CRINONE 8 %

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PROGESTERONE

Available from:

MERCK SERONO LTD

ATC code:

G03DA04

Pharmaceutical form:

GEL

Composition:

PROGESTERONE 8 %W/W

Administration route:

VAGINAL

Prescription type:

Required

Manufactured by:

MERCK SERONO S.A., SWITZERLAND

Therapeutic group:

PROGESTERONE

Therapeutic area:

PROGESTERONE

Therapeutic indications:

Treatment of infertility due to inadequete luteal phase. For use during in-vitro fertilisation, where infertility is mainly due to tubal idiopathic or endometriosis linked sterility associated with normal obulatory.

Authorization date:

2020-09-30

Patient Information leaflet

بناجلا نم ةيرئاد ةكرحب ءاطغلا عزن بجي
.كيمسلا فرطلل حطسملا ءزجلا نم لصوملا
كسم بجي
ءاوهلا نازخ ىلع ةلحرملا هذه يف طغضلا
زوجي لا ،لامعتسلإا لبق لجلا برست بنجتل
.عيفرلا سكاعملا
.كيمسلا فرطلاب دوجوملا
لصوملا لاخدإ
لصوملا يلخدأ .نيتحوتفمو نيتينثنم
نيتبكرلا نوكت ثيحب ءاقلتسلإاب وأ
ءارولا ىلإ دانتسلإاب يموق
.كمسج كدي سملات نأ ىلإ لبهملا لخادل ديج
لكشبو فطلب
.لبهملا ىلإ لصوملا نم لجلا ريرحتل كلذو
ةدشب لصوملل كيمسلا فرطلا نم ءاوهلا
نازخ ىلع يطغضإ قوف نم
ً
ابيرقت رتم 760 نم رثكأ هردق عافترإ ىلع
رضحتسملا لامعتسلإ ةصاخ تاميلعت
:رحبلا حطس
ىلع ودبي يذلا( كيمسلا فرطلا نم حطسملا
ءزجلا يف درفنم بقث ءارجإب يموق ةداح
ةادأ ةطساوب
،لصوملل يلخادلاو يجراخلا ءزجلا نيب
لكشتملا ءاوهلا طغض ررحي ءارجلإا اذه
.لصوملل )ةعاقف لكش
.قهاشلا عافترلإا ببسب
!كل ةدوزملا لجلا ةيمك نم ريغي لا
ءارجلإا اذه
.
ً
اقباس ةلصفملا تاميلعتلا بسحب
لامعتسلإا يلصاو
كيمسلا فرطلا ىلع يطغضإ .لصوملا يف
هئارجإب تمق يذلا بقثلا ىلع كعبصأ يعض
ةلاحلا هذه يف
لا تنأف ،قلقلل يعاد لا نكلو ،لصوملا يف
لجلا نم ةيمك ىقبت دق .لبهملل لجلا
ريرحتل كلذو ،لصوملل
.بوغرملا يئاودلا رادقملا نيقلتتس تلز
لصوملا لامعتسإ دعب
.لصوملا يف لجلا نم ةيقبتملا ةليئضلا
ةيمكلا كلذ يف امب ،لصوملا يمرب يموق
.ة

Summary of Product characteristics

Page 1
INTERNAL (incl. business partners)
Classification: INTERNAL
CRINONE
® 8%
Progesterone Vaginal Gel.
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Crinone® 8% w/w Progesterone Vaginal Gel.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
mg/dose
% w/w
Progesterone
90
8.0
Excipient with known effect: Contains Sorbic acid 0.08% w/w
(0.9mg/1.125 g dose). For the
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal gel
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of infertility due to inadequate luteal phase.
For use during in-vitro fertilization, where infertility is mainly due
to tubal, idiopathic or
endometriosis linked sterility associated with normal ovulatory
cycles.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Intravaginal application.
Treatment of infertility due to inadequate luteal phase
One application (1.125g 8% gel) every day, starting after documented
ovulation or arbitrarily
on the 18
th
-21
st
day of the cycle.
Page 2
INTERNAL (incl. business partners)
Classification: INTERNAL
Use during in-vitro fertilisation
Daily application of Crinone 8% gel should be continued for 30 days if
there is laboratory
evidence of pregnancy.
Paediatric population
Not applicable.
Older people
Not applicable.
Method of Administration
Crinone is applied directly from the specially designed sealed
applicator into the vagina. The
applicator should be removed from the sealed wrapper. The twist-off
cap should not be
removed at this time.
1.
The applicator should be gripped firmly by the thick end. It should be
shaken down like a
thermometer to ensure that the contents are at the thin end.
2.
The tab should be twisted off and discarded.
3.
The applicator may be inserted while patient is in a sitting position
or when lying on her
back with the knees bent. The thin end of applicator should be gently
inserted well into
the vagina.
4.
The thick end of the applicator should be pressed firmly to deposit
gel. The applicator
should be removed and discarded in a wa