح ةقيرطلا هذهب ةباذلإا
نكمي .ةيناثلا ةروراقلا يف هنقح مث
.كلذب بيبطلا
:نقحلا ةقيرط
ةليوطلا ةربلإا لدبتسا ،ةنقحملا لخاد
ىلإ بيبطلا كل اهفصو يتلا ةعرجلا بحست
نأ دعب
.نقحلل ة
ّ
دعملا ةعيفرلاو ةريصقلا ةربلإاب
ةنقحملاب ةلوصوملا
ىتح ةنقحملا ىلع فطلب قرطاو ىلعلأا وحن
ةهجتم ةربلإا نوكت ثيحب ةنقحملا كسمأ
ىتح ىلعلأا وحن ةنقحملا سبكم فطلب عفدا
.يولعلا اهفرط يـف ءاوهلا تاعاقف زكرتت
.ةربلإا فرط يف لولحملا نم ةطقن روهظو
ءاوهلا تاعاقف جورخ
ةيماملأا ةهجلا يف :لاثم( ةضرمملا وأ
بيبطلا تاميلعت بسحب نقحلا عقوم رايتخا
بجي
.)كلذ ريغو ،نطبلا ،ذخفلا نم
.نقحلا ةقطنم ريهطت بجي
ةدحاو ةكرحب ةربلإا لاخدإو ،دلجلا يـف ة
ّ
يط ليكشتو دلجلا صرق بجي ،نقحلا فدهب
.مسجلا عم ةجرد 90 ةيوازب ةعيرس
.دلجلا نم ةربلإا ج
ِ
رخأ كلذ دعب ،لولحملا نقحل لفسلأا
هاجتاب سبكملا ىلع طغضا
دعاسي .هثودح لاح يف فيزنلا فا�

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MENOPUR® 75IU
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial with powder for solution for injection contains: highly
purified
Menotrophin (human menopausal gonadotrophin, hMG) corresponding to 75
IU FSH and 75 IU LH.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Sterility in females with hypo or normogonadotropic ovarian
insufficiency: stimulation of follicle growth.
- Sterility in males with hypo or normogonadotropic hypogonadism:
In combination with hCG to stimulate spermatogenesis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology: single and daily dosages _
Sterility in females.
The dosage of hMG for the induction of follicle growth in normo- or
hypogonadotropic woman varies according to the individual. The amount
depends on ovarian reaction and should be checked by ultrasound
examinations of the ovaries and measuring estradiol levels. If the hMG
dosage
is too high for the treated individual, multiple uni- and bilateral
follicle growth
can occur.
hMG is administered intramuscularly or subcutaneously and in general,
the
therapy is begun with a daily dosage corresponding to 75 – 150 IU
FSH.
If the ovaries do not respond, the dosage can slowly be increased
until a rise in
estradiol secretion and follicle growth is evident. Treatment with the
same
dosage of hMG continues until pre-ovulatory estradiol serum level is
attained.
If the level rises too quickly, the dosage should be reduced. To
induce
ovulation, 5,000 or 10,000 IU hCG are injected IM to 2 days after the
last
hMG administration.
Note: after a hMG dosage too high for corresponding individual has
been
administered, the following hCG administration can cause an
unintentional
hyperstimulation of the ovaries.
Sterility in males.
Initially, 3 x 1,000 to 3,000 hCG a week are administered until a
normal
testosterone serum level is reached.
Children:
Not recommended for use in children.
Elderly:
Not recommende