Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
CYPROTERONE ACETATE; ETHINYLESTRADIOL
BAYER ISRAEL LTD
G03HB01
TABLETS
ETHINYLESTRADIOL 35 MCG; CYPROTERONE ACETATE 2 MG
PER OS
Required
BAYER WEIMAR GMBH UND CO.KG, GERMANY
CYPROTERONE AND ESTROGEN
CYPROTERONE AND ESTROGEN
Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, Diane-35 should only be used after topical therapy or systemic antibiotic treatments have failed.
2013-05-31
PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: JS86 material-no.: 88729846 PZ: 2711W-4D code-no.: name: LF-BRO DIANE 35 TASC 21 country: IL/MULI/BAG colors: BLACK / version: 03.03.2022/01 Restricted Document dimension: 98 X 31 MM Page 1 1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only DIANE 35 TABLETS PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: JS86 material-no.: 88729846 PZ: 2711W-4D code-no.: name: LF-BRO DIANE 35 TASC 21 country: IL/MULI/BAG colors: BLACK / version: 03.03.2022/01 Restricted Document dimension: 98 X 31 MM Page 2 2 Each tablet contains: ethinylestradiol 35 mcg cyproterone acetate 2 mg Inactive ingredients and allergens: see section 6 “Further Information” and section 2 “Important information regarding some of the ingredients of the medicine”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: JS86 material-no.: 88729846 PZ: 2711W-4D code-no.: name: LF-BRO DIANE 35 TASC 21 country: IL/MULI/BAG colors: BLACK / version: 03.03.2022/01 Restricted Document dimension: 98 X 31 MM Page 3 3 consult your doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1) WHAT IS THE MEDICINE INTENDED FOR? Diane 35 is a medicine with hormonal activity (estrogenic and anti-androgenic) and is intended to treat skin problems such as acne, very oily skin and excessive hair growth in women of reproductive age. PACKAGING TECHNOLOGY BERLIN SGQCL Bayer AG client: JS86 material-no.: 88729846 PZ: 2711W-4D code-no.: name: LF-BRO DIANE 35 TASC 21 country: IL/MULI/BAG colors: BLACK / version: 03.03.2022/01 Restricted Document dimension: 98 X 31 MM Page 4 4 Diane 35 is not intended for use in adolescent girls who have Perskaitykite visą dokumentą
1. NAME OF THE MEDICINAL PRODUCT Diane ® 35 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Actives: Cyproterone acetate 2.00 mg Ethinylestradiol 35 micrograms Excipients: Lactose monohydrate 30.965mg Sucrose 19.371 mg For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Sugar-coated tablets. Beige, round tablet, with convex faces. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, Diane 35 should only be used after topical therapy or systemic antibiotic treatments have failed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION _ Oral use _DOSAGE REGIMEN _ Diane 35 inhibits ovulation and thereby prevents conception. Patients who are using Diane 35 should not therefore use an additional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and is not necessary for effective contraception. _First treatment course:_ One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1). _Subsequent courses:_ Each subsequent course is started after 7 tablet-free days have followed the preceding course. 2 2 When the contraceptive action of Diane 35 is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started. When changing from an oral contraceptive and relying on the contraceptive action of Diane 35, follow the instructions given below: _Changing from 21-day combined oral contraceptives:_ The first tablet of Diane 35 should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required. _Changing from a combined Every Day pill (28 day tablets): _ Diane Perskaitykite visą dokumentą