Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
LEVOTHYROXINE SODIUM
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
H03AA01
TABLETS
LEVOTHYROXINE SODIUM 100 MCG
PER OS
Required
ASPEN BAD OLDESLOE GMBH, GERMANY
LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM
Treatment of hypothyroidism, cretinism and juvenile myxoedema.
2022-09-30
:عاضرلإاو لمحلا .ءاودلا لوانت لبق كبيبط ةراشتسإ بجي ،لمحلل نيططخت وأ لماح كنأب نيدقتعت ،ةعضرم وأ ً لاماح تنك اذإ ً ادج ةضفخنملا بسنلا نلأ كلذو ،ةرركتم تاقوأب لمحلا ةرتف للاخ ةيقردلا ةدغلا فئاظو ةبقارم بجي كبيبط ددحي فوس .نينجلا ةيهافرو روطتب ررضلا قحلت دق ةيقردلا ةدغلا تانومروهل ً ادج ةعفترملا وأ .نيسكورتلإ نم يئاودلا رادقملا ةمءلام رملأا بلطتي ناك اذإ اميف ةجلاعمل كلذو ةيقردلا ةدغلا طاشن طبثي ءاود ً اضيأ نيلوانتت تنك اذإ لمحلا ةرتف للاخ لوانتلا زوجي لا .ةيقردلا ةدغلا طاشن طرف تنك وأ ةعضرم تنك اذإ كبيبط ملاعإ بجي .ملأا بيلح يف ةلاعفلا ةداملا نم ةضفخنم بسن حرط ُ ت .عاضرلإل نيططخت جلاعلا ءدب دعب ينيتور لكشب مدلا طغض صحف متي ، ً ادج ضفخنم نزوب اودلو نيذلا ج ّ د ُ خلا ىدل ةيومدلا ةرودلا رايهنإ ىمس ُ ي( مدلا طغض يف عيرس ضافخنإ ثدحي دق هنلأ كلذو ،نيسكوريتوڤﯿل ـب .)Circulatory collapse :تانكاملا لامعتسإو ةقايسلا .ةقايسلا وأ تانكاملا لامعتسإ ىلع ةردقلا ىلع ريثأت نيسكورتلإ ـل دجوي لا :ءاودلا تابكرم ضعب نع ةماه تامولعم .'مويدوصلا نم ٍ لاخ' وه ً ايلمع ،يأ ،صرق لكب مويدوص غلم 23 نم لقأ ىلع ءاودلا اذه يوتحي ؟ءاودلا لامعتسإ ةيفيك )3 .بيبطلا تاميلعت بسحب ً امئاد ءاودلا لامعتسإ بجي ةقيرطو يئاودلا رادقملاب قلعتي اميف ً اقثاو نكت مل اذإ يلديصلا نم Lestu allt skjalið
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Eltroxin ® Tablets 50mcg Eltroxin ® Tablets 100mcg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Levothyroxine sodium 50 micrograms or 100 micrograms. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM non-scored tablets The tablets are round, white to off-white and biconvex. The tablet with 50 micrograms is engraved with “GS 11E” on one side and with “50” on the other. The tablet with 100 micrograms is engraved with “GS 21C” on one side and with “100” on the other. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of hypothyroidism, cretinism and juvenile myxoedema. 4.2 Posology and method of administration Posology _General _ If the dose is increased too rapidly symptoms such as diarrhoea, nervousness, high heart rate, insomnia, tremor and at times pain in the heart with latent myocardial ischaemia may occur. In such cases the dose should be reduced or treatment omitted for one or two days and then restarted at a lower dose. ECG changes caused by hypothyroidism may be confused with ECG signs of ischaemia. Therefore, it is recommended to have an ECG performed prior to start of Eltroxin. In patients on medicines including levothyroxine and known interfering substances administration should be at least 4 hours apart (see section 4.5 Interactions). _ _ _Adults _ The treatment is initiated with 50-100 micrograms daily, which is increased by 50 micrograms in intervals of 4 to 6 weeks until clinical and biochemical euthyroidism is obtained. This may require doses of 100-200 micrograms daily. _Elderly patients and patients with heart disease or serious, prolonged hypothyroidism _ Use with caution in patients over 50 years old, patients with heart disease and patients with serious or prolonged hypothyroidism. Page 2 of 11 For patients over 50 years it is not recommended to initially exceed 50 micrograms daily. For heart disease 50 micrograms every second day is more suitable, and the dose ma Lestu allt skjalið