البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
TESTOSTERONE
CTS LTD
G03BA03
GEL
TESTOSTERONE 0.05 G/DOSE
TRANSDERMAL
Required
BESINS-INTERNATIONAL LABORATORIES, FRANCE
TESTOSTERONE
Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
2016-11-09
لوحكلا ةبسن ّ نلأ ،ة ّ يلسانتلا ءاضعلأا ةقطنم ىلع نهدلا زوجي لا .ا ً ّ يعضوم ا ً ج ّ يهت ب ّ بست دق رضحتسملا يف ةعفترملا رضحتسملا ّ فجي ى ّ تح رانلل ض ّ رعتلا وأ ةراچيس لاعشإ زوجي لا .ا ً مامت .هعلب زوجي لا .طقف ّ يجراخلا لامعتسلال ةعباتملاو صوحفلا ءدبلا لبق ةلماش ة ّ ي ّ بط صوحف ءارجلإ كهيجوتب بيبطلا موقيس ءارجلإ ا ً ضيأ كهيجوت ّ متيس جلاعلا ةرتف للاخ .ءاودلا لامعتساب نيت ّ رم وأ ّ لقلأا ىلع ةنسلا يف ةدحاو ة ّ رم( ة ّ يرود ة ّ ي ّ بط صوحف ةئفلا وأ ّ نسلا يف ةم ّ دقتملا ة ّ ينا ّ كسلا ةئفلل ةبسنلاب ةنسلا يف .)رطخلا ةرئاد يف ةدوجوملا ة ّ ينا ّ كسلا رهظت دقف مزلالا نم ربكأ ة ّ يئاود ةعرج نهدب ً أطخ تمق اذإ ،نزولا دايدزا ،ة ّ يبصعلا ،ءودهلا مدع :ةيلاتلا تاملاعلا .لصاوتملاو ر ّ ركتملا باصتنلاا .بيبطلا ةراشتسا كيلع ب ّ جوتي ه ّ جوتف ، ً أطخ ءاودلا علبب دلو ماق اذإ وأ ةطرفم ةعرج تلوانت اذإ رضحأو ىفشتسملا يف ئراوطلا ةفرغ ىلإ وأ بيبطلا ىلإ ا ً روف .ءاودلا ة ّ وبع كعم ة ّ ي ّ مك نهدب مقت لاف ،بولطملا تقولا يف لجلا نهد تيسن اذإ ّ يدايتعلاا تقولا يف ة ّ يدايتعلاا ة ّ ي ّ مكلا نهدب مق .ةفعاضم .بيبطلا رشتساو .بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا بجي نم دكأتو قصل ُ ملا عجار !ةمتعلا يف ةيودلأا لوانت زوجي لا ة ّ ي ّ بطلا تارا ّ ظنلا عض .ءاودلا اهيف لوانتت ةرم اقرأ الوثيقة كاملة
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT: ANDROGEL, 50 mg, gel in unit-dose sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Testosterone 0.05 g per 5 g sachet Excipients with known effect: Ethanol. For the full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM: Gel Transparent or slightly opalescent, colorless gel in sachet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. (see 4.4 Special warnings and special precautions for use) 4.2 POSOLOGY AND ADMINISTRATION ROUTE Posology _Adults and elderly men _ The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily, at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved by 2.5 g of gel steps. Steady state plasma testosterone concentrations are reached approximately on the 2 nd day of treatment by this medicine . In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3 rd day on after starting treatment (one week seems reasonable). The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day. _Paediatric population _ This medicine is not indicated for use in children and has not been evaluated clinically in males under 18 years of age. Use in women This medicine is not indicated for use in women. Method of administration Transdermal use. The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms or abdomen. After opening the sachet, the total content must be extracted from the sachet and app اقرأ الوثيقة كاملة