国: イスラエル
言語: 英語
ソース: Ministry of Health
ESTRADIOL VALERATE; ESTRADIOL VALERATE; NORGESTREL
BAYER ISRAEL LTD
G03FB01
TABLETS
ESTRADIOL VALERATE 2 MG; NORGESTREL 0.5 MG; ESTRADIOL VALERATE 2 MG
PER OS
Required
BAYER WEIMAR GMBH UND CO.KG, GERMANY
NORGESTREL AND ESTROGEN
NORGESTREL AND ESTROGEN
Two phase preparation for climacteric and cycle disturbances.
2023-11-30
PACKAGING TECHNOLOGY BERLIN SGQCL page 1 Bayer AG client: JS86 material-no.: 89262240 PZ: 2708B-3B code-no.: name: LF-INS PROGYLUTON TASC country: IL/MULI/BAG colors: BLACK version: 17.08.2022/02 Restricted Document dimension: 420 X 698 MM 89262240_02.indd 1 17.08.2022 13:18:04 完全なドキュメントを読む
1. NAME OF THE MEDICINAL PRODUCT Progyluton 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Calendar-pack containing 11 white tablets of 2 mg estradiol valerate each, plus 10 light brown tablets of 2 mg estradiol valerate and 0.5 mg norgestrel each. Excipients: Each white coated tablet contains 46.220 mg lactose monohydrate. Each light brown coated tablets contain 45.720mg lactose monohydrate 3. PHARMACEUTICAL FORM Coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Two phase preparation for climacteric and cycle disturbances. 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 t 完全なドキュメントを読む