Posology : מינונים

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.
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.

The applicator has a ring marked on the body. Fill the applicator up to the ring mark with Ovestin cream to get the correct dose.

1.   Remove the cap from the tube and turn it upside down. Then use the sharp point to open the tube.
2.   Screw the end of the applicator onto the tube.



3.   Squeeze the tube to fill the applicator with the cream up to the red ring mark (the plunger will stop at the ring mark).



4.   Unscrew applicator from the tube and put the cap back on the tube.
5.   To apply the cream, lie down, put the end of the applicator deep into the vagina and slowly push plunger all the way in until applicator is empty.
Cleaning the applicator
After use, pull the plunger out of the barrel. Wash the plunger and barrel in hand hot, soapy water. Do not use detergents. Rinse well with clean water afterwards.
DO NOT PUT THE APPLICATOR IN BOILING WATER.

A missed dose should be administered as soon as remembered, unless it is more than 12 hours overdue. In the latter case the missed dose should be skipped and the next dose should be administered at the normal time. Two doses should never be administered on the same day.

Cyclic administration of a progestagen to prevent endometrial stimulation is not necessary provided the daily dose does not exceed 1 applicator-dose (0.5 mg estriol) and this maximum dose is not used for more than several weeks (see section 4.4 Endometrial hyperplasia).

Children
There are no clinical trials to support the use in children.