ELTROXIN TABLETS 100 MCG
Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
Taarifa za kipeperushi
(PIL)
13-04-2021
Tabia za bidhaa
(SPC)
07-12-2020
Ripoti ya Tathmini ya umma
(PAR)
17-08-2016
Viambatanisho vya kazi:
LEVOTHYROXINE SODIUM
Inapatikana kutoka:
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
ATC kanuni:
H03AA01
Dawa fomu:
TABLETS
Tungo:
LEVOTHYROXINE SODIUM 100 MCG
Njia ya uendeshaji:
PER OS
Dawa ya aina:
Required
Viwandani na:
ASPEN BAD OLDESLOE GMBH, GERMANY
Kundi la matibabu:
LEVOTHYROXINE SODIUM
Eneo la matibabu:
LEVOTHYROXINE SODIUM
Matibabu dalili:
Treatment of hypothyroidism, cretinism and juvenile myxoedema.
Idhini ya tarehe:
2022-09-30
Taarifa za kipeperushi
: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
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Tabia za bidhaa
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
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