Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
DROSPIRENONE; ESTRADIOL AS HEMIHYDRATE
BAYER ISRAEL LTD
G03CA03
FILM COATED TABLETS
DROSPIRENONE 2 MG; ESTRADIOL AS HEMIHYDRATE 1 MG
PER OS
Required
BAYER AG, GERMANY
ESTRADIOL
ESTRADIOL
Angeliq is indicated for hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women more than 1 year post menopause. Prevention of postmenopausal osteoporosis in women with an increased risk of future osteoporosis fractures.
2020-05-31
PACKAGING TECHNOLOGY BERLIN SGQCL page 2 Bayer AG client: 0021,GV15 material-no.: 89299268 PZ: 2688A-3A code-no.: name: LF-INS ANGELIQ 1/2 TAFI 28 country: IL/MULI/BAG colors: BLACK version: 15.09.2022/01 Restricted Document dimension: 355 X 594 MM ةيفاضإ تلااح كانه .ةركاذلا نادقف عنمي لا ليدبلا ينومروهلا جلاعلا نإ ● ةركاذ نادقف ثودحل ربكأ ةروطخ دوجو ىلع لدت دهاوش دعب ليدب ينومروه جلاع لوانت نأدبي يتاوللا ءاسنلا ىدل .بيبطلا يريشتسإ .ةنس 65 رمع ةعفترم بسن كيدلو ىلكلا يف ةلكشم نم نيناعت تنك اذإ ● ةيودأ نيلوانتت تنك اذإ صخلأاب ،مدلا يف مويساتوﭙلا نم زئاجلا نمف ،مدلا يف مويساتوﭙلا ةيمك نم عفرت ةيفاضإ رهشلا للاخ كمد يف مويساتوﭙلا ةبسن بيبطلا صحفي نأ .جلاعلا نم لولأا جلاعلا نإف ،مدلا طغض يف عافترإ نم نيناعت تنك اذإ ● لامعتسإ زوجي لا .مدلا طغض نم ضفخي نأ نكمي كيليجنأ ـب .مدلا طغض عافترلإ جلاعك كيليجنأ هجولا ىلع ةيبهذ ـ ةينب عقب ريوطتل ةيلباق كيدل تناك اذإ ● قوف ةعشلأا وأ سمشلل ضرعتلا نع عانتملإا كيلعف ،)فلك( .كيليجنأ ـب جلاعلا ءانثأ ةيجسفنبلا :ةيودلأا نيب تلاعافتلا/تلاخادتلا امب ىرخأ ةيودأ ، ً ارخؤم تلوانت اذإ وأ نيلوانتت تنك اذإ يكحإ ،ةيئاذغ تافاضإو ةيبط ةفصو نودب ةيودأ كلذ يف .كلذ نع يلديصلا وأ بيبطلل ريغ فزن ىلإ يدؤتو كيليجنأ لمع لقرعت دق ةنيعم ةيودأ :لمشت ةيودلأا هذه .مظتنم ،نوديميرپ ،نيئوتينيف ،تاروتيبراب لثم( عرصلا جلاعل ةي Διαβάστε το πλήρες έγγραφο
1. NAME OF THE MEDICINAL PRODUCT ANGELIQ Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 1 mg Oestradiol (as Oestradiol hemihydrate) and 2 mg drospirenone. Excipient with known effect: 48.2 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. Medium red, round tablet with convex faces, one side embossed with the letters DL in a regular hexagon. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women more than 1 year post menopause. Prevention of postmenopausal osteoporosis in women with an increased risk of future osteoporosis fractures. (See also section 4.4) The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Women who do not take hormone replacement therapy (HRT) or women who change from another continuous combined product may start treatment at any time. Women changing from a cyclic, sequential combined HRT regimen, treatment should begin the day following completion of the prior regimen. Posology One tablet is taken daily. Each blister is for 28 days of treatment. Method of administration The tablets are to be swallowed whole with some liquid irrespective of food intake. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets should preferably be taken at the same time every day. If a tablet is forgotten it should be taken as soon as possible. If more than 24 hours have elapsed no extra tablet needs to be taken. If several tablets are forgotten, vaginal bleeding may occur. For treatment of post menopausal symptoms, the lowest effective dose should be used. 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. ADDITIONAL INFORMATION ON SPECIAL POPULATIONS Paediatric population Angeliq is not indicated for Διαβάστε το πλήρες έγγραφο