Land: Israel
Språk: engelsk
Kilde: Ministry of Health
EVEROLIMUS
NOVARTIS ISRAEL LTD
L04AA18
TABLETS DISPERSIBLE
EVEROLIMUS 2 MG
PER OS
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
EVEROLIMUS
Votubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory epileptic seizures are associated with tuberous sclerosis complex (TSC).
2020-06-07
.6 ةيفاضإ تامولعم :ىلع ً اضيأ ءاودلا يوتحي ةلا ّ عفلا ةداملا ىلإ ةفاضلإاب Mannitol, cellulose microcrystalline, crospovidone, hypromellose, magnesium stearate, silica colloidal anhydrous, lactose monohydrate and butylated hydroxytoluene. .تارديهونوم زوتكلا غلم 1.96 ىلع يوتحي غلم 2 ايبوتوڤ صرق لك .تارديهونوم زوتكلا غلم 2.94 ىلع يوتحي غلم 3 ايبوتوڤ صرق لك :ة ّ وبعلا يوحت اذامو ءاودلا ودبي فيك ةحطسم ،ةريدتسم ، ً لايلق رفصلأل لئام نول ىتح نوللا ءاضيب نابوذلل ةلباقلا صارقلأا نوكت .رطشلل طخ نودبو ةلئام فاوح تاذ دحاو بناج ىلع "D2" متخ عم اهيلع روفحم نابوذلل ةلباقلا صارقلأا :غلم 2 ايبوتوڤ .رخلآا بناجلا ىلع "NVR" -و دحاو بناج ىلع "D3" متخ عم اهيلع روفحم نابوذلل ةلباقلا صارقلأا :غلم 3 ايبوتوڤ .رخلآا بناجلا ىلع "NVR" -و .ةطرشأ يف ةدوجوم نابوذلل لاباق ا ً صرق 30 ىلع يوتحت غلم 2 ايبوتوڤ نم ةوبع لك .ةطرشأ يف ةدوجوم نابوذلل لاباق ا ً صرق 30 ىلع يوتحت غلم 3 ايبوتوڤ ة ّ وبع لك .تا ّ وبعلا ماجحأ عيمج قيوست ّ متي لا دق :دروتسملاو ليجستلا بحاص .بيبأ لت ،7126 .ب.ص ،.ض.م ليئارسإ سيترڤون .ةحصلا ةرازو تاميلعت قفو 2021 بآ يف اهريرحت مت :ة ّ حصلا ةرازو يف ّ يمسرلا ةيودلأا ّ لجس يف ءاودلا ليجست مقر 164-73-35765 غلم 2 ايبوتوڤ 164-74-35766 غلم 3 ايبوتوڤ لاكل ّ دعم ءاودلاف اذه عم .ر ّ كذملا ةغيصب ّ صنلا درو اهليهستو ةرشنلا هذه ةءارق طيسبتل .نيسنجلا لامعتسلاا تاميلعت ود read_full_document
VOTU API SEP22 V3 1 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Votubia 2 mg Votubia 3 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Votubia 2 mg dispersible tablets Each dispersible tablet contains 2 mg everolimus. _Excipient with known effect _ Each dispersible tablet contains 1.96 mg lactose monohydrate. Votubia 3 mg dispersible tablets Each dispersible tablet contains 3 mg everolimus. _Excipient with known effect _ Each dispersible tablet contains 2.94 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersible tablet. Votubia 2 mg dispersible tablets White to slightly yellowish, round, flat, with beveled edges, unscored tablet, with smooth surface, debossed with “D2” on one side and “NVR” on the other side Votubia 3 mg dispersible tablets White to slightly yellowish, round, flat, with beveled edges, unscored tablet, with smooth surface, debossed with“D3” on one side and “NVR” on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Votubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory epileptic seizures are associated with tuberous sclerosis complex (TSC) VOTU API SEP22 V3 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage/Administration Treatment with Votubia should be initiated by a physician experienced in therapeutic drug monitoring and the treatment of patients with tuberous sclerosis complex (TSC). Votubia should be taken orally once daily at the same time every day, either consistently with or consistently without food. The patient should not make up for a missed dose, but should take the next prescribed dose as usual. Treatment should continue as long as a clinical benefit is observed or until unacceptable toxicity occurs.Votubia dispersible tablets are recommended only for the treatment of TSC patients with refractory epileptic seizures who are undergoing therapeutic drug monitoring. Votubia dispersible tablets disintegrate quickly in water, forming a suspension that read_full_document