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פרוגילוטון PROGYLUTON (ESTRADIOL VALERATE, NORGESTREL)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

טבליה : TABLETS

Posology : מינונים

4.2 Posology and method of administration
Progyluton is a cyclic HRT product. One tablet is to be taken orally once a day for 21 days, followed by a 7-day tablet free interval. Therefore each new pack is started after a 28 day cycle. The white tablets should be taken from days 1 to 11 followed by the brown tablets from days 12 to 21. It is recommended that the tablets are taken at the same time every day.


For initiation and continuation of treatment of peri- and post-menopausal symptoms the lowest effective dose for the shortest duration (see also 'Special warnings and special precautions for use') should be used.


For women still having periods, the first tablet should be taken on the 5th day of their menstrual period. If menstruation has stopped, or is infrequent or sporadic, then the first tablet can be taken any time.


If the patient is being transferred from a continuous HRT product, the patient may start Progyluton on any convenient day. For those transferring from a cyclic or sequential product, Progyluton should be started following completion of the previous regimen.


If a tablet is missed, it should be taken as soon as possible, unless it is more than 12 hours late. In this case the missed tablet should be left in the pack and the next tablet taken at the right time. Missing a dose may result in breakthrough bleeding or spotting.

Unless there is a previous diagnosis of endometriosis, it is not recommended that progestogen- containing HRT be given to hysterectomised women.
Children and adolescents
There are no data available on the safety and efficacy in children and adolescents under 18 years of age. Progyluton is not indicated for use in children and adolescents 

Geriatric patients
There are no data suggesting a need for dosage adjustment in women aged 65 years or older (see section 4.4 Special warnings and precautions for use)


Patients with renal impairment
Progyluton has not been specifically studied in renally impaired patients. Available data do not suggest a need for dosage adjustment in this patient population


Hepatic insufficiency
Progyluton has not been tested in patients with hepatic insufficiency. Progyluton is contraindicated in women with serious hepatic conditions.


שימוש לפי פנקס קופ''ח כללית 1994 Deficiency symptoms in the pre- & postmenopause, after oophorectomy or radiological castration for non-carcinomatous diseases, functional amenorrhea, irregularities of the menstrual cycle
תאריך הכללה מקורי בסל 01/01/1995
הגבלות תרופה שאושרה לשימוש כללי בקופ'ח

בעל רישום

BAYER ISRAEL LTD

רישום

032 90 22502 00

מחיר

0 ₪

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