OVESTIN

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

ESTRIOL

Disponible des:

PERRIGO ISRAEL AGENCIES LTD

Codi ATC:

G03CA04

formulario farmacéutico:

CREAM

Composición:

ESTRIOL 0.1 %

Vía de administración:

VAGINAL

tipo de receta:

Required

Fabricat per:

ORGANON (IRELAND) LTD, IRELAND

Grupo terapéutico:

ESTRIOL

Área terapéutica:

ESTRIOL

indicaciones terapéuticas:

For the treatment of vulvo-vaginal complaints related to estrogen deficiency.

Data d'autorització:

2014-10-31

Informació per a l'usuari

نبصت نأ عــقوتملا نــم ،١٠٠٠ نــیب
نــم ٧ :HRT نــلوانتت يـ
ـتاوللا ءاــسنلا ىدــل
.ةيومد ةرــثخب
:نينس ٥ ةرتفلو ،طسوتملاب ،نهرمع نم
تانیتسلا يف ءاسن ىلإ رظنلاب
نأ عــقوتملا نــم ،١٠٠٠ نــیب نــم ٨
:HRT نــلوانتت ل يــتاوللا ءاــسنلا
ىدــل
.ةــيومد ةرــثخب نــبصت
نبصت نأ عــقوتملا نم ،١٠٠٠ نــیب نم ١٧
:HRT نــلوانتت يـ
ـتاوللا ءاــسنلا ىدــل
.ةيومد ةرــثخب
كيدل وأ ردــصلا يف ئــجافم ملأ
،لــجرلا يف مــلؤم خاــفتنإ نــم
نــيناعت تــنك اذإ
!لاحلا يــف بیبطلا يـ
ـعجار ،سفنتلا يــف لكاــشم
نم .كلذ لــعف كــنكمي هــنأب بــيبطلا
كرــبخي نأ ىــلإ ن
آ
لاا دــعب HRT يلمعتــست لا
.ةيومد ةرــثخ ثودــحل تاملع نوــكت نأ
هذــه نأــش كــلذ يــف اــمب ،ىرــخأ ةــيودأ
ً
ارــخؤم تلمعتــسإ اذإ وأ نیلمعتــست
تــنك اذإ
! بــیبطلل
ِ
كــحإ ،ةــیئاذغ تاــفاضإو ةــیتابن ةـ
ـيودأ ،ةــیبط ةـ
ـفصو نودــب ةــيودأ
.كـ
ـلذ نــع يـ
ـلدیصلا وأ
:ةيلاتلا ةيود
أ
لاا نم دحاو يأ نيلوانتت تنك اذإ
يلديصلا وأ كبیبط يغلب
.نيپيزامابراكو نيئوتناديه
،تاروتيبراب لثم – عرصلل ةيودأ
.نيسيمافيرو نيڤلوفويسيرچ لثم –
تاثولتلل ةيودأ
.ريڤانيفلن وأ ريڤانوتير ،زنيريڤافيإ
،نيپاريڤن لثم – ةيسوريڤلا تاثولتلل
ةيودأ
– )موتاروفريپ موكيرپيه( St. John’s Wort ىلع
ةيواحلا ةيتابنلا ت�

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OVESTIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1mg estriol in 1g cream
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal cream
Homogeneous, smooth, white to nearly white mass of creamy consistency.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of vulvo-vaginal complaints related to estrogen
deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ovestin cream is an estrogen-only product for intravaginal use.
One applicator-dose (applicator filled to the red mark) is 0.5g
Ovestin cream
containing 0.5 mg estriol.
_Adults and Elderly _
•
Treatment of atrophic vaginitis
For initiation and continuation of treatment of postmenopausal
symptoms, the
lowest effective dose for the shortest duration (see also section 4.4)
should be
used.
The usual dose for atrophic vaginitis associated with the menopause is
one
applicator-dose per day for 2 to 3 weeks.
As maintenance dosage, one applicator-dose twice a week is
recommended.
Medication should be discontinued every 2 to 3 months for a period of
4 weeks
to assess the necessity for further treatment.
•
Pre-surgery therapy
One applicator-dose per day should begin 2 weeks before the operation.
•
Post-surgery therapy
Following surgery a period of at least 2 weeks should be allowed
before
resuming therapy using one applicator-dose twice a week.
1
In women not taking HRT or women who switch from another continuous
combined
HRT product, treatment with Ovestin cream may be started on any day.
Women who
switch from cyclic HRT regimen should start Ovestin cream treatment
one week after
completion of the cycle.
_Route of Administration _
Ovestin cream is administered intravaginally by means of a calibrated
applicator.
The following ‘Instructions for Use’ should be given to the
patient and are included in
the Patient Information Leaflet:
How to Apply the Cream
Use the applicator to apply the cream in the vagina. A good time to do
this is before
going to bed.