Land: Israel
Språk: engelsk
Kilde: Ministry of Health
SODIUM IODIDE (131 I)
ELDAN ELECTRONIC INSTRUMENTS CO LTD, ISRAEL
V09FX03
HARD CAPSULE
SODIUM IODIDE (131 I) 37 - 5550 MBQ
PER OS
Required
GE HEALTHCARE BUCHLER GmbH & Co. KG
SODIUM IODIDE (131I)
SODIUM IODIDE (131I)
Theracap 131 is a radioiodine thyroid therapy indicated for:1.Treatment of Grave's disease, toxic multinodular goitre or autonomous nodules.2.Treatmernt of papilary and follicular thyroid carcinoma including metastastic desease.
2015-09-30
.201 6 0 8 THERACAP 131 , HARD CAPSULES פאקארת 131 , תולוספק תושק ,ה/דבכנ ת/חקור ,ה/אפור ולעה ן כדוע אפורל ן ינויב 2018 . .הרמחה םניאש םיפסונ םייוניש ןולעב .הרמחה םיווהמה םייונישה םיניוצמ וז העדוהב .הצוח וקב ןמוסמ רסוהש טסקט ,יתחת וקב ןמוסמ ףסוותהש טסקט :ליעפה רמוחה I) 131 Sodium Iodide ( ןלהל חסונ היוותהה :רישכתל רשואמה Theracap 131 is a radioiodine thyroid therapy indicated for: 1. Treatment of Grave's disease, toxic multinodular goitre or autonomous nodules. 2. Treatmernt of papilary and follicular thyroid carcinoma including metastastic disease. ושענ אפורל ןולעב םיירקיעה םינוכדעה :םיאבה םיפיעסב 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE ]...[ Hyponatraemia: Serious manifestations of hyponatraemia have been reported after sodium iodide [131I] therapy in elderly patients who have undergone total thyroidectomy. Risk factors include older age, female sex, use of thiazide diuretics and hyponatraemia at the start of sodium iodide [131I] therapy. Regular serum electrolytes measurements shall be considered for these patients. ]...[ תואירבה דרשמ רתאבש תופורתה רגאמל ותאלעה ךרוצל תואירבה דרשמל חלשנ אפורל ןולעה . לבקל ןתינ ולע ן הז ספדומ די לע י הינפ הרישי :םושירה לעבל ,מ''עב ינורטקלא דויצ ןדלא 'חר חולישה 6 , .ד.ת 7641 הווקת חתפ , 4917001 לט , ןופ : 03-9371111 . ,הכרבב ךלוו זוע הנוממ חקור מ''עב ינורטקלא דויצ ןדלא Les hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT THERACAP 131 TM 37 MBq-5.55 GBq capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION THERACAP is presented as a single yellow capsule containing sodium iodide ( 131 l) in the following dosage range; 37-740 MBq in 37 MBq steps, 50 – 1000 MBq in 50 MBq steps, 0.925-5.55 GBq in 185 MBq steps and 1000 – 5500 MBq in 100 MBq steps at the activity reference date. Each capsule contains a maximum of 20 µg of sodium iodide. Iodine-131 is produced by fission of uranium-235 or by neutron bombardment of stable tellurium in a nuclear reactor. Iodine-131 has a half-life of 8.02 days. It decays by emission of gamma radiations of 365 keV (81.7%), 637 keV (7.2%) and 284 keV (6.1%) and beta radiations of maximal energy of 606 keV to stable Xenon-131. Excipient(s) with known effect One hard capsule contains not more than 50 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Yellow gelatin capsule. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Radioiodine thyroid therapy is indicated for: • Treat et of Graes’ disease, toi ulti odular goitre or autooous odules. • Treatment of papillary and follicular thyroid carcinoma including metastatic disease. Sodium iodide ( 131 l) therapy is often combined with surgical intervention and with antithyroid medicinal products. 4.2 Posology and method of administration The activity administered is a matter for clinical judgement. The therapeutic effect is only achieved after several months. • For the treatment of hyperthyroidism The activity administered is usually in the range of 200-800 MBq but repeated treatment may be necessary. The dose required depends on the diagnosis, the size of the gland, thyroid uptake and iodine clearance. Patients should be rendered euthyroid medically whenever possible before giving radioiodine treatment for hyperthyroidism. • For thyroid ablation and treatment of metastases The administered activities following total or sub total thyroidectomy to ablate remain Les hele dokumentet